Clinical trial · Interventional
Role of Individualized Intervention(s) in Hormone-Receptor Positive Early-stage Breast Cancer
Role of Individualized Intervention(s) on Quality of Life and Adherence to Adjuvant Endocrine Therapy in Premenopausal Women With Early-Stage Breast Cancer
- 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)
Although combination endocrine therapy has been associated with significant reduction in risk of recurrence in younger women with hormone receptor positive breast cancer, it has been associated with more adverse effects and decline in quality of life (QOL). Various behavioral and complementary interventions can be effective in reducing treatment-related side effects. The study aims to evaluate if individually-tailored behavioral and complementary interventions could improve treatment tolerance and adherence in women with early stage breast cancer. This benefit will be assessed primarily by change in QOL and secondarily by adherence to adjuvant endocrine treatment.
Conditions
Conditions (3)
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 |
| Hormone Receptor Positive Tumor | — | UNRESOLVED | — |
| Premenopausal Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Individualized interventions | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Individualized interventions
- description
- Exercise, Yoga, massage therapy, acupuncture, and others
- interventionNames
- Behavioral: Individualized interventions
Primary outcomes (1)
- measure
- Functional Assessment of Cancer Therapy - Breast Symptom Index (FACT-B)
- timeFrame
- Up to three years from the time of enrolment
- description
- For global assessment of quality of life of women with breast cancer
Secondary outcomes (3)
- measure
- Functional Assessment of Cancer Therapy - Endocrine System (FACT-ES)
- timeFrame
- Up to three years from the time of enrolment
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: • Premenopausal women with histologically-proven, completely resected, hormone receptor-positive (defined as ER≥10% and/or PgR≥10%) stage 1, 2, and 3 invasive breast cancer who are treated with combination of anti-estrogen therapy (LHRH agonist and an aromatase inhibitor or tamoxifen) Exclusion Criteria: * Post-menopausal women * Women who are on single agent endocrine therapy
References
Publications (0)
Data not yet available