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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-01597 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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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.
PRIMARY OBJECTIVE:
I. To evaluate the feasibility of the 12-week remotely delivered episodic future thinking (EFT) intervention.
SECONDARY OBJECTIVES:
I. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Intervention | Behavioral | Participate in EFT |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) | Up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in patient reported outcome (PRO) | PRO measured by standard instruments: PROMIS® scales 29 Profile v2.1 (domains: physical function, social roles, fatigue, depression, anxiety, pain, sleep disturbance) and Global Health Short Form (general physical and mental health) | Baseline to 12 weeks |
| Change in Insulin Resistance |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sagar D Sardesai, MBBS MPH | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
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| Label | URL |
|---|---|
| The Jamesline | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Mar 16, 2023 | Apr 3, 2024 |
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| Behavioral Intervention | Behavioral | Participate in ERT |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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| 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. | 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. | 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. | Baseline to 24 weeks |
Insulin Resistance will be measured by Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) |
| Baseline to 12 weeks |
| Change in quantity of serum high-sensitivity C-reactive protein | Inflammatory Biomarker | Baseline to 12 weeks |
| Change in diet quality | Measured by Health Eating Index 2015. | Baseline to 12 weeks |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D000071960 | Breast Carcinoma In Situ |
| D002285 | Carcinoma, Intraductal, Noninfiltrating |
| ID | Term |
|---|---|
| D002278 | Carcinoma in Situ |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D000230 | Adenocarcinoma |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
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| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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