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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2009-01456 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CCCWFU 97709 | Other Identifier | Wake Forest University Health Sciences |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This clinical trial studies massage therapy given by caregiver in treating quality of life of young patients undergoing treatment for cancer. Massage therapy given by a caregiver may improve the quality of life of young patients undergoing treatment for cancer
PRIMARY OBJECTIVES:
I. To determine the feasibility and acceptability of conducting a massage intervention with childhood cancer patients and their primary caregivers.
II. To investigate feasibility of implementing a brief targeted massage training protocol with caregivers.
III. To identify barriers to recruitment, intervention adherence, and full study completion by consented families.
IV. To assess preliminary effectiveness of the massage intervention in reducing caregiver and child psychological distress (anxiety, depression, parenting stress) and promoting child health-related quality of life.
V. To compare outcome data between two intervention arms (TOUCH: child massage only; TOUCH+: Caregiver massage plus child massage) and between each arm and a wait list control condition.
VI. To utilize the pilot data in a development of contextually specific and targeted grant application for a fully powered randomized controlled trial of the efficacy of caregiver massage of children undergoing treatment for cancer.
SECONDARY OBJECTIVES:
I. To investigate reciprocal change in self-reported psychosocial functioning within the caregiver-child dyad from baseline to post-intervention.
II. To assess impact of massage intervention upon levels of a stress biomarker (cortisol) in caregivers and children and to assess associations of cortisol levels with self-reported psychosocial functioning.
OUTLINE: Patients and their caregivers are randomized to 1 of 3 treatment arms.
ARM I (WAITLIST CONTROL GROUP): Patients and caregivers receive standard of care and are offered the massage intervention after 8 weeks.
ARM II (TOUCH): Caregivers undergo a 60-minute training session on simple massage techniques, including the "Massage Toolkit," comprising Swedish Massage and Trigger Point Therapy Massage, at week 0 and a booster 60-minute massage training session at week 4 with a licensed massage therapist. Caregivers are instructed to massage their children for at least 3 20-minute sessions per week for 8 weeks.
ARM III (TOUCH+): Caregivers undergo a 60-minute training session on simple massage techniques, including the "Massage Toolkit," comprising Swedish Massage and Trigger Point Therapy Massage, at week 0 and a booster 60-minute massage training session at week 4 with a licensed massage therapist. Caregivers are instructed to massage their children for at least 3 20-minute sessions per week for 8 weeks. Caregivers also receive a 45-minute massage by the massage therapist.
Patients complete questionnaires at weeks 0, 8, and 16.
After completion of study treatment, patients and caregivers are followed for 8 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (WAITLIST CONTROL GROUP) | Active Comparator | Patients and caregivers receive standard of care and are offered the massage intervention after 8 weeks. |
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| Arm II (TOUCH) | Experimental | Caregivers undergo a 60-minute training session on simple massage techniques, including the "Massage Toolkit," comprising Swedish Massage and Trigger Point Therapy Massage, at week 0 and a booster 60-minute massage training session at week 4 with a licensed massage therapist. Caregivers are instructed to massage their children for at least 3 20-minute sessions per week for 8 weeks. |
|
| Arm III (TOUCH+) | Experimental | Caregivers undergo a 60-minute training session on simple massage techniques, including the "Massage Toolkit," comprising Swedish Massage and Trigger Point Therapy Massage, at week 0 and a booster 60-minute massage training session at week 4 with a licensed massage therapist. Caregivers are instructed to massage their children for at least 3 20-minute sessions per week for 8 weeks. Caregivers also receive a 45-minute massage by the massage therapist. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| massage therapy | Procedure | Undergo massage therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility and acceptability of conducting a massage intervention with childhood cancer patients and their primary caregivers | Up to 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of caregiver massage to reduce child and caregiver distress and promote child health-related quality of life | Baseline | |
