SurvivorshipHEALNCT06442397
Anti-Inflammatory Lifestyle Intervention for Emerging Adult Cancer Survivors
A study testing Anti-Inflammatory Lifestyle Intervention in people with Survivorship, run by Virginia Commonwealth University.
Trial summary
To test the feasibility and acceptability of AILI and associated research procedures among emerging adult cancer survivors (EACS, N=16) age 18-29. Read more about this study
- Who is it for?
- Ages 18 to 29 years
- Conditions the study is for
- Survivorship
- What is being tested?
- Anti-Inflammatory Lifestyle Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2024to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 29 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-29
- Cancer diagnosis of any type
- Body fat percentage >16.2% for women; >10.6% for men
Who cannot join
- Individuals receiving active chemotherapy/radiation or those having completed active chemotherapy/radiation within the past 6 months
- Individuals who are currently pregnant or lactating
- Current involvement in a weight loss program or current use of weight loss medication
- Individuals who report any other uncontrolled medical conditions that may pose a safety issue given the recommendations for the diet and unsupervised physical activity (e.g., uncontrolled hypertension)
- Individuals with rheumatologic and gastrointestinal conditions associated with severe systemic inflammation (e.g., rheumatoid arthritis, systemic lupus erythematosus, Crohn's disease)
- Individuals with medical conditions resulting in known perturbations in the hypothalamic-pituitary-adrenal axis (e.g., endogenous hypercortisolemia [Cushing's syndrome] or adrenal insufficiency)
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- Individuals who report a heart condition, chest pain during periods of activity or rest, or loss of consciousness as assessed by the Physical Activity Readiness Questionnaire (PAR-Q)
- Report of lifetime diagnosis of Anorexia Nervosa or Bulimia Nervosa, or any compensatory behaviors (vomiting, laxative abuse) within the previous 3 months
- Hospitalization for depression or other psychiatric disorder within the past 12 months
- Report of lifetime diagnosis of bipolar disorder or psychotic disorder
- Indication of current suicidal intent
- Inability to speak and read English
About this study
Official title: Feasibility and Acceptability of an Anti-Inflammatory Lifestyle Intervention for Emerging Adult Cancer Survivors
To test the feasibility and acceptability of AILI and associated research procedures among emerging adult cancer survivors (EACS, N=16) age 18-29.
Read the detailed description
This is a single-arm pilot trial designed to assess the feasibility and acceptability of an anti-inflammatory lifestyle intervention (AILI) for emerging adults (EA) adapted for emerging adult cancer survivors (EACS).
- Conditions
- Survivorship
- Being tested
- Anti-Inflammatory Lifestyle Intervention
- Keywords
- Adult Cancer Survivors, Anti-Inflammatory Lifestyle for Cancer Survivors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-Inflammatory Lifestyle InterventionBehavioural
Content includes training in empirically-supported strategies to improve psychological function (e.g., restructuring negative thoughts, distress tolerance), with a focus on changing discrete behaviors linked to inflammation (e.g., sleep, processed foods, physical activity), all intertwined with evidence-based behavior change content adapted to meet the needs of EACS. Participants will also receive digital tools to facilitate daily self-monitoring (Fitbit activity monitor, wireless scales, self-monitoring app) and generate information for tailored weekly e-coaching
| Study group | Role | What they receive |
|---|---|---|
| Anti-Inflammatory Lifestyle Intervention | Experimental | A 16-week program consisting of 12 75-minute virtual group meetings Receives: Behavioral: Anti-Inflammatory Lifestyle Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test the feasibility of Anti-Inflammatory Lifestyle Intervention (AILI) and associated research procedures among emerging adult cancer survivors (EACS) age 18-29
The percentage of participants that enroll
Measured: Day 0, At end of recruitment period
Test the feasibility of AILI and associated research procedures among EACS age 18-29
The percentage of participants that complete the post intervention questionnaire
Measured: 4 months
Test the feasibility of Anti-Inflammatory Lifestyle Intervention (AILI) and associated research procedures among EACS age 18-29.
The percentage of participants that complete the post intervention blood draw
Measured: 4 months
Assess the acceptability of AILI and associated research procedures among EACS age 18-29.
The percentage of participants that complete all study sessions
Measured: 4 months
Assess the acceptability of AILI and associated research procedures among EACS age 18-29.
The percentage of participants that wear the Fitbit >/= 60% throughout the intervention period.
Measured: 4 months
Assess the acceptability of AILI and associated research procedures among EACS age 18-29.
Intervention satisfaction ratings>/= 4 on a 1-5 Likert scale at 4 months, where (1) Strongly Disagree; (2) Disagree; (3) Neither Agree nor Disagree; (4) Agree; (5) Strongly Agree.
Measured: 4 months
Assess the acceptability of AILI and associated research procedures among EACS age 18-29.
