Physical ActivityNCT05887401
Physical Activity and Healthy Eating Among Young Adult Cancer Survivors
A study testing Core Intervention, Simplified Dietary Monitoring (Green) and Simplified Dietary Monitoring (Red) in people with Physical Activity and Neoplasms, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
The purpose of this pilot randomized factorial trial is to test the feasibility, acceptability, and effects of a theory-based mobile physical activity and nutrition intervention designed specifically for young adult cancer survivors to increase physical activity and diet quality. Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- Physical Activity, Neoplasms, Cancer
- What is being tested?
- Core Intervention, Simplified Dietary Monitoring (Green) and Simplified Dietary Monitoring (Red)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2023to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Current age 18-39 years at the time of consent
- Diagnosed with invasive cancer malignancy between the ages of 15-39 years
- Diagnosed with invasive malignancy in the last 10 years of diagnosis, and with no evidence of progressive disease or second primary cancers
- Completed active cancer directed therapy (cytotoxic chemotherapy, radiation therapy and/or definitive surgical intervention), except may be receiving "maintenance" therapy to prevent recurrences
- No pre-existing medical conditions(s) that preclude adherence to an unsupervised exercise program including cardiovascular disease, congestive heart failure, pulmonary conditions, renal disease, and severe orthopedic conditions
- Not currently meeting guideline recommendations of 150 minutes/week moderate to vigorous physical activity (self-report) and guideline recommendations for fruit and vegetable consumption (self-report)
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- Have the ability to read, write and speak English
- Have access to the Internet on at least a weekly basis
- Possession and usage of an Internet e-mail address or willingness to sign up for a free email account (e.g., gmail)
- Have smartphone with internet access and text messaging plan
- Be willing to be randomized to any condition
Who cannot join
- History of heart attack or stroke within past 6 months
- Untreated hypertension, hyperlipidemia, or diabetes, unless permission is provided by their health care provider
- Health problems which preclude ability to walk for physical activity
- Report a diagnosis of psychiatric diseases (schizophrenia, bipolar disorder, depression leading to hospitalization in the past year), drug or alcohol dependency
- Report a past diagnosis of or treatment for a Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) eating disorder (anorexia nervosa or bulimia nervosa)
- Plans for major surgery (e.g., breast reconstruction) during the study time frame
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- Current participation in another physical activity or weight control program
- Currently using prescription weight loss medications
- Currently pregnant, pregnant within the past 6 months, or planning to become pregnant within the next 6 months
- Currently exercising > 150 minutes/week of moderate-to-vigorous intensity physical activity
- Currently consuming > 5 servings of fruits and vegetables/day.
Trial locations and contacts
1 site in 1 country.
United States1 site
Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27514
About this study
Official title: A Pilot Randomized Factorial Trial to Promote Physical Activity and Healthy Eating Among Young Adult Cancer Survivors
The purpose of this pilot randomized factorial trial is to test the feasibility, acceptability, and effects of a theory-based mobile physical activity and nutrition intervention designed specifically for young adult cancer survivors to increase physical activity and diet quality.
Read the detailed description
There are around 1 million young adult cancer survivors in the United States. Young adult cancer survivors are an underserved and vulnerable subgroup of survivors that experience increased risk for chronic health conditions like cardiovascular disease, metabolic syndrome, secondary cancers, premature aging, and premature death. Modifiable lifestyle factors contribute to and compound risks for late and long-term health effects from cancer and its treatment, making them high-impact targets for behavioral interventions. International consensus guidelines recommend cancer survivors of all ages be physically active, consume a healthy diet, and achieve and maintain a healthy weight. Fewer than half of young adult cancer survivors meet guideline recommendations for vegetable intake, physical activity and the majority self-report having an overweight/obese BMI. To date, there are few physical activity interventions, and no nutritional interventions designed specifically for young adult cancer survivors. Digital behavior change interventions have emerged as feasible and efficacious approaches to reach and address unmet needs among young adult cancer survivors as they overcome barriers of time, flexibility, affordability, and access. Reaching these populations has been facilitated by digital tools like wearable devices that enable real-time data capture to guide the provision of individualized feedback and tailored goal setting based on personal progress. This pilot trial will use the Multiphase Optimization Strategy (MOST), an engineering-inspired framework, and a highly efficient experimental design to evaluate the feasibility of 4 intervention components to improve physical activity and nutrition behaviors among young adult cancer survivors. Young adult cancer survivors (n=80), diagnosed between ages 18-39, will be recruited to receive a core 3-month digital physical activity and nutrition intervention that includes evidence-based lessons and behavioral skills training with an emphasis on adherence to American Cancer Society (ACS) guidelines for cancer survivors and self-monitoring of physical activity and dietary behaviors. Additionally, participants will be randomized to four intervention components--each with two levels-- including: 1) simplified dietary tracking (daily tracking of green (low-calorie, high nutrients) vs. red (high-calorie, high-fat, low nutrients) foods), 2) dietary goals using simplified approach (daily goals vs. no goals), 3) supportive text messages (yes vs. no), 4) lesson delivery (all provided once vs. weekly). Assessments of outcomes will be conducted at baseline, 6 weeks, and 3 months to accomplish the following specific aims: 1) Evaluate the feasibility and acceptability the intervention at 3 months; 2) Evaluate intervention effects on change in physical activity and diet quality; 3) Evaluate intervention effects on secondary outcomes at 6 weeks and 3 months; and 4) Explore whether theoretical constructs (perceived competence, self-regulation, self-efficacy, and perceived relatedness) mediated the effects of the intervention on change in health behaviors at 3 months.
