Anatomic Stage 0 Breast Cancer AJCC v8NCT05012176
An Episodic Future Thinking Intervention to Promote Weight Loss in Breast Cancer Survivors
A study testing Behavioral Intervention, Quality-of-Life Assessment and Questionnaire Administration in people with Anatomic Stage 0 Breast Cancer AJCC v8 and Anatomic Stage I Breast Cancer AJCC v8, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
This clinical trial evaluates the use of an Episodic Future thinking Intervention to promote weight loss in breast cancer survivors. Obesity is associated with multiple negative health sequelae in breast cancer survivors. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8
- What is being tested?
- Behavioral Intervention, Quality-of-Life Assessment and Questionnaire Administration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2021to 3 Nov 2023
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >= 18 years
- Breast cancer (BC) survivors (pathologically proven ductal carcinoma in situ or stage I-III invasive BC and completed primary breast surgery, radiation, chemotherapy >= 21 days prior to enrollment)
- Body mass index (BMI) >= 25 kg/m^2
- Endocrine and HER2- directed therapy is permitted
- Have access to a mobile electronic device
- Motivated to lose weight (readiness to change assessment)
Who cannot join
- Stage IV BC
- Have not completed definitive locoregional therapy (surgery +/- radiation therapy)
- Participating in another weight loss clinical trial
- Not able to speak and understand English
- Cognitive impairment which would interfere with performance of DD task or EFT procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: Episodic Future Thinking: An Interventional Pilot Study to Promote Weight Loss in Breast Cancer Survivors
This clinical trial evaluates the use of an Episodic Future thinking Intervention to promote weight loss in breast cancer survivors. Obesity is associated with multiple negative health sequelae in breast cancer survivors. This includes an increased risk of cancer recurrence and mortality, multiple quality of life issues, and increased risk of co-morbidities.
Delay Discounting is a behavioral health economic target that refers to the "discounting" of a larger benefit in the future for a smaller, more immediate reward in the present. A high delay discounting rate is correlated with poor dietary choices and sedentary lifestyle. Episodic Future Thinking (EFT) simulates positive events that may occur in one's future, engaging the science of prospection. EFT decreases delay discounting rate, resulting in healthier diet choices and weight reduction. However, valuation of the future may impact cancer survivors differently due to adjusted mortality perception and cancer-related stress.
This study will determine the feasibility and preliminary efficacy of remotely delivered (smartphone application) EFT as a behavioral intervention for weight loss in breast cancer survivors. Implementation of EFT as a complementary approach to standard lifestyle interventions could lead to improvement in weight loss, food choice, and quality of life, thereby positively impacting overall health and longevity in cancer survivors.
Read the detailed description
PRIMARY OBJECTIVE:
- To evaluate the feasibility of the 12-week remotely delivered episodic future thinking (EFT) intervention.
SECONDARY OBJECTIVES:
- To evaluate the impact of EFT compared to control (episodic recent thinking [ERT]) on weight loss and delay discounting (DD) in overweight and obese breast cancer survivors at 12 and 24 weeks.
II. To evaluate the baseline and 12 week change in:
IIa. Patient reported outcomes (PROs) measured by standard instruments: Patient Reported Outcomes Measurement Information System (PROMIS) scales 29 Profile version (v)2.1 (domains: physical function, social roles, fatigue, depression, anxiety, pain, sleep disturbance) and Global Health Short Form (general physical and mental health).
IIb. Insulin resistance (Homeostatic Model Assessment of Insulin Resistance [HOMA-IR]) and high-sensitivity C-reactive protein (hsCRP).
IIc. Diet quality, measured by Health Eating Index (HEI)-2015 on Vioscreen food frequency questionnaire (FFQ).
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients participate in EFT over 12 weeks, in which they will receive prompts via a guided smartphone application to engage in EFT in their daily lives. Patients are asked to recall future positive experiences to create text cues which vividly describes these experiences.
ARM II: Patients participate in Episodic Recent Thinking (ERT; control arm) over 12 weeks, in which they will receive prompts via a guided smartphone application to engage in control thinking in their daily lives. Patients are asked to recall past positive experiences to create text cues which vividly describes these experiences.
After completion of study intervention, patients are followed up for an additional12 weeks.