Research procedure satisfaction ratings>/= 3 on a 1-5 Likert scale, where (1) Strongly Disagree; (2) Disagree; (3) Neither Agree nor Disagree; (4) Agree; (5) Strongly Agree.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start30 Oct 2024
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Why it stopped: Unable to enroll a sufficient number of participants to launch a cohort despite increased recruitment efforts
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurvivorshipStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Autumn Lanoye, Ph.D, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06442397
- Sponsor's protocol ID
- MCC-24-21095
- Other IDs
- HM20029744
- Acronym
- HEAL
- Status last verified
- Aug 2025
- First submitted
- 28 May 2024
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans to share individual participant data at this time.
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of an Anti-Inflammatory Lifestyle Intervention for Emerging Adult Cancer Survivors
- ClinicalTrials.gov ID
- NCT06442397
- Acronym / sponsor ID
- HEAL / MCC-24-21095
- Conditions
- Survivorship
- Keywords
- Adult Cancer Survivors, Anti-Inflammatory Lifestyle for Cancer Survivors
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to enroll a sufficient number of participants to launch a cohort despite increased recruitment efforts
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 30 Oct 2024 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 4 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To test the feasibility and acceptability of AILI and associated research procedures among emerging adult cancer survivors (EACS, N=16) age 18-29.
Detailed description
This is a single-arm pilot trial designed to assess the feasibility and acceptability of an anti-inflammatory lifestyle intervention (AILI) for emerging adults (EA) adapted for emerging adult cancer survivors (EACS).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anti-Inflammatory Lifestyle Intervention | Experimental | Behavioral: Anti-Inflammatory Lifestyle InterventionA 16-week program consisting of 12 75-minute virtual group meetings |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18-29
- Cancer diagnosis of any type
- Body fat percentage >16.2% for women; >10.6% for men
Key exclusion criteria (12 listed)
- Individuals receiving active chemotherapy/radiation or those having completed active chemotherapy/radiation within the past 6 months
- Individuals who are currently pregnant or lactating
- Current involvement in a weight loss program or current use of weight loss medication
- Individuals who report any other uncontrolled medical conditions that may pose a safety issue given the recommendations for the diet and unsupervised physical activity (e.g., uncontrolled hypertension)
- Individuals with rheumatologic and gastrointestinal conditions associated with severe systemic inflammation (e.g., rheumatoid arthritis, systemic lupus erythematosus, Crohn's disease)
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 |
|---|---|---|
| Anti-Inflammatory Lifestyle InterventionContent includes training in empirically-supported strategies to improve psychological function (e.g., restructuring negative thoughts, distress tolerance), with a focus on changing discrete behaviors linked to inflammation (e.g., sleep, processed foods, physical activity), all intertwined with evidence-based behavior change content adapted to meet the needs of EACS. Participants will also receive digital tools to facilitate daily self-monitoring (Fitbit activity monitor, wireless scales, self-monitoring app) and generate information for tailored weekly e-coaching | Behavioural | Anti-Inflammatory Lifestyle Intervention |
Primary outcome
Test the feasibility of Anti-Inflammatory Lifestyle Intervention (AILI) and associated research procedures among emerging adult cancer survivors (EACS) age 18-29
Time frame: Day 0, At end of recruitment period
The percentage of participants that enroll
Test the feasibility of AILI and associated research procedures among EACS age 18-29
Time frame: 4 months
The percentage of participants that complete the post intervention questionnaire
Test the feasibility of Anti-Inflammatory Lifestyle Intervention (AILI) and associated research procedures among EACS age 18-29.
Time frame: 4 months
The percentage of participants that complete the post intervention blood draw
Assess the acceptability of AILI and associated research procedures among EACS age 18-29.
Time frame: 4 months
The percentage of participants that complete all study sessions
Assess the acceptability of AILI and associated research procedures among EACS age 18-29.
Time frame: 4 months
The percentage of participants that wear the Fitbit >/= 60% throughout the intervention period.
Assess the acceptability of AILI and associated research procedures among EACS age 18-29.
Time frame: 4 months
Intervention satisfaction ratings>/= 4 on a 1-5 Likert scale at 4 months, where (1) Strongly Disagree; (2) Disagree; (3) Neither Agree nor Disagree; (4) Agree; (5) Strongly Agree.
Assess the acceptability of AILI and associated research procedures among EACS age 18-29.
Time frame: 4 months
Research procedure satisfaction ratings>/= 3 on a 1-5 Likert scale, where (1) Strongly Disagree; (2) Disagree; (3) Neither Agree nor Disagree; (4) Agree; (5) Strongly Agree.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
- Individual participant dataSharing planned: No. There are no plans to share individual participant data at this time.
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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.
Autumn Lanoye, Ph.D principal investigator
Virginia Commonwealth University
Questions about this trial
What is this clinical trial studying?
A study testing Anti-Inflammatory Lifestyle Intervention in people with Survivorship, run by Virginia Commonwealth University.
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 3 inclusion and 12 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: withdrawn, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Test the feasibility of Anti-Inflammatory Lifestyle Intervention (AILI) and associated research procedures among emerging adult cancer survivors (EACS) age 18-29 (time frame: Day 0, At end of recruitment period). The study lists 7 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 20 Aug 2025.