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Clinical Trials/NCT01053494
NCT01053494
Completed
Not Applicable

The TOUCH Project: Reducing Distress and Promoting Quality of Life Via Caregiver Massage of Children Undergoing Treatment for Cancer

Wake Forest University Health Sciences1 site in 1 country80 target enrollmentApril 2010
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ConditionsAccelerated Phase Chronic Myelogenous LeukemiaAcute Undifferentiated LeukemiaAngioimmunoblastic T-cell LymphomaAtypical Chronic Myeloid Leukemia, BCR-ABL1 NegativeBlastic Phase Chronic Myelogenous LeukemiaBurkitt LymphomaChildhood Acute Lymphoblastic Leukemia in RemissionChildhood Acute Myeloid Leukemia in RemissionChildhood Chronic Myelogenous LeukemiaChildhood Diffuse Large Cell LymphomaChildhood Grade III Lymphomatoid GranulomatosisChildhood Immunoblastic Large Cell LymphomaChildhood Myelodysplastic SyndromesChildhood Nasal Type Extranodal NK/T-cell LymphomaChronic Eosinophilic LeukemiaChronic Myelomonocytic LeukemiaChronic Neutrophilic LeukemiaChronic Phase Chronic Myelogenous LeukemiaContiguous Stage II Mantle Cell LymphomaCutaneous B-cell Non-Hodgkin LymphomaEssential ThrombocythemiaExtramedullary PlasmacytomaIntraocular LymphomaIsolated Plasmacytoma of BoneJuvenile Myelomonocytic LeukemiaMast Cell LeukemiaMeningeal Chronic Myelogenous LeukemiaNoncontiguous Stage II Mantle Cell LymphomaPolycythemia VeraPost-transplant Lymphoproliferative DisorderPrimary MyelofibrosisPrimary Systemic AmyloidosisProgressive Hairy Cell Leukemia, Initial TreatmentProlymphocytic LeukemiaRecurrent Childhood Acute Lymphoblastic LeukemiaRecurrent Childhood Acute Myeloid LeukemiaRecurrent Childhood Anaplastic Large Cell LymphomaRecurrent Childhood Grade III Lymphomatoid GranulomatosisRecurrent Childhood Large Cell LymphomaRecurrent Childhood Lymphoblastic LymphomaRecurrent Childhood Small Noncleaved Cell LymphomaRecurrent Cutaneous T-cell Non-Hodgkin LymphomaRecurrent Mycosis Fungoides/Sezary SyndromeRecurrent/Refractory Childhood Hodgkin LymphomaRefractory Chronic Lymphocytic LeukemiaRefractory Hairy Cell LeukemiaRefractory Multiple MyelomaRelapsing Chronic Myelogenous LeukemiaSecondary Acute Myeloid LeukemiaStage 0 Chronic Lymphocytic LeukemiaStage I Childhood Anaplastic Large Cell LymphomaStage I Childhood Hodgkin LymphomaStage I Childhood Large Cell LymphomaStage I Childhood Lymphoblastic LymphomaStage I Childhood Small Noncleaved Cell LymphomaStage I Chronic Lymphocytic LeukemiaStage I Cutaneous T-cell Non-Hodgkin LymphomaStage I Multiple MyelomaStage I Mycosis Fungoides/Sezary SyndromeStage II Childhood Anaplastic Large Cell LymphomaStage II Childhood Hodgkin LymphomaStage II Childhood Large Cell LymphomaStage II Childhood Lymphoblastic LymphomaStage II Childhood Small Noncleaved Cell LymphomaStage II Chronic Lymphocytic LeukemiaStage II Cutaneous T-cell Non-Hodgkin LymphomaStage II Multiple MyelomaStage II Mycosis Fungoides/Sezary SyndromeStage III Childhood Anaplastic Large Cell LymphomaStage III Childhood Hodgkin LymphomaStage III Childhood Large Cell LymphomaStage III Childhood Lymphoblastic LymphomaStage III Childhood Small Noncleaved Cell LymphomaStage III Chronic Lymphocytic LeukemiaStage III Cutaneous T-cell Non-Hodgkin LymphomaStage III Multiple MyelomaStage III Mycosis Fungoides/Sezary SyndromeStage IV Childhood Anaplastic Large Cell LymphomaStage IV Childhood Hodgkin LymphomaStage IV Childhood Large Cell LymphomaStage IV Childhood Lymphoblastic LymphomaStage IV Childhood Small Noncleaved Cell LymphomaStage IV Chronic Lymphocytic LeukemiaStage IV Cutaneous T-cell Non-Hodgkin LymphomaStage IV Mycosis Fungoides/Sezary SyndromeT-cell Large Granular Lymphocyte LeukemiaUnspecified Childhood Solid Tumor, Protocol Specific

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Accelerated Phase Chronic Myelogenous Leukemia
Sponsor
Wake Forest University Health Sciences
Enrollment
80
Locations
1
Primary Endpoint
Feasibility and acceptability of conducting a massage intervention with childhood cancer patients and their primary caregivers
Status
Completed
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
April 2010
End Date
February 2012
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Feasibility and acceptability of conducting a massage intervention with childhood cancer patients and their primary caregivers

Time Frame: Up to 16 weeks

Secondary Outcomes

  • Effectiveness of caregiver massage to reduce child and caregiver distress and promote child health-related quality of life(Week 16)

Study Sites (1)

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