| Effectiveness of caregiver massage to reduce child and caregiver distress and promote child health-related quality of life |
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Inclusion Criteria:
Signed protocol specific informed consent by the child's caregiver Assent by the child Caregiver is at least 18 years of age The child is currently treated for cancer (chemotherapy alone, radiation therapy alone, chemotherapy and radiation therapy, chemotherapy and surgery, or radiation therapy and surgery) at Wake Forest Baptist Health (WFBH) Pediatric Oncology The child has at least 16 weeks remaining on their treatment regimen The caregiver and child understand written and spoken English The child has no medical or functional contraindications reported by his/her attending\physician
Exclusion Criteria:
Parents/caregivers who have previously provided consistent massage for their child will be excluded from the study Child is receiving radiation only
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| Name | Affiliation | Role |
|---|---|---|
| Janet Tooze, PhD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
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| questionnaire administration | Other | Ancillary studies |
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| quality-of-life assessment | Procedure | Ancillary studies |
|
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| intervention by caregiver | Other | Undergo massage by caregiver |
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| standard follow-up care | Procedure | Undergo standard follow-up care |
|
| Week 8 |
| Effectiveness of caregiver massage to reduce child and caregiver distress and promote child health-related quality of life | Week 16 |
| ID | Term |
|---|---|
| D015465 | Leukemia, Myeloid, Accelerated Phase |
| D015456 | Leukemia, Biphenotypic, Acute |
| D007119 | Immunoblastic Lymphadenopathy |
| D054438 | Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative |
| D001752 | Blast Crisis |
| D002051 | Burkitt Lymphoma |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D054391 | Lymphoma, Extranodal NK-T-Cell |
| C580364 | Pdgfra-Associated Chronic Eosinophilic Leukemia |
| D015477 | Leukemia, Myelomonocytic, Chronic |
| D015467 | Leukemia, Neutrophilic, Chronic |
| D015466 | Leukemia, Myeloid, Chronic-Phase |
| D013920 | Thrombocythemia, Essential |
| D064090 | Intraocular Lymphoma |
| D054429 | Leukemia, Myelomonocytic, Juvenile |
| D007946 | Leukemia, Mast-Cell |
| D011087 | Polycythemia Vera |
| D055728 | Primary Myelofibrosis |
| D000075363 | Immunoglobulin Light-chain Amyloidosis |
| D015463 | Leukemia, Prolymphocytic |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D017728 | Lymphoma, Large-Cell, Anaplastic |
| D054739 | Dendritic Cell Sarcoma, Interdigitating |
| D016410 | Lymphoma, T-Cell, Cutaneous |
| D009182 | Mycosis Fungoides |
| D012751 | Sezary Syndrome |
| D012008 | Recurrence |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D007943 | Leukemia, Hairy Cell |
| D009101 | Multiple Myeloma |
| D054066 | Leukemia, Large Granular Lymphocytic |
| ID | Term |
|---|---|
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D000072281 | Lymphadenopathy |
| D054437 | Myelodysplastic-Myeloproliferative Diseases |
| D002471 | Cell Transformation, Neoplastic |
| D063646 | Carcinogenesis |
| D009385 | Neoplastic Processes |
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D016399 | Lymphoma, T-Cell |
| D001778 | Blood Coagulation Disorders |
| D013922 | Thrombocytosis |
| D001791 | Blood Platelet Disorders |
| D006474 | Hemorrhagic Disorders |
| D005134 | Eye Neoplasms |
| D009371 | Neoplasms by Site |
| D015470 | Leukemia, Myeloid, Acute |
| D034721 | Mastocytosis, Systemic |
| D008415 | Mastocytosis |
| D000090362 | Mast Cell Activation Disorders |
| D019046 | Bone Marrow Neoplasms |
| D019337 | Hematologic Neoplasms |
| D054219 | Neoplasms, Plasma Cell |
| D000686 | Amyloidosis |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010265 | Paraproteinemias |
| D015620 | Histiocytic Disorders, Malignant |
| D015614 | Histiocytosis |
| D015448 | Leukemia, B-Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001796 | Blood Protein Disorders |
| D015458 | Leukemia, T-Cell |
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| ID | Term |
|---|---|
| D008405 | Massage |
| ID | Term |
|---|---|
| D064746 | Therapy, Soft Tissue |
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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