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

Sponsor
Wake Forest University Health Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT01053494
Collaborator
National Cancer Institute (NCI) (NIH)
80
1
3
22
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Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: massage therapy
  • Other: questionnaire administration
  • Procedure: quality-of-life assessment
  • Other: intervention by caregiver
  • Procedure: standard follow-up care
N/A

Detailed Description

PRIMARY OBJECTIVES:
  1. To determine the feasibility and acceptability of conducting a massage intervention with childhood cancer patients and their primary caregivers.

  2. To investigate feasibility of implementing a brief targeted massage training protocol with caregivers.

  3. To identify barriers to recruitment, intervention adherence, and full study completion by consented families.

  4. 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.

  1. 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:
  1. To investigate reciprocal change in self-reported psychosocial functioning within the caregiver-child dyad from baseline to post-intervention.

  2. 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
The TOUCH Project: Reducing Distress and Promoting Quality of Life Via Caregiver Massage of Children Undergoing Treatment for Cancer
Study Start Date :
Apr 1, 2010
Actual Primary Completion Date :
Feb 1, 2012
Actual Study Completion Date :
Feb 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Arm I (WAITLIST CONTROL GROUP)

Patients and caregivers receive standard of care and are offered the massage intervention after 8 weeks.

Other: questionnaire administration
Ancillary studies

Procedure: quality-of-life assessment
Ancillary studies
Other Names:
  • quality of life assessment
  • Procedure: standard follow-up care
    Undergo standard follow-up care

    Experimental: 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.

    Procedure: massage therapy
    Undergo massage therapy
    Other Names:
  • massage
  • therapeutic massage
  • Other: questionnaire administration
    Ancillary studies

    Procedure: quality-of-life assessment
    Ancillary studies
    Other Names:
  • quality of life assessment
  • Other: intervention by caregiver
    Undergo massage by caregiver

    Experimental: 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.

    Procedure: massage therapy
    Undergo massage therapy
    Other Names:
  • massage
  • therapeutic massage
  • Other: questionnaire administration
    Ancillary studies

    Procedure: quality-of-life assessment
    Ancillary studies
    Other Names:
  • quality of life assessment
  • Other: intervention by caregiver
    Undergo massage by caregiver

    Outcome Measures

    Primary Outcome Measures

    1. Feasibility and acceptability of conducting a massage intervention with childhood cancer patients and their primary caregivers [Up to 16 weeks]

    Secondary Outcome Measures

    1. Effectiveness of caregiver massage to reduce child and caregiver distress and promote child health-related quality of life [Baseline]

    2. Effectiveness of caregiver massage to reduce child and caregiver distress and promote child health-related quality of life [Week 8]

    3. Effectiveness of caregiver massage to reduce child and caregiver distress and promote child health-related quality of life [Week 16]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Wake Forest University Health Sciences Winston-Salem North Carolina United States 27157

    Sponsors and Collaborators

    • Wake Forest University Health Sciences
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Janet Tooze, PhD, Wake Forest University Health Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Wake Forest University Health Sciences
    ClinicalTrials.gov Identifier:
    NCT01053494
    Other Study ID Numbers:
    • IRB00011619
    • NCI-2009-01456
    • CCCWFU 97709
    First Posted:
    Jan 21, 2010
    Last Update Posted:
    Jul 2, 2018
    Last Verified:
    Jun 1, 2018

    Study Results

    No Results Posted as of Jul 2, 2018