Precise Exercise Regimen for Cancer Care (PERCC): A Pilot Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDana-Farber Cancer Institute
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
PERCC
BehavioralPersonalized 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.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: PERCCExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Attendance of Exercise Sessions (Feasibility)
Defined as the proportion of enrolled participants who complete ≥80% of the prescribed exercise sessions.
Time frame
From first exercise session to final exercise session (up to 24 weeks)Other outcomes
1
Treatment Delays
Time frame
Defined as time between neoadjuvant therapy and surgery2
Physical Function (Short Physical Performance Battery - SPPB)
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 weeks3
Quality of Life (Functional Assessment of Cancer Therapy - Lung [FACT-L])
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 weeks4
Fatigue (Functional Assessment of Cancer Therapy - Fatigue [FACT-F])
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 weeksSponsors and contacts
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Source ClinicalTrials.gov