Back to resultsSupportive Care Intervention (ROAR-LCT) for Patients With Stage IIIA, IIIB, and IV Lung Cancer, ROAR-LCT Trial
Primary Purpose
Advanced Lung Non-Small Cell Carcinoma, Advanced Lung Small Cell Carcinoma, Extensive Stage Lung Small Cell Carcinoma
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Best Practice
Exercise Intervention
Physical Therapy
Quality-of-Life Assessment
Questionnaire Administration
Relaxation Therapy
Sponsored by
About this trial
This is an interventional supportive care trial for Advanced Lung Non-Small Cell Carcinoma
Eligibility Criteria
Inclusion Criteria:
- Age >= 60 years
- Diagnosed with an 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
- A score of 2 or higher on the three functional items of the European Quality of Life Five Dimension Five Level Scale (EQ5D5L) patient reported outcome (PRO) assessment
- Patients are eligible at any time point during their treatment here at Ohio State University (OSU). Rationale for this timeframe is due to the overwhelming nature of the first few visits and uncertainty around an eventual treatment plan. Patients at any stage of their treatment can participate and benefit from a physical therapy and psychosocial intervention. Patients will be approached at their initial visit but the investigators can also offer enrollment at any one of the patients regularly scheduled clinic visits or via phone or email
- Ability to understand and willingness to sign an informed consent document (or indicate approval or disapproval by another means)
Exclusion Criteria:
- Prisoners are excluded from participation
- There is NO exclusion criteria pertaining to Eastern Cooperative Oncology Group (ECOG) performance status, laboratory values, prior cancer diagnoses, presence of comorbidities or brain metastases
Sites / Locations
- Carolyn PresleyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arm I (ROAR-LCT intervention)
Arm II (standard of care)
Arm Description
Patients receive ROAR-LCT intervention weekly for 12 weeks consisting of physical therapy visits and an exercise intervention. Patients also undergo progressive muscles relaxation exercises over 20 minutes for 12 weeks.
Patients receive standard of care for 12 weeks.
Outcomes
Primary Outcome Measures
Study adherence
Study adherence will be defined as the completion of 70% of the program sessions, repeated assessments, and collection of biospecimens either at the end of the study period or death, whichever occurs first.
Retention
Retention rates will be defined as the percentage of participants not lost to follow-up at 1.5 months,
Retention
Retention rates will be defined as the percentage of participants not lost to follow-up at 3 months
Retention
Retention rates will be defined as the percentage of participants not lost to follow-up at 6 months
Amount and duration of therapy that participants were able to complete
sessions completed, weeks it takes to complete all 12 session; missed sessions; reasons for missed sessions
Amount and duration of therapy that participants were able to complete
sessions completed, weeks it takes to complete all 12 session; missed sessions; reasons for missed sessions
Preliminary effect on functional status
A joint model using group-based trajectory modeling will be used to estimate clinically distinct trajectories of functional status and attrition probability (death or dropout). These models will be used to evaluate differences in change of functional scores between study arms through 3 months of follow-up. Additionally, generalized linear mixed models (GLMMs) will be used to model change in functional status from baseline to 3 months to explore if the intervention has both an immediate and sustained impact on function.
Preliminary effect on functional status
A joint model using group-based trajectory modeling will be used to estimate clinically distinct trajectories of functional status and attrition probability (death or dropout). These models will be used to evaluate differences in change of functional scores between study arms through 6 months of follow-up. Additionally, generalized linear mixed models (GLMMs) will be used to model change in functional status from baseline 6 months to explore if the intervention has both an immediate and sustained impact on function.
Preliminary effect on functional status
A joint model using group-based trajectory modeling will be used to estimate clinically distinct trajectories of functional status and attrition probability (death or dropout). These models will be used to evaluate differences in change of functional scores between study arms through 12 months of follow-up. Additionally, generalized linear mixed models (GLMMs) will be used to model change in functional status from baseline to 12 months to explore if the intervention has both an immediate and sustained impact on function.
Secondary Outcome Measures
Physical capability
Functional Status Assessment: This is a 16-item questionnaire that includes seven Activities of Daily Living (ADL) measures, 5 Instrumental Activities of Daily Living (IADL) measures, and 3 mobility activities. For each activity, disability is defined as the need for personal assistance or inability to perform the activity. Activities are scored as 0 being no help, 1 being with help, and 2 meaning unable to perform the activity. Higher scores indicate greater disability or a lower functional status.
