A Combined Exercise Training Program for Women Living With Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): Combined Exercise + Behavioural Counselling; Active Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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).
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: physical activity; chemotherapy treatment; cancer-related cognitive impairment; feasibility; mental health