Relieving Distress in Parents Caring for a Child Undergoing a Hematopoietic Stem Cell Transplant
Recruitment status was Recruiting
RATIONALE: A program that helps parents learn to cope with the distress of caring for a child undergoing stem cell transplant may reduce depression and anxiety and improve the well-being of the parent.
PURPOSE: This randomized clinical trial is studying ways to relieve distress in parents caring for a child undergoing transplant.
Psychosocial Effects of Cancer and Its Treatment
Other: computer-assisted intervention
Other: medical chart review
Other: psychosocial support for caregiver
Other: questionnaire administration
Other: study of socioeconomic and demographic variables
Procedure: assessment of therapy complications
Procedure: psychosocial assessment and care
|Study Design:||Allocation: Randomized
Masking: Single Blind
|Official Title:||Facilitating Parent Adaptation to Pediatric Transplant: The P-SCIP Trial|
- Depressive symptoms, anxiety, general well-being of parent [ Designated as safety issue: No ]
- Parent social and cognitive processing [ Designated as safety issue: No ]
- Barriers to participation in the intervention trial [ Designated as safety issue: No ]
|Study Start Date:||January 2008|
|Estimated Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
- To evaluate the relative impact of the Parent Social-Cognitive Intervention Program (P-SCIP) vs the Best-Recommended Psychosocial Care (BPC) interventions on parent short- and long-term psychological distress.
- To evaluate parent personal resources as well as child medical course variables that contribute to intervention response.
- To examine differential effects of P-SCIP vs BPC on parent social and cognitive processing.
- To investigate barriers to participation in the intervention trial.
OUTLINE: This is a multicenter study.
Participants are stratified according to caregiving parent status (father vs mother), study center, and primary parent caregiver language at CHLA vs Columbia (English vs Spanish). Participants are randomized to 1 of 2 intervention arms.
- Arm I (Parent Social-Cognitive Intervention Program [P-SCIP]): Participants undergo five 60-minute behavioral intervention sessions once or twice weekly for 3 weeks to learn how to engage in effective social and cognitive processing to deal with fears and worries about the transplant and transplant-related concerns. Participants receive a laptop computer and a CD-ROM after the first session.
- Arm II (Best-recommended Psychosocial Care [BPC]): Participants undergo usual care and receive a "Discovery to Recovery" DVD and pamphlet developed by the National Marrow Donor Program (NMDP) describing psychological issues associated with hematopoietic stem cell transplantation (HSCT), the booklet "Top Tips for Parent Caregivers During the BMT Process" published by National Marrow Donor Program-Link describing caregiver issues during HSCT and advice on how to handle them, 2 walkie-talkies, a laptop to view the DVD, and 5 hours of respite care from a child-life specialist once or twice weekly for 3 weeks.
Participants are assessed periodically by demographic information, hospitalization for emotional problems, psychosocial services (i.e., religious counseling, professional counseling, attending a support or therapy group, and other support services in the past month), psychosocial care services during the child's HSCT hospitalization, psychotropic medications and sleep medications taken, optimism by the Life Orientation Test, enacted social support, informational support from medical team, treatment Expectancy, Working Alliance Inventory, homework adherence (P-SCIP only), utilization of the CD-ROM/DVD, use of offer of respite care by Child Life Specialist (BPC only), psychosocial and supportive care available at site, and mental health services by the Awareness and Barriers to Counseling-Revised questionnaire.
After completion of study intervention, participants are followed up at 1, 6, and 12 months.
|United States, California|
|Childrens Hospital Los Angeles||Recruiting|
|Los Angeles, California, United States, 90027|
|Contact: Ernest Katz, PhD 323-669-2516|
|United States, Georgia|
|AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus||Recruiting|
|Atlanta, Georgia, United States, 30322|
|Contact: Laura L. Mee, PhD 404-785-1241|
|United States, New York|
|Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center||Recruiting|
|New York, New York, United States, 10032|
|Contact: Clinical Trials Office - Herbert Irving Comprehensive Cancer C 212-305-8615|
|Memorial Sloan-Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Abraham Bartell, MD, MBA 646-888-0023|
|United States, Pennsylvania|
|Fox Chase Cancer Center - Philadelphia||Recruiting|
|Philadelphia, Pennsylvania, United States, 19111-2497|
|Contact: Clinical Trials Office - Fox Chase Cancer Center - Philadelphi 215-728-4790|
|Principal Investigator:||Sharon Manne, PhD||Fox Chase Cancer Center|