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| Name | Class |
|---|---|
| Four Diamonds Research Fund at Penn State Health Childrens Hospital | UNKNOWN |
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The purpose of this study is to demonstrate that integration of exercise intervention into standard post-cancer directed treatment care will improve patient reported pain, decrease the need for medications to manage chronic pain and improve functional and psychosocial outcomes in survivors of cancers in children and adolescents. Our central hypothesis is that integration of exercise interventions into standard post-cancer directed treatment care will be acceptable and feasible while improving patients' pain, decreasing the cumulative dose of pain medication and improving patients' functional and psychosocial outcomes as compared to patients who only receive standard post-cancer directed treatment care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physical activity intervention coupled with standard post-cancer directed treatment care group | Experimental |
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| Standard post-cancer directed treatment care control group | Other |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical activity intervention coupled with standard post-cancer directed treatment care | Behavioral | CCS will participate in a 16-week physical activity program. CCS will be instructed to start with a session duration of <15-min, three days per week at low intensity (e.g., activities expending >1.5 to 3 METs or intensity <5 on a scale of 0 to 10). Any type of physical activity will be acceptable. The program will be individualized, and activity increased according to patients' health status, results from the physical function assessment, and most recent week's achieved physical activities. The program will include support calls and texts from research staff (exercise physiologist). The program will be modified and adapted during support calls or texts, including frequency, intensity, time and type to maximize CCS' success. CCS will receive a Fitbit at the beginning of the intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability of the intervention | The number of participants approached who agree to participate in the study | Baseline |
| Feasibility of the intervention | The number of participants randomized to the physical activity program intervention coupled with standard post-cancer directed treatment care who complete at least 50% of the physical activity intervention. | Baseline to week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Measure changes in chronic pain levels | Self-reported chronic pain questionnaire using the PedsQL pediatric pain questionnaire. The parent proxy-report format is used to assess the parent's perceptions of their child's pain. Range 0-100, Higher score indicates higher pain intensity | Baseline, week 8 and week 16 |
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Inclusion Criteria:
Note: The agreement of the attending oncologist will be required for the participation of CCS eligible for this study.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Smita Dandekar, MD | Penn State College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State Health Children's Hospital | Hershey | Pennsylvania | 17033 | United States |
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Randomized controlled trial
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| Standard post-cancer directed treatment care control | Other | CCS in the control group will not participate in a 16-week physical activity program and will not receive support calls or texts. Physical activity advice according to the Children's Oncology Group Guidelines for Diet and Physical Activity recommendations and the International Pediatric Oncology Exercise Guidelines will be offered to CCS following completion of 16-week follow-up. Moreover, CCS will receive a Fitbit following completion of 16-week follow-up |
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| Measure changes in cumulative dose of pain medications |
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| Baseline, week 4, week 8, week 12 and week 16 |
| Measure changes in patient reported outcomes | Psychosocial questionnaires using the NIH developed PROMIS pediatric questionnaires, which are validated for pediatric oncology, including: Self-reported physical function mobility, Anxiety, Depressive symptoms, Fatigue, Peer relationships, Social isolation, Pain interference, Pain intensity, Sleep disturbance, Cognitive function. PROMIS pediatric questionnaires assessing PROs on 5 point Likert scale responses | Baseline, week 8 and week 16 |
| Measure changes in physical activity level | Self-reported physical activity questionnaire using the Godin-Shephard leisure-time physical activity questionnaire.
| Baseline, week 8 and week 16 |
| Measure changes in patient functional outcomes (6-min walking test) | Validated physical function tests for pediatric patients, including the 6-min walking test Further distances indicate greater physical function | Baseline and week 16 |
| Measure changes in patient functional outcomes (30-second chair stand test) | Validated physical function tests for pediatric patients, including the 30-second chair stand test Greater amounts of sit/stands indicate greater physical function | Baseline and week 16 |
| Measure changes in patient functional outcomes ("Timed Up and Go" test) | Validated physical function tests for pediatric patients, including the "Timed Up and Go" test Shorter durations indicate greater physical function | Baseline and week 16 |
| Measure changes in patient functional outcomes (grip strength test) | Validated physical function tests for pediatric patients, including the grip strength test Greater grip strength indicate greater physical function | Baseline and week 16 |