- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07412041
Precise Exercise Regimen for Cancer Care (PERCC): A Pilot Study (PERCC)
Study Overview
Status
Intervention / Treatment
Detailed Description
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
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Christina Dieli-Conwright, PhD, MPH
- Phone Number: 617-582-8321
- Email: ChristinaM_Dieli-Conwright@dfci.harvard.edu
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ≥18 years at time of diagnosis; due to the rarity of the disease in those <18 years, this age bracket will not be included.
- Histologically diagnosed with stage II or III non-small cell lung cancer (NSCLC) and has not started lung cancer treatment.
- Patient's treatment plan is to receive neoadjuvant therapy (defined as chemotherapy, chemotherapy and immunotherapy, or chemotherapy and radiation therapy) followed by surgical treatment. Patients will be enrolled at least three weeks prior to receiving their first neoadjuvant treatment.
- Ability to follow directions and complete questionnaires in English and/or Spanish.
- Ability to understand and the willingness to sign a written informed consent document prior to any study-related procedures.
- Willing to travel to DFCI for necessary data collection.
Exclusion Criteria:
- Patients who are morbidly obese (BMI>40 kg/m2) or Anorexic (BMI<17 kg/m2).
- Unstable comorbidities that contraindicate participation in exercise program compliance. Patients with unstable comorbidities may develop unexpected adverse events from exercise. For the purpose of patients' safety, as well as because part of this study involves remote, home-based exercise where close supervision is not possible, patients with unstable medical conditions are excluded. Study staff will identify untreated or unmanaged conditions when screening and treating MDs must provide clearance prior to patient enrollment.
- Patients with alcohol or drug abuse, significant mental or emotional problems that would interfere with compliance (assessed by NCCN Distress Thermometer).
- Patients scheduled to receive single modality cancer treatment (unimodal therapy), scheduled surgery within 2 weeks of the pre-treatment clinic visit, or for whom treatment has already started.
- Patients who are pregnant, or plan to become pregnant during study duration will be excluded due to the unknown nature of exercise on developing fetuses.
- Subjects who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: PERCC
Receives personalized virtual exercise program (aerobic and resistance exercise) 1x weekly for patients with lung cancer who plan on receiving neoadjuvant treatment followed by surgery.
|
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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Attendance of Exercise Sessions (Feasibility)
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.
|
From first exercise session to final exercise session (up to 24 weeks)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Treatment Delays
Time Frame: Defined as time between neoadjuvant therapy and surgery
|
Defined as time between neoadjuvant therapy and surgery
|
|
|
Physical Function (Short Physical Performance Battery - SPPB)
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.
|
From baseline (T0) to intermodal visit (T1) to end-of-study (T2) - approximately 24 weeks
|
|
Quality of Life (Functional Assessment of Cancer Therapy - Lung [FACT-L])
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."
|
From baseline (T0) to intermodal visit (T1) to end-of-study (T2) - approximately 24 weeks
|
|
Fatigue (Functional Assessment of Cancer Therapy - Fatigue [FACT-F])
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.
|
From baseline (T0) to intermodal visit (T1) to end-of-study (T2) - approximately 24 weeks
|
|
Nutritional Risk (Nutriscore)
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
|
From baseline (T0) to intermodal visit (T1) to end-of-study (T2) - approximately 24 weeks
|
|
Personal Habits (Personal Habits Questionnaire)
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.
|
From baseline (T0) to intermodal visit (T1) to end-of-study (T2) - approximately 24 weeks
|
|
Smoking and Tobacco Usage
Time Frame: From baseline (T0) to intermodal visit (T1) to end-of-study (T2) - approximately 24 weeks
|
From baseline (T0) to intermodal visit (T1) to end-of-study (T2) - approximately 24 weeks
|
|
|
Emotional Status (Thoughts and Feelings Questionnaire)
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.
|
From baseline (T0) to intermodal visit (T1) to end-of-study (T2) - approximately 24 weeks
|
|
Exercise Self-Efficacy (Exercise Confidence Survey)
Time Frame: From baseline (T0) to intermodal visit (T1) to end-of-study (T2) - approximately 24 weeks
|
From baseline (T0) to intermodal visit (T1) to end-of-study (T2) - approximately 24 weeks
|
|
|
Social Support (Social Activities Survey)
Time Frame: From baseline (T0) to intermodal visit (T1) to end-of-study (T2) - approximately 24 weeks
|
From baseline (T0) to intermodal visit (T1) to end-of-study (T2) - approximately 24 weeks
|
|
|
Subjective Social Status (Society and Community Questionnaire)
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.
|
From baseline (T0) to intermodal visit (T1) to end-of-study (T2) - approximately 24 weeks
|
|
Healthcare Cost and Utilization
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.
|
From baseline (T0) to intermodal visit (T1) to end-of-study (T2) - approximately 24 weeks
|
|
Biomarker Levels
Time Frame: From baseline (T0) to intermodal visit (T1) to end-of-study (T2) - approximately 24 weeks
|
Biomarkers will be analyzed via blood
|
From baseline (T0) to intermodal visit (T1) to end-of-study (T2) - approximately 24 weeks
|
|
Body Composition
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. |
From baseline (T0) to intermodal visit (T1) to end-of-study (T2) - approximately 24 weeks
|
|
Hip and Waist Circumference
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.
|
From baseline (T0) to intermodal visit (T1) to end-of-study (T2) - approximately 24 weeks
|
|
Functional Mobility (Activity Measure for Post Acute Care [AM-PAC])
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.
|
Baseline (T0) to intermodal visit (T1) to end-of-study visit (T2) - approximately 24 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christina Dieli-Conwright, PhD, MPH, Dana-Farber Cancer Institute
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25-607
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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