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Clinical Trials/NCT03649737
NCT03649737
Completed
Not Applicable

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

OHSU Knight Cancer Institute2 sites in 1 country46 target enrollmentJuly 16, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lung Cancer
Sponsor
OHSU Knight Cancer Institute
Enrollment
46
Locations
2
Primary Endpoint
Study Feasibility: Proportion enrolled
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
July 16, 2018
End Date
October 22, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Donald Sullivan

Assistant Professor

OHSU Knight Cancer Institute

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

  • Change in physical function over time: 6-minute walk(12 weeks)
  • Incidence of Relationship Strain(12 weeks)
  • Level of exercise outside the exercise intervention assessed by GLTEQ(12 weeks)
  • Subjective evaluation of PEP-LC participant experience from phone interviews(1-2 months follow completion of program (up to 4 months))
  • Change in physical function over time: Hand grip test(12 weeks)
  • Change in physical function over time: Short Physical Performance Battery(12 weeks)
  • Fatigue assessed by PROMIS Short-Form(12 weeks)
  • Incidence of Depression(12 weeks)
  • Relationship Distress assessed by DAS-SF(12 weeks)
  • Incidence of Malnutrition(12 weeks)
  • Quality of Life for participants with lung cancer assessed by FACT-L(12 weeks)
  • Quality of Life for exercise partners assessed by CQOLC(12 weeks)
  • Pain assessed by PROMIS Short-Form(12 weeks)
  • Sleep assessed by PROMIS Short-Form(12 weeks)
  • Social Support assessed by PSSS(12 weeks)

Study Sites (2)

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