SR2204: A Randomized Phase III Trial of a Perioperative Physical Activity Intervention in Older Adults With Lung Cancer and Their Family Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 382
- 试验地点
- 25
- 主要终点
- Objective patient functional capacity
研究概览
简要总结
This clinical trial compares telephone-based physical activity coaching to self monitored physical activity for improving physical function in older adults who are undergoing surgery for lung cancer and their caregivers. Lung cancer surgery in older adults is associated with functional declines and unique challenges. Performing physical activity around the time of surgery has been shown to improve functional outcomes in patients and exercise programs delivered via telehealth may improve access and convenience for patients and minimize participant burden. Telephone-based physical activity coaching may improve physical functioning for older adults with lung cancer who are undergoing surgery.
详细描述
PRIMARY OBJECTIVE:
I. To compare changes from baseline in objective patient functional capacity as measured by 6 minute walk test (6MWT) at day 30 post-discharge between the two comparators.
SECONDARY OBJECTIVES:
I. To compare the following outcomes between the two comparators:
Ia. 6MWT at 60 and 180 days post discharge; Ib. Short Physical Performance Battery (SPPB) at 30, 60, and 180 days post-discharge; Ic. The following scores at 30, 60, and 180 days post-discharge: a) patient and family caregiver (FCG) reported self-efficacy; b) patient and FCG reported physical function; c) and patient and FCG quality of life (QOL); Id. Patient time at home and away from the hospital through 60 days post-discharge; Ie. Hospital readmissions rate and postoperative complications through 60 days post-discharge.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •PATIENT: Documented informed consent of the participant and/or legally authorized representative
- •PATIENT: Agreement to allow the use of preoperative chest CT scan for exploratory analysis, if available
- •PATIENT: Agreement to wear pedometer during study duration
- •If unwilling, exceptions may be granted with study primary investigator (PI) approval
- •PATIENT: Age >= 65 years
- •PATIENT: Ability to read and understand English or Spanish and willingness to complete participant-reported outcomes and assessments
- •PATIENT: Diagnosis of lung cancer or presumed lung cancer (as determined by surgeons) in patient
- •PATIENT: Scheduled to undergo lung surgery for lung cancer or suspected lung cancer with curative intent (neoadjuvant therapy allowed)
- •PATIENT: Adults lacking capacity to consent in the opinion of the attending surgeon will not be enrolled
- •FCG: Documented informed consent of the participant and/or legally authorized representative
- •FCG: Age >= 18
- •FCG: Ability to read and understand English or Spanish and willingness to complete participant-reported outcomes and assessments
- •FCG: Adults lacking capacity to consent in the opinion of the attending surgeon will not be enrolled
排除标准
- •PATIENT: Lung surgery is scheduled in less than 14 calendar days from the time of registration
- •PATIENT: Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including exercise program and compliance issues related to feasibility/logistics)
- •FCG: Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including exercise program and compliance issues related to feasibility/logistics)
研究组 & 干预措施
Arm I (Telephone-based coaching session)
Patients attend telephone-based coaching sessions over 20-50 minutes once 7-14 days before standard of care surgery, and then at days 7, 14, 21, and 51 post-discharge, for a total of 5 sessions. Patients also receive a personalized physical activity program and set fitness goals. FCGs also receive coaching and serve as a walking buddy for their patient. Patients and FCGs also wear an activity monitor throughout the trial.
干预措施: Educational Intervention (Other)
Arm II (Written education)
Patients receive written educational materials on physical activity and cancer survivorship. Patients and FCGs also wear an activity monitor throughout the trial.
干预措施: Medical Device Usage and Evaluation (Other)
Arm I (Telephone-based coaching session)
Patients attend telephone-based coaching sessions over 20-50 minutes once 7-14 days before standard of care surgery, and then at days 7, 14, 21, and 51 post-discharge, for a total of 5 sessions. Patients also receive a personalized physical activity program and set fitness goals. FCGs also receive coaching and serve as a walking buddy for their patient. Patients and FCGs also wear an activity monitor throughout the trial.
干预措施: Exercise Intervention (Other)
Arm I (Telephone-based coaching session)
Patients attend telephone-based coaching sessions over 20-50 minutes once 7-14 days before standard of care surgery, and then at days 7, 14, 21, and 51 post-discharge, for a total of 5 sessions. Patients also receive a personalized physical activity program and set fitness goals. FCGs also receive coaching and serve as a walking buddy for their patient. Patients and FCGs also wear an activity monitor throughout the trial.
干预措施: Medical Device Usage and Evaluation (Other)
Arm I (Telephone-based coaching session)
Patients attend telephone-based coaching sessions over 20-50 minutes once 7-14 days before standard of care surgery, and then at days 7, 14, 21, and 51 post-discharge, for a total of 5 sessions. Patients also receive a personalized physical activity program and set fitness goals. FCGs also receive coaching and serve as a walking buddy for their patient. Patients and FCGs also wear an activity monitor throughout the trial.
干预措施: Physical Performance Testing (Other)
Arm I (Telephone-based coaching session)
Patients attend telephone-based coaching sessions over 20-50 minutes once 7-14 days before standard of care surgery, and then at days 7, 14, 21, and 51 post-discharge, for a total of 5 sessions. Patients also receive a personalized physical activity program and set fitness goals. FCGs also receive coaching and serve as a walking buddy for their patient. Patients and FCGs also wear an activity monitor throughout the trial.
干预措施: Quality-of-Life Assessment (Other)
Arm I (Telephone-based coaching session)
Patients attend telephone-based coaching sessions over 20-50 minutes once 7-14 days before standard of care surgery, and then at days 7, 14, 21, and 51 post-discharge, for a total of 5 sessions. Patients also receive a personalized physical activity program and set fitness goals. FCGs also receive coaching and serve as a walking buddy for their patient. Patients and FCGs also wear an activity monitor throughout the trial.
干预措施: Questionnaire Administration (Other)
Arm II (Written education)
Patients receive written educational materials on physical activity and cancer survivorship. Patients and FCGs also wear an activity monitor throughout the trial.
干预措施: Educational Intervention (Other)
Arm II (Written education)
Patients receive written educational materials on physical activity and cancer survivorship. Patients and FCGs also wear an activity monitor throughout the trial.
干预措施: Physical Performance Testing (Other)
Arm II (Written education)
Patients receive written educational materials on physical activity and cancer survivorship. Patients and FCGs also wear an activity monitor throughout the trial.
干预措施: Quality-of-Life Assessment (Other)
Arm II (Written education)
Patients receive written educational materials on physical activity and cancer survivorship. Patients and FCGs also wear an activity monitor throughout the trial.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Objective patient functional capacity
时间窗: At 30 days post discharge
Measured by the 6 minute walk test (6MWT). Analysis will be a study group comparison via linear regression model.
次要结局
- Lower extremity function(At 30, 60 and 180 days post discharge)
- Postoperative complications(Up to 60 days post discharge)
- Patient and caregiver reported physical function(At 30, 60 and 180 days post discharge)
- Patient time at home and away from the hospital(Up to 60 days post discharge)
- Hospital readmissions(Up to 60 days post discharge)
- Functional capacity(At 60 and 180 days post discharge)
- Patient and caregiver reported self efficacy(At 30, 60, and 180 days post discharge)
- Patient reported quality of life(At 30, 60 and 180 days post discharge)
- Caregiver reported quality of life(At 30, 60 and 180 days post discharge)