Promoting Physical Activity Through Supervised vs Motivational Behavior Change Interventions in Breast Cancer Survivors on Aromatase Inhibitors (PAC-WOMAN): A 3-arm Pragmatic Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 122
- 试验地点
- 2
- 主要终点
- Change from baseline in self-reported physical activity on International Physical Activity Questionnaire (IPAQ-sf) at 16 months
研究概览
简要总结
Aromatase inhibitors (AI) are frequently used to treat hormone-receptor-positive breast cancer, but they have multiple adverse effects (eg, arthralgia), resulting in premature therapy discontinuation/switch. Physical activity (PA) can attenuate these negative effects and improve quality of life (QoL). However, most cancer survivors fail to perform/sustain adequate PA levels, especially in the long-term. Theory-based interventions, using evidence-based behavior change techniques, aimed at promoting long-term behavior change in breast cancer survivors are effective, but remain scarce and fail to promote self-regulatory skills and better-quality motivations associated with sustained PA adoption.
PAC-WOMAN will test the long-term effectiveness and cost-effectiveness of two state of the art, group-based interventions encouraging sustained changes in PA, sedentary behavior, and QoL. Additional aims include examining the impact of both interventions on secondary outcomes (eg, body composition, physical function), and key moderators/mediators of short and long-term changes in primary outcomes. A 3-arm pragmatic randomized controlled trial, involving a 4-month intervention and a 12-month follow-up, will be implemented, in a real exercise setting, to compare: 1) brief PA counseling/motivational intervention; 2) structured exercise program vs. waiting-list control group. Study recruitment goal is 122 hormone-receptor-positive breast cancer survivors (stage I-III), on AI therapy (post-primary treatment completion) ≥1 month, performance status 0-1. Outcome measures will be obtained at baseline, 4 months (i.e., post-intervention), 10 and 16 months. Process evaluation, analyzing implementation determinants, will also be conducted.
PAC-WOMAN is expected to have a relevant impact on participants PA and QoL, and on the improvement of interventions designed to promote sustained adherence to active lifestyle behaviors, facilitating its translation to community settings.
详细描述
Aromatase inhibitors (AI) are frequently used to treat hormone-receptor-positive breast cancer, but they have multiple adverse effects (eg, osteoporosis, arthralgia), resulting in premature therapy discontinuation/switch. Physical activity (PA) is safe and should be an integral and continuous part of care for all individuals diagnosed with cancer. There is compelling evidence suggesting that PA plays an important role in improving longevity among cancer survivors. PA effectively ameliorates short- and long-term adverse effects of cancer therapies (eg, comorbid conditions, improves physical fitness and function, attenuates cancer-related fatigue, enhances body image and quality of life (QoL), and decreases cancer recurrence and mortality. PA also allows women to benefit from endocrine therapy while being protected against the related risk of osteoporosis, fracture, and ultimately cancer recurrence or death. Thus, PA in breast cancer survivors, and specifically among women on AIs, is paramount to improve health outcomes, QoL, and prevent therapy discontinuation. However, most cancer survivors fail to meet established guidelines for PA.
Theory-based interventions, using evidence-based behavior change techniques, aimed at promoting long-term health behavior change in breast cancer survivors are effective, but remain scarce and predominantly focused on short-term adherence/outcomes. Also, most interventions fail to provide validated self-regulatory tools or explore meaningful links between PA and patients' values and life aspirations to foster lasting behavior changes. Prior research has shown that internal (better quality) forms of motivation play an important role in PA and behavior sustainability, suggesting that self-determination theory (SDT) can be a valid framework to promote sustained adherence to PA. A need-supportive intervention climate enhances people's wellbeing and their ability to self-regulate and sustain behavior changes. Finally, skills such as self-monitoring, goal setting or action planning have also been identified as important mediators of long-term PA and as core features of effective behavior change/maintenance interventions in breast cancer survivors.