Incidence and severity of toxicity
Toxicity assessment completed at the end of each chemotherapy or immunotherapy treatment cycle using the CTCAE V5; (irAEs, AEs, SAEs) Toxicities will be graded 1-5 with grade 5 being the worst and grade 1 being less severe.
Psychological symptoms
GAD-7; This assessment is a 7 item questionnaire that asks patients how often in the past 2 weeks, have they been bothered by each symptom. The responses are scored as 0 being "not at all," 1 being "several days," 2 being "more than half the days", and 3 being "nearly every day," for an aggregate score of 21. Higher scores indicate a higher prevalence of anxiety and are strongly associated with multiple domains of functional impairment and disability days.33
Psychological Symptoms
PHQ-9; This is a 9-item depression segment which assesses the severity of depressive symptoms within the last two weeks. Patients will complete the PHQ-9 approximately every 6 weeks administered by the CRC. Items are scored from 0-3 with higher scores indicating greater levels of depression. If 5 or more of the 9 symptoms have been present for "more than half the days," then major depression is indicated. Other depression is indicated if 2, 3, or 4 of the symptoms have been present at least "more than half the days" in the past 2 weeks, and 1 of the symptoms is depressed mood or anhedonia.
Physical function
Short Physical Performance Battery (SPPB);. The SPPB is a validated tool used to assess lower extremity functioning. It is comprised of three objective measures testing for standing balance, normal gait speed, and strength performance by use of a timed sit-to-stand. The participants are asked to stand with their feet side by side, semi tandem, and tandem for 10 seconds each to assess balance. Normal gait speed is tested by asking participants to walk 8 feet at his or her normal speed. Strength performance is tested by asking participants to complete five timed chair sit to stands without the use of hands. These three measures are scored individually from 0 to 4 with an aggregate score ranging from 0 to 12, with higher scores correlating with a greater functional status. The scores are then classified into 4 categories; very low physical function (0-3); low physical function (4-6); moderate physical function (7-9); and high physical function (10-12).
Physical Endurance
2-6 min walk test; This is a validated tool used to assess endurance and overall functional exercise capacity. Patients are instructed to walk on a treadmill at their own pace for as long as they are able. At the end of the allotted time, patients are told to stop and the total distance covered is recorded. Participants walking less than 300 meters are considered to have low endurance while those walking over 300 meters are considered to have normal endurance.
Full Information
NCT ID
NCT05339022
First Posted
March 1, 2022
Last Updated
August 30, 2022
Sponsor
Ohio State University Comprehensive Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT05339022
Brief Title
Supportive Care Intervention (ROAR-LCT) for Patients With Stage IIIA, IIIB, and IV Lung Cancer, ROAR-LCT Trial
Official Title
Resiliency Among Older Adults Receiving Lung Cancer Treatment (ROAR-LCT): A Phase II Randomized Supportive Care Intervention Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 14, 2022 (Actual)
Primary Completion Date
April 10, 2024 (Anticipated)
Study Completion Date
April 10, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University Comprehensive Cancer Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This phase II trial tests whether a supportive care intervention (Resiliency among Older Adults Receiving Lung Cancer Treatment [ROAR-LCT]) is effective in improving physical and emotional wellbeing in patients with stage IIIA, IIIB, and IV lung cancer undergoing cancer treatment. Lung cancers are one of the most common cancers. Lung cancers occur in the chest and often cause symptoms for patients. Poor physical performance and negative mood are two risk factors for a decline in functional status. Targeted interventions may address these two risk factors and improve functional status and resilience. Physical therapy and relaxation interventions (i.e. progressive muscle relaxation) are two such interventions that may improve symptoms and quality of life for patients with cancer.
Detailed Description
PRIMARY OBJECTIVE:
I. To determine the potential effectiveness of a novel, supervised virtual health-assisted physical therapy plus relaxation intervention vs. standard of care on the primary outcomes: functional status and overall feasibility of the study design.
SECONDARY OBJECTIVE:
I. To determine the potential effectiveness of the intervention on secondary outcomes: psychological symptoms, and physical capability among older adults with an advanced lung cancer (N=100).
EXPLORATORY OBJECTIVE:
I. Lung cancer symptom burden, treatment toxicity, and smoking cessation.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive ROAR-LCT intervention weekly for 12 weeks consisting of physical therapy visits and an exercise intervention. Patients also undergo progressive muscles relaxation exercises over 20 minutes for 12 weeks.
