Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
46 participants
Study Classification
INTERVENTIONAL
Study Start Date
2018-07-16
Study Completion Date
2019-10-22
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Lung Cancer
Depression
Physical Activity
Quality of Life
Pain
Lung Cancer Symptoms
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
SUPPORTIVE_CARE
Blinding Strategy
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Group Type
EXPERIMENTAL
Exercise Intervention
Intervention Type
BEHAVIORAL
Attend supervised and unsupervised exercise sessions
Survey Administration
Intervention Type
OTHER
Ancillary studies
Quality-of-Life Assessment
Intervention Type
OTHER
Ancillary studies
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Exercise Intervention
Attend supervised and unsupervised exercise sessions
Intervention Type
BEHAVIORAL
Survey Administration
Ancillary studies
Intervention Type
OTHER
Quality-of-Life Assessment
Ancillary studies
Intervention Type
OTHER
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Quality of Life Assessment
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Mild depression symptoms
* Able to participate in exercise program per physician approval
* Available partner/spouse to participate with patient
* 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
* Inability to participate in exercise
* Life expectancy less than 1 year
Minimum Eligible Age
18 Years
Maximum Eligible Age
100 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Portland VA Medical Center
FED
Sponsor Role
collaborator
Oregon Health and Science University
OTHER
Sponsor Role
collaborator
OHSU Knight Cancer Institute
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Donald Sullivan
Assistant Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Donald R Sullivan, MD
Role: PRINCIPAL_INVESTIGATOR
OHSU Knight Cancer Institute
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Oregon Health and Science University
Portland, Oregon, United States
Site Status
VA Portland Health Care System
Portland, Oregon, United States
Site Status
Countries
Review the countries where the study has at least one active or historical site.
United States
References
Explore related publications, articles, or registry entries linked to this study.
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Massie MJ. Prevalence of depression in patients with cancer. J Natl Cancer Inst Monogr. 2004;(32):57-71. doi: 10.1093/jncimonographs/lgh014.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Cooney GM, Dwan K, Greig CA, Lawlor DA, Rimer J, Waugh FR, McMurdo M, Mead GE. Exercise for depression. Cochrane Database Syst Rev. 2013 Sep 12;2013(9):CD004366. doi: 10.1002/14651858.CD004366.pub6.
Reference Type
BACKGROUND
DiLorenzo TM, Bargman EP, Stucky-Ropp R, Brassington GS, Frensch PA, LaFontaine T. Long-term effects of aerobic exercise on psychological outcomes. Prev Med. 1999 Jan;28(1):75-85. doi: 10.1006/pmed.1998.0385.
Reference Type
BACKGROUND
Buffart LM, Kalter J, Sweegers MG, Courneya KS, Newton RU, Aaronson NK, Jacobsen PB, May AM, Galvao 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.
Reference Type
BACKGROUND
Speck RM, Courneya KS, Masse LC, Duval S, Schmitz KH. An update of controlled physical activity trials in cancer survivors: a systematic review and meta-analysis. J Cancer Surviv. 2010 Jun;4(2):87-100. doi: 10.1007/s11764-009-0110-5. Epub 2010 Jan 6.
Reference Type
BACKGROUND
Cavalheri V, Jenkins S, Cecins N, Gain K, Phillips MJ, Sanders LH, Hill K. Exercise training for people following curative intent treatment for non-small cell lung cancer: a randomized controlled trial. Braz J Phys Ther. 2017 Jan-Feb;21(1):58-68. doi: 10.1016/j.bjpt.2016.12.005. Epub 2017 Jan 13.
Reference Type
BACKGROUND
Cavalheri V, Tahirah F, Nonoyama M, Jenkins S, Hill K. Exercise training undertaken by people within 12 months of lung resection for non-small cell lung cancer. Cochrane Database Syst Rev. 2013 Jul 31;(7):CD009955. doi: 10.1002/14651858.CD009955.pub2.
Reference Type
BACKGROUND
Winters-Stone KM, Moe EL, Perry CK, Medysky M, Pommier R, Vetto J, Naik A. Enhancing an oncologist's recommendation to exercise to manage fatigue levels in breast cancer patients: a randomized controlled trial. Support Care Cancer. 2018 Mar;26(3):905-912. doi: 10.1007/s00520-017-3909-z. Epub 2017 Sep 30.
Reference Type
BACKGROUND
Winters-Stone KM, Li F, Horak F, Luoh SW, Bennett JA, Nail L, Dieckmann N. Comparison of tai chi vs. strength training for fall prevention among female cancer survivors: study protocol for the GET FIT trial. BMC Cancer. 2012 Dec 5;12:577. doi: 10.1186/1471-2407-12-577.
