Clinical trial · Interventional
Health Education Intervention in Reducing Weight Gain in Patients With Newly Diagnosed Stage I-IV Breast Cancer Undergoing Chemotherapy
Taking Health Realization Into Valued Eating and Exercise (THRIVE): A Feasibility Study of an Intervention to Prevent Weight Gain for Breast Cancer Survivors During Chemotherapy
NCT01941784CI-TRIAL-00036756completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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 pilot clinical trial studies a health education intervention in reducing weight gain in patients with newly diagnosed stage I-IV breast cancer undergoing chemotherapy. A health education program may reduce weight gain and improve quality of life in patients undergoing chemotherapy for breast cancer.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage IA Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IB Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage II Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIA Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIB Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIC Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| counseling intervention | Other | — | UNRESOLVED |
| educational intervention | Other | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
| telephone-based intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Supportive care (health education program)
- description
- See Detailed Description.
- interventionNames
- Other: educational intervention
- Other: counseling intervention
- Behavioral: telephone-based intervention
- Other: questionnaire administration
- Procedure: quality-of-life assessment
Primary outcomes (1)
- measure
- Feasibility of conducting the weight gain prevention intervention, measured as the percent of screened participants that are eligible and agree to participate
- timeFrame
- Baseline
- description
- Reasons why participants are not eligible will be reported and inclusion/exclusion criteria will be reevaluated. The proportion of participants who completed all sessions and testing visits will be estimated and compared. Barriers to recruitment (e.g., timing of intervention, inconvenience, time constraints, participant feeling too sick) will be recorded to assist in designing the larger trial.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women with newly-diagnosed breast cancer, stage I-IV who are within first two rounds of chemotherapy * 3.1.2 Women who are receiving, or scheduled to receive, one of the following classes of therapy in the adjuvant or neo-adjuvant setting: anthracyclines, taxanes, cyclophosphamide, or trastuzumab. Participants must be within their first two rounds of chemotherapy - Body mass index (BMI) \> 20 * Treating physician approval to participate in study * Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document Exclusion Criteria: * Diagnosis of recurrent breast cancer * Women who are already participating in a formal or medically prescribed weight management program * Women who have already completed more than two rounds of chemotherapy * Women who are pregnant or nursing
References
Publications (0)
Data not yet available
No reference posted for this study.