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NCT Number: NCT07412041

Precise Exercise Regimen for Cancer Care (PERCC): A Pilot Study

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.

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Key information

Conditions

Stage II Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Cancer Lung Diseases Lung Neoplasms NSCLC Neoplasms Neoplasms by Site Non-small Cell Lung Cancer Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PERCC

Behavioral

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)

Primary outcomes

  1. 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.

Other outcomes

  1. Treatment Delays

    Time frame: Defined as time between neoadjuvant therapy and surgery

  2. 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.

  3. 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."

  4. 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.

  5. 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

  6. 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.

  7. Smoking and Tobacco Usage

    Time frame: From baseline (T0) to intermodal visit (T1) to end-of-study (T2) - approximately 24 weeks

  8. 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.

  9. Exercise Self-Efficacy (Exercise Confidence Survey)

    Time frame: From baseline (T0) to intermodal visit (T1) to end-of-study (T2) - approximately 24 weeks

  10. Social Support (Social Activities Survey)

    Time frame: From baseline (T0) to intermodal visit (T1) to end-of-study (T2) - approximately 24 weeks

  11. 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.

  12. 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.

  13. 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

  14. 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.

  15. 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.

  16. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Christina Dieli-Conwright, PhD, MPH

CONTACT

[email protected]

617-582-8321

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Registry information

Acronym: PERCC

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Feb 17, 2026
Registry last updated
Feb 17, 2026

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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