Targeted Telerehabilitation Following Curative Intent Therapy of Lung Cancer

NCT05179408 | Recruiting

• 2 other identifiers: F3661-WRX003661
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Lung Cancer; Cancer Survivors

Keywords

Rehabilitation; Exercise training; Mindfulness training; Survivorship; US Veterans; Telemedicine

Outcome Measures

Primary Outcomes (1)

• Health-related quality of life (HRQL)

  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 Outcomes (3)

• Dysnea and physical activity (participant-chosen)

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

• Cancer-related function (participant chosen)

  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)

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

Study Arms (2)

Targeted telerehabilitation

EXPERIMENTAL

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)

Behavioral: Targeted-telerehabilitation

Waitlist

ACTIVE COMPARATOR

8-week waiting period prior to participating in targeted telerehabilitation

Behavioral: Waitlist

Interventions

Targeted-telerehabilitation BEHAVIORAL

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)

Targeted telerehabilitation

Waitlist BEHAVIORAL

8-week waiting period prior to targeted telerehabilitation

Waitlist

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, 80045-7211, United States

RECRUITING

Related Publications (14)

• 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.

  PMID: 31965306 BACKGROUND

• 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.

  PMID: 29429006 BACKGROUND

• 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.

  PMID: 31361623 BACKGROUND

• 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.

  PMID: 33326358 BACKGROUND

• 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.

  PMID: 34896804 BACKGROUND

• 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.

  PMID: 37656252 BACKGROUND

• 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.

  PMID: 37355268 BACKGROUND

• 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.

  PMID: 35075444 BACKGROUND

• 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.

  PMID: 31592931 BACKGROUND

• 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.

  PMID: 31376471 BACKGROUND

• 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.

  PMID: 36856560 BACKGROUND

• 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.

  PMID: 22336677 BACKGROUND

• 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.

  PMID: 37581410 BACKGROUND

• 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.

  PMID: 33692719 BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Appointments and Schedules; Organization and Administration; Health Services Administration

Study Officials

• Duc M. Ha, MD MAS

  Rocky Mountain Regional VA Medical Center, Aurora, CO

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor will be blinded to participant allocation group.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 16, 2021
• First Posted: January 5, 2022
• Study Start: January 12, 2026
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): March 30, 2027
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)