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NCT Number: NCT01053494

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

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

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Key information

Conditions

Accelerated Phase Chronic Myelogenous Leukemia Acute Undifferentiated Leukemia Amyloidosis Angioimmunoblastic T-cell Lymphoma Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative Blast Crisis Blastic Phase Chronic Myelogenous Leukemia Blood Coagulation Disorders Blood Platelet Disorders Blood Protein Disorders Bone Marrow Diseases Bone Marrow Neoplasms Burkitt Lymphoma Carcinogenesis Cardiovascular Diseases Cell Transformation, Neoplastic 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 Disease 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 DNA Virus Infections Dendritic Cell Sarcoma, Interdigitating Disease Attributes Epstein-Barr Virus Infections Essential Thrombocythemia Extramedullary Plasmacytoma Eye Neoplasms Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Herpesviridae Infections Histiocytic Disorders, Malignant Histiocytosis Immune System Diseases Immunoblastic Lymphadenopathy Immunoglobulin Light-chain Amyloidosis Immunoproliferative Disorders Infections Intraocular Lymphoma Isolated Plasmacytoma of Bone Juvenile Myelomonocytic Leukemia Leukemia Leukemia, B-Cell Leukemia, Biphenotypic, Acute Leukemia, Hairy Cell Leukemia, Large Granular Lymphocytic Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Leukemia, Mast-Cell Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Leukemia, Myeloid, Accelerated Phase Leukemia, Myeloid, Acute Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Leukemia, Myeloid, Chronic-Phase Leukemia, Myelomonocytic, Chronic Leukemia, Myelomonocytic, Juvenile Leukemia, Neutrophilic, Chronic Leukemia, Prolymphocytic Leukemia, T-Cell Lymphadenopathy Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Extranodal NK-T-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Large-Cell, Anaplastic Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Lymphoproliferative Disorders Mast Cell Activation Disorders Mast Cell Leukemia Mastocytosis Mastocytosis, Systemic Meningeal Chronic Myelogenous Leukemia Metabolic Diseases Multiple Myeloma Mycosis Fungoides Myelodysplastic-Myeloproliferative Diseases Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Plasma Cell Neoplastic Processes Noncontiguous Stage II Mantle Cell Lymphoma Nutritional and Metabolic Diseases Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Pdgfra-Associated Chronic Eosinophilic Leukemia Polycythemia Vera Post-transplant Lymphoproliferative Disorder Precursor Cell Lymphoblastic Leukemia-Lymphoma Primary Myelofibrosis Primary Systemic Amyloidosis Progressive Hairy Cell Leukemia, Initial Treatment Prolymphocytic Leukemia Proteostasis Deficiencies Recurrence 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 Sezary Syndrome 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 Thrombocythemia, Essential Thrombocytosis Tumor Virus Infections Unspecified Childhood Solid Tumor, Protocol Specific Vascular Diseases Virus Diseases

Age range

3 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Massage therapy

Procedure

Undergo massage therapy

Other names: massage, therapeutic massage

Questionnaire Administration

Other

Ancillary studies

quality-of-life assessment

Procedure

Ancillary studies

Other names: quality of life assessment

intervention by caregiver

Other

Undergo massage by caregiver

standard follow-up care

Procedure

Undergo standard follow-up care

Primary outcomes

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

    Time frame: Up to 16 weeks

Secondary outcomes

  1. Effectiveness of caregiver massage to reduce child and caregiver distress and promote child health-related quality of life

    Time frame: Baseline

  2. Effectiveness of caregiver massage to reduce child and caregiver distress and promote child health-related quality of life

    Time frame: Week 8

  3. Effectiveness of caregiver massage to reduce child and caregiver distress and promote child health-related quality of life

    Time frame: Week 16

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jan 21, 2010
Registry last updated
Jul 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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