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

NCT ID: NCT03407768

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-01

Study Completion Date

2024-11-30

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.

Conditions

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Breast Cancer Premenopausal Breast Cancer Hormone Receptor Positive Tumor

Keywords

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Premenopausal breast cancer Individualized interventions Exercise Combination hormone therapy Massage therapy Yoga Acupuncture Treatment tolerance Treatment adherence Adverse effects Quality of life

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Individualized interventions

Exercise, Yoga, massage therapy, acupuncture, and others

Group Type OTHER

Individualized interventions

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Saskatchewan

OTHER

Sponsor Role lead

Responsible Party

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Shahid Ahmed

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shahid Ahmed, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Saskatchewan

Locations

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Allan Blair Cancer Center

Regina, Saskatchewan, Canada

Site Status

Saskatoon Cancer Center

Saskatoon, Saskatchewan, Canada

Site Status

Countries

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Canada

Other Identifiers

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348455

Identifier Type: -

Identifier Source: org_study_id