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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-04722 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| R03AG064374 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical Therapy | Procedure | Undergo physical therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carolyn J Presley, MD, MHS | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
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| Label | URL |
|---|---|
| The Jamesline | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Supportive Care (Physical Therapy, Muscle Relaxation) | 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. Physical Therapy: Undergo physical therapy Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Relaxation Therapy: Undergo progressive muscle relaxation |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 1, 2021 |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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| Relaxation Therapy | Procedure | Undergo progressive muscle relaxation |
|
| 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). | Up to 12 months |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Supportive Care (Physical Therapy, Muscle Relaxation) | 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. Physical Therapy: Undergo physical therapy Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Relaxation Therapy: Undergo progressive muscle relaxation |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Lung Cancer Type | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | Up to 24 weeks |
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| Primary | 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. | Posted | Count of Participants | Participants | Up to 24 weeks |
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| Primary | Retention Rates | Retention rates will be defined as the percentage of participants not lost to follow-up. | 22 patients were consented and enrolled. 4 of the patients that underwent informed consent withdrew from the study prior to completing any study activities. This leaves a total of 18 evaluable participants analyzed for study adherence and retention. Acceptability was defined as completing at least 70 percent of all study visits and not lost to follow up. 2 patients withdrew from the study after beginning the ROAR intervention. | Posted | Count of Participants | Participants | Up to 24 weeks |
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| Secondary | 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. | Data not collected and analyzed | Posted | At 12 months |
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| Secondary | 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). | Data not collected and analyzed | Posted | Up to 12 months |
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A minimum of 12 weeks or through study completion, an average of 1 year
Adverse event information was collected for study patients form baseline through study completion utilizing the CTCAE Version 4.0 to determine the severity of the event through study completion.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Supportive Care (Physical Therapy, Muscle Relaxation) | 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. Physical Therapy: Undergo physical therapy Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Relaxation Therapy: Undergo progressive muscle relaxation | 0 | 18 | 0 | 18 | 0 | 18 |
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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.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Carolyn Presley | The Ohio State University Comprehensive Cancer Center | 614-293-9424 | Carolyn.Presley@osumc.edu |
| Aug 17, 2023 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 1, 2021 | Aug 17, 2023 | ICF_002.pdf |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| D012064 | Relaxation Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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