A Combined Exercise Training Program for Women Living With Breast Cancer

NCT05704855 | Completed

• 1 other identifier: BCSPilot01
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

Women living with and beyond breast cancer are at a heightened risk for experiencing adverse mental health outcomes and declines in cognitive function following chemotherapy treatment. Women living with and beyond breast cancer have reported increased levels of anxiety and depression during the COVID-19 pandemic which may have significantly impacted their quality of life (QoL). Physical activity (PA) may be used to manage mental health and improve cognitive function in women living with and beyond breast cancer. Research is needed to assess the feasibility of a supervised, remotely delivered, combined (i.e., aerobic + resistance) exercise program to improve cognitive function and manage adverse mental health in women living with and beyond breast cancer. This study will pilot an 8-week, remotely delivered, combined (i.e., aerobic + resistance) exercise and behavioural counselling intervention on cognitive function and mental health outcomes (i.e.,anxiety, depression, self-efficacy and self esteem) in women living with breast cancer who received chemotherapy treatment within 12-48 months.

Conditions

Breast Cancer

Keywords

physical activity; chemotherapy treatment; cancer-related cognitive impairment; feasibility; mental health

Outcome Measures

Primary Outcomes (5)

• Enrolment rate

  Participant enrolment rate will be one measure of feasibility. This will be calculated by measuring the amount of participants who enrolled in the intervention, divided by the number of participants who were assessed for eligibility.

  Change from baseline (pre-intervention) to post-intervention (8 weeks).

• Adherence rate

  Adherence rate of participants to the intervention, will be one measure of feasibility. This will be measured by calculating the number of exercise sessions participants attend, divided by the total number of exercise sessions that took place in the intervention.

  Change from baseline (pre-intervention) to post-intervention (8 weeks).

• Attrition rate

  Attrition will be one measure of feasibility. This will be measured by calculating the number of participants who did not complete the intervention, divided by the number of participants who completed the entirety of the intervention

  Change from baseline (pre-intervention) to post-intervention (8 weeks).

• Burden and satisfaction

  Burden and satisfaction scores will be one measure of feasibility. This will be assessed using a researcher-generated 15-item questionnaire that asks participants about their experience with the intervention and assessments. Participants will rate items using a 5-point Likert scale (1= 'strongly disagree', 5 = 'strongly agree').

  Change from baseline (pre-intervention) to post-intervention (8 weeks).

• Adverse events

  Adverse events will be one measure of feasibility. This will be assessed as an unexpected and severe medical problem or injury that occurs during the exercise classes.

  Change from baseline (pre-intervention) to post-intervention (8 weeks).

Secondary Outcomes (12)

• Executive/Attention

  Change from baseline (pre-intervention) to post-intervention (8 weeks).

• Episodic Memory

  Change from baseline (pre-intervention) to post-intervention (8 weeks).

• Language

  Change from baseline (pre-intervention) to post-intervention (8 weeks).

• Crystallized Cognition

  Change from baseline (pre-intervention) to post-intervention (8 weeks).

• Immediate Recall

  Change from baseline (pre-intervention) to post-intervention (8 weeks).

Study Arms (2)

Combined Exercise + Behavioural Counselling

EXPERIMENTAL

The combine exercise intervention will consist of three 30-minute, supervised, remotely-delivered resistance training classes as well as three 30-minute, unsupervised aerobic training (i.e., walking) items each week. Participants will also participate in bi-weekly, 30-40 minute, remotely-delivered behavioural counselling sessions delivered via videoconferencing (i.e., Zoom). The program will be taught by a Registered Kinesiologist via videoconferencing (i.e., Zoom). Participants will be asked to participate in the intervention for 8 weeks.

Behavioral: Combined Exercise + Behavioural Counselling

Active Control

ACTIVE COMPARATOR

The active control group will participate in three 30-minute, supervised, remotely-delivered classes targeting balance and flexibility. The program will be delivered at a low-intensity by a Registered Kinesiologist via videoconferencing (i.e., Zoom). Participants will be asked to participate in the program for 8 weeks.

Behavioral: Active Control

Interventions

Combined Exercise + Behavioural Counselling BEHAVIORAL

The combine exercise intervention will consist of three 30-minute, supervised, remotely-delivered resistance training classes as well as three 30-minute, unsupervised aerobic training (i.e., walking) sessions each week. Participants will also participate in bi-weekly, 45-60 minute, remotely-delivered, group-based behavioural counselling sessions delivered via videoconferencing (i.e., Zoom). Participants will be asked to participate in the intervention for 8 weeks.

Combined Exercise + Behavioural Counselling

Active Control BEHAVIORAL

The active control group will participate in three 30-minute, supervised, remotely-delivered classes targeting balance and flexibility. The program will be delivered at a low-intensity by a Registered Kinesiologist via videoconferencing (i.e., Zoom). Participants will be asked to participate in the program for 8 weeks.

Active Control

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• previous invasive cancer
• neurological or musculoskeletal co-morbidity inhibiting exercise

Sponsors & Collaborators

• University of Toronto: lead

Study Sites (1)

Faculty of Kinesiology and Physical Education, University of Toronto

Toronto, Ontario, M5S2W6, Canada

Location

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MeSH Terms

Conditions

Breast Neoplasms; Motor Activity; Psychological Well-Being

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior; Personal Satisfaction

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Linda Trinh, PhD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participants will only be aware that the researchers are comparing two exercise conditions and therefore will be blinded to the study hypotheses.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants will be randomized to one of two conditions: combined exercise (aerobic + resistance training) or stretching/toning (active control). They will receive a home-based program lasting 1 hour on 3 days per week for 12 weeks. Randomization will be performed using a computer-generated program in blocks of four for even distribution between study conditions. BCS will be assigned in a 1:1 ratio to one of two study conditions, stratified by treatment type (anthracycline vs. non-anthracycline chemotherapy; hormonal vs. no hormonal therapy).

Study Record Dates

• First Submitted: January 10, 2023
• First Posted: January 30, 2023
• Study Start: February 1, 2023
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: November 28, 2023

Record last verified: 2023-11

Locations

CA (1)