Exercise Program Among Lung Cancer Dyads (PEP-LC)

December 7, 2020 updated by: Donald Sullivan, OHSU Knight Cancer Institute

Pilot Study of a Progressive Exercise Program Among Lung Cancer Patient-Partner Dyads

Pilot study of an exercise program among patients with all stages of lung cancer examining feasibility and acceptability. Preliminary outcomes include objective measures of physical function, depression, adherence to lung cancer treatments, Quality of Life (QOL), and social support.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. Determine the feasibility and acceptability of a progressive exercise program initiated after lung cancer diagnosis among patient partner dyads.

SECONDARY OBJECTIVE:

I. Examine the preliminary effects of partnered exercise on physical function, depression, adherence to lung cancer treatments, QOL and social support .

OUTLINE:

Participants attend supervised group exercises classes twice per week during weeks 1-6 and once per week during weeks 7-12. Participants also attend home-based unsupervised exercise sessions via an instructional DVD once per weeks over for 30 minutes during weeks 1-6 and twice per week during weeks 7-12.

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
      • Portland, Oregon, United States, 97239
        • VA Portland Health Care System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Mild depression symptoms
  • Able to participate in exercise program per physician approval
  • Available partner/spouse to participate with patient

Exclusion Criteria:

  • Persistent severe depression symptoms
  • Inability to participate in exercise
  • Life expectancy less than 1 year

