Protocol Number: 07-CC-0067

Title:

A Feasibility Study to Test an Individualized Dyadic Problem-Solving Education Intervention to Improve Problem-Solving Skills of Patients and Family Caregivers During Allogeneic HSCT

Number:

07-CC-0067

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.

Sponsoring Institute:

National Institutes of Health Clinical Center (CC)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria:

INCLUSION CRITERIA:

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.

Adult family member who meets the patient inclusion criteria.

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.

Special Instructions:

Currently Not Provided

Keywords:

Allogeneic Hematopoietic Stem Cell Transplant

Psychological Distress

Coping

Cognitive Behavior Therapy

Recruitment Keyword(s):

Bone Marrow Transplant

Coping Skills

Condition(s):

Family Caregivers

Bone Marrow Transplantation

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

Behavioral: Problem-Solving Education

Supporting Site:

NIH Clinical Center

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

Goldman JM, Horowitz MM. The international bone marrow ransplant registry. Int J Hematol. 2002 Aug;76 Suppl 1:393-7. eview.

Thomas ED, Blume KG. Historical markers in the development f allogeneic hematopoietic cell transplantation. Biol Blood Marrow Transplant. 1999;5(6):341-6. Review. No abstract available.

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. Review.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Networks and Applications, CC.

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National Institutes of Health Clinical Center Bethesda, Maryland 20892. Last update: 09/16/2008