An interventional study of Physical Therapy and Quality-of-Life Assessment in Advanced Lung Carcinoma, Extensive Stage Lung Small Cell Carcinoma and Stage IIIA Lung Cancer AJCC v8, sponsored by Ohio State University Comprehensive Cancer Center. Completed at 1 site in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2023-11-15.
Sponsored by Ohio State University Comprehensive Cancer Center · Not applicable, Interventional, and Supportive care
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.
PRIMARY OBJECTIVES:
I. To assess the feasibility of a novel, weekly supervised virtual health-assisted physical therapy plus relaxation intervention delivered to older adults with advanced thoracic malignancy (N=20).
OUTLINE:
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.
After completion of study therapy, patients are followed up at 24 weeks, and then periodically for up to 24 months.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 18 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Ohio State University Comprehensive Cancer Center is the lead sponsor of 369 studies on the registry; 81 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 19 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Undergo physical therapy
Also known as: Physiatric Procedure, Physical Medicine Procedure, Physical Therapeutics, Physical Therapy Procedure, Physiotherapy, Physiotherapy Procedure, PT
Ancillary studies
Also known as: Quality of Life Assessment
Ancillary studies
Undergo progressive muscle relaxation
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.
Time frame: 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.
Time frame: Up to 24 weeks
Retention Rates
Retention rates will be defined as the percentage of participants not lost to follow-up.
Time frame: Up to 24 weeks
Functional Trajectories
Evaluated using generalized linear mixed models (GLMMS). GLMMs can determine whether factors affect all patient trajectories in similar ways or whether they affect individual trajectories differently. To allow for possible changes in functional status over time (e.g., a change-point analysis) the 'segmented' package in R will be used. Participants' functional status scores will be modeled using a segmented mixed model with random change points. Estimating the change point identifies the point in time that patients' functional status scores change during the 12-months post-diagnosis.
Time frame: At 12 months
Factors Associated With Resiliency
Evaluated using GLMMS. Resiliency will be defined as the ability to maintain or regain at least 50% of baseline functional status at any point during the 12 months after diagnosis with specific emphasis at 3 and 6-months post- the start of treatment. The association between resiliency and clinical factors will be evaluated with appropriate statistical techniques for the specific measure (e.g. Chi-square tests will compare categorical variables between participants demonstrating resiliency vs. worsening functional status; a two-sample t-test or Wilcoxon Rank Sum test will compare continuous variables).
Time frame: Up to 12 months
| Milestone | Supportive Care (Physical Therapy, Muscle Relaxation) |
|---|---|
| Started | 18 |
| Completed | 18 |
| Not completed | 0 |
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.
| Participants | Supportive Care (Physical Therapy, Muscle Relaxation) |
|---|---|
| Recruitment Rates | 11 |
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.
| Participants | Supportive Care (Physical Therapy, Muscle Relaxation) |
|---|---|
| Adherence Rate | 11 |
Retention rates will be defined as the percentage of participants not lost to follow-up.
| Participants | Supportive Care (Physical Therapy, Muscle Relaxation) |
|---|---|
| Retention Rates | 16 |
Evaluated using generalized linear mixed models (GLMMS). GLMMs can determine whether factors affect all patient trajectories in similar ways or whether they affect individual trajectories differently. To allow for possible changes in functional status over time (e.g., a change-point analysis) the 'segmented' package in R will be used. Participants' functional status scores will be modeled using a segmented mixed model with random change points. Estimating the change point identifies the point in time that patients' functional status scores change during the 12-months post-diagnosis.
No measurements were reported for this outcome.
Evaluated using GLMMS. Resiliency will be defined as the ability to maintain or regain at least 50% of baseline functional status at any point during the 12 months after diagnosis with specific emphasis at 3 and 6-months post- the start of treatment. The association between resiliency and clinical factors will be evaluated with appropriate statistical techniques for the specific measure (e.g. Chi-square tests will compare categorical variables between participants demonstrating resiliency vs. worsening functional status; a two-sample t-test or Wilcoxon Rank Sum test will compare continuous variables).
No measurements were reported for this outcome.
Collected over A minimum of 12 weeks or through study completion, an average of 1 year. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Supportive Care (Physical Therapy, Muscle Relaxation) | 0/18 (0%) | 0/18 (0%) | 0/18 (0%) |
| Age, Continuous(years) | Supportive Care (Physical Therapy, Muscle Relaxation) |
|---|---|
| Mean | 71.9 (60 to 85) |
| Sex: Female, Male(Participants) | Supportive Care (Physical Therapy, Muscle Relaxation) |
|---|---|
| Female | 4 |
| Male | 14 |
| Ethnicity (NIH/OMB)(Participants) | Supportive Care (Physical Therapy, Muscle Relaxation) |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 18 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Supportive Care (Physical Therapy, Muscle Relaxation) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 18 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Supportive Care (Physical Therapy, Muscle Relaxation) |
|---|---|
| United States | 18 |
| Lung Cancer Type(Participants) | Supportive Care (Physical Therapy, Muscle Relaxation) |
|---|---|
| Non-Small Cell Lung Cancer (NSCLC) | 15 |
| Small Cell Lung Cancer (SCLC) | 3 |
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Ohio State University Comprehensive Cancer Center