Massage Therapy Given by Caregiver in Treating Quality of Life of Young Patients Undergoing Treatment for Cancer
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
Detailed Description
PRIMARY OBJECTIVES:
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To determine the feasibility and acceptability of conducting a massage intervention with childhood cancer patients and their primary caregivers.
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To investigate feasibility of implementing a brief targeted massage training protocol with caregivers.
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To identify barriers to recruitment, intervention adherence, and full study completion by consented families.
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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.
- 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:
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To investigate reciprocal change in self-reported psychosocial functioning within the caregiver-child dyad from baseline to post-intervention.
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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
Arms and Interventions
Arm | Intervention/Treatment |
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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:
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:
Other: questionnaire administration
Ancillary studies
Procedure: quality-of-life assessment
Ancillary studies
Other Names:
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:
Other: questionnaire administration
Ancillary studies
Procedure: quality-of-life assessment
Ancillary studies
Other Names:
Other: intervention by caregiver
Undergo massage by caregiver
|
Outcome Measures
Primary Outcome Measures
- Feasibility and acceptability of conducting a massage intervention with childhood cancer patients and their primary caregivers [Up to 16 weeks]
Secondary Outcome Measures
- Effectiveness of caregiver massage to reduce child and caregiver distress and promote child health-related quality of life [Baseline]
- Effectiveness of caregiver massage to reduce child and caregiver distress and promote child health-related quality of life [Week 8]
- Effectiveness of caregiver massage to reduce child and caregiver distress and promote child health-related quality of life [Week 16]
Eligibility Criteria
Criteria
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.- IRB00011619
- NCI-2009-01456
- CCCWFU 97709