- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05179408
Targeted Telerehabilitation Following Curative Intent Therapy of Lung Cancer
January 26, 2026 updated by: VA Office of Research and Development
Telerehabilitation for Veteran Lung Cancer Survivors Following Curative Intent Therapy
Lung cancer is the second-most commonly diagnosed cancer among U.S. Veterans.
Substantial advances have been made in early detection through screening and treatment.
The longevity of Veterans following lung cancer diagnosis and treatment has increased.
Following treatment however, many Veterans experience increased symptom burden, particularly in shortness of breath, fatigue, and fear/anxiety about lung cancer, and impairments in physical and psychosocial functioning.
Rehabilitation services are needed to address these survivorship challenges.
This study will evaluate multi-targeted telerehabilitation with Veterans following lung cancer treatment, with goals to reduce symptom burden, improve physical and psychosocial function, and enhance health-related quality of life.
This research will also develop the career of a physician researcher to acquire expertise in rehabilitation for many Veteran survivors of lung and other cancers.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Lung cancer is the second-most commonly diagnosed cancer among U.S. Veterans - over 8,200 incident cases are diagnosed each year.
Approximately 50% of lung cancers are diagnosed at stage I-III and therefore eligible for curative intent therapy.
Survival rates among Veterans with early stage lung cancer have increased along with advances in surgical and radiation techniques.
Following curative intent therapy, many Veterans experience physical function loss and increased symptom burden, particularly in dyspnea, fatigue, and fear/anxiety.
Approaches are needed to improve their physical and psychosocial function and health-related quality of life (HRQL).
We hypothesize that multi-targeted telerehabilitation could mitigate these HRQL impairments.
Therefore, we will conduct a pilot randomized trial to examine the (a) feasibility, (b) acceptability, (c) safety, and (d) explore the effects of multi-targeted telerehabilitation with these patients.
Participants (N=30-40) will be randomized (3:1) to receive 8 weeks of participant-chosen targeted telerehabilitation (experimental arm) or waitlist condition (control arm).
Feasibility will be assessed by enrollment, adherence, retention and exploratory effects by linear mixed effects models comparing changes in patient-centered outcomes from baseline to end-of-intervention between groups: dyspnea, daily step count, fatigue, role/social function, fear/anxiety, and HRQL.
This project will provide pilot data and training for an early career physician investigator to establish independence, with a goal of a large-scale, preference-informed randomized trial of targeted and patient-centered telerehabilitation, to improve the physical and psychosocial function, independence, and HRQL of Veteran lung cancer survivors following curative intent therapy.
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Duc M Ha, MD MAS
- Phone Number: (240) 643-6872
- Email: Duc.Ha@va.gov
Study Contact Backup
- Name: Robert L Keith, MD
- Phone Number: (720) 857-5120
- Email: robert.keith@va.gov
Study Locations
-
-
Colorado
-
Aurora, Colorado, United States, 80045-7211
- Recruiting
- Rocky Mountain Regional VA Medical Center, Aurora, CO
-
Contact:
- Duc M Ha, MD MAS
- Phone Number: 240-643-6872
- Email: Duc.Ha@va.gov
-
Principal Investigator:
- Duc M. Ha, MD MAS
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Adult Veterans with a history of stage I-III A/B lung cancer, and
- Completed curative intent therapy (i.e., lung cancer resection surgery, definitive radiation, or concurrent chemoradiation) within 1-6 months
Exclusion Criteria:
- Adult Veterans with any comorbid conditions that preclude participation in exercise and telerehabilitation:
- Orthopedic conditions (e.g., bilateral below-knee amputation), or
- Severe cardiopulmonary disease (e.g., unstable arrhythmias including ventricular tachycardia, heart failure with systolic ejection fraction < 25%, chronic hypoxemia needing > 5 L/min oxygen supplementation at rest), or
