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希望之城国家医学中心Telephone-based Physical Activity Coaching or Self Monitored Physical Activity to Improve Physical Function in Older Adults Who Are Undergoing Surgery for Lung Cancer and Their Caregivers
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.
EXPLORATORY OBJECTIVES:
I. To explore associations between comparators, outcomes, and the following:
Ia. Perioperative, image-based sarcopenia using standard-of care preoperative chest computed tomography (CT) scans; Ib. Pedometer documented daily steps; Ic. Participant demographic and clinical characteristics.
OUTLINE: Patients and their FCG are randomized together to 1 of 2 arms.
ARM I: 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.
ARM II: Patients receive written educational materials on physical activity and cancer survivorship. Patients and FCGs also wear an activity monitor throughout the trial.
After completion of study intervention, patients are followed up at days 60 and 180 post-discharge.
SR2204: A Randomized Phase III Trial of a Perioperative Physical Activity Intervention in Older Adults With Lung Cancer and Their Family Caregivers
- 23317
- NCI-2023-09810 (注册标识符) (CTRP (Clinical Trial Reporting Program))
- 23317 (其他标识符) (City of Hope Medical Center)
- P30CA033572 (美国 NIH 拨款/合同)
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性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. | 教育干预 Attend telephone-based coaching sessions 运动干预 Receive a personalized physical activity program, set fitness goals 医疗设备使用和评估 Wear activity monitor 身体性能测试 Ancillary studies 生活质量评估 Ancillary studies 问卷管理 Ancillary studies |
阳性对照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. | 教育干预 Receive written educational materials on physical activity and standard preoperative care 医疗设备使用和评估 Wear activity monitor 身体性能测试 Ancillary studies 生活质量评估 Ancillary studies 问卷管理 Ancillary studies |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Objective patient functional capacity | Measured by the 6 minute walk test (6MWT). Analysis will be a study group comparison via linear regression model. | At 30 days post discharge |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Functional capacity | Measured by 6MWT. Will be assessed via repeated measures linear regression model with adjustment for baseline value of the outcome, stratification factors, and time point. | At 60 and 180 days post discharge |
Lower extremity function | Measured by the short physical performance battery. Will be assessed via repeated measures linear regression model with adjustment for baseline value of the outcome, stratification factors, and time point. | At 30, 60 and 180 days post discharge |
Patient and caregiver reported self efficacy | Measured by patient reported outcomes measurement information system (PROMIS) self efficacy. Will be assessed via repeated measures linear regression model with adjustment for baseline value of the outcome, stratification factors, and time point. | At 30, 60, and 180 days post discharge |
Patient and caregiver reported physical function | Measured by PROMIS physical function. Will be assessed via repeated measures linear regression model with adjustment for baseline value of the outcome, stratification factors, and time point. | At 30, 60 and 180 days post discharge |
Patient reported quality of life | Measured by Functional Assessment of Cancer Therapy -Lung for patients. Will be assessed via repeated measures linear regression model with adjustment for baseline value of the outcome, stratification factors, and time point. | At 30, 60 and 180 days post discharge |
Caregiver reported quality of life | Measured by City of Hope-Quality of Life-Family Caregiver for caregivers. Will be assessed via repeated measures linear regression model with adjustment for baseline value of the outcome, stratification factors, and time point. | At 30, 60 and 180 days post discharge |
Patient time at home and away from the hospital | Will be compared by study arm by linear regression models. | Up to 60 days post discharge |
Hospital readmissions | Will be compared by study arm via logistic regression. | Up to 60 days post discharge |
Postoperative complications | Will be compared by study arm via logistic regression. | Up to 60 days post discharge |
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
- 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)
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