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Quality of Life in Patients Who Have Undergone Stem Cell Transplant

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00128960
Recruitment Status : Completed
First Posted : August 10, 2005
Last Update Posted : February 26, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC)

Brief Summary:

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.


Condition or disease
Long Term Psychological Affects on HSCT

Detailed Description:

Clinical research in allogeneic hematopoietic stem cell transplantation (HSCT) documents improvements in disease free intervals, disease free survival, and the severity of treatment related toxicities. Those who survive, however, continue to experience side-effects and psychological difficulties for years following allogeneic HSCT. Long term complications occur as delayed effects of the conditioning regimen and the transplant as well as side effects from medications required to maintain the new donor-derived immune system. In addition to various biological complications, long-term effects on the psychological, social, physical, functional and symptoms experience (growth and limitations) have been documented.

Although some knowledge exists to help us understand the experience of various groups of allogeneic HSCT patients, the face of allogeneic transplant has changed considerably over the last five years and limits the application of existing reports. Patients with new types of diseases e.g. solid tumor and those who are older (greater than 55 years) and with more significant debilitation are undergoing allogeneic HSCT. It is important for patients and families to know the effects they can expect following an allogeneic transplant. This lack of clarity of the research limits our ability to focus future intervention studies to begin making a difference for patients at high risk for poor health outcomes following allogeneic HSCT.

Understanding of factors associated with variability in recovery following allogeneic HSCT can increase the likelihood that patients will ultimately return to a normal, productive life. Existing research regarding the recovery of adult survivors of allogeneic HSCT indicates that many patients experience difficulties in a variety of Health Related Quality of Life (HRQL) domains. A critical issue which has remained unexamined concerns the extent to which domains improve, remain static, or perhaps even deteriorates with the passage of time after allogeneic HSCT. Results will be discussed with respect to their implications for both the encouragement of realistic expectations for recovery following allogeneic HSCT as well as the development of interventions.

The long term goal of this study is to characterize longitudinally the functional health, psychosocial adjustment, HRQL and symptom experience associated with long term survival after allogeneic HSCT. This study has two specific aims:

  1. To examine the functional status, psychosocial adjustment and HRQL of patients greater than or equal to 3 years following allogeneic HSCT.
  2. To examine the symptom experience of patients greater than or equal to 3 years following allogeneic HSCT.

Data will be analyzed using methods of longitudinal analysis, such as the generalized estimating equations, mixed-effects models and growth mixture modeling to evaluate change over time for each outcome variable.

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Study Type : Observational
Actual Enrollment : 173 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : August 11, 2005

Group/Cohort
1
Participants with different types of diseases and conditions who have undergone an allogeneic (donor) stem cell transplant.



Primary Outcome Measures :
  1. Characterize Longitudinally the functional health, psychosocial Adjustment, HRQL and symptom experience associated with LT Survival after allogeneic HSCT. [ Time Frame: 3 yrs ]
    Quality of Life

  2. To examine the symptom experience of patients following allogeneic HSCT [ Time Frame: 3 yrs ]
    Quality of Life


Secondary Outcome Measures :
  1. examine functional status, psychosocial adjustment, HRQL, and the symptom experience of patients = 3 years from their transplant as related to late and persistent effects (e.g. complications) of allogeneic HSCT. [ Time Frame: 3 years after HSCT ]
    description of functional status, psychosocial adjustment, HRQL, and the symptom experience



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
NIH Clinical Center patients who have undergone allogeneic stem cell transplant.
Criteria
  • 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00128960


Locations
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United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
Investigators
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Principal Investigator: Sandra A Mitchell, C.R.N.P. National Cancer Institute (NCI)

Additional Information:
Publications:
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Responsible Party: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00128960    
Other Study ID Numbers: 050216
05-CC-0216
First Posted: August 10, 2005    Key Record Dates
Last Update Posted: February 26, 2020
Last Verified: December 3, 2019
Keywords provided by National Institutes of Health Clinical Center (CC):
Allogeneic Hematopoietic Stem Cell Transplant
Health Related Quality of Life
Symptom Experience
Fatigue
Functional Status