- Inability to follow directions or provide informed consent (e.g., moderate to severe dementia), or
- Enrolled in hospice, or
- With an estimated life expectancy of < 6 months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Targeted telerehabilitation
Participant-chosen targets: 1) inspiratory muscle training + walking (to reduce dyspnea and improve physical activity/endurance; 2) resistance training (to reduce fatigue and improve role/social function; 3) mindfulness training (to reduce fear of cancer recurrence and anxiety)
|
Participant-chosen targets: 1) inspiratory muscle training + walking (to reduce dyspnea and improve physical activity/stept count; 2) resistance training (to reduce fatigue and improve role/social function; 3) mindfulness training (to reduce fear of cancer recurrence and anxiety)
|
|
Active Comparator: Waitlist
8-week waiting period prior to participating in targeted telerehabilitation
|
8-week waiting period prior to targeted telerehabilitation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Health-related quality of life (HRQL)
Time Frame: Difference in changes in HRQL between baseline and end-of-intervention (8 weeks)
|
Global health-related quality of life (EORTC QLQ C30 global/QoL subscale)
|
Difference in changes in HRQL between baseline and end-of-intervention (8 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dysnea and physical activity (participant-chosen)
Time Frame: Differences in changes in UCSD SOBQ and average steps/day between baseline and end-of-intervention (8 weeks)
|
University of California Shortness of Breath Questionnaire (UCSD SOBQ) and Fitbit stepcount
|
Differences in changes in UCSD SOBQ and average steps/day between baseline and end-of-intervention (8 weeks)
|
|
Cancer-related function (participant chosen)
Time Frame: Difference in changes in PROMIS-SF Cancer Function 3D Profile between baseline and end-of-intervention (8 weeks)
|
PROMIS-SF Cancer Function 3D Profile (fatigue, role, and social function)
|
Difference in changes in PROMIS-SF Cancer Function 3D Profile between baseline and end-of-intervention (8 weeks)
|
|
Fear of Cancer Recurrence and Cancer-related Anxiety (participant chosen)
Time Frame: Difference in changes in FCR and PROMIS-SF Anxiety 8a between baseline and end-of-intervention (8 weeks)
|
Fear of Cancer Recurrence (FCR) and PROMIS-SF Anxiety 8a
|
Difference in changes in FCR and PROMIS-SF Anxiety 8a between baseline and end-of-intervention (8 weeks)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Duc M. Ha, MD MAS, Rocky Mountain Regional VA Medical Center, Aurora, CO
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Ha D, Ries AL, Lippman SM, Fuster MM. Effects of curative-intent lung cancer therapy on functional exercise capacity and patient-reported outcomes. Support Care Cancer. 2020 Oct;28(10):4707-4720. doi: 10.1007/s00520-020-05294-3. Epub 2020 Jan 21.
- Ha D, Ries AL, Mazzone PJ, Lippman SM, Fuster MM. Exercise capacity and cancer-specific quality of life following curative intent treatment of stage I-IIIA lung cancer. Support Care Cancer. 2018 Jul;26(7):2459-2469. doi: 10.1007/s00520-018-4078-4. Epub 2018 Feb 10.
- Ha D, Kerr J, Ries AL, Fuster MM, Lippman SM, Murphy JD. A Model-Based Cost-Effectiveness Analysis of an Exercise Program for Lung Cancer Survivors After Curative-Intent Treatment. Am J Phys Med Rehabil. 2020 Mar;99(3):233-240. doi: 10.1097/PHM.0000000000001281.
- Ha DM, Zeng C, Chan ED, Gray M, Mazzone PJ, Samet JM, Steiner JF. Association of Exercise Behavior with Overall Survival in Stage I-IIIA Lung Cancer. Ann Am Thorac Soc. 2021 Jun;18(6):1034-1042. doi: 10.1513/AnnalsATS.202003-235OC.
- Parshall MB, Schwartzstein RM, Adams L, Banzett RB, Manning HL, Bourbeau J, Calverley PM, Gift AG, Harver A, Lareau SC, Mahler DA, Meek PM, O'Donnell DE; American Thoracic Society Committee on Dyspnea. An official American Thoracic Society statement: update on the mechanisms, assessment, and management of dyspnea. Am J Respir Crit Care Med. 2012 Feb 15;185(4):435-52. doi: 10.1164/rccm.201111-2042ST.
- Ha DM, Prochazka AV, Bekelman DB, Stevens-Lapsley JE, Studts JL, Keith RL. Modifiable factors associated with health-related quality of life among lung cancer survivors following curative intent therapy. Lung Cancer. 2022 Jan;163:42-50. doi: 10.1016/j.lungcan.2021.11.012. Epub 2021 Dec 2.
