Clinical trial · Interventional
Mobile-Health Delivery of Lifestyle Interventions for Women With Breast Cancer
Mobile-Health Delivery of Lifestyle Interventions for Women With Breast Cancer Multicenter Pilot Trial
- 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)
This clinical trial aims to develop a lifestyle program to improve clinical outcomes in women with breast cancer who do not have a healthy diet, regular exercise habits, or ways to manage their stress well. The program will include support and counseling in healthy eating, physical activity, stress management and mindfulness, learning sleep hygiene techniques, and behavioral counseling in addition to social support. Developing a lifestyle program may help improve quality of life and encourage healthy lifestyle choices among patients diagnosed with breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Behavioral Intervention | Behavioral | — | UNRESOLVED |
| Best Practice | Other | — | UNRESOLVED |
| FitBit | Device | — | UNRESOLVED |
| Nutrition Education | Behavioral | — | UNRESOLVED |
| Physical Activity | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- GROUP I (CLIP)
- description
- Patients undergo 60 minute sessions of nutrition education for 12 weeks and behavioral intervention 26 weeks. Patients receive FitBit and undergo physical activity for 30-60 minutes 5 days a week (aerobic activity) and 2 days a week (resistance training).
- interventionNames
- Behavioral: Behavioral Intervention
- Device: FitBit
- Behavioral: Nutrition Education
- Other: Physical Activity
- Other: Questionnaire Administration
- type
- ACTIVE_COMPARATOR
- label
- GROUP II (usual care)
- description
- Patients have access to all usual care supportive services.
- interventionNames
- Other: Best Practice
- Other: Questionnaire Administration
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women with stage I-III BCa scheduled to undergo radiation therapy (RT) or within the first 12 months of having completed primary treatment (they do not need to have undergone RT) * Underwent chemotherapy and surgery * Able to read, write, and speak English * BMI of 25 or higher * 18 years of age or older * Oriented to person, place, and time * Participants must meet at least two of the following criteria related to their lifestyle at the time of diagnosis: * Consume less than 3 servings of fruit and vegetable/day * Engage in less than 75 minutes of moderate/vigorous intensity activity per week, defined as anything that causes small increases in breathing or heart rate for a sustained amount of time (e.g., brisk walking, bicycling) * Engage in a mind-body practice less than 4 times a month * Access to internet connection * Access to a tablet, laptop or computer * Able to come to University of Texas (UT) MD Anderson or Wake Forest for blood collection * Able to perform light physical activity. if any medical issues exist or arise that may limit performing physical activity, a medical release will be required Exclusion Criteria: * Have not completed chemotherapy; have a recurrent BCa diagnosis; another primary cancer diagnosis within past 5 years (not including non-melanoma skin cancers) * Any major thought disorder (e.g., schizophrenia, dementia) * Any major communication barriers that would preclude being able to complete the intervention (e.g., visually or hearing impaired) * Poorly or uncontrolled diabetes in the opinion of the physician(s) * Extreme mobility issues (e.g., unable to get in and out of a chair unassisted)
References
Publications (0)
Data not yet available