- Conditions
- Physical Activity, Neoplasms, Cancer
- Being tested
- Core Intervention, Simplified Dietary Monitoring (Green), Simplified Dietary Monitoring (Red), Nutrition Goals (Yes), Nutrition Goals (No)
- Medical subject headings
- Motor Activity, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core InterventionBehavioural
The core intervention will include behavioral lessons, activity tracker, weekly adaptive physical activity goals, weekly tailored feedback summary.
Simplified Dietary Monitoring (Green)Behavioural
Simplified diet monitoring using smartphone tracking of green foods using a traffic light approach.
Simplified Dietary Monitoring (Red)Behavioural
Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.
Nutrition Goals (Yes)Behavioural
Participant will be assigned a personalized weekly nutrition goal related to nutrition monitoring condition.
Nutrition Goals (No)Behavioural
Participant will not be assigned a personalized weekly nutrition goal.
Supportive Text Messages (Yes)Behavioural
Participant will receive up to 5 supportive text-messages from the study staff per week.
Supportive Text Messages (No)Behavioural
Participant will not receive supportive text-messages.
Lesson Delivery (Once)Behavioural
All behavioral lessons will be made available to participant simultaneously.
Lesson Delivery (Weekly)Behavioural
A new behavioral lesson will be made available to participant weekly throughout the 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Green Foods Monitoring, Daily Nutrition Goals, Supportive Text Messages, All Lessons Once | Experimental | Core + Green Foods Monitoring + Nutrition Goals + Supportive Text Messages + Lessons Weekly Receives: Behavioral: Core Intervention; Behavioral: Simplified Dietary Monitoring (Green); Behavioral: Nutrition Goals (Yes); Behavioral: Supportive Text Messages (Yes); Behavioral: Lesson Delivery (Once) |
| Green Foods Monitoring, Daily Nutrition Goals, Supportive Text Messages, Weekly Lessons | Experimental | Core + Green Foods Monitoring + Nutrition Goals + Supportive Text Messages + Weekly Lessons Receives: Behavioral: Core Intervention; Behavioral: Simplified Dietary Monitoring (Green); Behavioral: Nutrition Goals (Yes); Behavioral: Supportive Text Messages (Yes); Behavioral: Lesson Delivery (Weekly) |
| Green Foods Monitoring, Daily Nutrition Goals, No Text Messages, All Lessons Once | Experimental | Core + Green Foods Monitoring + Nutrition Goals + No Supportive Text Messages + All Lessons Receives: Behavioral: Core Intervention; Behavioral: Simplified Dietary Monitoring (Green); Behavioral: Nutrition Goals (Yes); Behavioral: Supportive Text Messages (No); Behavioral: Lesson Delivery (Once) |
| Green Foods Monitoring, Daily Nutrition Goals, No Supportive Text Messages, Weekly Lessons | Experimental | Core + Green Foods Monitoring + Nutrition Goals + No Supportive Text Messages + Weekly Lessons Receives: Behavioral: Core Intervention; Behavioral: Simplified Dietary Monitoring (Green); Behavioral: Nutrition Goals (Yes); Behavioral: Supportive Text Messages (No); Behavioral: Lesson Delivery (Weekly) |
| Green Foods Monitoring, No Nutrition Goals, Supportive Text Messages, All Lessons Once | Experimental | Core + Green Foods Monitoring + No Nutrition Goals + Supportive Text Messages + All Lessons Receives: Behavioral: Core Intervention; Behavioral: Simplified Dietary Monitoring (Green); Behavioral: Nutrition Goals (No); Behavioral: Supportive Text Messages (Yes); Behavioral: Lesson Delivery (Once) |
| Green Foods Monitoring, No Nutrition Goals, Supportive Text Messages, Weekly Lessons | Experimental | Core + Green Foods Monitoring + No Nutrition Goals + Supportive Text Messages + Weekly Lessons Receives: Behavioral: Core Intervention; Behavioral: Simplified Dietary Monitoring (Green); Behavioral: Nutrition Goals (No); Behavioral: Supportive Text Messages (Yes); Behavioral: Lesson Delivery (Weekly) |
| Green Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, All Lessons Once | Experimental | Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons Receives: Behavioral: Core Intervention; Behavioral: Simplified Dietary Monitoring (Green); Behavioral: Nutrition Goals (No); Behavioral: Supportive Text Messages (No); Behavioral: Lesson Delivery (Once) |
| Green Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, Weekly Lessons | Experimental | Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons Receives: Behavioral: Core Intervention; Behavioral: Simplified Dietary Monitoring (Green); Behavioral: Nutrition Goals (No); Behavioral: Supportive Text Messages (No); Behavioral: Lesson Delivery (Weekly) |
| Red Foods Monitoring, Nutrition Goals, Supportive Text Messages, All Lessons Once | Experimental | Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + All Lessons Receives: Behavioral: Core Intervention; Behavioral: Simplified Dietary Monitoring (Red); Behavioral: Nutrition Goals (Yes); Behavioral: Supportive Text Messages (Yes); Behavioral: Lesson Delivery (Once) |
| Red Foods Monitoring, Nutrition Goals, Supportive Text Messages, Weekly Lessons | Experimental | Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + Weekly Lessons Receives: Behavioral: Core Intervention; Behavioral: Simplified Dietary Monitoring (Red); Behavioral: Nutrition Goals (Yes); Behavioral: Supportive Text Messages (Yes); Behavioral: Lesson Delivery (Weekly) |
