Exercise Therapy in Radiation Therapy (EXERT)
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|ClinicalTrials.gov Identifier: NCT03905356|
Recruitment Status : Recruiting
First Posted : April 5, 2019
Last Update Posted : February 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Cancer||Behavioral: Exercise Therapy||Not Applicable|
Study Objectives and Endpoints:
Aim 1. To determine the acceptability, feasibility, and safety of an exercise intervention among cancer patients receiving radiation therapy. The investigators anticipate that >25% of approached patients will consent to the protocol; >33% of eligible radiation therapy patients who consent will perform the exercise prescribed (based on the response rate from EnACT); and <25% of participants will experience a musculoskeletal impairment (without treatment alterations) and <5% will experience a musculoskeletal injury with symptoms lasting ≥ week or requiring medical attention. The investigators' approach will be to include patients receiving definitive RT; excluding patients at high risk for side effects from combination therapy, including fracture or cardiovascular events.
Aim 2. To discern the clinical outcomes of patients receiving RT+ET. The hypothesis is that adding ET to RT will improve patient reported outcomes and physical functioning. The investigators' approach will be to use standardized questionnaires and assessment tools: patient reported outcomes will be assessed using Common Terminology Criteria for Adverse Events - Patient Reported Outcomes (CTCAE-PROs), loaded onto tablets that patients use in the clinic. Questions will assess global PROs relevant to the ability to tolerate RT, including fatigue, pain, nausea, vomiting; and disease-site-specific PROs, including genitourinary/sexual symptoms for patients receiving pelvic RT. RT dose alterations will be documented. Scores will be compared pre- vs post- RT. The investigators will also use standardized measures already used in EnACT, including grip strength, 30-second chair stand, timed up-and-go, and 4-stage balance. Scores will be compared pre- vs post- RT.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Exercise Therapy in Radiation Therapy (EXERT)|
|Actual Study Start Date :||February 12, 2020|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||March 2021|
The exercise intervention will utilize the "Moving Through Cancer: A Guide to Exercise for Cancer Survivors" framework. A certified cancer exercise physiologist will work through this guide at radiation therapy visits, with at least 1 visit per week, per the study schema. The cancer exercise physiologist will teach participants proper: warm ups, use of equipment, exercise form, modes of activity, intensity of exercise, flexibility exercises, and cool down. The cancer exercise physiologist will tailor the instruction to convey special considerations for exercise based on treatment and cancer type. The patient will perform supervised exercise in the Exercise Medicine Unit under the guidance of the cancer exercise specialist. The exercise done will be educational in nature (i.e. learning about proper walking form, proper intensity for a warmup/cool down, proper techniques for resistance exercises).
Behavioral: Exercise Therapy
Certified exercise oncology specialists will personalize, prescribe, and guide ET, including twice weekly resistance training and walking, performed at home, with supervision in the Exercise Medicine Unit. The cancer exercise physiologist will teach participants proper warm ups, use of equipment, exercise form, modes of activity, intensity of exercise, flexibility exercises, and cool down. In addition, patients will be instructed to exercise on their own, at home, according to the instructions from the cancer exercise specialist.
- Acceptability of exercise intervention: (number of patients agreeing to perform RT+ET)/(number approached) [ Time Frame: 1 year ](number of patients agreeing to perform RT+ET)/(number approached)
- Feasibility of exercise intervention: (number of patients who completed RT+ET)/(number agreeing to perform RT+ET) [ Time Frame: 1 year ](number of patients who completed RT+ET)/(number agreeing to perform RT+ET)
- Incidence of Treatment- Emergent Adverse Events [ Time Frame: 1 year ]Safety of exercise intervention: freedom from any Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or higher event
- Change in timed up and go [ Time Frame: 3 Months ]Timed up and go
- change in grip strength [ Time Frame: 3 Months ]Grip strength
- change in quality of life measured via the Godin Physical Activity Questionnaire [ Time Frame: 3 Months ]The Godin Physical Activity Questionnaire asks how much physical activity the participant engages in during a typical 7-day period.
- change in quality of life measured via the Barriers to Exercise RM 5-FM survey [ Time Frame: 3 Months ]The Barriers to Exercise RM 5-FM survey asks participants about barriers to being active. Response options include: very likely; somewhat likely; somewhat unlikely; very unlikely.
- change in quality of life measured via the Work Productivity and Activity Impairment Questionnaire [ Time Frame: 3 Months ]The Work Productivity and Activity Impairment Questionnaire ask about the effect of the participant's health problems on the ability to work and perform regular activities. A variety of question/response styles are included in the survey.
- change in quality of life measured via the Scored Patient-Generated Subjective Global Assessment [ Time Frame: 3 Months ]The Score Patient-Generated Subjective Global Assessment asks about participant nutrition. A variety of question/response styles are included in the survey.
- change in quality of life measured via the EORTC questionnaire [ Time Frame: 3 Months ]The EORTC Quality of life questionnaire asks a variety of questions about their health regarding physical abilities. Response options include: not at all; a little; quite a bit; very much.
- change in quality of life measured via the ECHO EXERT survey [ Time Frame: 3 Months ]The Experience of Care and Health Outcomes (ECHO) Survey asks three questions about participant experience with the exercise intervention. Response options include: not at all; not much; mixed; somewhat; very much so.
- change in quality of life measured via the Health Belief Scale [ Time Frame: 3 Months ]The Health Belief Scale asks questions regarding exercise therapy. Response options include: strongly disagree - strongly agree, where 1 equals strongly disagree and 4 equals strongly agree.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03905356
|Contact: Nicholas G Zaorsky, MDemail@example.com|
|Contact: Kelsey C Stoltzfus, MPH||717-531-0003 ext firstname.lastname@example.org|
|United States, Pennsylvania|
|Penn State Cancer Institute||Recruiting|
|Hershey, Pennsylvania, United States, 17033|
|Contact: Nicholas G Zaorsky, MD 717-531-8024 email@example.com|
|Contact: Erica Schleicher, MS 717-531-0003 ext 323324 firstname.lastname@example.org|
|Principal Investigator: Nicholas G Zaorsky, MD|
|Principal Investigator:||Nicholas G Zaorsky, MD||Penn State Cancer Institute|
|Study Chair:||Kathryn Schmitz, MD||Penn State Cancer Institute|