ARM II: Patients receive standard of care for 12 weeks.
After completion of study intervention, patients are followed up for up to 24 months after date of study enrollment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Lung Non-Small Cell Carcinoma, Advanced Lung Small Cell 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 Non-Small Cell Carcinoma, Unresectable Lung Small Cell Carcinoma
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm I (ROAR-LCT intervention)
Arm Type
Experimental
Arm Description
Patients receive ROAR-LCT intervention weekly for 12 weeks consisting of physical therapy visits and an exercise intervention. Patients also undergo progressive muscles relaxation exercises over 20 minutes for 12 weeks.
Arm Title
Arm II (standard of care)
Arm Type
Active Comparator
Arm Description
Patients receive standard of care for 12 weeks.
Intervention Type
Other
Intervention Name(s)
Best Practice
Other Intervention Name(s)
standard of care, standard therapy
Intervention Description
Receive standard of care
Intervention Type
Other
Intervention Name(s)
Exercise Intervention
Intervention Description
Undergo exercise intervention
Intervention Type
Procedure
Intervention Name(s)
Physical Therapy
Other Intervention Name(s)
Physiatric Procedure, Physical Medicine Procedure, Physical Therapeutics, Physical Therapy Procedure, Physiotherapy, Physiotherapy Procedure, PT
Intervention Description
Undergo physical therapy
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Procedure
Intervention Name(s)
Relaxation Therapy
Intervention Description
Undergo progressive muscles relaxation exercises
Primary Outcome Measure Information:
Title
Study adherence
Description
Study adherence will be defined as the completion of 70% of the program sessions, repeated assessments, and collection of biospecimens either at the end of the study period or death, whichever occurs first.
Time Frame
Up to 12 weeks
Title
Retention
Description
Retention rates will be defined as the percentage of participants not lost to follow-up at 1.5 months,
Time Frame
1.5 month
Title
Retention
Description
Retention rates will be defined as the percentage of participants not lost to follow-up at 3 months
Time Frame
3 Month
Title
Retention
Description
Retention rates will be defined as the percentage of participants not lost to follow-up at 6 months
Time Frame
6 Month
Title
Amount and duration of therapy that participants were able to complete
Description
sessions completed, weeks it takes to complete all 12 session; missed sessions; reasons for missed sessions
Time Frame
Week 12
Title
Amount and duration of therapy that participants were able to complete
Description
sessions completed, weeks it takes to complete all 12 session; missed sessions; reasons for missed sessions
Time Frame
Week 24
Title
Preliminary effect on functional status
Description
A joint model using group-based trajectory modeling will be used to estimate clinically distinct trajectories of functional status and attrition probability (death or dropout). These models will be used to evaluate differences in change of functional scores between study arms through 3 months of follow-up. Additionally, generalized linear mixed models (GLMMs) will be used to model change in functional status from baseline to 3 months to explore if the intervention has both an immediate and sustained impact on function.
Time Frame
3 Month
Title
Preliminary effect on functional status
Description
A joint model using group-based trajectory modeling will be used to estimate clinically distinct trajectories of functional status and attrition probability (death or dropout). These models will be used to evaluate differences in change of functional scores between study arms through 6 months of follow-up. Additionally, generalized linear mixed models (GLMMs) will be used to model change in functional status from baseline 6 months to explore if the intervention has both an immediate and sustained impact on function.
Time Frame
6 Month
Title
Preliminary effect on functional status
Description
A joint model using group-based trajectory modeling will be used to estimate clinically distinct trajectories of functional status and attrition probability (death or dropout). These models will be used to evaluate differences in change of functional scores between study arms through 12 months of follow-up. Additionally, generalized linear mixed models (GLMMs) will be used to model change in functional status from baseline to 12 months to explore if the intervention has both an immediate and sustained impact on function.
Time Frame
12 month
Secondary Outcome Measure Information:
Title
Physical capability
Description
Functional Status Assessment: This is a 16-item questionnaire that includes seven Activities of Daily Living (ADL) measures, 5 Instrumental Activities of Daily Living (IADL) measures, and 3 mobility activities. For each activity, disability is defined as the need for personal assistance or inability to perform the activity. Activities are scored as 0 being no help, 1 being with help, and 2 meaning unable to perform the activity. Higher scores indicate greater disability or a lower functional status.