| Red Foods Monitoring, Nutrition Goals, No Supportive Text Messages, All Lessons Once | Experimental | Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + All Lessons Receives: Behavioral: Core Intervention; Behavioral: Simplified Dietary Monitoring (Red); Behavioral: Nutrition Goals (Yes); Behavioral: Supportive Text Messages (No); Behavioral: Lesson Delivery (Once) |
| Red Foods Monitoring, Nutrition Goals, No Supportive Text Messages, Weekly Lessons | Experimental | Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + Weekly Lessons Receives: Behavioral: Core Intervention; Behavioral: Simplified Dietary Monitoring (Red); Behavioral: Nutrition Goals (Yes); Behavioral: Supportive Text Messages (No); Behavioral: Lesson Delivery (Weekly) |
| Red Foods Monitoring, No Nutrition Goals, Supportive Text Messages, All Lessons Once | Experimental | Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + All Lessons Receives: Behavioral: Core Intervention; Behavioral: Simplified Dietary Monitoring (Red); Behavioral: Nutrition Goals (No); Behavioral: Supportive Text Messages (Yes); Behavioral: Lesson Delivery (Once) |
| Red Foods Monitoring, No Nutrition Goals, Supportive Text Messages, Weekly Lessons | Experimental | Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + Weekly Lessons Receives: Behavioral: Core Intervention; Behavioral: Simplified Dietary Monitoring (Red); Behavioral: Nutrition Goals (No); Behavioral: Supportive Text Messages (Yes); Behavioral: Lesson Delivery (Weekly) |
| Red Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, All Lessons Once | Experimental | Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons Receives: Behavioral: Core Intervention; Behavioral: Simplified Dietary Monitoring (Red); Behavioral: Nutrition Goals (No); Behavioral: Supportive Text Messages (No); Behavioral: Lesson Delivery (Once) |
| Red Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, Weekly Lessons | Experimental | Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons Receives: Behavioral: Core Intervention; Behavioral: Simplified Dietary Monitoring (Red); Behavioral: Nutrition Goals (No); Behavioral: Supportive Text Messages (No); Behavioral: Lesson Delivery (Weekly) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accrual Rate
Number of participants who agreed to participate divided by the number of months of recruitment.
Measured: End of study enrollment period (7 months).
Participation Rate
Percentage of consented participants who were randomized.
Measured: End of study enrollment period (7 months).
Retention Rate
Number of intervention participants who completed 3-month measures divided by the number randomized to intervention arms.
Measured: 3 months
Secondary outcomes (14)
Acceptability: How Satisfied Are You Overall With the Program You Received?
1-item measure; a benchmark of 80% of participants answering "somewhat" or "very" satisfied would indicate acceptability
Measured: 3 months
Adherence to Physical Activity Monitoring.
Number of days physical activity tracked, as measured by Fitbit.
Measured: Through study completion, 3 months.
Adherence to Diet Self-monitoring
Number of days of complete dietary tracking.
Measured: Through study completion, 3 months.
Moderate-to-vigorous Physical Activity (Objective)
Estimated mean change in MVPA from baseline to 3 months for each of the two levels of each component obtained from intent-to-treat (ITT) linear mixed models of analysis of variance.
Measured: Baseline, 3 months.
Moderate-to-vigorous Physical Activity (Self-report)
Change in physical activity from baseline to 3 months as measured using the Paffenbarger Physical Activity Questionnaire (PPAQ). The PPAQ assesses the amount of planned and lifestyle associated physical activity performed during a typical week. The PPAQ consists of three components: (1) stair climbing, (2) walking, and (3) sports and recreation. Participants report the frequency and duration of physical activity in the past week. PA Activities were classified as light, moderate, and vigorous based on their metabolic equivalent (MET) value and commonly used cut points. Moderate and vigorous activities were combined for self-reported minutes per week of MVPA. Range is 0 - no theoretical maximum.
Measured: Baseline, 3 months.
Dietary Intake: Healthy Eating Index (HEI)
Dietary intake will be defined as the change in HEI score as measured by the NCI's Automated Self-Administered 24-hour (ASA 24-hour) dietary recalls from baseline to 3 months.The HEI consists of 13 component scores, including: total fruit, whole fruit, total protein foods, total vegetables, greens and beans, whole grains, dairy, seafood and plant proteins, fatty acids, sodium, refined grains, added sugars, and saturated fats. The summation of the 13 component scores ranges from 0 to 100, with higher scores indicating closer compliance with the Dietary Guidelines for Americans. Estimated mean change in HEI from baseline to 3 months for each of the two levels of each component obtained from intent-to-treat (ITT) linear mixed models of analysis of variance.
