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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01CA211705-05 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| National Institutes of Health (NIH) | NIH |
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This is a Phase 3 study aimed at investigating the effects of a personalized exercise program (PEP) in NSCLC patients (stage I, II, IIIa) and secondary lung cancer patients undergoing surgical treatment at the University of Utah and comparing the intervention to the current standard of care (no exercise program).
This is a Phase 3 study aimed at investigating the effects of a personalized exercise program (PEP) in NSCLC patients (stage I, II, IIIa) and secondary lung cancer patients undergoing surgical treatment at the University of Utah and comparing the intervention to the current standard of care (no exercise program).
Eligible patients will be randomized between two arms (1:1 ratio) prior to the surgery and will be followed for approximately 6 months post-surgery:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Personalized Exercise Program | Experimental |
| |
| Standard of Care - No Exercise | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Personalized Exercise Program | Behavioral | The PEP intervention involves a combination of home-based exercise as well as in-patient exercise. The exercise modes will include basic transfer and calisthenics mobility, aerobic and resistance exercises and will be performed in various postures (supine, sitting, standing and walking) with variable challenges (level walking, bending, inclines, steps and squatting). For patients randomized to the Intervention Group (Group 1), the PEP intervention will be personalized, implemented, and modified (based on the patients AM-PAC mobility stage) by a licensed physical therapist in face-to-face, virtual, or phone meetings (~30-40 minutes). An exercise education manual, specifically developed for this study, will be used by the physical therapist to educate the patients on all aspects of starting and maintaining the exercise intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Mobility Performance - Six Minute Walk (6MW) Distance | Six Minute Walk (6MW) distance is the distance patients can walk indoors on a 25-meter level, smooth-surfaced track over the course of 6 minutes. This outcome will report the mean 6MW distance at hospital discharge (up to 38 days after the initiation of the study intervention), at the 2-Month Post Surgery Visit (up to 5 months from the initiation of the study intervention), and at the 6-Month Post Surgery Visit (up to 9 months from the initiation of the study intervention). | Hospital Discharge (up to 38 days after the initiation of the study therapy), 2-Month Post Surgery Visit (up to 5 months after the initiation of the study therapy), and 6-Month Post Surgery Visit (up to 9 months after the initiation of study therapy) |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the Change Short Physical Performance Battery (SPPB) Score | This outcome will report the results from the Short Physical Performance Battery (SPPB). This secondary outcome measure is associated with the evaluation of improvement in physical performance is the result of the short physical performance battery test. The SPPB score (ranging from 0 to 12) will be obtained for each patient at the time points described above. A score of 0 indicates the worst performance, and a score of 12 indicates the best performance. This outcome will report median SPPB scores at hospital discharge (up to 38 days after the initiation of the study intervention), at the 2-Month Post Surgery Visit (up to 5 months from the initiation of the study intervention), and at the 6-Month Post Surgery Visit (up to 9 months from the initiation of the study intervention). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40072448 | Derived | Ulrich CM, Himbert C, Barnes CA, Boucher KM, Daniels B, Bandera VM, Ligibel JA, Wetter DW, Hess R, Kim J, Lundberg K, Mitzman B, Marcus R, Finlayson SRG, LaStayo PC, Varghese TK Jr. Precision Exercise Effect on Fatigue and Function in Lung Cancer Surgery: A Randomized Clinical Trial. JAMA Surg. 2025 May 1;160(5):495-519. doi: 10.1001/jamasurg.2025.0130. | |
| 38418709 | Derived | Assmann ES, Ose J, Hathaway CA, Oswald LB, Hardikar S, Himbert C, Chellam V, Lin T, Daniels B, Kirchhoff AC, Gigic B, Grossman D, Tward J, Varghese TK Jr, Shibata D, Figueiredo JC, Toriola AT, Beck A, Scaife C, Barnes CA, Matsen C, Ma DS, Colman H, Hunt JP, Jones KB, Lee CJ, Larson M, Onega T, Akerley WL, Li CI, Grady WM, Schneider M, Dinkel A, Islam JY, Gonzalez BD, Otto AK, Penedo FJ, Siegel EM, Tworoger SS, Ulrich CM, Peoples AR. Risk factors and health behaviors associated with loneliness among cancer survivors during the COVID-19 pandemic. J Behav Med. 2024 Jun;47(3):405-421. doi: 10.1007/s10865-023-00465-z. Epub 2024 Feb 28. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Personalized Exercise Program | Personalized Exercise Program: The PEP intervention involved a combination of home-based exercise as well as in-patient exercise. The exercise modes included basic transfer and calisthenics mobility, aerobic and resistance exercises and were performed in various postures (supine, sitting, standing, and walking) with variable challenges (level walking, bending, inclines, steps, and squatting). For patients randomized to the Intervention Group (Group 1), the PEP intervention was personalized, implemented, and modified (based on the patients AM-PAC mobility stage) by a licensed physical therapist in face-to-face, virtual, or phone meetings (~30-40 minutes). An exercise education manual, specifically developed for this study, was used by the physical therapist to educate the patients on all aspects of starting and maintaining the exercise intervention. |
| FG001 | Standard of Care - No Exercise | For Participants randomized to the Standard of Care Group (Group 2), no personalized exercise program was utilized. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hospital Discharge to 2 Month Follow up |
|
| |||||||||||||||||||||
| 2 Month to 6 Month Follow up |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Personalized Exercise Program | Personalized Exercise Program: The PEP intervention involved a combination of home-based exercise as well as in-patient exercise. The exercise modes included basic transfer and calisthenics mobility, aerobic and resistance exercises and were performed in various postures (supine, sitting, standing, and walking) with variable challenges (level walking, bending, inclines, steps, and squatting). For patients randomized to the Intervention Group (Group 1), the PEP intervention was personalized, implemented, and modified (based on the patients AM-PAC mobility stage) by a licensed physical therapist in face-to-face, virtual, or phone meetings (~30-40 minutes). An exercise education manual, specifically developed for this study, was used by the physical therapist to educate the patients on all aspects of starting and maintaining the exercise intervention. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mobility Performance - Six Minute Walk (6MW) Distance | Six Minute Walk (6MW) distance is the distance patients can walk indoors on a 25-meter level, smooth-surfaced track over the course of 6 minutes. This outcome will report the mean 6MW distance at hospital discharge (up to 38 days after the initiation of the study intervention), at the 2-Month Post Surgery Visit (up to 5 months from the initiation of the study intervention), and at the 6-Month Post Surgery Visit (up to 9 months from the initiation of the study intervention). | Posted | Mean | Standard Deviation | meters | Hospital Discharge (up to 38 days after the initiation of the study therapy), 2-Month Post Surgery Visit (up to 5 months after the initiation of the study therapy), and 6-Month Post Surgery Visit (up to 9 months after the initiation of study therapy) |
|
Adverse event, Safety Adverse Event, and All Cause Mortality data were collected from the initiation of the study intervention to the Month 6 Follow-Up Visit, up to 6 months.
For this low-risk study, adverse events of interest were collected, recorded, and followed as appropriate. This includes any injuries, events, and conditions with a causal relation to the PEP intervention and require medical attention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Personalized Exercise Program | Personalized Exercise Program: The PEP intervention involved a combination of home-based exercise as well as in-patient exercise. The exercise modes included basic transfer and calisthenics mobility, aerobic and resistance exercises and were performed in various postures (supine, sitting, standing, and walking) with variable challenges (level walking, bending, inclines, steps, and squatting). For patients randomized to the Intervention Group (Group 1), the PEP intervention was personalized, implemented, and modified (based on the patients AM-PAC mobility stage) by a licensed physical therapist in face-to-face, virtual, or phone meetings (~30-40 minutes). An exercise education manual, specifically developed for this study, was used by the physical therapist to educate the patients on all aspects of starting and maintaining the exercise intervention. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Neli Urich | University of Utah | 801-213-5716 | u0991242@umail.utah.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 24, 2021 | Dec 10, 2024 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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|
