Clinical trial NCT03407768: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Premenopausal Breast Cancer
Hormone Receptor Positive Tumor
Keywords: Premenopausal breast cancer
Individualized interventions
Exercise
Combination hormone therapy
Massage therapy
Yoga
Acupuncture
Treatment tolerance
Treatment adherence
Adverse effects
Quality of life
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
First posted: 2018-01-23
Enrollment: 41
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Functional Assessment of Cancer Therapy - Breast Symptom Index (FACT-B)
timeFrame: Up to three years from the time of enrolment
Secondary outcomes:
measure: Functional Assessment of Cancer Therapy - Endocrine System (FACT-ES)
timeFrame: Up to three years from the time of enrolment
measure: Functional Assessment of Cancer Therapy - (FACT)-Cognitive
timeFrame: Up to three years from time of enrolment
measure: Treatment discontinuation rate
timeFrame: Up to three years from the time of enrolment
Other outcomes:
Locations:
city: Regina
country: Canada
facility: Allan Blair Cancer Center
state: Saskatchewan
city: Saskatoon
country: Canada
facility: Saskatoon Cancer Center
state: Saskatchewan
Study officials:
affiliation: University of Saskatchewan
name: Shahid Ahmed, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: