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

Official Title

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

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 behavioural and complementary interventions can be effective in reducing treatment-related side effects. The study aims to evaluate if individually-tailored behavioural 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.

Trial Description

Primary Outcome:

  • Functional Assessment of Cancer Therapy - Breast Symptom Index (FACT-B)
Secondary Outcome:
  • Functional Assessment of Cancer Therapy - Endocrine System (FACT-ES)
  • Functional Assessment of Cancer Therapy - (FACT)-Cognitive
  • Treatment discontinuation rate
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 behavioural 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 behavioural 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 behavioural 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 behavioural and complementary interventions could promote self-management and empower the women with early stage breast cancer to manage treatment related side effects.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

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