| Hospital Discharge (up to 38 days after the initiation of the study therapy), 2-Month Post Surgery Visit (up to 5 months after the initiation of the study therapy), and 6-Month Post Surgery Visit (up to 9 months after the initiation of study therapy) |
| FACT-L (Functional Assessment of Cancer Therapy-Lung) Questionnaire | The FACT-L (Functional Assessment of Cancer Therapy-Lung) questionnaire assesses health-related quality of life (QOL). Total scores range from 0-136, with lower scores representing worse QOL and higher scores representing better QOL. This outcome measure will report mean FACT-L total scores at Hospital Discharge (up to 38 days after the initiation of the study therapy), 2-Month Post Surgery Visit (up to 5 months after the initiation of the study therapy), and 6-Month Post Surgery Visit (up to 9 months after the initiation of the study therapy). | Hospital Discharge (up to 38 days after the initiation of the study therapy), 2-Month Post Surgery Visit (up to 5 months after the initiation of the study therapy), and 6-Month Post Surgery Visit (up to 9 months after the initiation of the study therapy) |
| Fatigue Subscale (FS) | This outcome will report the results of the Fatigue Subscale (FS) from the FACIT-F (Chronic Illness Fatigue Scale) questionnaire. The FACIT-F is a self-reported evaluation of fatigue in cancer patients. This questionnaire has patients rank statements regarding physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns from 0 Not at All to 4 Very Much. This outcome will report the FS score from the FACIT-F. The FS has a minimum of 0 and a maximum of 52; the higher the score the better the Quality of Life (QOL). The FS Score is calculated from 13 survey items. Individual items that were "reverse items" (meaning a high value indicates poor QOL) were subtracted from 4. Then all "reverse items" and normal items were added together to calculate the FS score. This assessment was scored according to the FACIT-F Scoring Guidelines (Version 4). | Hospital Discharge (up to 38 days after the initiation of the study therapy), 2-Month Post Surgery Visit (up to 5 months after the initiation of the study therapy), and 6-Month Post Surgery Visit (up to 9 months after the initiation of study therapy) |
| BREQ-3 (Behavioral Regulation in Exercise Questionnaire 3) Questionnaire | This outcome will report the results of the BREQ-3. The questionnaire has 24 items, each item ranging from 0 "Not True for Me" to 4 "Very True for Me". This questionnaire will report 6 sub-scores, Amotivation, External Regulation, Introjected Regulation, Identified Regulation, Integrated Regulation, Intrinsic Regulation. Each sub score is a the average of 4 items, ranging from 0-4 with higher values indicating higher motivation. | Hospital Discharge (up to 38 days after the initiation of the study therapy), 2-Month Post Surgery Visit (up to 5 months after the initiation of the study therapy), and 6-Month Post Surgery Visit (up to 9 months after the initiation of study therapy) |
| 30559162 | Derived | Ulrich CM, Himbert C, Boucher K, Wetter DW, Hess R, Kim J, Lundberg K, Ligibel JA, Barnes CA, Rushton B, Marcus R, Finlayson SRG, LaStayo PC, Varghese TK. Precision-Exercise-Prescription in patients with lung cancer undergoing surgery: rationale and design of the PEP study trial. BMJ Open. 2018 Dec 16;8(12):e024672. doi: 10.1136/bmjopen-2018-024672. |
| Did not perform 6MW test |
|
| NOT COMPLETED |
|
|
| BG001 | Standard of Care - No Exercise | For Participants randomized to the Standard of Care Group (Group 2), no personalized exercise program was utilized. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Rural-Urban Status | Count of Participants | Participants |
|
| OG001 | Standard of Care - No Exercise | For Participants randomized to the Standard of Care Group (Group 2), no personalized exercise program was utilized. |
|
|
