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

Psychosocial Effects of Cancer and Its Treatment Clinical Trial

Official title:

Art Therapy Interventions With Caregivers Supporting Pediatric Patients Who Are Undergoing Bone Marrow Transplantation for Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00922285
• Other study ID #: 08028
• Secondary ID: P30CA033572CHNMC
• Status: Completed
• Phase: N/A
• First received: June 16, 2009
• Last updated: June 3, 2015
• Start date: June 2008
• Est. completion date: January 2010

Study information

• Verified date: June 2015
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Health Status Unknown
• Psychosocial Effects of Cancer and Its Treatment

Intervention

Other:
• psychosocial support for caregiver
6 weekly 60 minute sessions
• 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
• stress management therapy
6 weekly 60 minute sessions

Locations

Country	Name	City	State
United States	City of Hope Comprehensive Cancer Center	Duarte	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Emotional distress		Baseline, week 1 and week 6 of art therapy	No
Primary	Pro-social interactions		Baseline, week 1 and week 6 of art therapy	No
Primary	Illness experience of caregivers and how it is impacted by the art therapy intervention		Baseline, week 1 and week 6 of art therapy	No
Primary	Caregivers' current health-related quality of life and life meaning		Baseline, week 1 and week 6 of art therapy	No