Clinical Trials Directory

Trials / Completed

CompletedNCT01053494

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
80 (actual)
Sponsor
Wake Forest University Health Sciences · Academic / Other
Sex
All
Age
3 Years – 17 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREmassage therapyUndergo massage therapy
OTHERquestionnaire administrationAncillary studies
PROCEDUREquality-of-life assessmentAncillary studies
OTHERintervention by caregiverUndergo massage by caregiver
PROCEDUREstandard follow-up careUndergo standard follow-up care

Timeline

Start date
2010-04-01
Primary completion
2012-02-01
Completion
2012-02-01
First posted
2010-01-21
Last updated
2018-07-02

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01053494. Inclusion in this directory is not an endorsement.