Breast Cancer Clinical Trial
— MyCHOICEOfficial title:
Role of Individualized Intervention(s) on Quality of Life and Adherence to Adjuvant Endocrine Therapy in Premenopausal Women With Early-Stage Breast Cancer
Verified date | November 2023 |
Source | University of Saskatchewan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 41 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Allan Blair Cancer Center | Regina | Saskatchewan |
Canada | Saskatoon Cancer Center | Saskatoon | Saskatchewan |
Lead Sponsor | Collaborator |
---|---|
University of Saskatchewan |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Functional Assessment of Cancer Therapy - Breast Symptom Index (FACT-B) | For global assessment of quality of life of women with breast cancer | Up to three years from the time of enrolment | |
Secondary | Functional Assessment of Cancer Therapy - Endocrine System (FACT-ES) | For the assessment of quality of life of women with breast cancer on endocrine therapy | Up to three years from the time of enrolment | |
Secondary | Functional Assessment of Cancer Therapy - (FACT)-Cognitive | For the assessment of self-reported cognitive function | Up to three years from time of enrolment | |
Secondary | Treatment discontinuation rate | Rate of combination of endocrine treatment at 3 year. | Up to three years from the time of enrolment |
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