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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCity of Hope Medical Center

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Educational Intervention

    Other intervention

    Attend telephone-based coaching sessions

  • Educational Intervention

    Other intervention

    Receive written educational materials on physical activity and standard preoperative care

  • Exercise Intervention

    Other intervention

    Receive a personalized physical activity program, set fitness goals

  • Medical Device Usage and Evaluation

    Other intervention

    Wear activity monitor

  • Physical Performance Testing

    Other intervention

    Ancillary studies

  • Quality-of-Life Assessment

    Other intervention

    Ancillary studies

  • Questionnaire Administration

    Other intervention

    Ancillary studies

Treatment groups

382 Participants
are divided into 2 treatment groups
Group A: Arm I (Telephone-based coaching session)Experimental treatment 6 interventions
Group B: Arm II (Written education)Active comparator 5 interventions

Trial outcomes

Primary outcomes

1

Objective patient functional capacity

Measured by the 6 minute walk test (6MWT). Analysis will be a study group comparison via linear regression model.

Time frame
At 30 days post discharge

Secondary outcomes

1

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.

Time frame
At 60 and 180 days post discharge
2

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.

Time frame
At 30, 60 and 180 days post discharge
3

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.

Time frame
At 30, 60, and 180 days post discharge
4

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.

Time frame
At 30, 60 and 180 days post discharge

Other outcomes

Sponsors and contacts

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City of Hope Medical Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator