PancFit: Multimodal Exercise During Preoperative Therapy for Pancreatic Cancer: A Randomized Trial Testing Effects on Fitness, Health-Related Quality of Life, and Tumor Vasculature
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- Change in 6 Minute Walk Test (6MWT)
研究概览
简要总结
Any time the words "you," "your," "I," or "me" appear, it is meant to apply to the potential participant.
The goal of this clinical research study is to learn if regular exercise and behavioral skills training can help to improve physical activity in patients with pancreatic cancer who are scheduled to receive chemotherapy and/or radiation before standard-of-care surgery.
This is an investigational study.
Up to 128 participants will be enrolled on this study. All will take part at MD Anderson.
详细描述
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study arms. This is done because no one knows if one study arm is better than, the same, or worse than the other group.
If you are in Arm A, you will not take part in a structured exercise program. If you are in Arm B, you will take part in a structured exercise program and behavioral skills training as described below.
Length of Study:
You will continue to take part in this study for up to 7 months after your scheduled standard-of-care surgery. However, if intolerable side effects occur or the disease appears to get worse, the study staff will decide if continuing the exercise program is in your best interest.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pancreatic cancer of any type, biopsy-proven
- •Scheduled to receive preoperative therapy (chemotherapy, radiation or chemoradiation) either on- or off-protocol.
- •Anticipated to undergo pancreatectomy in >/= 6 weeks from enrollment
- •Able to understand the description of the study and willing to participate
- •Able to understand the exercise program
- •Able to maintain daily exercise logs
- •Telephone or email access and agreement to engage with the research personnel via phone or email
- •Meet all screening requirements.
排除标准
- •Non-English speaking
- •Unable to complete the baseline assessment questionnaires or functional assessments
- •Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease (New York Heart Association functional class III or IV)
- •Recent fracture or acute musculoskeletal injury that precludes the ability to weight bear fully on all 4 limbs in order to participate in an exercise intervention
- •Numeric pain rating scale of >/= 7 out of 10
- •Myopathic or rheumatologic disease that impacts physical function
- •Recurrent cancer following prior resection
- •Neuroendocrine cancer
- •Completed preoperative therapy and are on their presurgical rest period.
研究组 & 干预措施
Arm A: Standard of Care (SOC)
After completion of chemotherapy and/or radiation, 3-6 weeks after surgery, and then 3-7 months after surgery: Participants complete 4 questionnaires about physical abilities, motivation, and quality of life. Participant's hand grip strength measured. Participants arm strength measured using an arm curl test. Participants asked to rise from a chair without using their arms to push off. Participants complete a 6-minute walk test to see how far participant can walk in 6 minutes. Participants complete a nutritional questionnaire and receive nutritional counseling. Participants receive educational materials and personalized counseling based on participant's answers.
Participants encouraged to remain active during chemotherapy and/or radiation. Participants receive a booklet that contains a stretching guide with full-body stretches and safety.
干预措施: Questionnaires (Behavioral)
Arm A: Standard of Care (SOC)
After completion of chemotherapy and/or radiation, 3-6 weeks after surgery, and then 3-7 months after surgery: Participants complete 4 questionnaires about physical abilities, motivation, and quality of life. Participant's hand grip strength measured. Participants arm strength measured using an arm curl test. Participants asked to rise from a chair without using their arms to push off. Participants complete a 6-minute walk test to see how far participant can walk in 6 minutes. Participants complete a nutritional questionnaire and receive nutritional counseling. Participants receive educational materials and personalized counseling based on participant's answers.
Participants encouraged to remain active during chemotherapy and/or radiation. Participants receive a booklet that contains a stretching guide with full-body stretches and safety.
干预措施: Nutritional Questionnaire and Nutritional Counseling (Behavioral)
Arm A: Standard of Care (SOC)
After completion of chemotherapy and/or radiation, 3-6 weeks after surgery, and then 3-7 months after surgery: Participants complete 4 questionnaires about physical abilities, motivation, and quality of life. Participant's hand grip strength measured. Participants arm strength measured using an arm curl test. Participants asked to rise from a chair without using their arms to push off. Participants complete a 6-minute walk test to see how far participant can walk in 6 minutes. Participants complete a nutritional questionnaire and receive nutritional counseling. Participants receive educational materials and personalized counseling based on participant's answers.
Participants encouraged to remain active during chemotherapy and/or radiation. Participants receive a booklet that contains a stretching guide with full-body stretches and safety.
干预措施: Booklet (Other)
Arm A: Standard of Care (SOC)
After completion of chemotherapy and/or radiation, 3-6 weeks after surgery, and then 3-7 months after surgery: Participants complete 4 questionnaires about physical abilities, motivation, and quality of life. Participant's hand grip strength measured. Participants arm strength measured using an arm curl test. Participants asked to rise from a chair without using their arms to push off. Participants complete a 6-minute walk test to see how far participant can walk in 6 minutes. Participants complete a nutritional questionnaire and receive nutritional counseling. Participants receive educational materials and personalized counseling based on participant's answers.
