Resiliency Among Older Adults Receiving Lung Cancer Treatment

NCT04229381 | Completed Results DMC

• 3 other identifiers: OSU-19115NCI-2019-04722R03AG064374
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This trial studies how well physical therapy and progressive muscle relaxation works in improving physical performance and mood in older patients with stage IIIA-B or IV lung cancer who are undergoing treatment. Improving physical performance and mood may help older patients maintain an independent lifestyle by helping to improve their resilience, the ability to bounce back to normal functioning after a stressor or intervening health event such as treatment or disease progression. Giving physical therapy and progressive muscle relaxation may work in improving symptoms and quality of life in patients with lung cancer.

Conditions

Advanced Lung Carcinoma; Extensive Stage Lung Small Cell Carcinoma; Stage IIIA Lung Cancer AJCC v8; Stage IIIB Lung Cancer AJCC v8; Stage IV Lung Cancer AJCC v8; Stage IVA Lung Cancer AJCC v8; Stage IVB Lung Cancer AJCC v8; Unresectable Lung Carcinoma; Unresectable Lung Non-Small Cell Carcinoma

Outcome Measures

Primary Outcomes (3)

• Recruitment Rates

  Recruitment rates will be defined as the proportion of screened older adults accrued relative to those approached in the Ohio State University Comprehensive Cancer Center (OSUCCC) Thoracic Oncology Clinic. Successful recruitment rates will be defined as \>= 50% of older adults (\>= 60 years) approached agree to participate.

  Up to 24 weeks

• Adherence Rate

  Study adherence will be defined as the completion of \>= 70% of the program sessions, repeated assessments, and collection of bio specimens either at the end of the study period or death, whichever occurs first.

  Up to 24 weeks

• Retention Rates

  Retention rates will be defined as the percentage of participants not lost to follow-up.

  Up to 24 weeks

Secondary Outcomes (2)

• Functional Trajectories

  At 12 months

• Factors Associated With Resiliency

  Up to 12 months

Study Arms (1)

Supportive Care (physical therapy, muscle relaxation)

EXPERIMENTAL

Patients participate physical therapy sessions consisting of cardiovascular and resistance training exercises in person or online and also undergo progressive muscle relaxation sessions once weekly for up to 12 weeks.

Procedure: Physical Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Procedure: Relaxation Therapy

Interventions

Physical Therapy PROCEDURE

Undergo physical therapy

Also known as: Physiatric Procedure, Physical Medicine Procedure, Physical Therapeutics, Physical Therapy Procedure, Physiotherapy, Physiotherapy Procedure, PT

Supportive Care (physical therapy, muscle relaxation)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Supportive Care (physical therapy, muscle relaxation)

Questionnaire Administration OTHER

Ancillary studies

Supportive Care (physical therapy, muscle relaxation)

Relaxation Therapy PROCEDURE

Undergo progressive muscle relaxation

Supportive Care (physical therapy, muscle relaxation)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with advanced lung cancer: unresectable stage IIIA, IIIB, or stage IV non-small cell lung cancer (NSCLC) or extensive stage small cell lung cancer (SCLC).
• Intent to receive treatment from the Ohio State University Comprehensive Cancer Center (OSUCCC) Thoracic Oncology Clinic.
• Willingness to participate and adhere to the study intervention program.
• Ability to understand and willingness to sign an informed consent document (or indicate approval or disapproval by another means).

You may not qualify if:

• Prisoners are excluded from participation.

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Physical Therapy Modalities; Relaxation Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Mind-Body Therapies; Complementary Therapies; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Limitations and Caveats

Study opened in February of 2020 and COVID-19 lockdown in Ohio occurred in March of 2020. We had participants already in this first month of accrual who did decide to dropout due to COVID-19 related concerns. The study design was modified as most patients were being seen via virtual health for standard oncology care visits. The first and final intervention sessions were in-person with the remainder conducted via virtual health.

Results Point of Contact

• Title: Dr. Carolyn Presley
• Organization: The Ohio State University Comprehensive Cancer Center

Carolyn.Presley@osumc.edu

614-293-9424

Study Officials

• Carolyn J Presley, MD, MHS

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 26, 2019
• First Posted: January 18, 2020
• Study Start: January 22, 2020
• Primary Completion: June 22, 2021
• Study Completion: June 22, 2022
• Last Updated: November 15, 2023
• Results First Posted: November 15, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)