- Conditions
- Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8
- Being tested
- Behavioral Intervention, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Breast Carcinoma In Situ, Carcinoma, Intraductal, Noninfiltrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral InterventionBehavioural
Also called Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy
Participate in EFT
Behavioral InterventionBehavioural
Also called Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy
Participate in ERT
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (EFT) | Experimental | Patients participate in EFT over 12 weeks, in which they will receive prompts via a guided smartphone application to engage in EFT in their daily lives. Patients are asked to recall future positive experiences to create text cues which vividly describes these experiences. Receives: Behavioral: Behavioral Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
| Arm II (ERT) | Active comparator | Patients participate in ERT over 12 weeks, in which they will receive prompts via a guided smartphone application to engage in ERT in their daily lives. Patients are asked to recall past positive experiences to create text cues which vividly describes these experiences. Receives: Behavioral: Behavioral Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility measured by Adherence
A one-sample t-test will be used to evaluate adherence (average proportion of smartphone prompts participants open and attended to during the 12-week trial recorded by the web application)
Measured: Up to 12 weeks
Secondary outcomes (4)
Change in total body weight
Evaluated using a linear mixed effects model. The model will include baseline measure, timepoint (12 and 24 weeks), treatment assignment, and the timepoint by treatment interaction as fixed effects. A subject-level random effect will be included to account for the correlation of multiple measurements of the same individual.
Measured: Up to 12 weeks
Change in total body weight
Evaluated using a linear mixed effects model. The model will include baseline measure, timepoint (12 and 24 weeks), treatment assignment, and the timepoint by treatment interaction as fixed effects. A subject-level random effect will be included to account for the correlation of multiple measurements of the same individual.
Measured: Up to 24 weeks
Change in delay discounting rate
Evaluated using a linear mixed effects model. The model will include baseline measure, timepoint (12 weeks), treatment assignment, and the timepoint by treatment interaction as fixed effects. A subject-level random effect will be included to account for the correlation of multiple measurements of the same individual.
Measured: Baseline to 12 weeks
Change in delay discounting rate
Evaluated using a linear mixed effects model. The model will include baseline measure, timepoint (24 weeks), treatment assignment, and the timepoint by treatment interaction as fixed effects. A subject-level random effect will be included to account for the correlation of multiple measurements of the same individual.
Measured: Baseline to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start1 Nov 2021
- Primary completion3 Nov 2023
- Study completion3 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anatomic Stage 0 Breast Cancer AJCC v8Studies of the same condition, open and under way.
- More trials run by Ohio State University 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sagar Sardesai, Ohio State University Comprehensive Cancer Center
- Investigators
- Sagar D Sardesai, MBBS MPH, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05012176
- Sponsor's protocol ID
- OSU-20408
- Other IDs
- NCI-2021-01597
- Status last verified
- Feb 2025
- First submitted
- 13 Jul 2021
- Last updated
- 7 Feb 2025
- Results posted
- No
- 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 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Episodic Future Thinking: An Interventional Pilot Study to Promote Weight Loss in Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT05012176
- Acronym / sponsor ID
- OSU-20408
- Conditions
- Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 3 Nov 2023 (actual)
- Study completion
- 3 Nov 2023 (actual)
- First posted
- 19 Aug 2021 (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.
This clinical trial evaluates the use of an Episodic Future thinking Intervention to promote weight loss in breast cancer survivors. Obesity is associated with multiple negative health sequelae in breast cancer survivors. This includes an increased risk of cancer recurrence and mortality, multiple quality of life issues, and increased risk of co-morbidities.
Delay Discounting is a behavioral health economic target that refers to the "discounting" of a larger benefit in the future for a smaller, more immediate reward in the present. A high delay discounting rate is correlated with poor dietary choices and sedentary lifestyle. Episodic Future Thinking (EFT) simulates positive events that may occur in one's future, engaging the science of prospection. EFT decreases delay discounting rate, resulting in healthier diet choices and weight reduction. However, valuation of the future may impact cancer survivors differently due to adjusted mortality perception and cancer-related stress.
This study will determine the feasibility and preliminary efficacy of remotely delivered (smartphone application) EFT as a behavioral intervention for weight loss in breast cancer survivors. Implementation of EFT as a complementary approach to standard lifestyle interventions could lead to improvement in weight loss, food choice, and quality of life, thereby positively impacting overall health and longevity in cancer survivors.
