A Remotely-Delivered, Combined Exercise Training Program for Cognitive Function in Women Living With and Beyond Breast Cancer: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Adherence rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
The participants will only be aware that the researchers are comparing two exercise conditions and therefore will be blinded to the study hypotheses.
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •previous invasive cancer
- •neurological or musculoskeletal co-morbidity inhibiting exercise
研究组 & 干预措施
Combined Exercise + Behavioural Counselling
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.
干预措施: Combined Exercise + Behavioural Counselling (Behavioral)
Active Control
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.
干预措施: Active Control (Behavioral)
结局指标
主要结局
Adherence rate
时间窗: Change from baseline (pre-intervention) to post-intervention (8 weeks).
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.
Adverse events
时间窗: Change from baseline (pre-intervention) to post-intervention (8 weeks).
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.
Enrolment rate
时间窗: Change from baseline (pre-intervention) to post-intervention (8 weeks).
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.
Attrition rate
时间窗: Change from baseline (pre-intervention) to post-intervention (8 weeks).
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
Burden and satisfaction
时间窗: Change from baseline (pre-intervention) to post-intervention (8 weeks).
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').
次要结局
- Language(Change from baseline (pre-intervention) to post-intervention (8 weeks).)
- Episodic Memory(Change from baseline (pre-intervention) to post-intervention (8 weeks).)
- Processing Speed(Change from baseline (pre-intervention) to post-intervention (8 weeks).)
- Semi-structured qualitative interviews(Post-intervention (8 weeks).)
- Immediate Recall(Change from baseline (pre-intervention) to post-intervention (8 weeks).)
- Objectively-assessed physical activity(Change from baseline (pre-intervention) to post-intervention (8 weeks).)
- Executive/Attention(Change from baseline (pre-intervention) to post-intervention (8 weeks).)
- Self-reported anxiety and depression(Change from baseline (pre-intervention) to post-intervention (8 weeks).)
- Self-esteem(Change from baseline (pre-intervention) to post-intervention (8 weeks).)
- Crystallized Cognition(Change from baseline (pre-intervention) to post-intervention (8 weeks).)
- Self-efficacy(Change from baseline (pre-intervention) to post-intervention (8 weeks).)
- Therapeutic alliance(Post-intervention (8 weeks).)
研究者
Linda Trinh
Assistant Professor
University of Toronto