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

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ClinicalTrials.gov Identifier: NCT03407768
Recruitment Status : Not yet recruiting
First Posted : January 23, 2018
Last Update Posted : May 21, 2018
Sponsor:
Information provided by (Responsible Party):
Shahid Ahmed, University of Saskatchewan

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Premenopausal Breast Cancer Hormone Receptor Positive Tumor Behavioral: Individualized interventions Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : June 1, 2018
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : May 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.





Primary Outcome Measures :
  1. Functional Assessment of Cancer Therapy - Breast Symptom Index (FACT-B) [ Time Frame: Up to three years from the time of enrolment ]
    For global assessment of quality of life of women with breast cancer


Secondary Outcome Measures :
  1. Functional Assessment of Cancer Therapy - Endocrine System (FACT-ES) [ Time Frame: Up to three years from the time of enrolment ]
    For the assessment of quality of life of women with breast cancer on endocrine therapy

  2. Functional Assessment of Cancer Therapy - (FACT)-Cognitive [ Time Frame: Up to three years from time of enrolment ]
    For the assessment of self-reported cognitive function

  3. Treatment discontinuation rate [ Time Frame: Up to three years from the time of enrolment ]
    Rate of combination of endocrine treatment at 3 year.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03407768


Contacts
Contact: Shahid Ahmed 3066552710 shahid.ahmed@saskcancer.ca

Locations
Canada, Saskatchewan
Allan Blair Cancer Center
Regina, Saskatchewan, Canada
Saskatoon Cancer Center Not yet recruiting
Saskatoon, Saskatchewan, Canada, S7N4H4
Contact: Shahid Ahmed    3066552710    shahid.ahmed@saskcancer.ca   
Sub-Investigator: Anne Leis         
Sub-Investigator: Lynn Dwernychuk         
Sub-Investigator: Saija Kontulainen         
Sub-Investigator: Deb Bulych         
Sub-Investigator: June Lim         
Sub-Investigator: Amer Sami         
Sub-Investigator: Donelda Gwen-Moody         
Sponsors and Collaborators
University of Saskatchewan
Investigators
Principal Investigator: Shahid Ahmed, MD, PhD University of Saskatchewan

Responsible Party: Shahid Ahmed, MD, University of Saskatchewan
ClinicalTrials.gov Identifier: NCT03407768     History of Changes
Other Study ID Numbers: 348455
First Posted: January 23, 2018    Key Record Dates
Last Update Posted: May 21, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: If requested in future after meeting all the regulatory requirement data will be shared.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Shahid Ahmed, University of Saskatchewan:
Premenopausal breast cancer
Individualized interventions
Exercise
Combination hormone therapy
Massage therapy
Yoga
Acupuncture
Treatment tolerance
Treatment adherence
Adverse effects
Quality of life

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases