Trial Outcomes & Findings for Resiliency Among Older Adults Receiving Lung Cancer Treatment (NCT NCT04229381)

Last Updated: 2023-11-15

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

18 participants

Primary outcome timeframe

Up to 24 weeks

Results posted on

2023-11-15

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	18
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Resiliency Among Older Adults Receiving Lung Cancer Treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Supportive Care (Physical Therapy, Muscle Relaxation) n=18 Participants 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
Age, Continuous	71.9 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants
Lung Cancer Type Non-Small Cell Lung Cancer (NSCLC)	15 Participants n=5 Participants
Lung Cancer Type Small Cell Lung Cancer (SCLC)	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 24 weeks

Outcome measures

Outcome measures
Measure	Supportive Care (Physical Therapy, Muscle Relaxation) n=18 Participants 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
Recruitment Rates	11 Participants

PRIMARY outcome

Timeframe: Up to 24 weeks

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.

Outcome measures

Outcome measures
Measure	Supportive Care (Physical Therapy, Muscle Relaxation) n=18 Participants 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
Adherence Rate	11 Participants

PRIMARY outcome

Timeframe: Up to 24 weeks

Population: 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.

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

Outcome measures

Outcome measures
Measure	Supportive Care (Physical Therapy, Muscle Relaxation) n=18 Participants 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
Retention Rates	16 Participants

SECONDARY outcome

Timeframe: At 12 months

Population: Data not collected and analyzed

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 12 months

Population: Data not collected and analyzed

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).

Outcome measures

Outcome data not reported

Adverse Events

Supportive Care (Physical Therapy, Muscle Relaxation)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Carolyn Presley

The Ohio State University Comprehensive Cancer Center

Phone: 614-293-9424

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place