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Exercise in all Chemotherapy (EnACT) is a study to assess safety, feasibility, and acceptability of an exercise program within chemotherapy. This will be a single group study to capture the effects of an exercise intervention on the average chemotherapy patient and the patients compliance to the study.
Several national and international agencies recommend exercise participation for all persons following a cancer diagnosis. The current evidence suggests that exercise training is safe during primary adjuvant therapy and improves physical function and quality of life outcomes. Moderate exercise has been shown to improve fatigue (extreme tiredness), anxiety, and self-esteem. It also helps heart and blood vessel fitness, muscle strength, and body composition. However, despite guidance on implementing exercise recommendations for cancer patients, exercise counseling is still not standard of care in cancer centers across the U.S. Our goal is to collect data that will assist with translation of the evidence from randomized clinical trials into standard of care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | Exercise intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise Intervention | Behavioral | Exercise intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assess Feasibility | Feasibility will be obtained if one third of chemotherapy patients actually do the exercise prescribed (one exercise session per week for four weeks). | Feasibility will be assessed at the completion of the study for each patient (average of 5 months of chemotherapy). |
| Measure | Description | Time Frame |
|---|---|---|
| Compare changes in pain, physical function, nausea, vomiting, arthralgias, chemotherapy alterations (dose delays and alterations). | This will be compared using surveys at the beginning and end of chemotherapy (or intervention). Data will also be collected on the initial chemotherapy prescription and whether there are dose alterations. | Surveys will be given once the patient is consented and again at the completion of the study for each patient (average of 5 months per patient). |
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Inclusion Criteria:
Exclusion Criteria:
Receiving chemotherapy at a location other than Penn State Cancer Institute
Not fluent in written and spoken English
Hematological malignancy
Evidence in the medical record of an absolute contraindication for exercise
Cardiac exclusion criteria:
Non-English speaking
Pregnant women
Children (the protocol will only include individuals 18 and older)
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| Name | Affiliation | Role |
|---|---|---|
| Kathryn Schmitz, PhD | Penn State College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State Cancer Institute | Hershey | Pennsylvania | 17033 | United States |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| Qualitative assessments of clinician perspectives regarding the study. At the end of the study clinicians will be asked a series of qualitative questions to gain their insight into the study. | At the conclusion of the study, clinicians within the institution will be asked qualitative questions regarding the study. | Surveys will be provided to clinicians at the completion of the study (up to 38 months) |
| Assessing safety through number of patients with injuries related to the intervention | The investigator will be using a standardized Adverse Events/Injury History survey as the primary instrument in assessing safety. This survey focuses on asking questions to gauge the participants experience with muscle strain, joint pain, among other things, in order to assess if there were any complications associated with the intervention. The investigator will consider the intervention safe if less than 25% of included patients report mild musculoskeletal impairments and less than 5% experienced musculoskeletal injuries (defined as symptoms lasting a week or longer and or requiring the attention of a medical professional). | A standardized survey for assessing injuries will be used and administered at the end of the patients chemotherapy (average of 5 months).. |
| Assess Acceptability | We will consider the intervention to be acceptable if more than 50% of the patients approached agree to receive at least the first session of exercise counseling. | Acceptability will be assessed at the completion of the study for each patient (average of 5 months of chemotherapy). |