Measured: Baseline, 3 months
Weight (kg)
Estimated mean weight change in kg from baseline to 3 months. More negative values of weight change indicate greater weight loss (3-month weight - baseline weight).
Measured: Baseline, 3 months
Fried Physical Frailty : FRAIL Index
The FRAIL Questionnaire includes five components that assess: 1) self-reported fatigue (PROMIS Fatigue Short form), 2) weight loss, 3) comorbidities (11 items from University of North Carolina Health Registry Comorbidity Assessment), 4) difficulty with ambulation (1 item from PROMIS Physical Function Short Form), and 5) ability to overcome resistance (1 item from PROMIS Physical Function)). The number of positive responses for these components is summed to create the FRAIL index (range 0-5) and characterized as "Frailty Status"; 0-1: robust, 2: prefrail, and 3+: frail. Changes in Frailty Status from baseline to 3 months will be assessed.
Measured: Baseline, 3 Months
Health-related Quality of Life: AYA PROMIS PRO Core Battery
Changes in health-related quality of life from baseline to 3 months as measured using the Adolescent and Young Adult (AYA) PROMIS PRO Core Battery. These measures assess relevant HRQoL domains for AYA cancer survivors that are most likely to be impacted during and after cancer treatment. The AYA PRO Core battery includes the following PROMIS short forms: depression, anxiety, fatigue, physical function, pain interference, emotional support, and cognitive function. For each measure, each question has five responses ranging in value from 1 to 5, which are summed to find the total raw score. Total raw scores are translated to a T-score, standardized with a population mean of 50 and a standard deviation of 10. A higher PROMIS T-score represents more of the concept being measured.
Measured: Baseline, 3 months
Health-related Quality of Life: AYA PROMIS PRO Core Battery (Pain Intensity)
Changes in health-related quality of life from baseline to 3 months as measured using the Adolescent and Young Adult (AYA) PROMIS PRO Core Battery. Pain intensity was assessed with the 1-tiem PROMIS v1.0 pain intensity 1a, "In the past 7 days, how would you rate your pain on average?" Scored 0-10 from no pain to the worst imaginable pain.
Measured: Baseline, 3 months
Competence for Exercise and Nutrition
Changes in perceived competence from baseline to 3 months as measured using the Perceived Competence Scale. The Scale measures perceived competence for diet (4 items) and physical activity (4 items). Items are rated on a 7-point Likert scale (1 = not at all true, 7 = very true), and include items such as "I feel confident in my ability to maintain a healthy diet." Scores are summed for the items in the subscale (diet and physical activity) and the range for each subscale is 4 - 28. Greater values indicate higher levels of perceived competence for engaging in positive diet and physical activity behaviors. Scores are summed for the items in each subscale separately (diet and physical activity). Outcomes are change in perceived competence for diet and change in perceived competence.
Measured: Baseline, 3 months
Self-efficacy for Exercise and Nutrition
Changes in self-efficacy from baseline to 3 months as measured using the Nutrition and Physical Activity Self-Efficacy Scale, a 10-items measured on a 4-point Likert scale that assesses an individual's confidence (where where 1 is 'very uncertain' to 4 'very certain') with in their ability to eat healthy foods (5 items) and exercise (5 items) in the presence of barriers. Self-efficacy for each behavior is calculated as the sum of the 5 Likert-type responses with a range of 5-20 for each subscale. Higher values indicate higher levels of self-efficacy for the behavior. Outcomes are changes in self-eficacy for exercise and self-efficacy for nutrition from baseline to 3 months.
Measured: Baseline, 3 months
Self-Regulation for Exercise and Nutrition
Changes in self-regulation from baseline to 3 months as measured using the Treatment Self-Regulation Questionnaire (TSRQ). The TSRQ assesses autonomous and controlled motivation for making changes in diet (15 items) and physical activity (15 items). Ratings are on a 7-point Likert scale indicating agreement with statements regarding motivation for behavior change. Examples item: "Because I feel that I want to take responsibility for my own health" answered on a scale of 1 (not at all true) to 7 (very true)." Calculating the scores for the sub-scales will consist of averaging the items on that subscale. Responses to the items within the subscale are averaged with the range of scores being 1 to 7. Higher values on each subscale indicate greater levels of that type of motivation. Outcomes are changes in autonomous and controlled motivation for exercise and diet at 3 months.
Measured: Baseline, 3 months
Autonomy Support
Changes in perceived autonomy support from baseline to 3 months as measured using the Virtual Care Climate Questionnaire (VCCQ) a 15-item measure of perceived support for autonomy provided by the study team in a virtual care setting. Ratings are on a 7-point Likert scale from 1 (strongly disagree) to 7 (strongly agree). Responses are averaged with a range of 1 to 7. Higher scores indicate a higher level of perceived autonomy support in a virtual setting.
