Overview

This trial is active, not recruiting.

Conditions 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
Treatments massage therapy, questionnaire administration, quality-of-life assessment, intervention by caregiver, standard follow-up care
Sponsor Comprehensive Cancer Center of Wake Forest University
Collaborator National Cancer Institute (NCI)
Start date April 2010
End date February 2012
Trial size 80 participants
Trial identifier NCT01053494, CCCWFU 97709, NCI-2009-01456

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Active Comparator)
Patients and caregivers receive standard of care and are offered the massage intervention after 8 weeks.
questionnaire administration
Ancillary studies
quality-of-life assessment quality of life assessment
Ancillary studies
standard follow-up care
Undergo standard follow-up care
(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.
massage therapy massage
Undergo massage therapy
questionnaire administration
Ancillary studies
quality-of-life assessment quality of life assessment
Ancillary studies
intervention by caregiver
Undergo massage by caregiver
(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.
massage therapy massage
Undergo massage therapy
questionnaire administration
Ancillary studies
quality-of-life assessment quality of life assessment
Ancillary studies
intervention by caregiver
Undergo massage by caregiver

Primary Outcomes

Measure
Feasibility and acceptability of conducting a massage intervention with childhood cancer patients and their primary caregivers
time frame: Up to 16 weeks

Secondary Outcomes

Measure
Effectiveness of caregiver massage to reduce child and caregiver distress and promote child health-related quality of life
time frame: Baseline
Effectiveness of caregiver massage to reduce child and caregiver distress and promote child health-related quality of life
time frame: Week 8
Effectiveness of caregiver massage to reduce child and caregiver distress and promote child health-related quality of life
time frame: Week 16

Eligibility Criteria

Male or female participants from 3 years up to 17 years old.

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

Additional Information

Official title The TOUCH Project: Reducing Distress and Promoting Quality of Life Via Caregiver Massage of Children Undergoing Treatment for Cancer
Principal investigator Janet Tooze, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Comprehensive Cancer Center of Wake Forest University.
Location data was received from the National Cancer Institute and was last updated in June 2016.