Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Location status: Recruiting
NCT Number: NCT07412041
The purpose of this study is to test the feasibility of the Precise Exercise Regimen for Cancer Care (PERCC) exercise program in participants with stage II-III primary lung cancer.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02215, United States
Location status: Recruiting
This research study is a feasibility pilot study and to test the feasibility of the Precise Exercise Regimen for Cancer Care (PERCC) exercise program in participants with stage II-III primary lung cancer.
The research study procedures include screening for eligibility including evaluations of fitness and physical health, surveys, and study entry visits.
Participation in the study is expected to be about 24 weeks.
It is expected that about 20 people will take part in this research study
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Personalized at-home exercise program, including aerobic and resistance exercise. Supervised by trained exercise professional via ZOOM (HIPPA complaint video conferencing platform).
Study equipment of Fitbit and resistance bands will be provided to participants.
Other names: Precise Exercise Regimen for Cancer Care (PERCC)
Time frame: From first exercise session to final exercise session (up to 24 weeks)
Defined as the proportion of enrolled participants who complete ≥80% of the prescribed exercise sessions.
Time frame: Defined as time between neoadjuvant therapy and surgery
Time frame: From baseline (T0) to intermodal visit (T1) to end-of-study (T2) - approximately 24 weeks
The SPPB is comprised of three sections: 1) balance with feet together, semi tandem, and full tandem is held for up to 10 seconds with no support (seconds); 2) usual gait speed over four meters is timed (seconds); and 3) chair stand where the time(s) to complete five chair sit-to-stands is recorded.
Time frame: From baseline (T0) to intermodal visit (T1) to end-of-study (T2) - approximately 24 weeks
Assessed by the Functional Assessment of Cancer Therapy - Lung (FACT-L), a 36-item instrument, which specifically determines the QoL in patients with lung cancer with subscales assessing "physical well-being", "emotional well-being", "social well-being", "functional well-being", and "disease-specific items."
Time frame: From baseline (T0) to intermodal visit (T1) to end-of-study (T2) - approximately 24 weeks
Assessed by the Functional Assessment of Cancer Therapy - Fatigue (FACT-F), which a 13-item instrument, added to the end of the FACT-L, which assessed self-reported fatigue and impact on daily activities.
Time frame: From baseline (T0) to intermodal visit (T1) to end-of-study (T2) - approximately 24 weeks
Nutritional risk will be assessed by a brief survey called the Nutriscore
Time frame: From baseline (T0) to intermodal visit (T1) to end-of-study (T2) - approximately 24 weeks
The Personal Habits Questionnaire will be used to ascertain an idea of participants' habits in their personal lives.
Time frame: From baseline (T0) to intermodal visit (T1) to end-of-study (T2) - approximately 24 weeks
Time frame: From baseline (T0) to intermodal visit (T1) to end-of-study (T2) - approximately 24 weeks
The Thoughts and Feelings Questionnaire will be administered to ascertain participants' emotional status.
Time frame: From baseline (T0) to intermodal visit (T1) to end-of-study (T2) - approximately 24 weeks
Time frame: From baseline (T0) to intermodal visit (T1) to end-of-study (T2) - approximately 24 weeks
Time frame: From baseline (T0) to intermodal visit (T1) to end-of-study (T2) - approximately 24 weeks
The Society and Community Questionnaire will determine where participants feel they fall in society using subjective social status ladders.
Time frame: From baseline (T0) to intermodal visit (T1) to end-of-study (T2) - approximately 24 weeks
The Healthcare Cost and Utilization Questionnaire that will be used measures PERCC intervention's impact on healthcare cost and utilization. This established survey looks at length of stay, hospital admissions, emergency room visits and healthcare-associated costs.
Time frame: From baseline (T0) to intermodal visit (T1) to end-of-study (T2) - approximately 24 weeks
Biomarkers will be analyzed via blood
Time frame: From baseline (T0) to intermodal visit (T1) to end-of-study (T2) - approximately 24 weeks
Bioelectrical Impedance Analysis (BIA), and blood pressure as measured twice on both arms with a seated position with a minimum of 1-minute interval and the higher pressure will be recorded when there are differences.
BIA: Assessed via bioelectrical impedance using a validated device (Tanita 780, Arlington Heights, IL). Participants will be asked to remove their shoes and socks after which height will be taken using a stadiometer they will then proceed to move to the BIA and stand still on the device while holding the handles with their hands at their sides. The device will estimate body fat using an algorithm based on their age, sex, height, and body weight.
Time frame: From baseline (T0) to intermodal visit (T1) to end-of-study (T2) - approximately 24 weeks
Hip and waist circumference will be assessed and recorded in cm.
Time frame: Baseline (T0) to intermodal visit (T1) to end-of-study visit (T2) - approximately 24 weeks
The Activity Measure for Post Acute Care (AM-PAC) enables functional mobility assessment and assignment of functional stage. Participants will complete the AM-PAC questionnaire at T0 and every two weeks throughout their participation in the study.
Contact information is provided by the study sponsor or research team.
Dana-Farber Cancer Institute
Other
Acronym: PERCC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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