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Lung CancerPEP-LCNCT03649737

Exercise Program Among Lung Cancer Dyads

A study testing Exercise Intervention, Survey Administration and Quality-of-Life Assessment in people with Lung Cancer and Depression, run by OHSU Knight Cancer Institute at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Lung Cancer, Depression, Physical Activity
What is being tested?
Exercise Intervention, Survey Administration and Quality-of-Life Assessment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
2 sitesUnited States
Study dates
16 Jul 2018to 22 Oct 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • VA Portland Health Care System

    Portland, Oregon, 97239

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. Determine the feasibility and acceptability of a progressive exercise program initiated after lung cancer diagnosis among patient partner dyads.

SECONDARY OBJECTIVE:

  1. 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.

Being tested
Exercise Intervention, Survey Administration, Quality-of-Life Assessment
Medical subject headings
Lung Neoplasms, Depression, Motor Activity, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise InterventionBehavioural

    Attend supervised and unsupervised exercise sessions

  • Survey AdministrationOther

    Ancillary studies

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

Study groups in NCT03649737
Study groupRoleWhat they receive
Supportive care (exercise)ExperimentalParticipants 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.
Receives: Behavioral: Exercise Intervention; Other: Survey Administration; Other: Quality-of-Life Assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Study Feasibility: Proportion enrolled

    Will be measured as the number of couples who enroll out of those approached. Will evaluate using descriptive statistics.

    Measured: 12 weeks

  2. 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.

    Measured: 12 weeks

Secondary outcomes (15)

  1. Incidence of Depression

    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.

    Measured: 12 weeks

  2. Change in physical function over time: 6-minute walk

    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.

    Measured: 12 weeks

  3. Change in physical function over time: Hand grip test

    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.

    Measured: 12 weeks

  4. Change in physical function over time: Short Physical Performance Battery

    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.

    Measured: 12 weeks

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

    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.

    Measured: 12 weeks

  6. Quality of Life for exercise partners assessed by CQOLC

    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)

    Measured: 12 weeks

  7. Fatigue assessed by PROMIS Short-Form

    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).

    Measured: 12 weeks

  8. Pain assessed by PROMIS Short-Form

    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."

    Measured: 12 weeks

  9. Sleep assessed by PROMIS Short-Form

    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).

    Measured: 12 weeks

  10. Relationship Distress assessed by DAS-SF

    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)

    Measured: 12 weeks

  11. Social Support assessed by PSSS

    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.

    Measured: 12 weeks

  12. Level of exercise outside the exercise intervention assessed by GLTEQ

    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.

    Measured: 12 weeks

  13. Incidence of Malnutrition

    Measured using a Malnutrition Screening Tool (MST). Patients with lung cancer with a score of 2 or more are considered at risk for malnutrition.

    Measured: 12 weeks

  14. Subjective evaluation of PEP-LC participant experience from phone interviews

    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

    Measured: 1-2 months follow completion of program (up to 4 months)

  15. Incidence of Relationship Strain

    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)

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2018
  2. Study start16 Jul 2018
  3. Primary completion22 Oct 2019
  4. Study completion22 Oct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03649737
Sponsor's protocol ID
STUDY00018245
Acronym
PEP-LC
Status last verified
Dec 2020
First submitted
27 Jul 2018
Last updated
9 Dec 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Walker J, Holm Hansen C, Martin P, Sawhney A, Thekkumpurath P, Beale C, Symeonides S, Wall L, Murray G, Sharpe M. Prevalence of depression in adults with cancer: a systematic review. Ann Oncol. 2013 Apr;24(4):895-900. doi: 10.1093/annonc/mds575. Epub 2012 Nov 21.

    PubMed 23175625

  • Sullivan DR, Ganzini L, Duckart JP, Lopez-Chavez A, Deffebach ME, Thielke SM, Slatore CG. Treatment receipt and outcomes among lung cancer patients with depression. Clin Oncol (R Coll Radiol). 2014 Jan;26(1):25-31. doi: 10.1016/j.clon.2013.09.001. Epub 2013 Sep 27.

    PubMed 24080122

  • Sullivan DR, Forsberg CW, Ganzini L, Au DH, Gould MK, Provenzale D, Slatore CG. Longitudinal Changes in Depression Symptoms and Survival Among Patients With Lung Cancer: A National Cohort Assessment. J Clin Oncol. 2016 Nov 20;34(33):3984-3991. doi: 10.1200/JCO.2016.66.8459. Epub 2016 Oct 31.

