Problem-Solving Education for Caregivers and Patients During Stem Cell Transplant

NCT00766883 | Completed Phase 2

• 2 other identifiers: 08022008-CC-0220
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine the effectiveness of problem-solving education for patients who are undergoing a stem cell transplant and their caregivers. The emotional stress of transplant extends beyond patients to their caregivers; this study will identify the type of education that will be most helpful to transplant caregivers. Adult patients undergoing stem cell transplant at the NIH s Clinical Center and their adult caregivers are eligible for this study. The caregiver must be caring for the patient from before hospital admission for the procedure until 6 weeks following the transplant. Both patient and caregiver must be able to read and speak English. Patients and caregivers have three education sessions (in addition to the routine transplant education provided at the Clinical Center) and complete three study questionnaires as follows:

• Questionnaires: The questionnaires vary somewhat for patient and caregiver, but include information on demographics (e.g., sex, race, marital status, education level), distress, lifestyle, relationship with the caregiver/patient, confidence level, symptoms, pain, fatigue and sleep quality. Questionnaires are completed before the patient undergoes the transplant (and before attending any education sessions), before the patient is discharged from the hospital and 6 weeks after hospital discharge.
• Education sessions: The 60-minute sessions are designed to teach problem-solving strategies by looking at problems in a new way and learning effective communication skills. The sessions are conducted before the patient is discharged from the hospital, 1 week after discharge and 3 weeks after discharge.

Conditions

Distress; Hematopoietic Stem Cell Transplantation

Keywords

Allogeneic HSCT; Psychosocial Distress; Coping; Cognitive Behavior Therapy; Self Efficacy; Allogeneic Stem Cell Transplant

Outcome Measures

Primary Outcomes (1)

• To determine the effect of a PSE intervention on self-efficacy (a sense of control of oneself) in caregivers during the experience of an allogeneic HSCT.

Secondary Outcomes (1)

• To determine the effect of a PSE intervention on self-efficacy (a sense of control of oneself) in patients during the experience of an allogeneic HSCT.

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 caregiver(s) available and/or living with transplant recipient.
• Caregiver(s) agrees to participate in the study.
• Caregiver(s):
• 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.
• Agrees to participate in the study.

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 (4)

• 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

• 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

• 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

• Sundaramurthi T, Wehrlen L, Friedman E, Thomas S, Bevans M. Hematopoietic Stem Cell Transplantation Recipient and Caregiver Factors Affecting Length of Stay and Readmission. Oncol Nurs Forum. 2017 Sep 1;44(5):571-579. doi: 10.1188/17.ONF.571-579.

  PMID: 28820507 DERIVED

Study Officials

• Margaret F Bevans, Ph.D.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2008
• First Posted: October 6, 2008
• Study Start: September 29, 2008
• Primary Completion: December 15, 2010
• Study Completion: December 15, 2010
• Last Updated: December 17, 2019

Record last verified: 2017-09-28

Locations

US (1)