In sum, although regular PA is a promising and safe way of helping cancer survivors navigate their disease, alleviating the growing pressure on the health care system, most cancer survivors do not meet the recommended PA doses. It is a goal of this project to overcome the abovementioned shortcomings, by testing an intervention model informed by solid evidence and a robust theoretical rationale (SDT), provided by qualified exercise professionals, which appear to add value to the treatment process, improving the therapeutic effect and safety of the exercise practice.
PAC-WOMAN will test the long-term effectiveness and cost-effectiveness of two 4-month group-based interventions aimed at promoting sustained changes in PA, sedentary behavior, and QoL. Additional aims include examining the impact of both interventions on secondary outcomes (eg, body composition, physical function), and key moderators and mediators of short and long-term changes in primary outcomes. A 3-arm randomized controlled trial, involving a 4-month intervention period and a 12-month follow-up, will be implemented to compare: 1) a brief PA counseling intervention; 2) a structured exercise program; and 3) a. waiting-list control group. Study recruitment goal is 122 breast cancer survivors with hormone-receptor-positive breast cancer (stage I-III), on AI therapy (post-primary treatment completion) for at least 1 month, ECOG performance status 0-1. Outcome measures will be obtained at baseline, 4 months (i.e., post-intervention), 10 and 16 months. Process evaluation, analyzing implementation determinants, will also be conducted.
PAC-WOMAN is expected to have a relevant impact on the improvement of interventions designed to promote sustained adherence to active lifestyle behaviors and facilitate its translation to community settings.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •post-menopausal women, below 70 years old;
- •histologically confirmed hormone-receptor-positive breast cancer (stage I, II, III);
- •having initiated aromatase inhibitor hormonal therapy following the primary treatment (surgery, radiotherapy, chemotherapy, etc.), at least 1 month before being enrolled;
- •ECOG-Performance Status 0-1.
排除标准
- •evidence of stage IV cancer or synchronous tumors;
- •uncontrolled hypertension, cardiac or pulmonary disease;
- •contraindications to exercise training according to the assistant doctor;
- •inability to provide informed consent;
- •expected inability to fulfill the proposed schedule.
结局指标
主要结局
Change from baseline in self-reported physical activity on International Physical Activity Questionnaire (IPAQ-sf) at 16 months
时间窗: baseline and 16 months
The 9-item IPAQ-sf measures the weekly frequency and duration of PA across three specific intensities (i.e., light, moderate, and vigorous), and time spent sitting during week and weekend days. Scores for weekly minutes of total physical activity, and discriminated by intensity, will be obtained. Total minutes of sitting time will be also obtained.
Change from baseline in self-reported physical activity on International Physical Activity Questionnaire (IPAQ-sf) at 4 months
时间窗: baseline and 4 months
The 9-item IPAQ-sf measures the weekly frequency and duration of PA across three specific intensities (i.e., light, moderate, and vigorous), and time spent sitting during week and weekend days. Scores for weekly minutes of total physical activity, and discriminated by intensity, will be obtained. Total minutes of sitting time will be also obtained.
Change from baseline in self-reported physical activity on International Physical Activity Questionnaire (IPAQ-sf) at 10 months
时间窗: baseline and 10 months
The 9-item IPAQ-sf measures the weekly frequency and duration of PA across three specific intensities (i.e., light, moderate, and vigorous), and time spent sitting during week and weekend days. Scores for weekly minutes of total physical activity, and discriminated by intensity, will be obtained. Total minutes of sitting time will be also obtained.
Change from baseline in Physical activity on Actigraph GT9X accelerometers at 10 months
时间窗: baseline and 10 months
Accelerometers Actigraph GT9X will be worn in the wrist for 7 days to assess the amount of activity expressed as minutes per day spent in different intensities (sedentary, light, moderate, vigorous).
Change from baseline in Physical activity on Actigraph GT9X accelerometers at 16 months
时间窗: baseline and 16 months
Accelerometers Actigraph GT9X will be worn in the wrist for 7 days to assess the amount of activity expressed as minutes per day spent in different intensities (sedentary, light, moderate, vigorous).
