Education Program to Manage Emotional Stress of Stem Cell Transplant Recipients and Their Caregivers

NCT00423774 | Completed Phase 1

• 2 other identifiers: 07006707-CC-0067
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

his study will evaluate a series of problem-solving education sessions for patients undergoing a stem cell transplant and their family caregivers. The emotional stress of transplant extends beyond patients to their families, especially caregivers. Little is known about managing the emotional distress associated with stem cell transplant or the support and education most helpful to caregivers of stem cell recipients. Patients undergoing a stem cell transplant and their family caregivers may be eligible for this study. All participants must be 18 years of age and older. Patients and their caregivers receive routine treatment-specific education from transplant team members. This study adds a series of educational sessions focusing on problem-solving skills. In addition to the study education, participants do the following:

• Complete a 130-item questionnaire when they consent to participate in the study.
• Complete a 60-item questionnaire and attend a 60-minute face-to-face education session before the transplant.
• Complete a 40-item questionnaire and attend a 60-minute face-to-face education session before hospital discharge.
• Complete the same 40-item questionnaire and attend a 60-minute face-to-face education session 2 weeks after hospital discharge.
• Attend a 30-minute face-to-face education session 4 weeks after hospital discharge.
• Complete a 60-item questionnaire 6 weeks after hospital discharge.

Conditions

Family Caregivers; Bone Marrow Transplantation

Keywords

Allogeneic Hematopoietic Stem Cell Transplant; Psychological Distress; Coping; Cognitive Behavior Therapy; Bone Marrow Transplant; Coping Skills

Outcome Measures

Primary Outcomes (1)

• Participation themes and implementation variances

Secondary Outcomes (1)

• Problem solving skills in patient and caregiver

Interventions

Problem-Solving Education BEHAVIORAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients: Receiving their first allogeneic HSCT at the CC, NIH
• Age greater than or equal to 18 years old.
• Ability to comprehend the investigational nature of the study and provide informed consent.
• Able to read and speak English.
• Adult family member serves as primary caregiver throughout study period.\*
• Family caregiver agrees to participate in the study.
• Family Caregiver (FC):
• Age greater than or equal to 18 years old.
• Ability to comprehend the investigational nature of the study and provide informed consent.
• Able to read and speak English.
• Family member (patient) agrees to participate in the study.
• Intends to serve as primary caregiver throughout study period\*
• \*If the FC changes during the study, the PSE intervention will continue as scheduled with the new FC, however, FC data will no longer be collected and will be excluded from the analyses.

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Goldman JM, Horowitz MM. The international bone marrow transplant registry. Int J Hematol. 2002 Aug;76 Suppl 1:393-7. doi: 10.1007/BF03165291.

  PMID: 12430889 BACKGROUND

• Thomas ED, Blume KG. Historical markers in the development of allogeneic hematopoietic cell transplantation. Biol Blood Marrow Transplant. 1999;5(6):341-6. doi: 10.1016/s1083-8791(99)70010-8. No abstract available.

  PMID: 10595811 BACKGROUND

• Tabbara IA, Zimmerman K, Morgan C, Nahleh Z. Allogeneic hematopoietic stem cell transplantation: complications and results. Arch Intern Med. 2002 Jul 22;162(14):1558-66. doi: 10.1001/archinte.162.14.1558.

  PMID: 12123398 BACKGROUND

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH

Study Record Dates

• First Submitted: January 17, 2007
• First Posted: January 18, 2007
• Study Start: January 11, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: July 2, 2017

Record last verified: 2010-09-28

Locations

US (1)