Participants encouraged to remain active during chemotherapy and/or radiation. Participants receive a booklet that contains a stretching guide with full-body stretches and safety.
干预措施: Physical Assessments (Behavioral)
Arm B: Multi-Modal Exercise and Nutrition Program (MMENP)
After completion of chemotherapy and/or radiation, 3-6 weeks after surgery, then 3-7 months after surgery: Participants complete 4 questionnaires about physical abilities, motivation, and quality of life. Participant's hand grip strength measured. Participants arm strength measured. Participants asked to rise from a chair without using their arms to push off. Participants complete a 6-minute walk test to see how far participant can walk in 6 minutes. Participants complete a nutritional questionnaire and receive nutritional counseling. Participants receive educational materials and personalized counseling based on participant's answers.
Participants complete moderate-intensity aerobic exercise 5 days each week. Participants complete strength training exercises 2 times per week.
Participants contacted by phone by member of study staff 1 time each week for the first 4 weeks, and then every 2 weeks after that for behavioral skills training and to see how participant is doing.
干预措施: Questionnaires (Behavioral)
Arm B: Multi-Modal Exercise and Nutrition Program (MMENP)
After completion of chemotherapy and/or radiation, 3-6 weeks after surgery, then 3-7 months after surgery: Participants complete 4 questionnaires about physical abilities, motivation, and quality of life. Participant's hand grip strength measured. Participants arm strength measured. Participants asked to rise from a chair without using their arms to push off. Participants complete a 6-minute walk test to see how far participant can walk in 6 minutes. Participants complete a nutritional questionnaire and receive nutritional counseling. Participants receive educational materials and personalized counseling based on participant's answers.
Participants complete moderate-intensity aerobic exercise 5 days each week. Participants complete strength training exercises 2 times per week.
Participants contacted by phone by member of study staff 1 time each week for the first 4 weeks, and then every 2 weeks after that for behavioral skills training and to see how participant is doing.
干预措施: Nutritional Questionnaire and Nutritional Counseling (Behavioral)
Arm B: Multi-Modal Exercise and Nutrition Program (MMENP)
After completion of chemotherapy and/or radiation, 3-6 weeks after surgery, then 3-7 months after surgery: Participants complete 4 questionnaires about physical abilities, motivation, and quality of life. Participant's hand grip strength measured. Participants arm strength measured. Participants asked to rise from a chair without using their arms to push off. Participants complete a 6-minute walk test to see how far participant can walk in 6 minutes. Participants complete a nutritional questionnaire and receive nutritional counseling. Participants receive educational materials and personalized counseling based on participant's answers.
Participants complete moderate-intensity aerobic exercise 5 days each week. Participants complete strength training exercises 2 times per week.
Participants contacted by phone by member of study staff 1 time each week for the first 4 weeks, and then every 2 weeks after that for behavioral skills training and to see how participant is doing.
干预措施: Aerobic Exercise and Strength Training Exercises (Behavioral)
Arm B: Multi-Modal Exercise and Nutrition Program (MMENP)
After completion of chemotherapy and/or radiation, 3-6 weeks after surgery, then 3-7 months after surgery: Participants complete 4 questionnaires about physical abilities, motivation, and quality of life. Participant's hand grip strength measured. Participants arm strength measured. Participants asked to rise from a chair without using their arms to push off. Participants complete a 6-minute walk test to see how far participant can walk in 6 minutes. Participants complete a nutritional questionnaire and receive nutritional counseling. Participants receive educational materials and personalized counseling based on participant's answers.
Participants complete moderate-intensity aerobic exercise 5 days each week. Participants complete strength training exercises 2 times per week.
Participants contacted by phone by member of study staff 1 time each week for the first 4 weeks, and then every 2 weeks after that for behavioral skills training and to see how participant is doing.
干预措施: Phone Calls (Behavioral)
Arm B: Multi-Modal Exercise and Nutrition Program (MMENP)
After completion of chemotherapy and/or radiation, 3-6 weeks after surgery, then 3-7 months after surgery: Participants complete 4 questionnaires about physical abilities, motivation, and quality of life. Participant's hand grip strength measured. Participants arm strength measured. Participants asked to rise from a chair without using their arms to push off. Participants complete a 6-minute walk test to see how far participant can walk in 6 minutes. Participants complete a nutritional questionnaire and receive nutritional counseling. Participants receive educational materials and personalized counseling based on participant's answers.
Participants complete moderate-intensity aerobic exercise 5 days each week. Participants complete strength training exercises 2 times per week.
Participants contacted by phone by member of study staff 1 time each week for the first 4 weeks, and then every 2 weeks after that for behavioral skills training and to see how participant is doing.
干预措施: Physical Assessments (Behavioral)
结局指标
主要结局
Change in 6 Minute Walk Test (6MWT)
时间窗: Change compared from baseline to date surgery is scheduled
Primary endpoint is the change in 6MWT distance, measured in meters, between the time at which preoperative therapy is administered (T0) and the time at which it ends (T1).
次要结局
未报告次要终点