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Exercise Program Among Lung Cancer Dyads (PEP-LC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03649737
Recruitment Status : Completed
First Posted : August 28, 2018
Last Update Posted : February 21, 2020
Sponsor:
Collaborators:
Portland VA Medical Center
Oregon Health and Science University
Information provided by (Responsible Party):
Donald Sullivan, OHSU Knight Cancer Institute

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.

Condition or disease Intervention/treatment Phase
Lung Cancer Depression Physical Activity Quality of Life Pain Lung Cancer Symptoms Behavioral: Exercise Intervention Other: Survey Administration Other: Quality-of-Life Assessment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Pilot Study of a Progressive Exercise Program Among Lung Cancer Patient-Partner Dyads
Actual Study Start Date : July 16, 2018
Actual Primary Completion Date : October 22, 2019
Actual Study Completion Date : October 22, 2019

Resource links provided by the National Library of Medicine


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.
Behavioral: Exercise Intervention
Attend supervised and unsupervised exercise sessions

Other: Survey Administration
Ancillary studies

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment




Primary Outcome Measures :
  1. 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.

  2. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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)

  7. 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).

  8. 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."

  9. 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).

  10. 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)

  11. 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. 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.

  13. 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.

  14. 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

  15. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03649737


Locations
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United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
VA Portland Health Care System
Portland, Oregon, United States, 97239
Sponsors and Collaborators
OHSU Knight Cancer Institute
Portland VA Medical Center
Oregon Health and Science University
Investigators
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Principal Investigator: Donald R Sullivan, MD OHSU Knight Cancer Institute

Publications:
Buffart LM, Kalter J, Sweegers MG, Courneya KS, Newton RU, Aaronson NK, Jacobsen PB, May AM, Galvão DA, Chinapaw MJ, Steindorf K, Irwin ML, Stuiver MM, Hayes S, Griffith KA, Lucia A, Mesters I, van Weert E, Knoop H, Goedendorp MM, Mutrie N, Daley AJ, McConnachie A, Bohus M, Thorsen L, Schulz KH, Short CE, James EL, Plotnikoff RC, Arbane G, Schmidt ME, Potthoff K, van Beurden M, Oldenburg HS, Sonke GS, van Harten WH, Garrod R, Schmitz KH, Winters-Stone KM, Velthuis MJ, Taaffe DR, van Mechelen W, Kersten MJ, Nollet F, Wenzel J, Wiskemann J, Verdonck-de Leeuw IM, Brug J. Effects and moderators of exercise on quality of life and physical function in patients with cancer: An individual patient data meta-analysis of 34 RCTs. Cancer Treat Rev. 2017 Jan;52:91-104. doi: 10.1016/j.ctrv.2016.11.010. Epub 2016 Dec 5. Review.

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Responsible Party: Donald Sullivan, Assistant Professor, OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT03649737    
Other Study ID Numbers: STUDY00018245
First Posted: August 28, 2018    Key Record Dates
Last Update Posted: February 21, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases