Long Term Psychological Affects on HSCTNCT00128960
Quality of Life in Patients Who Have Undergone Stem Cell Transplant
An observational study of Long Term Psychological Affects on HSCT, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Long Term Psychological Affects on HSCT
- How many people
- 173 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2005to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: NIH Clinical Center patients who have undergone allogeneic stem cell transplant.
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
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
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.
Read more
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.
...
Read the 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:
- To examine the functional status, psychosocial adjustment and HRQL of patients greater than or equal to 3 years following allogeneic HSCT.
- 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.
- Conditions
- Long Term Psychological Affects on HSCT
- Keywords
- Allogeneic Hematopoietic Stem Cell Transplant, Health Related Quality of Life, Symptom Experience, Fatigue, Functional Status, Natural History
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Participants with different types of diseases and conditions who have undergone an allogeneic (donor) stem cell transplant. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterize Longitudinally the functional health, psychosocial Adjustment, HRQL and symptom experience associated with LT Survival after allogeneic HSCT.
Quality of Life
Measured: 3 yrs
To examine the symptom experience of patients following allogeneic HSCT
Quality of Life
Measured: 3 yrs
Secondary outcomes (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.
description of functional status, psychosocial adjustment, HRQL, and the symptom experience
Measured: 3 years after HSCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2005 (estimated)
- Study start11 Aug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Long Term Psychological Affects on HSCTStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Sandra A Mitchell, C.R.N.P., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00128960
- Sponsor's protocol ID
- 050216
- Other IDs
- 05-CC-0216
- Status last verified
- 2 Oct 2026
- First submitted
- 9 Aug 2005
- Last updated
- 5 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 24355521Bevans 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.
PubMed 21496339Prince 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.
PubMed 26315721
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00128960
- Acronym / sponsor ID
- 050216
- Conditions
- Long Term Psychological Affects on HSCT
- Keywords
- Allogeneic Hematopoietic Stem Cell Transplant, Health Related Quality of Life, Symptom Experience, Fatigue, Functional Status, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 11 Aug 2005 (actual)
- First posted
- 10 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
...
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:
- To examine the functional status, psychosocial adjustment and HRQL of patients greater than or equal to 3 years following allogeneic HSCT.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Participants with different types of diseases and conditions who have undergone an allogeneic (donor) stem cell transplant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- NIH Clinical Center patients who have undergone allogeneic stem cell transplant.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
To examine the symptom experience of patients following allogeneic HSCT
Time frame: 3 yrs
Quality of Life
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Background: PubMed 24355521Bevans 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.
- Background: PubMed 21496339Bevans 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.
- Background: PubMed 26315721Prince 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.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra A Mitchell, C.R.N.P. principal investigator
National Institutes of Health Clinical Center (CC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Long Term Psychological Affects on HSCT, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterize Longitudinally the functional health, psychosocial Adjustment, HRQL and symptom experience associated with LT Survival after allogeneic HSCT. (time frame: 3 yrs). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00128960, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.