Time Frame
Up to 12 weeks
Title
Incidence and severity of toxicity
Description
Toxicity assessment completed at the end of each chemotherapy or immunotherapy treatment cycle using the CTCAE V5; (irAEs, AEs, SAEs) Toxicities will be graded 1-5 with grade 5 being the worst and grade 1 being less severe.
Time Frame
Up to 12 weeks
Title
Psychological symptoms
Description
GAD-7; This assessment is a 7 item questionnaire that asks patients how often in the past 2 weeks, have they been bothered by each symptom. The responses are scored as 0 being "not at all," 1 being "several days," 2 being "more than half the days", and 3 being "nearly every day," for an aggregate score of 21. Higher scores indicate a higher prevalence of anxiety and are strongly associated with multiple domains of functional impairment and disability days.33
Time Frame
Up to 12 weeks
Title
Psychological Symptoms
Description
PHQ-9; This is a 9-item depression segment which assesses the severity of depressive symptoms within the last two weeks. Patients will complete the PHQ-9 approximately every 6 weeks administered by the CRC. Items are scored from 0-3 with higher scores indicating greater levels of depression. If 5 or more of the 9 symptoms have been present for "more than half the days," then major depression is indicated. Other depression is indicated if 2, 3, or 4 of the symptoms have been present at least "more than half the days" in the past 2 weeks, and 1 of the symptoms is depressed mood or anhedonia.
Time Frame
Up to 12 weeks
Title
Physical function
Description
Short Physical Performance Battery (SPPB);. The SPPB is a validated tool used to assess lower extremity functioning. It is comprised of three objective measures testing for standing balance, normal gait speed, and strength performance by use of a timed sit-to-stand. The participants are asked to stand with their feet side by side, semi tandem, and tandem for 10 seconds each to assess balance. Normal gait speed is tested by asking participants to walk 8 feet at his or her normal speed. Strength performance is tested by asking participants to complete five timed chair sit to stands without the use of hands. These three measures are scored individually from 0 to 4 with an aggregate score ranging from 0 to 12, with higher scores correlating with a greater functional status. The scores are then classified into 4 categories; very low physical function (0-3); low physical function (4-6); moderate physical function (7-9); and high physical function (10-12).
Time Frame
Up to 12 weeks
Title
Physical Endurance
Description
2-6 min walk test; This is a validated tool used to assess endurance and overall functional exercise capacity. Patients are instructed to walk on a treadmill at their own pace for as long as they are able. At the end of the allotted time, patients are told to stop and the total distance covered is recorded. Participants walking less than 300 meters are considered to have low endurance while those walking over 300 meters are considered to have normal endurance.
Time Frame
Up to 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age >= 60 years
Diagnosed with an 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
A score of 2 or higher on the three functional items of the European Quality of Life Five Dimension Five Level Scale (EQ5D5L) patient reported outcome (PRO) assessment
Patients are eligible at any time point during their treatment here at Ohio State University (OSU). Rationale for this timeframe is due to the overwhelming nature of the first few visits and uncertainty around an eventual treatment plan. Patients at any stage of their treatment can participate and benefit from a physical therapy and psychosocial intervention. Patients will be approached at their initial visit but the investigators can also offer enrollment at any one of the patients regularly scheduled clinic visits or via phone or email
Ability to understand and willingness to sign an informed consent document (or indicate approval or disapproval by another means)
Exclusion Criteria:
Prisoners are excluded from participation
There is NO exclusion criteria pertaining to Eastern Cooperative Oncology Group (ECOG) performance status, laboratory values, prior cancer diagnoses, presence of comorbidities or brain metastases
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
The Ohio State University Comprehensive Cancer Center
Phone
800-293-5066
Email
OSUCCCClinicaltrials@osumc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolyn J Presley, MD
Organizational Affiliation
Ohio State University Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carolyn Presley
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carolyn J. Presley, MD, MHS
Phone
614-293-6786
Email
carolyn.presley@osumc.edu
First Name & Middle Initial & Last Name & Degree
Madison Grogan
Email
madison.grogan@osumc.edu
First Name & Middle Initial & Last Name & Degree
Carolyn J. Presley
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://cancer.osu.edu
Description
The Jamesline
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Supportive Care Intervention (ROAR-LCT) for Patients With Stage IIIA, IIIB, and IV Lung Cancer, ROAR-LCT Trial
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