Massage Therapy Given by Caregiver in Treating Quality of Life of Young Patients Undergoing Treatment for Cancer
- Conditions
- Childhood Diffuse Large Cell LymphomaChildhood Nasal Type Extranodal NK/T-cell LymphomaChronic Myelomonocytic LeukemiaEssential ThrombocythemiaIsolated Plasmacytoma of BoneMeningeal Chronic Myelogenous LeukemiaPost-transplant Lymphoproliferative DisorderPrimary Systemic AmyloidosisProgressive Hairy Cell Leukemia, Initial TreatmentAcute Undifferentiated Leukemia
- Interventions
- Procedure: massage therapyOther: questionnaire administrationProcedure: quality-of-life assessmentProcedure: standard follow-up careOther: intervention by caregiver
- Registration Number
- NCT01053494
- Lead Sponsor
- Wake Forest University Health Sciences
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
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
Parents/caregivers who have previously provided consistent massage for their child will be excluded from the study Child is receiving radiation only
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm II (TOUCH) massage therapy 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+) quality-of-life assessment 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. Arm I (WAITLIST CONTROL GROUP) questionnaire administration Patients and caregivers receive standard of care and are offered the massage intervention after 8 weeks. Arm I (WAITLIST CONTROL GROUP) quality-of-life assessment Patients and caregivers receive standard of care and are offered the massage intervention after 8 weeks. Arm II (TOUCH) quality-of-life assessment 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+) questionnaire administration 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. Arm II (TOUCH) questionnaire administration 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+) massage therapy 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. Arm II (TOUCH) intervention by caregiver 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 I (WAITLIST CONTROL GROUP) standard follow-up care Patients and caregivers receive standard of care and are offered the massage intervention after 8 weeks. Arm III (TOUCH+) intervention by caregiver 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.
- Primary Outcome Measures
Name Time Method Feasibility and acceptability of conducting a massage intervention with childhood cancer patients and their primary caregivers Up to 16 weeks
- Secondary Outcome Measures
Name Time Method Effectiveness of caregiver massage to reduce child and caregiver distress and promote child health-related quality of life Week 16
Trial Locations
- Locations (1)
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States