Metastatic Cancer
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALExercise 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.
Sponsors
Milton S. Hershey Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males and females ≥18 years of age * Fluent in written and spoken English * Must be able to provide and understand informed consent * Must have an ECOG PS of ≤ 2 * Diagnosed with metastatic disease * Cancer patients (stage 1-4) * Treatment to primary site or metastatic disease * Scheduled to receive radiation therapy at Penn State Cancer Institute * Absence of absolute contraindications for exercise according to the American Heart Association (see below) * Primary attending oncologist approval * Receiving treatment as an outpatient
Exclusion criteria
* Receiving radiation therapy at a location other than Penn State Cancer Institute * Not fluent in written and spoken English * Evidence in the medical record of an absolute contraindication for exercise * Performing \> 90 minutes/week of physical activity at the time of initial evaluation * Cardiac
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of exercise intervention: (number of patients agreeing to perform RT+ET)/(number approached) | 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) | 1 year | (number of patients who completed RT+ET)/(number agreeing to perform RT+ET) |
| Incidence of Treatment- Emergent Adverse Events | 1 year | Safety of exercise intervention: freedom from any Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or higher event |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in quality of life measured via the Barriers to Exercise RM 5-FM survey | 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 | 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 | 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 timed up and go | 3 Months | Timed up and go |
| change in quality of life measured via the ECHO EXERT survey | 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 | 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. |
| change in quality of life measured via the EORTC questionnaire | 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 grip strength | 3 Months | Grip strength |
| change in quality of life measured via the Godin Physical Activity Questionnaire | 3 Months | The Godin Physical Activity Questionnaire asks how much physical activity the participant engages in during a typical 7-day period. |
Countries
United States
Outcome results
None listed