Measured: Baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start2 Oct 2023
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- This study uses a full factorial experimental design testing the efficacy of four intervention components, each with two levels
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Erin M Coffman, MA, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05887401
- Sponsor's protocol ID
- LCCC2233
- Other IDs
- T32CA057726
- Status last verified
- Nov 2025
- First submitted
- 24 May 2023
- Last updated
- 24 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Factorial Trial to Promote Physical Activity and Healthy Eating Among Young Adult Cancer Survivors
- ClinicalTrials.gov ID
- NCT05887401
- Acronym / sponsor ID
- LCCC2233
- Conditions
- Physical Activity, Neoplasms, Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 2 Jun 2023 (actual)
- Results
- Posted 24 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this pilot randomized factorial trial is to test the feasibility, acceptability, and effects of a theory-based mobile physical activity and nutrition intervention designed specifically for young adult cancer survivors to increase physical activity and diet quality.
Detailed description
There are around 1 million young adult cancer survivors in the United States. Young adult cancer survivors are an underserved and vulnerable subgroup of survivors that experience increased risk for chronic health conditions like cardiovascular disease, metabolic syndrome, secondary cancers, premature aging, and premature death. Modifiable lifestyle factors contribute to and compound risks for late and long-term health effects from cancer and its treatment, making them high-impact targets for behavioral interventions. International consensus guidelines recommend cancer survivors of all ages be physically active, consume a healthy diet, and achieve and maintain a healthy weight. Fewer than half of young adult cancer survivors meet guideline recommendations for vegetable intake, physical activity and the majority self-report having an overweight/obese BMI. To date, there are few physical activity interventions, and no nutritional interventions designed specifically for young adult cancer survivors. Digital behavior change interventions have emerged as feasible and efficacious approaches to reach and address unmet needs among young adult cancer survivors as they overcome barriers of time, flexibility, affordability, and access. Reaching these populations has been facilitated by digital tools like wearable devices that enable real-time data capture to guide the provision of individualized feedback and tailored goal setting based on personal progress. This pilot trial will use the Multiphase Optimization Strategy (MOST), an engineering-inspired framework, and a highly efficient experimental design to evaluate the feasibility of 4 intervention components to improve physical activity and nutrition behaviors among young adult cancer survivors. Young adult cancer survivors (n=80), diagnosed between ages 18-39, will be recruited to receive a core 3-month digital physical activity and nutrition intervention that includes evidence-based lessons and behavioral skills training with an emphasis on adherence to American Cancer Society (ACS) guidelines for cancer survivors and self-monitoring of physical activity and dietary behaviors. Additionally, participants will be randomized to four intervention components--each with two levels-- including: 1) simplified dietary tracking (daily tracking of green (low-calorie, high nutrients) vs. red (high-calorie, high-fat, low nutrients) foods), 2) dietary goals using simplified approach (daily goals vs. no goals), 3) supportive text messages (yes vs. no), 4) lesson delivery (all provided once vs. weekly). Assessments of outcomes will be conducted at baseline, 6 weeks, and 3 months to accomplish the following specific aims: 1) Evaluate the feasibility and acceptability the intervention at 3 months; 2) Evaluate intervention effects on change in physical activity and diet quality; 3) Evaluate intervention effects on secondary outcomes at 6 weeks and 3 months; and 4) Explore whether theoretical constructs (perceived competence, self-regulation, self-efficacy, and perceived relatedness) mediated the effects of the intervention on change in health behaviors at 3 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 16
- Model description
- This study uses a full factorial experimental design testing the efficacy of four intervention components, each with two levels
| Arm | Type | Receives |
|---|---|---|
| Green Foods Monitoring, Daily Nutrition Goals, Supportive Text Messages, All Lessons Once | Experimental | Behavioral: Core Intervention, Behavioral: Simplified Dietary Monitoring (Green), Behavioral: Nutrition Goals (Yes), Behavioral: Supportive Text Messages (Yes), Behavioral: Lesson Delivery (Once)Core + Green Foods Monitoring + Nutrition Goals + Supportive Text Messages + Lessons Weekly |
| Green Foods Monitoring, Daily Nutrition Goals, Supportive Text Messages, Weekly Lessons | Experimental | Behavioral: Core Intervention, Behavioral: Simplified Dietary Monitoring (Green), Behavioral: Nutrition Goals (Yes), Behavioral: Supportive Text Messages (Yes), Behavioral: Lesson Delivery (Weekly)Core + Green Foods Monitoring + Nutrition Goals + Supportive Text Messages + Weekly Lessons |
