Clinical Trial 23199

• Overview

  Study Title:

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

  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.

  Objective:

  Primary Objective(s) Compare the impact of telephone-based physical activity coaching vs. physical activity self-monitoring only on patient physical function (measured by 6MWT). Secondary Objective(s) Compare the impact of telephone-based physical activity coaching vs. physical activity self-monitoring only on patient-centered outcomes, including patient functional capacity, patient and FCG self-efficacy, and patient and FCG QOL, and on patient surgical/clinical outcomes and healthcare resource use.

• Inclusion Criteria

  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
  • Family Care Giver (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

  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)

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