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Supportive care (exercise)
Participants attend supervised group exercises classes twice per week during weeks 1-6 and once per week during weeks 7-12. Participants also attend home-based unsupervised exercise sessions via an instructional DVD once per weeks over for 30 minutes during weeks 1-6 and twice per week during weeks 7-12.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Survey Administration
Ancillary studies
Behavioral: Exercise Intervention
Attend supervised and unsupervised exercise sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Study Feasibility: Proportion enrolled
Time Frame: 12 weeks
Will be measured as the number of couples who enroll out of those approached. Will evaluate using descriptive statistics.
12 weeks
Study Acceptability: Average attendance
Time Frame: 12 weeks
Will be measured by the average attendance at sessions over the course of the intervention. This will be calculated as the total number of classes attended divided by the total possible they could have attended over the course of the study. Attendance will be categorized by sessions couples attended together and those where only one partner attends. Will evaluate using descriptive statistics.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Depression
Time Frame: 12 weeks
Will be measured using the Patient Health Questionnaire - 8 (PHQ-8). Total sum scores range from 0-24 with 0 indicating no symptoms to higher scores (>=10) indicating major depressive symptoms.
12 weeks
Change in physical function over time: 6-minute walk
Time Frame: 12 weeks
We will monitor the change in physical function over time of the participants with lung cancer in our study. Physical functioning will be measured at baseline, week 6, and week 12 of the exercise program. For this test, the participants ability to walk for 6 minutes, and the distance (meters) walked within that 6 minutes will be recorded and compared at each time point.
12 weeks
Change in physical function over time: Hand grip test
Time Frame: 12 weeks
We will monitor the change in physical function over time of the participants with lung cancer in our study. Physical functioning will be measured at baseline, week 6, and week 12 of the exercise program. For the hand grip test, participants will grip a dynamometer that measures force in kg. The force of the grip will be measured and compared at each time point.
12 weeks
Change in physical function over time: Short Physical Performance Battery
Time Frame: 12 weeks
We will monitor the change in physical function over time of the participants with lung cancer in our study. Physical functioning will be measured at baseline, week 6, and week 12 of the exercise program. The Short Physical Performance Battery test includes height/weight measurements, standing balance tests (semi-tandem, side-by-side, full tandem), walking speed (at 4 meters), and chair stands. Participants are assigned scores based on their ability to complete each exercise. For the Balance test, 0=incomplete, 1=complete. For the time it takes to walk 4 meters, point values of 1 to 4 are assigned. (1=8.7 sec, 2=6.21 to 8.70 sec, 3=4.82 to 6.20 sec, 4=less than 4.82 sec). For the chair stands, 1=between 16.7 sec and 60 sec, 2=13.7 sec to 16.69 sec, 3=11.2 sec to 13.69 sec, 4=11.19 sec or less. Each of these scores are then summed. The sum scores will be compared at each time point to measure change in physical function over time.
12 weeks
Quality of Life for participants with lung cancer assessed by FACT-L
Time Frame: 12 weeks
Quality of life for participants with lung cancer will be measured using the Functional Assessment of Cancer Therapy - Lung (FACT-L). The 36-item questionnaire uses a 5-point scale ranging from 0 (Not at all) to 4 (Very Much). We will measure the sum of all responses as well as look at sub-scales: physical, social/family, emotional, functional, and additional concerns.
12 weeks
Quality of Life for exercise partners assessed by CQOLC
Time Frame: 12 weeks
Quality of life for exercise partners will be measured using the Caregiver Quality of Life Index - Cancer (CQOLC), a 35-item questionnaire about caring for loved ones with lung cancer. It uses a 5-point scale ranging from 0 (Not at all) to 4 (Very much)
12 weeks
Fatigue assessed by PROMIS Short-Form
Time Frame: 12 weeks
PROMIS® (Patient-Reported Outcomes Measurement Information System) Short-Form - Fatigue questionnaires measure the fatigue experienced in the past 7 days and its level of interference with daily activities. All participants will answer the 7-item questionnaire using a 5-point scale ranging from 0 (Never) to 4 (Always).
12 weeks
Pain assessed by PROMIS Short-Form
Time Frame: 12 weeks
PROMIS® (Patient-Reported Outcomes Measurement Information System) Short-From - Pain questionnaires measure both pain intensity, quality, and impact on daily function experienced in the past 7 days. All participants will answer the 16 questions using a 5-point Likert scale. Scores range from 0, "no pain" to 4, "very severe"; and 0, "not at all" to 4, "very much."
12 weeks
Sleep assessed by PROMIS Short-Form
Time Frame: 12 weeks
PROMIS® (Patient-Reported Outcomes Measurement Information System) Short-Form - Sleep questionnaire measures the sleep quality using an 8-item questionnaire on a 5-point scale, with responses ranging from 0 (Very Poor/Not at all) to 4 (Very Good/Not at all).
12 weeks
Relationship Distress assessed by DAS-SF
Time Frame: 12 weeks
Measured using the DAS-SF (Dyadic Adjustment Scale - Short Form) a 7-item scale asking about relationship satisfaction and scored using a 5-point scale ranging from 1 (Low) to 5 (High)
12 weeks
Social Support assessed by PSSS
Time Frame: 12 weeks
The Multidimensional Scale of Perceived Social Support (PSSS) is a 12-item questionnaire that uses a 7 point Likert scale that measures the support one receives from friends, family, and significant others.
12 weeks
Level of exercise outside the exercise intervention assessed by GLTEQ
Time Frame: 12 weeks
The Godin Leisure-Time Exercise Questionnaire (GLTEQ) is a self-report questionnaire asking the patient-participant how often they engaged in mild effort, moderate exercise, strenuous exercise, and resistance (weight bearing exercise). This will be measured in three different ways: 1) total activity = vigorous + moderate + mild + resistance, 2) physical activity guidelines = moderate + (vigorous x 2), 3) moderate + vigorous.
12 weeks
Incidence of Malnutrition
Time Frame: 12 weeks
Measured using a Malnutrition Screening Tool (MST). Patients with lung cancer with a score of 2 or more are considered at risk for malnutrition.
12 weeks
Subjective evaluation of PEP-LC participant experience from phone interviews
Time Frame: 1-2 months follow completion of program (up to 4 months)
Dyads participating in the exercise intervention will complete a follow up phone interview regarding their experience in the program. They will be ask to describe their overall experience as well as indicate if they have any suggestions on making the program better
1-2 months follow completion of program (up to 4 months)
Incidence of Relationship Strain
Time Frame: 12 weeks
Partner participants will complete the Modified Caregiver Strain Index (MCSI), an 18-item questionnaire about strain caused by caretaking for a person with cancer. Uses a 5-point scale ranging from 0 (Never) to 4 (A great deal)
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OHSU Knight Cancer Institute

Collaborators

Oregon Health and Science University
Portland VA Medical Center

Investigators

  • Principal Investigator: Donald R Sullivan, MD, OHSU Knight Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 16, 2018

Primary Completion (Actual)

October 22, 2019

Study Completion (Actual)

October 22, 2019

Study Registration Dates

First Submitted

July 27, 2018

First Submitted That Met QC Criteria

August 24, 2018

First Posted (Actual)

August 28, 2018

Study Record Updates

Last Update Posted (Actual)

December 9, 2020

Last Update Submitted That Met QC Criteria

December 7, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00018245

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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