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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA129384 | U.S. NIH Grant/Contract | View source | |
| NCI-2012-00017 | Registry Identifier | NCI Clinical Trial Registraiton Program |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This will be the first multidisciplinary, randomized, longitudinal trial of a tailored, parent- and child-focused physical activity program for children (ages 4- <19 years) with newly diagnosed ALL. It will test the ability of the intervention to prevent or diminish early physical function limitations and improve health-related quality of life (HRQL). The intervention will be tested for its effect on: 1) physical function outcomes (muscle strength, range of motion, endurance, gross motor skills), bone density and bone mineral content (end of therapy only); and 2) HRQL. This multi-site trial will test the intervention in 76 evaluable children with ALL (38 receiving the intervention and 38 receiving a placebo "minimal movement" standard care strategy).
An advanced practice nurse (APN) will meet twice weekly with the patient and family for the first 4 weeks of the intervention to initiate the motivation-based dialogue and therapeutic interaction; this will be followed by once weekly visits during weeks 5-8 of the intervention; and monthly visits during weeks 9-through end of therapy. The physical therapist (PT) will meet at least once weekly with the patient and family during weeks 1-4 to initiate the prescriptive tailored exercise program; subsequent visits to reinforce and modify the program will occur at least once every other week during weeks 5-8, and at least once monthly during weeks 9-135 of the intervention. The PT will visit at least once weekly during weeks 1-4, at least once every other week during weeks 5-8, and at least once monthly during weeks 9-135. During weeks 9-135 of the intervention, the APN will call between the monthly in person-visits, if needed to those randomized to the MAP group to assure fidelity to the intervention and to provide booster support to the intervention where needed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Minimal movement | No Intervention | Minimal movement group with usual care non-intervention. | |
| Physical Therapy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical Therapy | Behavioral | Each patient in this group will have physical therapy performed. The intervention will be tested for its effect on: 1) physical function outcomes (muscle strength, range of motion, endurance, gross motor skills), bone density and bone mineral content (end of therapy only); and 2) HRQL. |
| Measure | Description | Time Frame |
|---|---|---|
| Bone Mineral Density/Bone Mineral Content | Assessed at baseline and at completion of therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Health- related quality of life | Assessed at baseline, 8 and 15 weeks after baseline and at completion of therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cheryl L Cox, RN, PhD | St. Jude Children's Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AFLAC Cancer Center Children's Healthcare of Atlanta | Atlanta | Georgia | 30342 | United States | ||
| St. Jude Children's Research Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25030039 | Derived | Ness KK, Kaste SC, Zhu L, Pui CH, Jeha S, Nathan PC, Inaba H, Wasilewski-Masker K, Shah D, Wells RJ, Karlage RE, Robison LL, Cox CL. Skeletal, neuromuscular and fitness impairments among children with newly diagnosed acute lymphoblastic leukemia. Leuk Lymphoma. 2015 Apr;56(4):1004-11. doi: 10.3109/10428194.2014.944519. Epub 2014 Aug 20. |
| Label | URL |
|---|---|
| St. Jude Children's Research Hospital | View source |
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| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
| D005791 | Patient Care |
| D006296 | Health Services |
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| Support | Behavioral | Visits with an Advanced Practice Nurse to support sustained motivation. |
|
| Memphis |
| Tennessee |
| 38105 |
| United States |
| MD Anderson | Houston | Texas | 77030 | United States |
| Toronto Hospital for Sick Children | Toronto | Ontario | M5G1X8 | Canada |
| Clinical Trials Open at St. Jude | View source |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D005159 |
| Health Care Facilities Workforce and Services |