    PubMed 27996350

  • Massie MJ. Prevalence of depression in patients with cancer. J Natl Cancer Inst Monogr. 2004;(32):57-71. doi: 10.1093/jncimonographs/lgh014.

    PubMed 15263042

  • Lyons KS, Miller LM, McCarthy MJ. The Roles of Dyadic Appraisal and Coping in Couples With Lung Cancer. J Fam Nurs. 2016 Nov;22(4):493-514. doi: 10.1177/1074840716675976. Epub 2016 Oct 31.

    PubMed 27803239

  • Brown Johnson CG, Brodsky JL, Cataldo JK. Lung cancer stigma, anxiety, depression, and quality of life. J Psychosoc Oncol. 2014;32(1):59-73. doi: 10.1080/07347332.2013.855963.

    PubMed 24428251

  • Cataldo JK, Jahan TM, Pongquan VL. Lung cancer stigma, depression, and quality of life among ever and never smokers. Eur J Oncol Nurs. 2012 Jul;16(3):264-9. doi: 10.1016/j.ejon.2011.06.008. Epub 2011 Jul 30.

    PubMed 21803653

  • Piderman KM, Sytsma TT, Frost MH, Novotny PJ, Rausch Osian SM, Solberg Nes L, Patten CA, Sloan JA, Rummans TA, Bronars CA, Yang P, Clark MM. Improving Spiritual Well-Being in Patients with Lung Cancers. J Pastoral Care Counsel. 2015 Sep;69(3):156-62. doi: 10.1177/1542305015602711.

    PubMed 26463853

  • Miller LM, Sullivan DR, Lyons KS. Dyadic Perceptions of the Decision Process in Families Living With Lung Cancer. Oncol Nurs Forum. 2017 Jan 1;44(1):108-115. doi: 10.1188/17.ONF.108-115.

    PubMed 27991611

  • Lyons KS, Bennett JA, Nail LM, Fromme EK, Dieckmann N, Sayer AG. The role of patient pain and physical function on depressive symptoms in couples with lung cancer: a longitudinal dyadic analysis. J Fam Psychol. 2014 Oct;28(5):692-700. doi: 10.1037/fam0000017. Epub 2014 Aug 4.

    PubMed 25090253

  • Kim Y, Carver CS, Spillers RL, Crammer C, Zhou ES. Individual and dyadic relations between spiritual well-being and quality of life among cancer survivors and their spousal caregivers. Psychooncology. 2011 Jul;20(7):762-70. doi: 10.1002/pon.1778. Epub 2010 May 25.

    PubMed 20878868

  • Berg CA, Upchurch R. A developmental-contextual model of couples coping with chronic illness across the adult life span. Psychol Bull. 2007 Nov;133(6):920-54. doi: 10.1037/0033-2909.133.6.920.

    PubMed 17967089

  • Brown LF, Kroenke K, Theobald DE, Wu J, Tu W. The association of depression and anxiety with health-related quality of life in cancer patients with depression and/or pain. Psychooncology. 2010 Jul;19(7):734-41. doi: 10.1002/pon.1627.

    PubMed 19777535

  • Lazenby M, Ercolano E, Grant M, Holland JC, Jacobsen PB, McCorkle R. Supporting commission on cancer-mandated psychosocial distress screening with implementation strategies. J Oncol Pract. 2015 May;11(3):e413-20. doi: 10.1200/JOP.2014.002816. Epub 2015 Mar 10.

    PubMed 25758447

  • Walker J, Sawhney A, Hansen CH, Ahmed S, Martin P, Symeonides S, Murray G, Sharpe M. Treatment of depression in adults with cancer: a systematic review of randomized controlled trials. Psychol Med. 2014 Apr;44(5):897-907. doi: 10.1017/S0033291713001372. Epub 2013 Jun 19.

    PubMed 23778105

Questions about this trial

What is this clinical trial studying?

A study testing Exercise Intervention, Survey Administration and Quality-of-Life Assessment in people with Lung Cancer and Depression, run by OHSU Knight Cancer Institute at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Study Feasibility: Proportion enrolled (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03649737, which also lists 37 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2020.

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