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

Study Overview
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Brief Summary
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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.

Detailed Description
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Recent evidence suggest that ovarian suppression in combination with exemestane compared with tamoxifen alone has been associated with significant reduction in risk of breast cancer recurrence in premenopausal women with high risk estrogen or progesterone receptor positive breast cancer. However, combination therapy has been associated with more adverse effects, poor treatment adherence, and decline in quality of life (QOL). Various behavioral and complementary interventions such as exercise, yoga, acupuncture, and massage therapy can be effective to reduce treatment-related side effects and thereby to improve QOL. Nevertheless, there is a paucity of evidence about effect of individualized behavioral and complementary interventions in younger women who are treated with combination endocrine therapy. The study aims to evaluate if younger women with early stage breast cancer treated with combination endocrine therapy could benefit from individualized behavioral and complementary intervention (s) during their treatment. This benefit will be assessed primarily by change in QoL and cognitive function from the baseline measurement and secondarily by adherence to adjuvant endocrine treatment. Furthermore, the study will explore correlation between selection of intervention(s) and various socio-demographic and clinical factors. Forty premenopausal women with early stage breast cancer treated with combination endocrine therapy will be recruited over a two year period in Saskatchewan with a median follow up period of about two years. All participants will be provided a list of interventions that alone or in combination could be helpful to improve treatment tolerance to hormonal therapy. A participant will be able to select one or more intervention based on her preferences. The QOL and cognitive function will be assessed every three months using Functional Assessment of Cancer Therapy - Breast Symptom Index (FACT-B), FACT - Endocrine System (FACT-ES), and FACT-Cognitive Function scales. Treatment adherence will be monitored monthly basis. Individually-tailored behavioral and complementary interventions could promote self-management and empower the women with early stage breast cancer to manage treatment related side effects.

Official Title
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Role of Individualized Intervention(s) on Quality of Life and Adherence to Adjuvant Endocrine Therapy in Premenopausal Women With Early-Stage Breast Cancer

Conditions
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Breast Cancer, Premenopausal Breast Cancer, Hormone Receptor Positive Tumor

Intervention / Treatment
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* Behavioral: Individualized interventions


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Individualized interventions<br>Exercise, Yoga, massage therapy, acupuncture, and others | Behavioral: Individualized interventions<br>* A participant will be able to select one or more (or no intervention) based on her preferences. Individualized exercise program Yoga and mindfulness Massage therapy Acupuncture Others: Women who are not interested in any above intervention but like to explore other interventions will be offered material pertinent to their choice of complimentary techniques.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Functional Assessment of Cancer Therapy - (FACT)-Cognitive | For the assessment of self-reported cognitive function | Up to three years from time of enrolment | 
| Treatment discontinuation rate | Rate of combination of endocrine treatment at 3 year. | Up to three years from the time of enrolment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Yoga, Premenopausal breast cancer, Individualized interventions, Exercise, Combination hormone therapy, Massage therapy, Acupuncture, Treatment tolerance, Treatment adherence, Adverse effects, Quality of life