Clinical trial · Interventional
Reducing Metabolic Syndrome Among Breast Cancer Survivors
Reducing Metabolic Syndrome and Unmet Needs Among Rural Breast Cancer Survivors During the Survivorship Transition
- 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)
Using a pilot 1-arm pre-post design, investigators will implement an intervention that is personalized, low burden (the majority of interactions are telephone coaching sessions), and delivered during the initial survivorship transition. To determine the feasibility of the intervention 48 community-dwelling rural breast cancer survivors (BCS) (ages 40 and older) will receive the intervention. The 12-week intervention consists of three home-based face-to-face consultations with the therapist, 9 weekly habit tele phone coaching sessions, and the use of implementation intentions, environmental modifications, and tailored text messages to support physical activity and dietary habit formation and address unmet needs.
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 Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Habit development intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Habit development intervention
- description
- Treatment includes occupational therapy evaluation and consultation to address any deficits in physical function, safety, social participation and/or life roles. After the occupational therapy evaluation, the therapist delivers education on physical activity and dietary recommendations and habit development techniques, and uses behavioral skills training to develop habit plans, as well as prompts/cues, environmental modifications, and reminder text messages to reinforce engagement in the plan. The intervention is delivered through 3 face to face sessions, 9 tele coaching calls, and text messages.
- interventionNames
- Behavioral: Habit development intervention
Primary outcomes (1)
- measure
- Self Reported Behavioral Automaticity Index
- timeFrame
- From week 0-2
- description
- Measures changes in habit strength, scores range from 1-7 with higher scores indicating a stronger habit
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * English speaking * Diagnosis of stage 1-3 histologically confirmed first cancer of the breast * Reside in a zip code designated as rural by the United States Department of Agriculture Economic Research Service * Be within the initial 12 months following the end of primary treatment and meet 3 of the following 5 criteria for MetS confirmed via point-of-care testing or documentation in their medical record: A large waistline \> 35 inches Blood pressure \> 130/85; HbA1c of 5.7%-6.4%; Triglyceride levels \> 150 mg/dL; HDL cholesterol levels \< 50 mg/dL Exclusion Criteria: * Will not exclude participants based on hormone receptivity, one exception is that we will exclude HER2 positive BCS * Pregnant patients * Resistant Hypertension * Steroid-dependent asthma or Chronic obstructive pulmonary disease * Cirrhosis or hepatic failure * A major cardiovascular event (e.g., stroke, myocardial infarction) within the previous 90 days * Chronic kidney disease on renal replacement therapy * Type one or two diabetes * Stage 4 cancer; those with a secondary cancer (except for nonmelanomatous skin cancers and carcinoma of the cervix in situ) * Taking weight loss medications * Current involvement in a behavioral program * Neuropsychiatric disorder or dementia
References
Publications (0)
Data not yet available