An interventional study of Exercise Therapy in Metastatic Cancer, sponsored by Milton S. Hershey Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-06.
Sponsored by Milton S. Hershey Medical Center · Not applicable, Interventional, and Supportive care
The purpose of this study is to evaluate exercise therapy as a method for potentially improving radiation therapy treatment toxicities for metastatic cancer patients receiving radiation therapy.
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.
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This study's enrollment of 16 is below the median of 54 across 2,767 interventional studies indexed under Neoplasm Metastasis.
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Exclusion Criteria:
Cardiac exclusion criteria:
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)
(number of patients agreeing to perform RT+ET)/(number approached)
Time frame: 1 year
Feasibility of exercise intervention: (number of patients who completed RT+ET)/(number agreeing to perform RT+ET)
(number of patients who completed RT+ET)/(number agreeing to perform RT+ET)
Time frame: 1 year
Incidence of Treatment- Emergent Adverse Events
Safety of exercise intervention: freedom from any Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or higher event
Time frame: 1 year
Change in timed up and go
Timed up and go
Time frame: 3 Months
change in grip strength
Grip strength
Time frame: 3 Months
change in quality of life measured via the Godin Physical Activity Questionnaire
The Godin Physical Activity Questionnaire asks how much physical activity the participant engages in during a typical 7-day period.
Time frame: 3 Months
change in quality of life measured via the Barriers to Exercise RM 5-FM survey
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.
Time frame: 3 Months
change in quality of life measured via the Work Productivity and Activity Impairment Questionnaire
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.
Time frame: 3 Months
change in quality of life measured via the Scored Patient-Generated Subjective Global Assessment
The Score Patient-Generated Subjective Global Assessment asks about participant nutrition. A variety of question/response styles are included in the survey.
Time frame: 3 Months
change in quality of life measured via the EORTC questionnaire
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.
Time frame: 3 Months
change in quality of life measured via the ECHO EXERT survey
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.
Time frame: 3 Months
change in quality of life measured via the Health Belief Scale
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.
Time frame: 3 Months
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Milton S. Hershey Medical Center