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Lung CancerNCT05179408

Targeted Telerehabilitation Following Curative Intent Therapy of Lung Cancer

A study testing Targeted-telerehabilitation and Waitlist in people with Lung Cancer and Cancer Survivors, run by VA Office of Research and Development at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer, Cancer Survivors
What is being tested?
Targeted-telerehabilitation and Waitlist
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
12 Jan 2026to 30 Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Duc M Ha, MD MAS contact

(240) 643-6872

Duc.Ha@va.gov

Robert L Keith, MD contact

(720) 857-5120

robert.keith@va.gov

United States1 site, 1 recruiting
  • Rocky Mountain Regional VA Medical Center, Aurora, CO

    Aurora, Colorado, 80045-7211

    Duc M Ha, MD MAS, 240-643-6872, Duc.Ha@va.gov

    Duc M. Ha, MD MAS

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Targeted-telerehabilitation, Waitlist
Keywords
Rehabilitation, Exercise training, Mindfulness training, Survivorship, US Veterans, Telemedicine
Medical subject headings
Lung Neoplasms

What participants receive

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

  • Targeted-telerehabilitationBehavioural

    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)

  • WaitlistBehavioural

    8-week waiting period prior to targeted telerehabilitation

Study groups in NCT05179408
Study groupRoleWhat they receive
Targeted telerehabilitationExperimentalParticipant-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)
Receives: Behavioral: Targeted-telerehabilitation
WaitlistActive comparator8-week waiting period prior to participating in targeted telerehabilitation
Receives: Behavioral: Waitlist

What is being measured

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

  1. Health-related quality of life (HRQL)

    Global health-related quality of life (EORTC QLQ C30 global/QoL subscale)

    Measured: Difference in changes in HRQL between baseline and end-of-intervention (8 weeks)

Secondary outcomes (3)
  1. Dysnea and physical activity (participant-chosen)

    University of California Shortness of Breath Questionnaire (UCSD SOBQ) and Fitbit stepcount

    Measured: Differences in changes in UCSD SOBQ and average steps/day between baseline and end-of-intervention (8 weeks)

  2. Cancer-related function (participant chosen)

    PROMIS-SF Cancer Function 3D Profile (fatigue, role, and social function)

    Measured: Difference in changes in PROMIS-SF Cancer Function 3D Profile between baseline and end-of-intervention (8 weeks)

  3. Fear of Cancer Recurrence and Cancer-related Anxiety (participant chosen)

    Fear of Cancer Recurrence (FCR) and PROMIS-SF Anxiety 8a

    Measured: Difference in changes in FCR and PROMIS-SF Anxiety 8a between baseline and end-of-intervention (8 weeks)

Timeline

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

  1. First posted5 Jan 2022
  2. Study start12 Jan 2026
  3. Primary completion30 Mar 2027 (estimated)
  4. Study completion30 Mar 2027 (estimated)

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
Randomised
Intervention model
Parallel groups
Model description
This project will evaluate multi-targeted telerehabilitation with Veteran lung cancer survivors following curative intent therapy. Targets include: 1) inspiratory muscle training + walking promotion to reduce dyspnea and improve physical activity; 2) resistance training to reduce cancer-related fatigue and improve social/role functioning; and 3) mindfulness training to reduce fear of cancer recurrence and cancer-related anxiety.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05179408
Sponsor's protocol ID
F3661-W
Other IDs
RX003661
Status last verified
Jan 2026
First submitted
16 Dec 2021
Last updated
27 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 31965306
  • 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.

    PubMed 29429006
  • 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.

    PubMed 31361623
  • 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.

    PubMed 33326358
  • 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.

    PubMed 34896804
  • 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.

    PubMed 37656252
  • 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.

    PubMed 37355268
  • 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.

    PubMed 35075444
  • 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.

    PubMed 31592931
  • 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.

    PubMed 31376471
  • 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.

    PubMed 36856560
  • 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.

    PubMed 22336677
  • 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.

    PubMed 37581410
  • 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.

    PubMed 33692719

Questions about this trial

What is this clinical trial studying?

A study testing Targeted-telerehabilitation and Waitlist in people with Lung Cancer and Cancer Survivors, run by VA Office of Research and Development at 1 site 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 2 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Duc M Ha, MD MAS ((240) 643-6872, Duc.Ha@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Health-related quality of life (HRQL) (time frame: Difference in changes in HRQL between baseline and end-of-intervention (8 weeks)). 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 NCT05179408, which also lists 14 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 27 Jan 2026.

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