Tele-PancFit: A Multi-site Trial of Video-based Strengthening Exercise Prehabilitation for Patients With Resectable Pancreatic Cancer
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Safety and adverse events (AEs)
研究概览
简要总结
To learn if a supervised exercise program during chemotherapy treatments can help to improve outcomes in patients who have been diagnosed with pancreatic cancer
详细描述
Primary Objectives:
Compare the rate of adjuvant chemotherapy initiation in patients who receive Tele-PancFit (telesupervised strengthening and remotely-monitored moderate intensity aerobic exercise) versus an enhanced usual care group who receive general recommendations for physical activity and receive an activity tracker.
Hypothesis: Tele-PancFit participation (Arm B) will improve the rate of adjuvant therapy compared to enhanced usual care (Arm A).
Secondary Objectives:
- Determine the effects of Tele-PancFit intervention on HRQOL among patients with localized PDAC, including the change of the HRQOL over time and the between study groups.
- Compare skeletal muscle maintenance indicated by SMI using CT between patients in the exercise and UC groups of the Tele-PancFit intervention.
- Define the effects of Tele-PancFit participation on tumor vascular density and maturity among patients undergoing neoadjuvant chemotherapy for PDAC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- 否
入选标准
- •In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- •Provision of signed and dated informed consent form
- •Biopsy-proven pancreatic adenocarcinoma, resectable/borderline resectable (T1-3, N0-2, M0)
- •Recommended to receive 2-6 months of neoadjuvant chemotherapy followed by surgical resection including participants who have not yet received chemotherapy and participants who have already received their first cycle of chemotherapy.
- •Willingness to adhere to the Tele-PancFit study intervention
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- •Able to schedule baseline (T0) appointment for fitness testing and program teaching at the fitness testing location at each study site or able to schedule remote fitness testing and program teaching:
- •Behavioral Research and Treatment Center (BRTC) at MDACC
- •Exercise Physiology laboratory in the Department of Kinesiology and Health Education at UT Austin
- •Outpatient Rehabilitation gymnasium at Banner MDA
- •Able to understand the description of the study, exercise program, and willing to participate
- •Home or community access to wireless internet (Wi-Fi) and agreement to engage with study personnel for real-time tele-RT sessions
- •Meet all screening requirements (described below).
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •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 PAR-Q and/or PROMIS questions as described in section 4.4 (Screening Procedure).
- •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 GI Medical Oncology; females of childbearing potential receive advice to use methods of contraception per usual care.
研究组 & 干预措施
Group A-Enhanced Usual Care
Participants will be given general recommendations to increase physical activity and improve nutrition before surgery.
干预措施: Enhanced Usual Care (Other)
Group B-Tele-supervised resistance exercises
Participants will take part in a monitored exercise program. The study team will provide more instructions and information about the program
干预措施: Tele-supervised resistance exercises (Behavioral)
结局指标
主要结局
Safety and adverse events (AEs)
时间窗: thorugh study completion; an average of 1 year.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
次要结局
未报告次要终点