| Secondary | Evaluate the Change Short Physical Performance Battery (SPPB) Score | This outcome will report the results from the Short Physical Performance Battery (SPPB). This secondary outcome measure is associated with the evaluation of improvement in physical performance is the result of the short physical performance battery test. The SPPB score (ranging from 0 to 12) will be obtained for each patient at the time points described above. A score of 0 indicates the worst performance, and a score of 12 indicates the best performance. This outcome will report median SPPB scores at hospital discharge (up to 38 days after the initiation of the study intervention), at the 2-Month Post Surgery Visit (up to 5 months from the initiation of the study intervention), and at the 6-Month Post Surgery Visit (up to 9 months from the initiation of the study intervention). | Posted | Median | Inter-Quartile Range | score on a scale | Hospital Discharge (up to 38 days after the initiation of the study therapy), 2-Month Post Surgery Visit (up to 5 months after the initiation of the study therapy), and 6-Month Post Surgery Visit (up to 9 months after the initiation of study therapy) |
|
|
|
| Secondary | FACT-L (Functional Assessment of Cancer Therapy-Lung) Questionnaire | The FACT-L (Functional Assessment of Cancer Therapy-Lung) questionnaire assesses health-related quality of life (QOL). Total scores range from 0-136, with lower scores representing worse QOL and higher scores representing better QOL. This outcome measure will report mean FACT-L total scores at Hospital Discharge (up to 38 days after the initiation of the study therapy), 2-Month Post Surgery Visit (up to 5 months after the initiation of the study therapy), and 6-Month Post Surgery Visit (up to 9 months after the initiation of the study therapy). | Posted | Mean | Standard Deviation | score on a scale | Hospital Discharge (up to 38 days after the initiation of the study therapy), 2-Month Post Surgery Visit (up to 5 months after the initiation of the study therapy), and 6-Month Post Surgery Visit (up to 9 months after the initiation of the study therapy) |
|
|
|
| Secondary | Fatigue Subscale (FS) | This outcome will report the results of the Fatigue Subscale (FS) from the FACIT-F (Chronic Illness Fatigue Scale) questionnaire. The FACIT-F is a self-reported evaluation of fatigue in cancer patients. This questionnaire has patients rank statements regarding physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns from 0 Not at All to 4 Very Much. This outcome will report the FS score from the FACIT-F. The FS has a minimum of 0 and a maximum of 52; the higher the score the better the Quality of Life (QOL). The FS Score is calculated from 13 survey items. Individual items that were "reverse items" (meaning a high value indicates poor QOL) were subtracted from 4. Then all "reverse items" and normal items were added together to calculate the FS score. This assessment was scored according to the FACIT-F Scoring Guidelines (Version 4). | Posted | Mean | Standard Deviation | score on a scale | Hospital Discharge (up to 38 days after the initiation of the study therapy), 2-Month Post Surgery Visit (up to 5 months after the initiation of the study therapy), and 6-Month Post Surgery Visit (up to 9 months after the initiation of study therapy) |
|
|
|
| Secondary | BREQ-3 (Behavioral Regulation in Exercise Questionnaire 3) Questionnaire | This outcome will report the results of the BREQ-3. The questionnaire has 24 items, each item ranging from 0 "Not True for Me" to 4 "Very True for Me". This questionnaire will report 6 sub-scores, Amotivation, External Regulation, Introjected Regulation, Identified Regulation, Integrated Regulation, Intrinsic Regulation. Each sub score is a the average of 4 items, ranging from 0-4 with higher values indicating higher motivation. | Posted | Mean | Standard Deviation | score on a scale | Hospital Discharge (up to 38 days after the initiation of the study therapy), 2-Month Post Surgery Visit (up to 5 months after the initiation of the study therapy), and 6-Month Post Surgery Visit (up to 9 months after the initiation of study therapy) |
|
|
|
| 0 |
| 92 |
| 0 |
| 92 |
| 5 |
| 92 |
| EG001 | Standard of Care - No Exercise | For Participants randomized to the Standard of Care Group (Group 2), no personalized exercise program was utilized. | 4 | 90 | 0 | 90 | 0 | 90 |
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Joint range of motion decreased cervical spine | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001519 | Behavior |
| 6-Month Post Surgery Visit |
|
| 6-Month Follow up |
|
| 6-Month Follow-up |
|
| Discharge: Introjected Regulation |
|
| Discharge: Identified Regulation |
|
| Discharge: Integrated Regulation |
|
| Discharge: Intrinsic Regulation |
|
| 2-Month: Amotivation |
|
| 2-Month: External Regulation |
|
| 2-Months: Introjected Regulation |
|
| 2-Months: Identified Regulation |
|
| 2-Months: Integrated Regulation |
|
| 2-Months: Intrinsic Regulation |
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| 6-Months: Amotivation |
|
| 6-Months: External Regulation |
|
| 6-Months: Introjected Regulation |
|
| 6-Months: Identified Regulation |
|
| 6-Months: Integrated Regulation |
|
| 6-Months: Intrinsic Regulation |
|