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Trial record 1 of 2 for:    15263042 [PUBMED-IDS]
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Exercise Program Among Lung Cancer Dyads (PEP-LC)

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ClinicalTrials.gov Identifier: NCT03649737
Recruitment Status : Recruiting
First Posted : August 28, 2018
Last Update Posted : August 28, 2018
Sponsor:
Collaborator:
Portland VA Medical Center
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 Other: Questionnaire Administration Other: Survey Administration 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:

All participants complete questionnaires about their health status, physical activity habits and relationship with their spouse/partner and undergo physical tests at baseline, and then 6 weeks and 12 weeks after the start of the exercise program.

EXERCISE PROGRAM: Participants complete a 12-week exercise program with their dyad-partners. The exercise program consists of 3 weekly sessions (approximately 1-hour sessions) consisting of either a supervised group exercise class or home-based, unsupervised exercise session via an instructional DVD. Participants with lung cancer will also receive a physical activity monitor to track changes in activity throughout the intervention.

Participants will complete a baseline, week 6 and week 12 assessment consisting of physical tests and questionnaires


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 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
Estimated Primary Completion Date : May 1, 2019
Estimated Study Completion Date : August 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: intervention

Survey and Questionnaire administration: All participants complete questionnaires about their health status, physical activity habits and relationship with their exercise partner.

Exercise Intervention. All participants undergo three physical tests at baseline, week 6, and week 12. Participants may participate in the exercise program during or after completion of their lung cancer treatment.

PEP LC Program: For 6 weeks, participants complete 3 1-hour exercise sessions per week: two in-person and one using a DVD of a partnered exercise program. For the following 6 weeks, participants will continue participating in 3 sessions a week, but two will use the DvD and one will be in-person.

Behavioral: Exercise
Exercise program

Other: Questionnaire Administration
Ancillary studies

Other: Survey Administration
Ancillary studies




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 week 1, 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 week 1, 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 week 1, 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


Contacts
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Contact: Philip Tostado, MA 520-220-8262 ext 53030 tostado@ohsu.edu
Contact: Donald R Sullivan, MD 5032208262 ext 58087 sullivad@ohsu.edu

Locations
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United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Phil Tostado, MA       tostado@ohsu.edu   
Principal Investigator: Donald R Sullivan, MD         
VA Portland Health Care System Recruiting
Portland, Oregon, United States, 97239
Contact: Phil Tostado, MA         
Principal Investigator: Donald R Sullivan, MD         
Sponsors and Collaborators
OHSU Knight Cancer Institute
Portland VA Medical Center
Investigators
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Principal Investigator: Donald F Sullivan 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     History of Changes
Other Study ID Numbers: STUDY00018245
First Posted: August 28, 2018    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018
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