Detailed description
PRIMARY OBJECTIVE:
- To evaluate the feasibility of the 12-week remotely delivered episodic future thinking (EFT) intervention.
SECONDARY OBJECTIVES:
- To evaluate the impact of EFT compared to control (episodic recent thinking [ERT]) on weight loss and delay discounting (DD) in overweight and obese breast cancer survivors at 12 and 24 weeks.
II. To evaluate the baseline and 12 week change in:
IIa. Patient reported outcomes (PROs) measured by standard instruments: Patient Reported Outcomes Measurement Information System (PROMIS) scales 29 Profile version (v)2.1 (domains: physical function, social roles, fatigue, depression, anxiety, pain, sleep disturbance) and Global Health Short Form (general physical and mental health).
IIb. Insulin resistance (Homeostatic Model Assessment of Insulin Resistance [HOMA-IR]) and high-sensitivity C-reactive protein (hsCRP).
IIc. Diet quality, measured by Health Eating Index (HEI)-2015 on Vioscreen food frequency questionnaire (FFQ).
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients participate in EFT over 12 weeks, in which they will receive prompts via a guided smartphone application to engage in EFT in their daily lives. Patients are asked to recall future positive experiences to create text cues which vividly describes these experiences.
ARM II: Patients participate in Episodic Recent Thinking (ERT; control arm) over 12 weeks, in which they will receive prompts via a guided smartphone application to engage in control thinking in their daily lives. Patients are asked to recall past positive experiences to create text cues which vividly describes these experiences.
After completion of study intervention, patients are followed up for an additional12 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (EFT) | Experimental | Behavioral: Behavioral Intervention, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients participate in EFT over 12 weeks, in which they will receive prompts via a guided smartphone application to engage in EFT in their daily lives. Patients are asked to recall future positive experiences to create text cues which vividly describes these experiences. |
| Arm II (ERT) | Active comparator | Behavioral: Behavioral Intervention, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients participate in ERT over 12 weeks, in which they will receive prompts via a guided smartphone application to engage in ERT in their daily lives. Patients are asked to recall past positive experiences to create text cues which vividly describes these experiences. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age >= 18 years
- Breast cancer (BC) survivors (pathologically proven ductal carcinoma in situ or stage I-III invasive BC and completed primary breast surgery, radiation, chemotherapy >= 21 days prior to enrollment)
- Body mass index (BMI) >= 25 kg/m^2
- Endocrine and HER2- directed therapy is permitted
- Have access to a mobile electronic device
Key exclusion criteria (5 listed)
- Stage IV BC
- Have not completed definitive locoregional therapy (surgery +/- radiation therapy)
- Participating in another weight loss clinical trial
- Not able to speak and understand English
- Cognitive impairment which would interfere with performance of DD task or EFT procedures
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 |
|---|---|---|
| Behavioral InterventionAlso: Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior TherapyParticipate in EFT | Behavioural | Arm I (EFT) |
| Behavioral InterventionAlso: Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior TherapyParticipate in ERT | Behavioural | Arm II (ERT) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Arm I (EFT), Arm II (ERT) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (EFT), Arm II (ERT) |
Primary outcome
Feasibility measured by Adherence
Time frame: Up to 12 weeks
A one-sample t-test will be used to evaluate adherence (average proportion of smartphone prompts participants open and attended to during the 12-week trial recorded by the web application)
4 secondary outcomes
Change in total body weight
Time frame: Up to 12 weeks
Change in total body weight
Time frame: Up to 24 weeks
Change in delay discounting rate
Time frame: Baseline to 12 weeks
Change in delay discounting rate
Time frame: Baseline to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- The JameslineLink 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.
Sagar D Sardesai, MBBS MPH principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Intervention, Quality-of-Life Assessment and Questionnaire Administration in people with Anatomic Stage 0 Breast Cancer AJCC v8 and Anatomic Stage I Breast Cancer AJCC v8, run by Ohio State University 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 6 inclusion and 5 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 7 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Feasibility measured by Adherence (time frame: Up to 12 weeks). 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 7 Feb 2025.