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

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Hormone Receptor Positive Tumor; Premenopausal Breast Cancer
• Intervention / Treatment: Behavioral: Individualized interventions

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.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Saskatchewan
    • Regina, Saskatchewan, Canada
      • Allan Blair Cancer Center
    • Saskatoon, Saskatchewan, Canada, S7N4H4
      • Saskatoon Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Individualized interventions; Exercise, Yoga, massage therapy, acupuncture, and others

Behavioral: Individualized interventions; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Saskatchewan
• Investigators: Principal Investigator: Shahid Ahmed, MD, PhD, University of Saskatchewan

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Actual): November 30, 2024
• Study Completion (Actual): November 30, 2024

Study Registration Dates

• First Submitted: October 24, 2017
• First Submitted That Met QC Criteria: January 16, 2018
• First Posted (Actual): January 23, 2018

Study Record Updates

• Last Update Posted (Actual): December 5, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Exercise; Yoga; Acupuncture; Quality of life; Massage therapy; Adverse effects; Treatment adherence; Treatment tolerance; Premenopausal breast cancer; Individualized interventions; Combination hormone therapy
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 348455

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: If requested in future after meeting all the regulatory requirement data will be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No