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| Sponsor: | Comprehensive Cancer Center of Wake Forest University |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Comprehensive Cancer Center of Wake Forest University |
| ClinicalTrials.gov Identifier: | NCT01053494 |
Purpose
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
| Condition | Intervention |
|---|---|
|
Accelerated Phase Chronic Myelogenous Leukemia Acute Undifferentiated Leukemia Angioimmunoblastic T-cell Lymphoma Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative Blastic Phase Chronic Myelogenous Leukemia Burkitt Lymphoma Childhood Acute Lymphoblastic Leukemia in Remission Childhood Acute Myeloid Leukemia in Remission Childhood Chronic Myelogenous Leukemia Childhood Diffuse Large Cell Lymphoma Childhood Grade III Lymphomatoid Granulomatosis Childhood Immunoblastic Large Cell Lymphoma Childhood Myelodysplastic Syndromes Childhood Nasal Type Extranodal NK/T-cell Lymphoma Chronic Eosinophilic Leukemia Chronic Myelomonocytic Leukemia Chronic Neutrophilic Leukemia Chronic Phase Chronic Myelogenous Leukemia Contiguous Stage II Mantle Cell Lymphoma Cutaneous B-cell Non-Hodgkin Lymphoma Essential Thrombocythemia Extramedullary Plasmacytoma Intraocular Lymphoma Isolated Plasmacytoma of Bone Juvenile Myelomonocytic Leukemia Mast Cell Leukemia Meningeal Chronic Myelogenous Leukemia Noncontiguous Stage II Mantle Cell Lymphoma Polycythemia Vera Post-transplant Lymphoproliferative Disorder Primary Myelofibrosis Primary Systemic Amyloidosis Progressive Hairy Cell Leukemia, Initial Treatment Prolymphocytic Leukemia Recurrent Childhood Acute Lymphoblastic Leukemia Recurrent Childhood Acute Myeloid Leukemia Recurrent Childhood Anaplastic Large Cell Lymphoma Recurrent Childhood Grade III Lymphomatoid Granulomatosis Recurrent Childhood Large Cell Lymphoma Recurrent Childhood Lymphoblastic Lymphoma Recurrent Childhood Small Noncleaved Cell Lymphoma Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma Recurrent Mycosis Fungoides/Sezary Syndrome Recurrent/Refractory Childhood Hodgkin Lymphoma Refractory Chronic Lymphocytic Leukemia Refractory Hairy Cell Leukemia Refractory Multiple Myeloma Relapsing Chronic Myelogenous Leukemia Secondary Acute Myeloid Leukemia Stage 0 Chronic Lymphocytic Leukemia Stage I Childhood Anaplastic Large Cell Lymphoma Stage I Childhood Hodgkin Lymphoma Stage I Childhood Large Cell Lymphoma Stage I Childhood Lymphoblastic Lymphoma Stage I Childhood Small Noncleaved Cell Lymphoma Stage I Chronic Lymphocytic Leukemia Stage I Cutaneous T-cell Non-Hodgkin Lymphoma Stage I Multiple Myeloma Stage I Mycosis Fungoides/Sezary Syndrome Stage II Childhood Anaplastic Large Cell Lymphoma Stage II Childhood Hodgkin Lymphoma Stage II Childhood Large Cell Lymphoma Stage II Childhood Lymphoblastic Lymphoma Stage II Childhood Small Noncleaved Cell Lymphoma Stage II Chronic Lymphocytic Leukemia Stage II Cutaneous T-cell Non-Hodgkin Lymphoma Stage II Multiple Myeloma Stage II Mycosis Fungoides/Sezary Syndrome Stage III Childhood Anaplastic Large Cell Lymphoma Stage III Childhood Hodgkin Lymphoma Stage III Childhood Large Cell Lymphoma Stage III Childhood Lymphoblastic Lymphoma Stage III Childhood Small Noncleaved Cell Lymphoma Stage III Chronic Lymphocytic Leukemia Stage III Cutaneous T-cell Non-Hodgkin Lymphoma Stage III Multiple Myeloma Stage III Mycosis Fungoides/Sezary Syndrome Stage IV Childhood Anaplastic Large Cell Lymphoma Stage IV Childhood Hodgkin Lymphoma Stage IV Childhood Large Cell Lymphoma Stage IV Childhood Lymphoblastic Lymphoma Stage IV Childhood Small Noncleaved Cell Lymphoma Stage IV Chronic Lymphocytic Leukemia Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma Stage IV Mycosis Fungoides/Sezary Syndrome T-cell Large Granular Lymphocyte Leukemia Unspecified Childhood Solid Tumor, Protocol Specific |
Procedure: massage therapy Other: questionnaire administration Procedure: quality-of-life assessment Other: intervention by caregiver Procedure: standard follow-up care |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | The TOUCH Project: Reducing Distress and Promoting Quality of Life Via Caregiver Massage of Children Undergoing Treatment for Cancer |
| Estimated Enrollment: | 64 |
| Study Start Date: | April 2010 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Arm I (WAITLIST CONTROL GROUP)
Patients and caregivers receive standard of care and are offered the massage intervention after 8 weeks.
|
Other: questionnaire administration
Ancillary studies
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Procedure: standard follow-up care
Undergo standard follow-up care
|
|
Experimental: 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.
|
Procedure: massage therapy
Undergo massage therapy
Other Names:
Other: questionnaire administration
Ancillary studies
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Other: intervention by caregiver
Undergo massage by caregiver
|
|
Experimental: 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.
|
Procedure: massage therapy
Undergo massage therapy
Other Names:
Other: questionnaire administration
Ancillary studies
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Other: intervention by caregiver
Undergo massage by caregiver
|
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.
Eligibility| Ages Eligible for Study: | 3 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, North Carolina | |
| Wake Forest University Health Sciences | |
| Winston-Salem, North Carolina, United States, 27157 | |
| Principal Investigator: | Alexandra Allen | Comprehensive Cancer Center of Wake Forest University |
More Information
| Responsible Party: | Brown, Megan, Comprehensive Cancer Center of Wake Forest University |
| ClinicalTrials.gov Identifier: | NCT01053494 History of Changes |
| Other Study ID Numbers: | CCCWFU 97709, NCI-2009-01456 |
| Study First Received: | January 20, 2010 |
| Last Updated: | March 22, 2012 |
| Health Authority: | United States: Institutional Review Board |
|
Primary Myelofibrosis Amyloidosis Blast Crisis Burkitt Lymphoma Hodgkin Disease Immunoblastic Lymphadenopathy Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Hairy Cell Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Mast-Cell Leukemia, Myeloid, Acute Leukemia, Myeloid Leukemia, Myeloid, Accelerated Phase |
Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid, Chronic-Phase Leukemia, Myelomonocytic, Chronic Leukemia, Neutrophilic, Chronic Leukemia, Prolymphocytic Lymphoma Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphomatoid Granulomatosis Lymphoproliferative Disorders Multiple Myeloma Neoplasms, Plasma Cell Mycoses Mycosis Fungoides Myelodysplastic Syndromes |
