A Combined Exercise Training Program for Women Living With Breast Cancer

University of Toronto

Status: Completed

Conditions: Breast Cancer

Treatments: Behavioral: Active Control; Behavioral: Combined Exercise + Behavioural Counselling

Study type: Interventional

Funder types: Other

Identifiers

NCT05704855

BCSPilot01

Details and patient eligibility

About

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.

Full description

Women living with and beyond breast cancer who received chemotherapy treatment are at a heightened risk for experiencing adverse mental health outcomes (i.e., anxiety, depression, self-efficacy and self esteem) and declines in cognitive function (i.e., impairments to memory, learning, concentration, reasoning, executive function, attention, processing speed and/or visual-spatial skills deficits) compared to those without a history of cancer. These effects may be worsened among those who received chemotherapy treatment and may persist for up to 5 and 20 years following chemotherapy treatment completion, respectively. The COVID-19 pandemic has exacerbated existing adversities in the mental health of women living with and beyond breast cancer due to reduced social opportunities, greater sedentary time, fear of susceptibility to the virus and barriers to in-person support services. Physical activity (PA) may be used to manage mental health adversities and improve QoL among women living with and beyond breast cancer. In addition, preliminary evidence has demonstrated the potential mediating effect of PA on cognitive impairments among women living with and beyond breast cancer. Remote-based interventions could be an effective option to increase PA during the COVID-19 pandemic while maintaining physical distancing protocols. In addition, the combination of exercise with group-based counselling has been found to be feasible and provide favourable improvements in depression, self-efficacy, social support, and quality of life and long-term PA maintenance among women living with and beyond breast cancer, compared to exercise interventions alone. However, no studies have evaluated the feasibility and impact of a supervised, remotely delivered, combined (i.e., aerobic and resistance) exercise + behaviour counselling program on mental health and cognitive function in women living with and beyond breast cancer following chemotherapy treatment. Using a mixed-method approach, this study will address these gaps by evaluating the feasibility of a supervised, remotely delivered combined (i.e., aerobic and resistance) exercise and behavioural counselling program for mental health and cognitive function in women living with and beyond breast cancer. This project is necessary given the remote-based format of exercise delivery that has been adopted because of the COVID-19 pandemic and the need for programs to be adapted to an environment that is safe and reliable to deliver to women living with and beyond breast cancer.

Enrollment: 21 patients

Sex: Female

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• 40 - 65 years of age
• primary diagnosis of stage I-III breast cancer (non-metastatic)
• received chemotherapy within the past 12-48 months from enrollment
• experience mild cognitive impairment as determined by the TICS [scores between 28-31 to separate individuals with dementia (range a to b) and normal cognition (range c to d)] (Knopman et al., 2010)
• self-reported low-active defined as <3 days of exercise (<20 min/day) per week in the previous six months (Godin & Shephard, 1985)
• physician clearance to participate in testing and exercise
• no previous invasive cancer
• no neurological or musculoskeletal co-morbidity inhibiting exercise
• access to a webcam and internet for videoconferencing
• English fluency.

Exclusion Criteria:

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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21 participants in 2 patient groups

Combined Exercise + Behavioural Counselling

Experimental group

Description:

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.

Treatment:

Behavioral: Combined Exercise + Behavioural Counselling

Active Control

Active Comparator group

Description:

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.

Treatment:

Behavioral: Active Control