| Green Foods Monitoring, Daily Nutrition Goals, No Text Messages, All Lessons Once | Experimental | Behavioral: Core Intervention, Behavioral: Simplified Dietary Monitoring (Green), Behavioral: Nutrition Goals (Yes), Behavioral: Supportive Text Messages (No), Behavioral: Lesson Delivery (Once)Core + Green Foods Monitoring + Nutrition Goals + No Supportive Text Messages + All Lessons |
| Green Foods Monitoring, Daily Nutrition Goals, No Supportive Text Messages, Weekly Lessons | Experimental | Behavioral: Core Intervention, Behavioral: Simplified Dietary Monitoring (Green), Behavioral: Nutrition Goals (Yes), Behavioral: Supportive Text Messages (No), Behavioral: Lesson Delivery (Weekly)Core + Green Foods Monitoring + Nutrition Goals + No Supportive Text Messages + Weekly Lessons |
| Green Foods Monitoring, No Nutrition Goals, Supportive Text Messages, All Lessons Once | Experimental | Behavioral: Core Intervention, Behavioral: Simplified Dietary Monitoring (Green), Behavioral: Nutrition Goals (No), Behavioral: Supportive Text Messages (Yes), Behavioral: Lesson Delivery (Once)Core + Green Foods Monitoring + No Nutrition Goals + Supportive Text Messages + All Lessons |
| Green Foods Monitoring, No Nutrition Goals, Supportive Text Messages, Weekly Lessons | Experimental | Behavioral: Core Intervention, Behavioral: Simplified Dietary Monitoring (Green), Behavioral: Nutrition Goals (No), Behavioral: Supportive Text Messages (Yes), Behavioral: Lesson Delivery (Weekly)Core + Green Foods Monitoring + No Nutrition Goals + Supportive Text Messages + Weekly Lessons |
| Green Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, All Lessons Once | Experimental | Behavioral: Core Intervention, Behavioral: Simplified Dietary Monitoring (Green), Behavioral: Nutrition Goals (No), Behavioral: Supportive Text Messages (No), Behavioral: Lesson Delivery (Once)Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons |
| Green Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, Weekly Lessons | Experimental | Behavioral: Core Intervention, Behavioral: Simplified Dietary Monitoring (Green), Behavioral: Nutrition Goals (No), Behavioral: Supportive Text Messages (No), Behavioral: Lesson Delivery (Weekly)Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons |
| Red Foods Monitoring, Nutrition Goals, Supportive Text Messages, All Lessons Once | Experimental | Behavioral: Core Intervention, Behavioral: Simplified Dietary Monitoring (Red), Behavioral: Nutrition Goals (Yes), Behavioral: Supportive Text Messages (Yes), Behavioral: Lesson Delivery (Once)Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + All Lessons |
| Red Foods Monitoring, Nutrition Goals, Supportive Text Messages, Weekly Lessons | Experimental | Behavioral: Core Intervention, Behavioral: Simplified Dietary Monitoring (Red), Behavioral: Nutrition Goals (Yes), Behavioral: Supportive Text Messages (Yes), Behavioral: Lesson Delivery (Weekly)Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + Weekly Lessons |
| Red Foods Monitoring, Nutrition Goals, No Supportive Text Messages, All Lessons Once | Experimental | Behavioral: Core Intervention, Behavioral: Simplified Dietary Monitoring (Red), Behavioral: Nutrition Goals (Yes), Behavioral: Supportive Text Messages (No), Behavioral: Lesson Delivery (Once)Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + All Lessons |
| Red Foods Monitoring, Nutrition Goals, No Supportive Text Messages, Weekly Lessons | Experimental | Behavioral: Core Intervention, Behavioral: Simplified Dietary Monitoring (Red), Behavioral: Nutrition Goals (Yes), Behavioral: Supportive Text Messages (No), Behavioral: Lesson Delivery (Weekly)Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + Weekly Lessons |
| Red Foods Monitoring, No Nutrition Goals, Supportive Text Messages, All Lessons Once | Experimental | Behavioral: Core Intervention, Behavioral: Simplified Dietary Monitoring (Red), Behavioral: Nutrition Goals (No), Behavioral: Supportive Text Messages (Yes), Behavioral: Lesson Delivery (Once)Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + All Lessons |
| Red Foods Monitoring, No Nutrition Goals, Supportive Text Messages, Weekly Lessons | Experimental | Behavioral: Core Intervention, Behavioral: Simplified Dietary Monitoring (Red), Behavioral: Nutrition Goals (No), Behavioral: Supportive Text Messages (Yes), Behavioral: Lesson Delivery (Weekly)Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + Weekly Lessons |
| Red Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, All Lessons Once | Experimental | Behavioral: Core Intervention, Behavioral: Simplified Dietary Monitoring (Red), Behavioral: Nutrition Goals (No), Behavioral: Supportive Text Messages (No), Behavioral: Lesson Delivery (Once)Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons |
| Red Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, Weekly Lessons | Experimental | Behavioral: Core Intervention, Behavioral: Simplified Dietary Monitoring (Red), Behavioral: Nutrition Goals (No), Behavioral: Supportive Text Messages (No), Behavioral: Lesson Delivery (Weekly)Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Current age 18-39 years at the time of consent
- Diagnosed with invasive cancer malignancy between the ages of 15-39 years
- Diagnosed with invasive malignancy in the last 10 years of diagnosis, and with no evidence of progressive disease or second primary cancers
- Completed active cancer directed therapy (cytotoxic chemotherapy, radiation therapy and/or definitive surgical intervention), except may be receiving "maintenance" therapy to prevent recurrences
