Chronic Myelomonocytic Leukemia Clinical Trial
Official title:
The TOUCH Project: Reducing Distress and Promoting Quality of Life Via Caregiver Massage of Children 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
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.
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