Change from baseline in Physical activity on Actigraph GT9X accelerometers at 4 months
时间窗: baseline and 4 months
Accelerometers Actigraph GT9X will be worn in the wrist for 7 days to assess the amount of activity expressed as minutes per day spent in different intensities (sedentary, light, moderate, vigorous).
Change from baseline in cancer-related quality of fife on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and its breast cancer module (EORTC-BR23) at 16 months
时间窗: baseline and 16 months
The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and its breast cancer module (EORTC QLQ-BR23). Five items specifically related to joint, bone, and muscle pain/discomfort, derived from the new EORTC QLQ-BR45, were added provided the specificity of aromatase inhibitors' side effects. Scores generally range from 1 to 4. Higher scores generally reflect worse quality of life.
Change from baseline in cancer-related quality of fife on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and its breast cancer module (EORTC-BR23) at 4 months
时间窗: baseline and 4 months
The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and its breast cancer module (EORTC QLQ-BR23). Five items specifically related to joint, bone, and muscle pain/discomfort, derived from the new EORTC QLQ-BR45, were added provided the specificity of aromatase inhibitors' side effects. Scores generally range from 1 to 4. Higher scores generally reflect worse quality of life.
Change from baseline in cancer-related quality of fife on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and its breast cancer module (EORTC-BR23) at 10 months
时间窗: baseline and 10 months
The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and its breast cancer module (EORTC QLQ-BR23). Five items specifically related to joint, bone, and muscle pain/discomfort, derived from the new EORTC QLQ-BR45, were added provided the specificity of aromatase inhibitors' side effects. Scores generally range from 1 to 4. Higher scores generally reflect worse quality of life.
Healthcare Use
时间窗: 6-month after the end of the intervention
Healthcare use will be assessed by phone interview 6 months after ending the intervention period. Data will be collected on healthcare resources use during the study period, namely number and type of consultations, drugs, medical tests and exams, in-patient stays and day care sessions. Absenteeism will be assessed using participants' reports of their number of absence days or percentage of normal working hours worked, valued at patients' hourly wage. These resources will then be valued using usual official sources.
次要结局
- Change from baseline in body composition on bioelectrical impedance at 16 months(baseline, 4 months (intervention's end), 10 and 16 months)
- Change from baseline in body mass index (BMI) at 16 months(baseline and 16 months)
- Change from baseline in body composition on bioelectrical impedance at 4 months(baseline and 4 months)
- Change from baseline in body composition on bioelectrical impedance at 10 months(baseline and 10 months)
- Change from baseline in body mass index (BMI) at 4 months(baseline and 4 months)
- Change from baseline in body mass index (BMI) at 10 months(baseline and 10 months)
- Change from baseline in cardio-respiratory fitness at 16 months(baseline and 16 months)
- Change from baseline in cardio-respiratory fitness at 4 months(baseline and 4 months)
- Change from baseline in cardio-respiratory fitness at 10 months(baseline and 10 months)
- Change from baseline in strength at 16 months(baseline and 16 months)
- Change from baseline in strength at 4 months(baseline and 4 months)
- Change from baseline in strength at 10 months(baseline and 10 months)
- Change from baseline in physical function on the Stand on one foot Test at 16 months(baseline and 16 months)
- Change from baseline in physical function on the Stand on one foot Test at 4 months(baseline and 4 months)
- Change from baseline in physical function on the Stand on one foot Test at 10 months(baseline and 10 months)
- Change from baseline in physical function on the Sit to Stand Test at 16 months(baseline and 16 months)
- Change from baseline in physical function on the Sit to Stand Test at 10 months(baseline and 10 months)
