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

Browse trials for

• Lung Neoplasms 7,243
• Carcinoma, Non-Small-Cell Lung 6,488

Keywords

• Stage II Lung Cancer
• Lung Cancer
• Non-small Cell Lung Cancer
• NSCLC

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 20 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Lead sponsor

Dana-Farber Cancer Institute is the lead sponsor of 813 studies on the registry; 124 are open to participants now.

Of its 113 completed or terminated interventional studies of FDA-regulated products, 77 (68%) have results posted.

Study arms

• 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.

  Behavioral: PERCC

Interventions

• BehavioralPERCC

  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.

  Also known as: Precise Exercise Regimen for Cancer Care (PERCC)

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 surgery

2. 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 weeks

3. 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 weeks

4. 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 weeks

5. Nutritional Risk (Nutriscore)

   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

6. Personal Habits (Personal Habits Questionnaire)

   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

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)

   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

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)

    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

12. Healthcare Cost and Utilization

    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

13. Biomarker Levels

    Biomarkers will be analyzed via blood

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

14. Body Composition

    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

15. Hip and Waist Circumference

    Hip and waist circumference will be assessed and recorded in cm.

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

16. Functional Mobility (Activity Measure for Post Acute Care [AM-PAC])

    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.

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

Individual participant data

Plan to share: Yes — The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Supporting information: Study protocol, Sap