Educational Intervention
OtherAttend telephone-based coaching sessions
Other names: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
NCT Number: NCT06196008
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
University of California, Davis, California, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Attend telephone-based coaching sessions
Other names: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Receive a personalized physical activity program, set fitness goals
Wear activity monitor
Ancillary studies
Other names: Physical Fitness Testing, Physical Function Testing
Ancillary studies
Other names: Quality of Life Assessment
Ancillary studies
Time frame: At 30 days post discharge
Measured by the 6 minute walk test (6MWT). Analysis will be a study group comparison via linear regression model.
Time frame: At 60 and 180 days post discharge
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.
Time frame: At 30, 60 and 180 days post discharge
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.
Time frame: At 30, 60, and 180 days post discharge
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.
Time frame: At 30, 60 and 180 days post discharge
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.
Time frame: At 30, 60 and 180 days post discharge
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.
Time frame: At 30, 60 and 180 days post discharge
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.
Time frame: Up to 60 days post discharge
Will be compared by study arm by linear regression models.
Time frame: Up to 60 days post discharge
Will be compared by study arm via logistic regression.
Time frame: Up to 60 days post discharge
Will be compared by study arm via logistic regression.
Contact information is provided by the study sponsor or research team.
City of Hope Medical Center
Other
SR2204: A Randomized Phase III Trial of a Perioperative Physical Activity Intervention in Older Adults With Lung Cancer and Their Family Caregivers
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07285044
Adenocarcinoma, Adnexal Diseases
Jacksonville, Florida, United States
View Trial DetailsNCT07176000
Lung Carcinoma, Lung Diseases
Auburn, Washington, United States
View Trial DetailsNCT07490860
Lung Carcinoma, Lung Diseases
Seattle, Washington, United States
View Trial DetailsNCT06995898
Adenocarcinoma, Adnexal Diseases
Pleasanton, California, United States
View Trial Details