- Change from baseline in flexibility using angular measures at 16 months(baseline and 16 months)
- Change from baseline in flexibility using angular measures at 4 months(baseline and 4 months)
- Change from baseline in flexibility using angular measures at 10 months(baseline and 10 months)
- Change from baseline in pain severity on the Brief Pain Inventory at 4 months(baseline and 4 months)
- Change from baseline in pain severity on the Brief Pain Inventory at 10 months(baseline and 10 months)
- Change from baseline in pain interference on the Pain Disability Index at 4 months(baseline and 4 months)
- Change from baseline in physical function on the Sit to Stand Test at 4 months(baseline and 4 months)
- Change from baseline in physical function on the Timed up and go Test at 16 months(baseline and 16 months)
- Change from baseline in physical function on the Timed up and go Test at 4 months(baseline and 4 months)
- Change from baseline in pain interference on the Pain Disability Index at 16 months(baseline and 16 months)
- Change from baseline in pain interference on the Pain Disability Index at 10 months(baseline and 10 months)
- Change from baseline in physical function on the Timed up and go Test at 10 months(baseline and 10 months)
- Change from baseline in flexibility using linear measures at 16 months(baseline and 16 months)
- Change from baseline in flexibility using linear measures at 4 months(baseline and 4 months)
- Change from baseline in Body Image on the Body Image Scale at 10 months(baseline and 10 months)
- Change from baseline in depressive symptoms on the Hospital Anxiety and Depression Scale at 16 months(baseline and 16 months)
- Change from baseline in psychological well-being at 4 months(baseline and 4 months)
- Change from baseline in exercise motivations on the Behavioral Regulation in Exercise Questionnaire-3 at 10 months(baseline and 10 months)
- Change from baseline in flexibility using linear measures at 10 months(baseline and 10 months)
- Change from baseline in pain severity on the Brief Pain Inventory at 16 months(baseline and 16 months)
- Change from baseline in depressive symptoms on the Hospital Anxiety and Depression Scale at 4 months(baseline and 4 months)
- Change from baseline in psychological well-being at 16 months(baseline and 16 months)
- Change from baseline in psychological well-being at 10 months(baseline and 10 months)
- Change from baseline in exercise motivations on the Behavioral Regulation in Exercise Questionnaire-3 at 16 months(baseline and 16 months)
- Change from baseline in sleep quality on the Pittsburgh Sleep Quality Index at 16 months(baseline and 16 months)
- Change from baseline in Body Image on the Body Image Scale at 16 months(baseline and 16 months)
- Change from baseline in sleep quality on the Pittsburgh Sleep Quality Index at 4 months(baseline and 4 months)
- Change from baseline in depressive symptoms on the Hospital Anxiety and Depression Scale at 10 months(baseline and 10 months)
- Change from baseline in sleep quality on the Pittsburgh Sleep Quality Index at 10 months(baseline and 10 months)
- Change from baseline in Body Image on the Body Image Scale at 4 months(baseline and 4 months)
- Change from baseline in exercise motivations on the Behavioral Regulation in Exercise Questionnaire-3 at 4 months(baseline and 4 months)
- Change from baseline in Exercise Needs Satisfaction and Frustration at 16 months(baseline and 16 months)
- Change from baseline in Exercise Needs Satisfaction and Frustration at 4 months(baseline and 4 months)
- Change from baseline in Exercise Needs Satisfaction and Frustration at 10 months(baseline and 10 months)
- Change from baseline in Affective Response to Exercise at 10 months(baseline and 10 months)
- Change from baseline in Affective Response to Exercise at 16 months(baseline and 16 months)
- Perceived intervention climate(4 months (intervention's end))
- Change from baseline in Affective Response to Exercise at 4 months(baseline and 4 months)
- Change from baseline in Exercise Self-Efficacy at 16 months(baseline and 16 months)
- Change from baseline in Exercise Self-Efficacy at 4 months(baseline and 4 months)
- Change from baseline in Exercise Self-Efficacy at 10 months(baseline and 10 months)
- Self-regulation skills(4 months (intervention's end), 10 and 16 months)