Clinical trial · Interventional
Lifestyle Program (Scalable Nutrition and Physical Activity) for the Improvement of Nutrition and Physical Activity in Stage 0-III Breast Cancer Survivors
Testing a Scalable Nutrition and Physical Activity Program for Breast Cancer Survivors: A Dose-Finding Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this phase II trial is to identify the most effective dose level (number of classes) of a diet and physical activity lifestyle program based on how well it improves diet and physical activity in stage 0-III breast cancer survivors. Study results may provide researchers with information on how to best implement diet and physical activity recommendations among breast cancer survivors.
Conditions
Conditions (22)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anatomic Stage 0 Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage IA Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage IB Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage I Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage IIA Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage IIB Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage II Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage IIIA Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage IIIB Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage III Breast Cancer AJCC v8 | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Electronic (e) Health (eHealth) Communication Intervention | Other | — | UNRESOLVED |
| One Diet and Physical Activity Session | Behavioral | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
| Twelve Diet and Physical Activity Group Sessions | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm A (low dose nutrition and PA class, eHealth intervention)
- description
- Participants attend one diet and physical activity class delivered remotely via Zoom and receive an eHealth communication intervention for 6 months.
- interventionNames
- Behavioral: One Diet and Physical Activity Session
- Other: Electronic (e) Health (eHealth) Communication Intervention
- Other: Questionnaire Administration
- Other: Quality-of-Life Assessment
- type
- EXPERIMENTAL
- label
- Arm B (high dose nutrition and PA class, eHealth intervention)
- description
- Participants attend 12 twice monthly diet and physical activity online sessions delivered remotely via Zoom and receive an eHealth communication intervention for 6 months.
- interventionNames
- Other: Electronic (e) Health (eHealth) Communication Intervention
- Behavioral: Twelve Diet and Physical Activity Group Sessions
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Previous diagnosis of stage 0-III breast cancer in the past 10 years at the time of enrollment * No evidence of recurrent or metastatic disease * No uncontrolled diabetes mellitus defined as glycosylated hemoglobin (Hgb A1C) \> 8% * No uncontrolled hypertension per Seattle Cancer Care Alliance (SCCA) standard of care * At least 60 days post final chemotherapy, biologic therapy, or radiation therapy and/or surgery. Current use of endocrine therapy is permitted (e.g., tamoxifen and aromatase inhibitors) * Access to phone for study contacts * Access to smartphone, tablet, or computer and internet to attend online session(s) and receive study electronic eHealth communication (text messages and access to website) * Willing and able to attend the online session(s) on Saturdays, or via online accessed videos, for up to 12 sessions in 6 months * Successfully complete all run-in activities, including at-home and over the phone assessments, 7 days of collecting physical activity data via accelerometer, and providing blood and stool sample * Willing and able to complete all study activities for 6 months after randomization * Participants must consume \< 5 servings of fruits and vegetables per day and/or engage in \< 150 minutes per week of moderate to vigorous physical activity, as assessed by brief questionnaires * Participants must have an Eastern Cooperative Oncology Group (ECOG) Scale of performance status score of 0 or 1 for performance status. * Signed physician approval for diet change and physical activity * Able to understand and willing to sign written informed electronic (e) consent in English Exclusion Criteria: * Participants must not be active smokers within the past 30 days. * Women must not be pregnant at time of enrollment
References
Publications (2)
- DERIVEDUeland K, Sanchez SC, Rillamas-Sun E, Shen H, Schattenkerk L, Garcia G, VanDoren M, Myers SA, Santiago-Torres M, Di C, Dey N, Guthrie KA, Yung R, Davidson NE, Greenlee H. A digital health intervention to improve nutrition and physical activity in breast cancer survivors: Rationale and design of the Cook and Move for Your Life pilot and feasibility randomized controlled trial. Contemp Clin Trials. 2022 Dec;123:106993. doi: 10.1016/j.cct.2022.106993. Epub 2022 Nov 3. PMID 36336249
- DERIVEDRillamas-Sun E, Schattenkerk L, Cobos S, Ueland K, Gaffney AO, Greenlee H. Characteristics of Users of the Cook for Your Life Website, an Online Nutrition Resource for Persons Affected by Cancer: Descriptive Study. JMIR Cancer. 2022 Jul 5;8(3):e37212. doi: 10.2196/37212. PMID 35788100