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Art Therapy for Caregivers of Young Patients Undergoing Bone Marrow Transplant for Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00922285
First received: June 16, 2009
Last updated: March 4, 2011
Last verified: March 2011
History of Changes
  Purpose

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.


Condition Intervention
Health Status Unknown
Psychosocial Effects of Cancer and Its Treatment
 Other: psychosocial support for caregiver
Other: questionnaire administration
Procedure: quality-of-life assessment
Procedure: stress management therapy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Art Therapy Interventions With Caregivers Supporting Pediatric Patients Who Are Undergoing Bone Marrow Transplantation for Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:
  • Emotional distress [ Time Frame: Baseline, week 1 and week 6 of art therapy ] [ Designated as safety issue: No ]
  • Pro-social interactions [ Time Frame: Baseline, week 1 and week 6 of art therapy ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Caregivers' current health-related quality of life and life meaning [ Time Frame: Baseline, week 1 and week 6 of art therapy ] [ Designated as safety issue: No ]

Enrollment: 11
Study Start Date: June 2008
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Art Therapy Other: psychosocial support for caregiver
6 weekly 60 minute sessions
Other: questionnaire administration
Evaluated at baseline, week 1 and week 6 of art therapy
Procedure: quality-of-life assessment
Evaluated at baseline, week 1 and week 6 of art therapy
Procedure: stress management therapy
6 weekly 60 minute sessions

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00922285

Locations
United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
Sponsors and Collaborators
City of Hope Medical Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Kate Kravits, RN, MA Beckman Research Institute
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Kate Kravits, City of Hope Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00922285     History of Changes
Other Study ID Numbers: 08028, P30CA033572, CHNMC-08028, CDR0000642781
Study First Received: June 16, 2009
Last Updated: March 4, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by City of Hope Medical Center:
psychosocial effects of cancer and its treatment
health status unknown

ClinicalTrials.gov processed this record on May 19, 2013