Exercise Program Among Lung Cancer Dyads

NCT03649737 | Completed DMC

• 1 other identifier: STUDY00018245
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 2

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.

Conditions

Lung Cancer; Depression; Physical Activity; Quality of Life; Pain; Lung Cancer Symptoms

Outcome Measures

Primary Outcomes (2)

• Study Feasibility: Proportion enrolled

  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

  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 Outcomes (15)

• Incidence of Depression

  12 weeks

• Change in physical function over time: 6-minute walk

  12 weeks

• Change in physical function over time: Hand grip test

  12 weeks

• Change in physical function over time: Short Physical Performance Battery

  12 weeks

• Quality of Life for participants with lung cancer assessed by FACT-L

  12 weeks

Study Arms (1)

Supportive care (exercise)

EXPERIMENTAL

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.

Behavioral: Exercise Intervention; Other: Survey Administration; Other: Quality-of-Life Assessment

Interventions

Exercise Intervention BEHAVIORAL

Attend supervised and unsupervised exercise sessions

Supportive care (exercise)

Survey Administration OTHER

Ancillary studies

Supportive care (exercise)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Supportive care (exercise)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• Portland VA Medical Center: collaborator
• Oregon Health and Science University: collaborator

Study Sites (2)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

VA Portland Health Care System

Portland, Oregon, 97239, United States

Location

Related Publications (37)

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MeSH Terms

Conditions

Lung Neoplasms; Depression; Motor Activity; Pain

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Behavioral Symptoms; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Donald R Sullivan, MD

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 27, 2018
• First Posted: August 28, 2018
• Study Start: July 16, 2018
• Primary Completion: October 22, 2019
• Study Completion: October 22, 2019
• Last Updated: December 9, 2020

Record last verified: 2020-12

Locations

US (2)