- No pre-existing medical conditions(s) that preclude adherence to an unsupervised exercise program including cardiovascular disease, congestive heart failure, pulmonary conditions, renal disease, and severe orthopedic conditions
Key exclusion criteria (11 listed)
- History of heart attack or stroke within past 6 months
- Untreated hypertension, hyperlipidemia, or diabetes, unless permission is provided by their health care provider
- Health problems which preclude ability to walk for physical activity
- Report a diagnosis of psychiatric diseases (schizophrenia, bipolar disorder, depression leading to hospitalization in the past year), drug or alcohol dependency
- Report a past diagnosis of or treatment for a Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) eating disorder (anorexia nervosa or bulimia nervosa)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Core InterventionThe core intervention will include behavioral lessons, activity tracker, weekly adaptive physical activity goals, weekly tailored feedback summary. | Behavioural | Green Foods Monitoring, Daily Nutrition Goals, No Supportive Text Messages, Weekly Lessons, Green Foods Monitoring, Daily Nutrition Goals, No Text Messages, All Lessons Once, Green Foods Monitoring, Daily Nutrition Goals, Supportive Text Messages, All Lessons Once, Green Foods Monitoring, Daily Nutrition Goals, Supportive Text Messages, Weekly Lessons, Green Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, All Lessons Once, Green Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, Weekly Lessons, Green Foods Monitoring, No Nutrition Goals, Supportive Text Messages, All Lessons Once, Green Foods Monitoring, No Nutrition Goals, Supportive Text Messages, Weekly Lessons, Red Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, All Lessons Once, Red Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, Weekly Lessons, Red Foods Monitoring, No Nutrition Goals, Supportive Text Messages, All Lessons Once, Red Foods Monitoring, No Nutrition Goals, Supportive Text Messages, Weekly Lessons, Red Foods Monitoring, Nutrition Goals, No Supportive Text Messages, All Lessons Once, Red Foods Monitoring, Nutrition Goals, No Supportive Text Messages, Weekly Lessons, Red Foods Monitoring, Nutrition Goals, Supportive Text Messages, All Lessons Once, Red Foods Monitoring, Nutrition Goals, Supportive Text Messages, Weekly Lessons |
| Simplified Dietary Monitoring (Green)Simplified diet monitoring using smartphone tracking of green foods using a traffic light approach. | Behavioural | Green Foods Monitoring, Daily Nutrition Goals, No Supportive Text Messages, Weekly Lessons, Green Foods Monitoring, Daily Nutrition Goals, No Text Messages, All Lessons Once, Green Foods Monitoring, Daily Nutrition Goals, Supportive Text Messages, All Lessons Once, Green Foods Monitoring, Daily Nutrition Goals, Supportive Text Messages, Weekly Lessons, Green Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, All Lessons Once, Green Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, Weekly Lessons, Green Foods Monitoring, No Nutrition Goals, Supportive Text Messages, All Lessons Once, Green Foods Monitoring, No Nutrition Goals, Supportive Text Messages, Weekly Lessons |
| Simplified Dietary Monitoring (Red)Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach. | Behavioural | Red Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, All Lessons Once, Red Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, Weekly Lessons, Red Foods Monitoring, No Nutrition Goals, Supportive Text Messages, All Lessons Once, Red Foods Monitoring, No Nutrition Goals, Supportive Text Messages, Weekly Lessons, Red Foods Monitoring, Nutrition Goals, No Supportive Text Messages, All Lessons Once, Red Foods Monitoring, Nutrition Goals, No Supportive Text Messages, Weekly Lessons, Red Foods Monitoring, Nutrition Goals, Supportive Text Messages, All Lessons Once, Red Foods Monitoring, Nutrition Goals, Supportive Text Messages, Weekly Lessons |
| Nutrition Goals (Yes)Participant will be assigned a personalized weekly nutrition goal related to nutrition monitoring condition. | Behavioural | Green Foods Monitoring, Daily Nutrition Goals, No Supportive Text Messages, Weekly Lessons, Green Foods Monitoring, Daily Nutrition Goals, No Text Messages, All Lessons Once, Green Foods Monitoring, Daily Nutrition Goals, Supportive Text Messages, All Lessons Once, Green Foods Monitoring, Daily Nutrition Goals, Supportive Text Messages, Weekly Lessons, Red Foods Monitoring, Nutrition Goals, No Supportive Text Messages, All Lessons Once, Red Foods Monitoring, Nutrition Goals, No Supportive Text Messages, Weekly Lessons, Red Foods Monitoring, Nutrition Goals, Supportive Text Messages, All Lessons Once, Red Foods Monitoring, Nutrition Goals, Supportive Text Messages, Weekly Lessons |
| Nutrition Goals (No)Participant will not be assigned a personalized weekly nutrition goal. | Behavioural | Green Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, All Lessons Once, Green Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, Weekly Lessons, Green Foods Monitoring, No Nutrition Goals, Supportive Text Messages, All Lessons Once, Green Foods Monitoring, No Nutrition Goals, Supportive Text Messages, Weekly Lessons, Red Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, All Lessons Once, Red Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, Weekly Lessons, Red Foods Monitoring, No Nutrition Goals, Supportive Text Messages, All Lessons Once, Red Foods Monitoring, No Nutrition Goals, Supportive Text Messages, Weekly Lessons |
