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

NCT03407768 | Completed

• 1 other identifier: 348455
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Functional Assessment of Cancer Therapy - Endocrine System (FACT-ES)

  Up to three years from the time of enrolment

• Functional Assessment of Cancer Therapy - (FACT)-Cognitive

  Up to three years from time of enrolment

• Treatment discontinuation rate

  Up to three years from the time of enrolment

Study Arms (1)

Individualized interventions

OTHER

Exercise, Yoga, massage therapy, acupuncture, and others

Behavioral: Individualized interventions

Interventions

Individualized interventions BEHAVIORAL

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.

Individualized interventions

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Post-menopausal women
• Women who are on single agent endocrine therapy

Sponsors & Collaborators

• University of Saskatchewan: lead

Study Sites (2)

Allan Blair Cancer Center

Regina, Saskatchewan, Canada

Location

Saskatoon Cancer Center

Saskatoon, Saskatchewan, S7N4H4, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior; Health Behavior

Study Officials

• Shahid Ahmed, MD, PhD

  University of Saskatchewan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 24, 2017
• First Posted: January 23, 2018
• Study Start: July 1, 2018
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)