NCT00922285

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 17, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

June 8, 2015

Status Verified

June 1, 2015

Enrollment Period

1.6 years

First QC Date

June 16, 2009

Last Update Submit

June 3, 2015

Conditions

Health Status UnknownPsychosocial Effects of Cancer and Its Treatment

Keywords

psychosocial effects of cancer and its treatmenthealth status unknown

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (1)

Art Therapy

EXPERIMENTAL
Other: psychosocial support for caregiverOther: questionnaire administrationProcedure: quality-of-life assessmentProcedure: stress management therapy

Interventions

psychosocial support for caregiverOTHER

6 weekly 60 minute sessions

Art Therapy
questionnaire administrationOTHER

Evaluated at baseline, week 1 and week 6 of art therapy

Art Therapy
quality-of-life assessmentPROCEDURE

Evaluated at baseline, week 1 and week 6 of art therapy

Art Therapy
stress management therapyPROCEDURE

6 weekly 60 minute sessions

Art Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

MeSH Terms

Interventions

Psychiatric RehabilitationCaregivers

Intervention Hierarchy (Ancestors)

RehabilitationTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesHealth Personnel

Study Officials

  • Kate Kravits, RN, MA

    City of Hope Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2009

First Posted

June 17, 2009

Study Start

June 1, 2008

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

June 8, 2015

Record last verified: 2015-06

Locations

US(1)