| Supportive Text Messages (Yes)Participant will receive up to 5 supportive text-messages from the study staff per week. | Behavioural | Green Foods Monitoring, Daily Nutrition Goals, Supportive Text Messages, All Lessons Once, Green Foods Monitoring, Daily Nutrition Goals, Supportive Text Messages, Weekly Lessons, Green Foods Monitoring, No Nutrition Goals, Supportive Text Messages, All Lessons Once, Green Foods Monitoring, No Nutrition Goals, Supportive Text Messages, Weekly Lessons, Red Foods Monitoring, No Nutrition Goals, Supportive Text Messages, All Lessons Once, Red Foods Monitoring, No Nutrition Goals, Supportive Text Messages, Weekly Lessons, Red Foods Monitoring, Nutrition Goals, Supportive Text Messages, All Lessons Once, Red Foods Monitoring, Nutrition Goals, Supportive Text Messages, Weekly Lessons |
| Supportive Text Messages (No)Participant will not receive supportive text-messages. | Behavioural | Green Foods Monitoring, Daily Nutrition Goals, No Supportive Text Messages, Weekly Lessons, Green Foods Monitoring, Daily Nutrition Goals, No Text Messages, All Lessons Once, Green Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, All Lessons Once, Green Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, Weekly Lessons, Red Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, All Lessons Once, Red Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, Weekly Lessons, Red Foods Monitoring, Nutrition Goals, No Supportive Text Messages, All Lessons Once, Red Foods Monitoring, Nutrition Goals, No Supportive Text Messages, Weekly Lessons |
| Lesson Delivery (Once)All behavioral lessons will be made available to participant simultaneously. | Behavioural | Green Foods Monitoring, Daily Nutrition Goals, No Text Messages, All Lessons Once, Green Foods Monitoring, Daily Nutrition Goals, Supportive Text Messages, All Lessons Once, Green Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, All Lessons Once, Green Foods Monitoring, No Nutrition Goals, Supportive Text Messages, All Lessons Once, Red Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, All Lessons Once, Red Foods Monitoring, No Nutrition Goals, Supportive Text Messages, All Lessons Once, Red Foods Monitoring, Nutrition Goals, No Supportive Text Messages, All Lessons Once, Red Foods Monitoring, Nutrition Goals, Supportive Text Messages, All Lessons Once |
| Lesson Delivery (Weekly)A new behavioral lesson will be made available to participant weekly throughout the 12 weeks. | Behavioural | Green Foods Monitoring, Daily Nutrition Goals, No Supportive Text Messages, Weekly Lessons, Green Foods Monitoring, Daily Nutrition Goals, Supportive Text Messages, Weekly Lessons, Green Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, Weekly Lessons, Green Foods Monitoring, No Nutrition Goals, Supportive Text Messages, Weekly Lessons, Red Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, Weekly Lessons, Red Foods Monitoring, No Nutrition Goals, Supportive Text Messages, Weekly Lessons, Red Foods Monitoring, Nutrition Goals, No Supportive Text Messages, Weekly Lessons, Red Foods Monitoring, Nutrition Goals, Supportive Text Messages, Weekly Lessons |
Primary outcome
Accrual Rate
Time frame: End of study enrollment period (7 months).
Number of participants who agreed to participate divided by the number of months of recruitment.
Participation Rate
Time frame: End of study enrollment period (7 months).
Percentage of consented participants who were randomized.
Retention Rate
Time frame: 3 months
Number of intervention participants who completed 3-month measures divided by the number randomized to intervention arms.
14 secondary outcomes
Acceptability: How Satisfied Are You Overall With the Program You Received?
Time frame: 3 months
Adherence to Physical Activity Monitoring.
Time frame: Through study completion, 3 months.
Adherence to Diet Self-monitoring
Time frame: Through study completion, 3 months.
Moderate-to-vigorous Physical Activity (Objective)
Time frame: Baseline, 3 months.
Moderate-to-vigorous Physical Activity (Self-report)
Time frame: Baseline, 3 months.
Dietary Intake: Healthy Eating Index (HEI)
Time frame: Baseline, 3 months
Weight (kg)
Time frame: Baseline, 3 months
Fried Physical Frailty : FRAIL Index
Time frame: Baseline, 3 Months
Health-related Quality of Life: AYA PROMIS PRO Core Battery
Time frame: Baseline, 3 months
Health-related Quality of Life: AYA PROMIS PRO Core Battery (Pain Intensity)
Time frame: Baseline, 3 months
Competence for Exercise and Nutrition
Time frame: Baseline, 3 months
Self-efficacy for Exercise and Nutrition
Time frame: Baseline, 3 months
Self-Regulation for Exercise and Nutrition
Time frame: Baseline, 3 months
Autonomy Support
Time frame: Baseline, 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of North Carolina Lineberger Comprehensive Cancer Center Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erin M Coffman, MA principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Core Intervention, Simplified Dietary Monitoring (Green) and Simplified Dietary Monitoring (Red) in people with Physical Activity and Neoplasms, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accrual Rate (time frame: End of study enrollment period (7 months).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.