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

Lung Carcinoma Clinical Trial

Official title:

SR2204: A Randomized Phase III Trial of a Perioperative Physical Activity Intervention in Older Adults With Lung Cancer and Their Family Caregivers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06196008
• Other study ID #: 23317
• Secondary ID: NCI-2023-0981023
• Status: Recruiting
• Phase: N/A
• Start date: December 5, 2023
• Est. completion date: May 16, 2028

Study information

• Verified date: June 2024
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 382
• Est. completion date: May 16, 2028
• Est. primary completion date: May 16, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Lung Carcinoma
• Lung Neoplasms

Intervention

Other:
• Educational Intervention
Attend telephone-based coaching sessions
• Educational Intervention
Receive written educational materials on physical activity and standard preoperative care
• Exercise Intervention
Receive a personalized physical activity program, set fitness goals
• Medical Device Usage and Evaluation
Wear activity monitor
• Physical Performance Testing
Ancillary studies
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Massachusetts General Hospital (MGH) / Harvard	Boston	Massachusetts
United States	City of Hope Medical Center	Duarte	California
United States	Duke University	Durham	North Carolina
United States	MD Anderson Cancer Center	Houston	Texas
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Yale New Haven Medical Center	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Hospital readmissions	Will be compared by study arm via logistic regression.	Up to 60 days post discharge
Secondary	Postoperative complications	Will be compared by study arm via logistic regression.	Up to 60 days post discharge