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Protocol Details

Prospective Assessment of Functional Status, Psychosocial Adjustment, Health Related Quality of Life and the Symptom Experience in Patients Treated with Allogeneic Hematopoietic Stem Cell Transplantation

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

05-CC-0216

Sponsoring Institute

National Institutes of Health Clinical Center (CC)

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 18
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Children

Keywords

Allogeneic Hematopoietic Stem Cell Transplant;
Health Related Quality of Life;
Symptom Experience;
Fatigue;
Functional Status;
Natural History

Recruitment Keyword(s)

None

Condition(s)

Long Term Psychological Affects on HSCT

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

NIH Clinical Center

This study will evaluate the long-term functional status, psychosocial adjustment and quality of life of patients with different types of diseases and conditions who have had an allogeneic (donor) stem cell transplant. Information from this study may help patients and families know better what they may expect long-term after transplant and will help health care workers improve services to aid in patients' recovery.

People 18 years of age or older who have had an allogeneic stem cell transplant three or more years before the start of this study may be eligible to participate.

Participants complete a series of questionnaires once a year for three years. The questionnaires take about 40 minutes to complete and include information on patient demographics, patients' physical, social, and emotional functioning, spiritual well being, pain, mental health, general health, fatigue, and other areas of health-related quality of life. The questionnaires are completed at home or during normally scheduled follow-up visits to the NIH.

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Eligibility

INCLUSION CRITERIA:

Patients surviving three years or more from the date of first allogeneic HSCT provided at the Clinical Center, 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 or Spanish.

Life expectancy of at least 6 months.


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Citations:

Bevans MF, Mitchell SA, Barrett JA, Bishop MR, Childs R, Fowler D, Krumlauf M, Prince P, Shelburne N, Wehrlen L, Yang L. Symptom distress predicts long-term health and well-being in allogeneic stem cell transplantation survivors. Biol Blood Marrow Transplant. 2014 Mar;20(3):387-95. doi: 10.1016/j.bbmt.2013.12.001. Epub 2013 Dec 17.

Bevans MF, Mitchell SA, Barrett AJ, Bishop M, Childs R, Fowler D, Krumlauf M, Prince P, Shelburne N, Wehrlen L. Function, adjustment, quality of life and symptoms (FAQS) in allogeneic hematopoietic stem cell transplantation (HSCT) survivors: a study protocol. Health Qual Life Outcomes. 2011 Apr 17;9:24. doi: 10.1186/1477-7525-9-24.

Prince P, Mitchell SA, Wehrlen L, Childs R, Savani B, Yang L, Bevans M. Spiritual Well-Being in Hispanic and Non-Hispanic Survivors of Allogeneic Hematopoietic Stem Cell Transplantation. J Psychosoc Oncol. 2015;33(6):635-54. doi: 10.1080/07347332.2015.1082167.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Sandra A. Mitchell, C.R.N.P.
National Institutes of Health Clinical Center (CC)
BG 9609 MEDICAL CENTER DRIVE RM 3E448
9609 MEDICAL CENTER DR.
ROCKVILLE MD 20850
(240) 276-6929
mitchlls@mail.nih.gov

Sandra A. Mitchell, C.R.N.P.
National Institutes of Health Clinical Center (CC)
BG 9609 MEDICAL CENTER DRIVE RM 3E448
9609 MEDICAL CENTER DR.
ROCKVILLE MD 20850
(240) 276-6929
mitchlls@mail.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT00128960

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