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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

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 Summary:

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
Sponsor: Wake Forest University Health Sciences

Current Primary Outcome: Feasibility and acceptability of conducting a massage intervention with childhood cancer patients and their primary caregivers [ Time Frame: Up to 16 weeks ]

Original Primary Outcome: Feasibility and acceptability [ Time Frame: 8 weeks ]

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Effectiveness of caregiver massage to reduce child and caregiver distress and promote child health-related quality of life [ Time Frame: 8 weeks ]

Information By: Wake Forest University Health Sciences

Dates:
Date Received: January 20, 2010
Date Started: April 2010
Date Completion:
Last Updated: January 17, 2017
Last Verified: July 2016