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

June 3, 2015 updated by: City of Hope Medical Center

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

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010-3000
        • City of Hope Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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

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

This is where you will find people and organizations involved with this study.

Sponsor

City of Hope Medical Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Kate Kravits, RN, MA, City of Hope Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (ACTUAL)

January 1, 2010

Study Completion (ACTUAL)

January 1, 2010

Study Registration Dates

First Submitted

June 16, 2009

First Submitted That Met QC Criteria

June 16, 2009

First Posted (ESTIMATE)

June 17, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

June 8, 2015

Last Update Submitted That Met QC Criteria

June 3, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

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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