Reference Type
BACKGROUND
Winters-Stone KM, Lyons KS, Dobek J, Dieckmann NF, Bennett JA, Nail L, Beer TM. Benefits of partnered strength training for prostate cancer survivors and spouses: results from a randomized controlled trial of the Exercising Together project. J Cancer Surviv. 2016 Aug;10(4):633-44. doi: 10.1007/s11764-015-0509-0. Epub 2015 Dec 29.
Reference Type
BACKGROUND
Kamen C, Heckler C, Janelsins MC, Peppone LJ, McMahon JM, Morrow GR, Bowen D, Mustian K. A Dyadic Exercise Intervention to Reduce Psychological Distress Among Lesbian, Gay, and Heterosexual Cancer Survivors. LGBT Health. 2016 Feb;3(1):57-64. doi: 10.1089/lgbt.2015.0101. Epub 2015 Nov 24.
Reference Type
BACKGROUND
Rasekaba T, Lee AL, Naughton MT, Williams TJ, Holland AE. The six-minute walk test: a useful metric for the cardiopulmonary patient. Intern Med J. 2009 Aug;39(8):495-501. doi: 10.1111/j.1445-5994.2008.01880.x.
Reference Type
BACKGROUND
Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
Reference Type
BACKGROUND
Andersen BL, Rowland JH, Somerfield MR. Screening, assessment, and care of anxiety and depressive symptoms in adults with cancer: an american society of clinical oncology guideline adaptation. J Oncol Pract. 2015 Mar;11(2):133-4. doi: 10.1200/JOP.2014.002311. Epub 2014 Dec 16. No abstract available.
Reference Type
BACKGROUND
Zimet GD, Powell SS, Farley GK, Werkman S, Berkoff KA. Psychometric characteristics of the Multidimensional Scale of Perceived Social Support. J Pers Assess. 1990 Winter;55(3-4):610-7. doi: 10.1080/00223891.1990.9674095.
Reference Type
BACKGROUND
Wright SP, Hall Brown TS, Collier SR, Sandberg K. How consumer physical activity monitors could transform human physiology research. Am J Physiol Regul Integr Comp Physiol. 2017 Mar 1;312(3):R358-R367. doi: 10.1152/ajpregu.00349.2016. Epub 2017 Jan 4.
Reference Type
BACKGROUND
Zhang X, McClean D, Ko E, Morgan MA, Schmitz K. Exercise Among Women With Ovarian Cancer: A Feasibility and Pre-/Post-Test Exploratory Pilot Study. Oncol Nurs Forum. 2017 May 1;44(3):366-374. doi: 10.1188/17.ONF.366-374.
Reference Type
BACKGROUND
Guralnik JM, Ferrucci L, Simonsick EM, Salive ME, Wallace RB. Lower-extremity function in persons over the age of 70 years as a predictor of subsequent disability. N Engl J Med. 1995 Mar 2;332(9):556-61. doi: 10.1056/NEJM199503023320902.
Reference Type
BACKGROUND
Newman AB, Simonsick EM, Naydeck BL, Boudreau RM, Kritchevsky SB, Nevitt MC, Pahor M, Satterfield S, Brach JS, Studenski SA, Harris TB. Association of long-distance corridor walk performance with mortality, cardiovascular disease, mobility limitation, and disability. JAMA. 2006 May 3;295(17):2018-26. doi: 10.1001/jama.295.17.2018.
Reference Type
BACKGROUND
Eickmeyer SM, Walczak CK, Myers KB, Lindstrom DR, Layde P, Campbell BH. Quality of life, shoulder range of motion, and spinal accessory nerve status in 5-year survivors of head and neck cancer. PM R. 2014 Dec;6(12):1073-80. doi: 10.1016/j.pmrj.2014.05.015. Epub 2014 May 28.
Reference Type
BACKGROUND
Stark T, Walker B, Phillips JK, Fejer R, Beck R. Hand-held dynamometry correlation with the gold standard isokinetic dynamometry: a systematic review. PM R. 2011 May;3(5):472-9. doi: 10.1016/j.pmrj.2010.10.025.
Reference Type
BACKGROUND
Ameringer S, Elswick RK Jr, Menzies V, Robins JL, Starkweather A, Walter J, Gentry AE, Jallo N. Psychometric Evaluation of the Patient-Reported Outcomes Measurement Information System Fatigue-Short Form Across Diverse Populations. Nurs Res. 2016 Jul-Aug;65(4):279-89. doi: 10.1097/NNR.0000000000000162.
Reference Type
BACKGROUND
Leng QL, Lyons KS, Winters-Stone KM, Medysky ME, Dieckmann NF, Denfeld QE, Sullivan DR. Preliminary effects of a yoga intervention for lung cancer dyads: benefits for care partners. Support Care Cancer. 2024 Jun 20;32(7):447. doi: 10.1007/s00520-024-08638-5.
Reference Type
DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
STUDY00018245
Identifier Type: -
Identifier Source: org_study_id