- Ha DM, Comer A, Dollar B, Bedoy R, Ford M, Gozansky WS, Zeng C, Arch JJ, Leach HJ, Malhotra A, Prochazka AV, Keith RL, Boxer RS. Telemedicine-based inspiratory muscle training and walking promotion with lung cancer survivors following curative intent therapy: a parallel-group pilot randomized trial. Support Care Cancer. 2023 Sep 1;31(9):546. doi: 10.1007/s00520-023-07999-7.
- Ha DM, Nunnery MA, Klocko RP, Haverhals LM, Bekelman DB, New ML, Randhawa SK, Stevens-Lapsley JE, Studts JL, Prochazka AV, Keith RL. Lung cancer survivors' views on telerehabilitation following curative intent therapy: a formative qualitative study. BMJ Open. 2023 Jun 23;13(6):e073251. doi: 10.1136/bmjopen-2023-073251.
- Ha DM, Prochazka AV, Bekelman DB, Stevens-Lapsley JE, Chan ED, Keith RL. Association of Leisure-Time Physical Activity With Health-Related Quality of Life Among US Lung Cancer Survivors. JNCI Cancer Spectr. 2021 Jan 23;5(1):pkaa118. doi: 10.1093/jncics/pkaa118. eCollection 2021 Feb.
- Ha D, Ries AL. Characterization of Dyspnea in Veteran Lung Cancer Survivors Following Curative-Intent Therapy. J Cardiopulm Rehabil Prev. 2020 Mar;40(2):120-127. doi: 10.1097/HCR.0000000000000464.
- Ha D, Malhotra A, Ries AL, O'Neal WT, Fuster MM. Heart rate variability and heart rate recovery in lung cancer survivors eligible for long-term cure. Respir Physiol Neurobiol. 2019 Nov;269:103264. doi: 10.1016/j.resp.2019.103264. Epub 2019 Jul 31.
- Bade BC, Faiz SA, Ha DM, Tan M, Barton-Burke M, Cheville AL, Escalante CP, Gozal D, Granger CL, Presley CJ, Smith SM, Chamberlaine DM, Long JM, Malone DJ, Pirl WF, Robinson HL, Yasufuku K, Rivera MP. Cancer-related Fatigue in Lung Cancer: A Research Agenda: An Official American Thoracic Society Research Statement. Am J Respir Crit Care Med. 2023 Mar 1;207(5):e6-e28. doi: 10.1164/rccm.202210-1963ST.
- Rochester CL, Alison JA, Carlin B, Jenkins AR, Cox NS, Bauldoff G, Bhatt SP, Bourbeau J, Burtin C, Camp PG, Cascino TM, Dorney Koppel GA, Garvey C, Goldstein R, Harris D, Houchen-Wolloff L, Limberg T, Lindenauer PK, Moy ML, Ryerson CJ, Singh SJ, Steiner M, Tappan RS, Yohannes AM, Holland AE. Pulmonary Rehabilitation for Adults with Chronic Respiratory Disease: An Official American Thoracic Society Clinical Practice Guideline. Am J Respir Crit Care Med. 2023 Aug 15;208(4):e7-e26. doi: 10.1164/rccm.202306-1066ST.
- Shaw J, Kamphuis H, Sharpe L, Lebel S, Smith AB, Hulbert-Williams N, Dhillon HM, Butow P. Setting an International Research Agenda for Fear of Cancer Recurrence: An Online Delphi Consensus Study. Front Psychol. 2021 Feb 22;12:596682. doi: 10.3389/fpsyg.2021.596682. eCollection 2021.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 12, 2026
Primary Completion (Estimated)
March 30, 2027
Study Completion (Estimated)
March 30, 2027
Study Registration Dates
First Submitted
December 16, 2021
First Submitted That Met QC Criteria
December 16, 2021
First Posted (Actual)
January 5, 2022
Study Record Updates
Last Update Posted (Actual)
January 27, 2026
Last Update Submitted That Met QC Criteria
January 26, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- F3661-W
- RX003661 (Other Grant/Funding Number: Department of Veterans Affairs)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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