| ID | Type | Description | Link |
|---|---|---|---|
| 1R01CA127488-01A1 | U.S. NIH Grant/Contract | View source | |
| CDR0000632012 | Registry Identifier | PDQ (Physician Data Query) | |
| FCCC-07848 | |||
| 0220090280 | Other Identifier | IRB Number | |
| P30CA072720 | U.S. NIH Grant/Contract | View source | |
| IRB#07-848; 15032-01 | Other Identifier | Fox Chase number |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Children's Hospital Los Angeles | OTHER |
| Columbia University | OTHER |
| Emory University |
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The investigators have developed a parent social-cognitive processing intervention (P-SCIP) to help decrease distress among parent caregivers of children undergoing hematopoietic stem cell transplant (HSCT). The investigators will evaluate the efficacy of P-SCIP in reducing short- and long-term distress and parenting stress among 300 parents of children undergoing HSCT. P-SCIP will be delivered during the child's inpatient HSCT hospitalization and is specifically designed to improve parent social (e.g., sharing concerns) and cognitive (e.g., acceptance) processing of the transplant experience. The intervention includes five in-person sessions that are accompanied by an interactive CD-ROM. The CD-ROM complements the materials in the in-person sessions and provides parents with the opportunity to enhance and deepen their cognitive and social processing of the HSCT experience. The intervention will be tested against best-practices psychosocial care (BPC) available in four enriched pediatric HSCT settings across the United States. P-SCIP will be provided to both Spanish- and English-speaking parents. Participants will complete measures of psychological distress, well-being, and social and cognitive processing at the time of HSCT, two, six and twelve months after HSCT. Research questions will address the effects of P-SCIP versus BPC on parent psychological adaptation and social and cognitive processing, as well as evaluate parent personal resources as well as child medical course variables that contribute to intervention response. The investigators will also examine barriers to participation in the intervention by comparing barriers to participation among parents who refuse participation in the trial and parents who accept.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| P-SCIP | Experimental | 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. |
|
| BPC | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral intervention sessions | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Beck Depression Inventory | 7 years | |
| Beck Anxiety Inventory | 7 years | |
| Mental Health Inventory | 7 years | |
| Impact of Events Scale-Revised | 7 years | |
| Axis I Structured Clinical Interview for DSM-IV (SCID) | 7 years |
| Measure | Description | Time Frame |
|---|---|---|
| Fear Structure | 7 years | |
| Brief COPE | 7 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sharon L Manne, Ph.D. | Rutgers Cancer Institute of New Jersey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Childrens Hospital Los Angeles | Los Angeles | California | 90027 | United States | ||
| Emory University/Childrens Healthcare of Atlanta |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D016251 | CD-ROM |
| D012144 | Respite Care |
| ID | Term |
|---|---|
| D016250 | Compact Disks |
| D014742 | Videodisc Recording |
| D016249 | Optical Storage Devices |
| D001296 | Audiovisual Aids |
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| OTHER |
| Memorial Sloan Kettering Cancer Center | OTHER |
| University of Medicine and Dentistry of New Jersey | OTHER |
| Icahn School of Medicine at Mount Sinai | OTHER |
| Weill Medical College of Cornell University | OTHER |
| National Marrow Donor Program | OTHER |
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| CD-ROM | Other | Participants receive a laptop computer and a CD-ROM after the first session of behavioral intervention. |
|
| DVD and pamphlet | Other | Participants 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. |
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| Respite care | Other | Participants receive 5 hours of respite care from a child-life specialist once or twice weekly for 3 weeks. |
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| Atlanta |
| Georgia |
| 30322 |
| United States |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 080903 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10021 | United States |
| Columbia University | New York | New York | 10032 | United States |
| D018961 |
| Educational Technology |
| D013672 | Technology |
| D013676 | Technology, Industry, and Agriculture |
| D013690 | Television |
| D006701 | Home Nursing |
| D009732 | Nursing Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006699 | Home Care Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |