Clinical trial NCT03649737: Exercise Program Among Lung Cancer Dyads
Official title: Pilot Study of a Progressive Exercise Program Among Lung Cancer Patient-Partner Dyads
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Depression
Physical Activity
Quality of Life
Pain
Lung Cancer Symptoms
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
Collaborators: name: Portland VA Medical Center
name: Oregon Health and Science University
First posted: 2018-08-28
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Study Feasibility: Proportion enrolled
timeFrame: 12 weeks
measure: Study Acceptability: Average attendance
timeFrame: 12 weeks
Secondary outcomes:
measure: Incidence of Depression
timeFrame: 12 weeks
measure: Change in physical function over time: 6-minute walk
timeFrame: 12 weeks
measure: Change in physical function over time: Hand grip test
timeFrame: 12 weeks
measure: Change in physical function over time: Short Physical Performance Battery
timeFrame: 12 weeks
measure: Quality of Life for participants with lung cancer assessed by FACT-L
timeFrame: 12 weeks
measure: Quality of Life for exercise partners assessed by CQOLC
timeFrame: 12 weeks
measure: Fatigue assessed by PROMIS Short-Form
timeFrame: 12 weeks
measure: Pain assessed by PROMIS Short-Form
timeFrame: 12 weeks
measure: Sleep assessed by PROMIS Short-Form
timeFrame: 12 weeks
measure: Relationship Distress assessed by DAS-SF
timeFrame: 12 weeks
measure: Social Support assessed by PSSS
timeFrame: 12 weeks
measure: Level of exercise outside the exercise intervention assessed by GLTEQ
timeFrame: 12 weeks
measure: Incidence of Malnutrition
timeFrame: 12 weeks
measure: Subjective evaluation of PEP-LC participant experience from phone interviews
timeFrame: 1-2 months follow completion of program (up to 4 months)
measure: Incidence of Relationship Strain
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Portland
country: United States
facility: VA Portland Health Care System
state: Oregon
Study officials:
affiliation: OHSU Knight Cancer Institute
name: Donald R Sullivan, MD
role: PRINCIPAL_INVESTIGATOR
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