- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00922285
Art Therapy for Caregivers of Young Patients Undergoing Bone Marrow Transplant for Cancer
Art Therapy Interventions With Caregivers Supporting Pediatric Patients Who Are Undergoing Bone Marrow Transplantation for Cancer
RATIONALE: Art therapy may help relieve emotional distress in caregivers of young patients undergoing bone marrow transplant for cancer.
PURPOSE: This clinical trial is studying art therapy for caregivers of young patients undergoing bone marrow transplant for cancer.
Study Overview
Status
Detailed Description
OBJECTIVES:
- Test the effects of an art therapy intervention on emotional distress in caregivers of pediatric patients undergoing bone marrow transplantation for cancer.
- Describe pro-social interactions of caregivers of pediatric patients undergoing bone marrow transplantation for cancer.
- Describe the illness experience of caregivers and how it is impacted by the art therapy intervention.
- Describe the caregivers' current health-related quality of life and life meaning prior to pediatric patients initiation of bone marrow transplantation for cancer.
- Determine the effect size for calculating the sample needed for a randomized clinical trial.
OUTLINE: Caregivers undergo art therapy over 60 minutes once a week for 6 weeks. Each session comprises developing trust through the expression of support, affirmation, and collaboration; creating intimacy through attunement; exploring affective states; integrative processing through the creation of an autobiographical narrative; and identifying opportunities for continued exploration and resources that support the client, should that exploration become necessary.
Caregivers also complete a Meaning of Life Questionnaire and a Family Quality of Life Scale at baseline and at the end of week 6.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Duarte, California, United States, 91010-3000
- City of Hope Comprehensive Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Family caregiver identified by the patient's physician as most involved in the patient care including, but not limited to, the following:
- Mother
- Father
- Grandmother
- Grandfather
- Aunt
- Uncle
- Older sibling
- One caregiver per pediatric patient
- No caregivers who are part of an institutional system and are temporarily fulfilling the custodial role of the patient (i.e., foster parents)
PATIENT CHARACTERISTICS:
- Able to speak and read English and/or Spanish
- No uncontrolled mental health and/or physical condition
PRIOR CONCURRENT THERAPY:
- Not specified
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Art Therapy
|
6 weekly 60 minute sessions
Evaluated at baseline, week 1 and week 6 of art therapy
Evaluated at baseline, week 1 and week 6 of art therapy
6 weekly 60 minute sessions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Emotional distress
Time Frame: Baseline, week 1 and week 6 of art therapy
|
Baseline, week 1 and week 6 of art therapy
|
Pro-social interactions
Time Frame: Baseline, week 1 and week 6 of art therapy
|
Baseline, week 1 and week 6 of art therapy
|
Illness experience of caregivers and how it is impacted by the art therapy intervention
Time Frame: Baseline, week 1 and week 6 of art therapy
|
Baseline, week 1 and week 6 of art therapy
|
Caregivers' current health-related quality of life and life meaning
Time Frame: Baseline, week 1 and week 6 of art therapy
|
Baseline, week 1 and week 6 of art therapy
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kate Kravits, RN, MA, City of Hope Comprehensive Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 08028
- P30CA033572 (U.S. NIH Grant/Contract)
- CHNMC-08028
- CDR0000642781 (REGISTRY: NCI PDQ)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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