Massage Therapy Given by Caregiver in Treating Quality of Life of Young Patients Undergoing Treatment for Cancer

Wake Forest University (WFU)

Status: Completed

Conditions: Stage IV Childhood Lymphoblastic Lymphoma; Stage I Childhood Anaplastic Large Cell Lymphoma; Stage I Mycosis Fungoides/Sezary Syndrome; Polycythemia Vera; Cutaneous B-cell Non-Hodgkin Lymphoma; T-cell Large Granular Lymphocyte Leukemia; Chronic Neutrophilic Leukemia; Chronic Eosinophilic Leukemia; Noncontiguous Stage II Mantle Cell Lymphoma; Stage I Childhood Large Cell Lymphoma; Childhood Myelodysplastic Syndromes; Stage II Childhood Lymphoblastic Lymphoma; Post-transplant Lymphoproliferative Disorder; Progressive Hairy Cell Leukemia, Initial Treatment; Stage IV Childhood Small Noncleaved Cell Lymphoma; Stage III Childhood Hodgkin Lymphoma; Stage I Multiple Myeloma; Stage IV Childhood Hodgkin Lymphoma; Blastic Phase Chronic Myelogenous Leukemia; Stage III Chronic Lymphocytic Leukemia; Angioimmunoblastic T-cell Lymphoma; Recurrent/Refractory Childhood Hodgkin Lymphoma; Primary Systemic Amyloidosis; Essential Thrombocythemia; Chronic Myelomonocytic Leukemia; Childhood Chronic Myelogenous Leukemia; Stage II Childhood Large Cell Lymphoma; Juvenile Myelomonocytic Leukemia; Accelerated Phase Chronic Myelogenous Leukemia; Stage II Mycosis Fungoides/Sezary Syndrome; Stage III Multiple Myeloma; Stage I Childhood Hodgkin Lymphoma; Recurrent Childhood Anaplastic Large Cell Lymphoma; Recurrent Mycosis Fungoides/Sezary Syndrome; Chronic Phase Chronic Myelogenous Leukemia; Refractory Hairy Cell Leukemia; Recurrent Childhood Small Noncleaved Cell Lymphoma; Recurrent Childhood Grade III Lymphomatoid Granulomatosis; Stage II Cutaneous T-cell Non-Hodgkin Lymphoma; Childhood Immunoblastic Large Cell Lymphoma; Stage I Childhood Lymphoblastic Lymphoma; Contiguous Stage II Mantle Cell Lymphoma; Refractory Multiple Myeloma; Stage I Chronic Lymphocytic Leukemia; Stage 0 Chronic Lymphocytic Leukemia; Recurrent Childhood Acute Lymphoblastic Leukemia; Relapsing Chronic Myelogenous Leukemia; Isolated Plasmacytoma of Bone; Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma; Stage IV Childhood Anaplastic Large Cell Lymphoma; Childhood Grade III Lymphomatoid Granulomatosis; Stage I Cutaneous T-cell Non-Hodgkin Lymphoma; Recurrent Childhood Acute Myeloid Leukemia; Refractory Chronic Lymphocytic Leukemia; Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative; Stage III Mycosis Fungoides/Sezary Syndrome; Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma; Stage II Childhood Anaplastic Large Cell Lymphoma; Stage IV Mycosis Fungoides/Sezary Syndrome; Burkitt Lymphoma; Prolymphocytic Leukemia; Intraocular Lymphoma; Childhood Nasal Type Extranodal NK/T-cell Lymphoma; Stage III Childhood Large Cell Lymphoma; Stage II Childhood Hodgkin Lymphoma; Meningeal Chronic Myelogenous Leukemia; Childhood Acute Myeloid Leukemia in Remission; Stage III Cutaneous T-cell Non-Hodgkin Lymphoma; Stage II Chronic Lymphocytic Leukemia; Stage III Childhood Lymphoblastic Lymphoma; Stage III Childhood Anaplastic Large Cell Lymphoma; Childhood Acute Lymphoblastic Leukemia in Remission; Stage IV Childhood Large Cell Lymphoma; Stage II Childhood Small Noncleaved Cell Lymphoma; Stage III Childhood Small Noncleaved Cell Lymphoma; Recurrent Childhood Lymphoblastic Lymphoma; Childhood Diffuse Large Cell Lymphoma; Extramedullary Plasmacytoma; Mast Cell Leukemia; Stage IV Chronic Lymphocytic Leukemia; Primary Myelofibrosis; Secondary Acute Myeloid Leukemia; Recurrent Childhood Large Cell Lymphoma; Acute Undifferentiated Leukemia; Stage I Childhood Small Noncleaved Cell Lymphoma; Unspecified Childhood Solid Tumor, Protocol Specific; Stage II Multiple Myeloma

Treatments: Procedure: quality-of-life assessment; Other: intervention by caregiver; Procedure: massage therapy; Other: questionnaire administration; Procedure: standard follow-up care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01053494

NCI-2009-01456 (Registry Identifier)

CCCWFU 97709 (Other Identifier)

IRB00011619

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 3 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 3 patient groups

Arm I (WAITLIST CONTROL GROUP)

Active Comparator group

Description:

Patients and caregivers receive standard of care and are offered the massage intervention after 8 weeks.

Treatment:

Procedure: standard follow-up care

Other: questionnaire administration

Procedure: quality-of-life assessment

Arm II (TOUCH)

Experimental group

Description:

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.

Treatment:

Other: intervention by caregiver

Other: questionnaire administration

Procedure: massage therapy

Procedure: quality-of-life assessment

Arm III (TOUCH+)

Experimental group

Description:

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.

Treatment:

Other: intervention by caregiver

Other: questionnaire administration

Procedure: massage therapy

Procedure: quality-of-life assessment