CompletedNot Applicable

Role of Individualized Intervention(s) in Hormone-Receptor Positive Early-stage Breast Cancer

Canada41 participantsStarted 2018-07-01

Plain-language summary

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.

Who can participate

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Functional Assessment of Cancer Therapy - Breast Symptom Index (FACT-B)

Timeframe: Up to three years from the time of enrolment

Trial details

NCT IDNCT03407768

SponsorUniversity of Saskatchewan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11-30

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