Art Therapy for Caregivers of Young Patients Undergoing B... | NCT00922285

ID	Type	Description	Link
P30CA033572	U.S. NIH Grant/Contract		View source
CHNMC-08028
CDR0000642781	Registry Identifier	NCI PDQ

Status Module

Record Verification Date

Jun 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

Jan 2010Actual

Completion Date

Jan 2010Actual

First Submitted Date

Jun 16, 2009

First Submission Date that Met QC Criteria

Jun 16, 2009

First Posted Date

Jun 17, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 3, 2015

Last Update Posted Date

Jun 8, 2015Estimated

Name	Class
National Cancer Institute (NCI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

11Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Art Therapy	Experimental		Other: psychosocial support for caregiver Other: questionnaire administration Procedure: quality-of-life assessment Procedure: stress management therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
psychosocial support for caregiver	Other	6 weekly 60 minute sessions	Art Therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Emotional distress		Baseline, week 1 and week 6 of art therapy
Pro-social interactions		Baseline, week 1 and week 6 of art therapy
Illness experience of caregivers and how it is impacted by the art therapy intervention		Baseline, week 1 and week 6 of art therapy
Caregivers' current health-related quality of life and life meaning		Baseline, week 1 and week 6 of art therapy

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kate Kravits, RN, MA	City of Hope Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
City of Hope Comprehensive Cancer Center		Duarte	California	91010-3000	United States

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

MeSH Terms

ID	Term
D012046	Rehabilitation
D013812	Therapeutics
D006296	Health Services
D005159	Health Care Facilities Workforce and Services
D006282	Health Personnel

ID	Term
D000067250	Psychiatric Rehabilitation
D017028	Caregivers