PancStrength: Safety, Feasibility, and Acceptability of a Tele-Exercise Resistance Training Intervention During Pancreatic Cancer Treatment
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Post-exercise muscle soreness
研究概览
简要总结
This clinical trial studies the safety of a real-time tele-exercise resistance training (training done using a tablet) in maintaining skeletal muscle, strength, physical function, and health-related quality of life in patients with pancreatic cancer who are receiving combination chemotherapy or have undergone surgery for the treatment of pancreatic cancer. Tele-exercise resistance training may improve physical function and quality of life in patients with pancreatic cancer.
详细描述
PRIMARY OBJECTIVE:
I. Evaluate the safety of a progressive, home-based, tele-exercise resistance training (tele-RT) intervention in patients undergoing first line FOLFIRINOX chemotherapy for advanced pancreatic ductal adenocarcinoma (PDAC) (Study 1) and in survivors who have undergone pancreatic cancer resection (Study 2).
SECONDARY OBJECTIVES:
I. Evaluate the feasibility and acceptability of the tele-RT intervention.
II. Evaluate changes in the following exploratory outcome measures over the course of first-line FOLFIRINOX for advanced PDAC and associations between resistance training (RT) volumes and their changes:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- 是
入选标准
- •Biopsy-proven pancreatic adenocarcinoma, advanced stage (III-IV) (study 1) OR biopsy-proven pancreatic adenocarcinoma, at least 10 weeks post-surgical tumor resection and currently with no radiographic evidence of disease on recent computerized tomography (CT) scan (study 2)
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- •Treatment plan of first-line FOLFIRINOX chemotherapy with planned return visit to MD Anderson Main Campus for restaging (study 1) OR plans to return to MDACC for restaging appointments in 3-4 months, including follow up CT scan (study 2)
- •Able to schedule baseline (T0) appointment for fitness testing and program teaching at the Behavioral Research and Treatment Center (BRTC) or able to schedule remote fitness testing and program teaching
- •Able to understand the description of the study, exercise program, and willing to participate
- •Home access to wireless internet (Wi-Fi) and agreement to engage with study personnel for real-time tele-RT sessions
- •Age >= 18
- •Meet all screening requirements
- •PROVIDERS (FOR ACCEPTABILITY INTERVENTION): All GI medical oncologists, GI surgeons, advanced practice providers, and clinical dietitians who are involved in participants' care and have some interaction with intervention personnel during recruitment, referral, scheduling, or follow up will be asked to complete questionnaires assessing intervention acceptability. The exact number of providers who will be asked to complete questionnaires will depend on whether patients enroll from the different GI Medical Oncology and GI Surgery clinics, but we expect 10-20 providers to be eligible
排除标准
- •Non-English speaking
- •Has participated in regular RT (RT for all major muscle groups at least twice per week) throughout the month prior to recruitment
- •Unable to complete the baseline assessment questionnaires or functional assessments
- •Screen failure for exercise safety based on Physical Activity Readiness Questionnaire (PAR-Q) and/or Patient Reported Outcomes Measurement Information System (PROMIS) questions
- •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
- •FEMALES ONLY: Known pregnancy, as communicated to study personnel by clinicians in gastrointestinal (GI) Medical Oncology; females of childbearing potential receive advice to use methods of contraception per usual care
研究组 & 干预措施
Supportive care (resistance training)
SEE DETAILED DESCRIPTION.
干预措施: Educational Intervention (Other)
Supportive care (resistance training)
SEE DETAILED DESCRIPTION.
干预措施: Quality-of-Life Assessment (Other)
Supportive care (resistance training)
SEE DETAILED DESCRIPTION.
干预措施: Questionnaire Administration (Other)
Supportive care (resistance training)
SEE DETAILED DESCRIPTION.
干预措施: Resistance Training (Other)
结局指标
主要结局
Post-exercise muscle soreness
时间窗: 3-4 months
Soreness will be assessed at the beginning of each tele-RT session, with participants asked to describe how soreness has changed since the previous RT session and how soreness has changed over the course of RT sessions. If soreness is not becoming more manageable with ongoing RT, participants will be referred to Dr. Ngo-Huang (study co-principal investigator \[PI\] and physiatrist) for follow-up to rule out any underlying injuries.
Safety of the tele-resistance training (RT) program
时间窗: 3-4 months
Safety will be assessed based on the rate of musculoskeletal injuries and other adverse health events that participants incur while participating in tele-RT sessions. Participants will be monitored throughout the exercise intervention for musculoskeletal injuries and other adverse health events and referred to a Physical Medicine and Rehabilitation physician or their gastrointestinal (GI) Medical Oncology teams as necessary. The association of the injury with strength training will be assessed by asking participants to rate the injury on a scale of 1-4 (1=not related, 2=unlikely related, 3=likely related, 4=definitely related). The severity of the injury will be rated on a scale of 1-4 (1=mild/no change in daily activity, 2=some limitation of daily activity, 3=major limitation of daily activity, 4=life threatening). The duration for which daily activities were impacted will be rated on a scale from 1-5 (1=no change, 2=1-3 days, 3=4-7 days, 4=1-2 weeks, 5=more than 2 weeks).
Body composition
时间窗: 3-4 months
Cross-sectional areas (CSA) of skeletal muscle, intramuscular fat, visceral fat, and subcutaneous fat will be measured using SliceOMatic software (TomoVision, 2012) using computed tomography images routinely obtained for cancer assessment and staging purposes. Imaging dates will align with cancer staging and restaging appointments at T0 and T1. Cross-sectional areas at the L3 vertebral level will be standardized to the square of participants' heights in meters. Average radiodensity (in Hounsfield Units) of skeletal muscle will also be collected using SliceOMatic software.
Aerobic fitness
时间窗: 3-4 months
Will be measured using 6-minute walk test (6MWT) distance, measured in meters. For participants who undergo remote exercise testing, the 2-minute step test will be used to assess aerobic fitness. Participants will be guided to step in place as quickly as possible, raising each knee to the proper height (midway between the opposite knee and hip), with trainers recording the number of complete steps they can complete in 2 minutes.
次要结局
- Acceptability for participants(3-4 months)
- Acceptability for providers(3-4 months)
- Dynamic upper- and lower-body muscular strength(3-4 months)
- Dynamic upper- and lower-body muscular endurance(3-4 months)
- Chemotherapy tolerance and delivery(3-4 months)
- Acceptability for Feasibility(3-4 months)
- Self-reported physical activity(3-4 months)
- Fatigue(3-4 months)
- Health-related QOL(3-4 months)
- Chemotherapy-induced peripheral neuropathy (CIPN)(3-4 months)
- Exercise barriers self-efficacy(3-4 months)
- Exercise motivation(3-4 months)
- Social support for exercise(3-4 months)
- Self-reported physical functioning(3-4 months)
- Feasibility of Automated Self Assisted 24-hour recall (ASA24) (24-hour dietary recall)(At time of enrollment up to 7-10 days before date of surgery)