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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PERCC | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Attendance of Exercise Sessions (Feasibility) | 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) |
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| Measure | Description | Time Frame |
|---|---|---|
| Treatment Delays | Defined as time between neoadjuvant therapy and surgery | |
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christina Dieli-Conwright, PhD, MPH | Contact | 617-582-8321 | christinam_dieli-conwright@dfci.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Christina Dieli-Conwright, PhD, MPH | Dana-Farber Cancer Institute | Principal Investigator |
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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.
Data can be shared no earlier than 1 year following the date of publication
DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 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]) | 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]) | 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) | 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) | 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 | From baseline (T0) to intermodal visit (T1) to end-of-study (T2) - approximately 24 weeks |
| Emotional Status (Thoughts and Feelings Questionnaire) | 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) | From baseline (T0) to intermodal visit (T1) to end-of-study (T2) - approximately 24 weeks |
| Social Support (Social Activities Survey) | From baseline (T0) to intermodal visit (T1) to end-of-study (T2) - approximately 24 weeks |
| 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. | From baseline (T0) to intermodal visit (T1) to end-of-study (T2) - approximately 24 weeks |
| 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. | From baseline (T0) to intermodal visit (T1) to end-of-study (T2) - approximately 24 weeks |
| Biomarker Levels | Biomarkers will be analyzed via blood | From baseline (T0) to intermodal visit (T1) to end-of-study (T2) - approximately 24 weeks |
| 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. | From baseline (T0) to intermodal visit (T1) to end-of-study (T2) - approximately 24 weeks |
| Hip and Waist Circumference | 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]) | 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 |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |