Social AdaptationNCT01165788
Social Adaptation in Long Term Survivors of Blood and Marrow Transplantation
An observational study of Social Adaptation, run by Stanford University at 1 site in United States.
Trial summary
1. To explore specific aspects of social adaptation such as social connectedness, occupational outcomes and family relationships in lymphoma patients after autologous blood or marrow transplantation (BMT). 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Social Adaptation
- What is being tested?
- Semi structured personal interview
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to 28 Jun 2017
- 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: Subjects will be identified from the comprehensive database of the Blood and Marrow Transplant Division of Stanford Hospitals \& Clinics. We will target lymphoma patients who received an autologous BMT as adults (18 years or older). We estimate there are ~580 surviving who are between 2 and 22 years post-BMT.
Who may be able to join
- Lymphoma patients treated with blood and marrow transplantation at Stanford University Medical Center
- Age > 18 years at the time of transplant
- English speaking
- Willingness to sign a written informed consent document
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
- To explore specific aspects of social adaptation such as social connectedness, occupational outcomes and family relationships in lymphoma patients after autologous blood or marrow transplantation (BMT).
- To investigate how social adaptation varies with time lapsed since BMT and with the life stage as determined by patient?s age. Understanding both the positive and negative aspects of cancer and cancer therapy leads to opportunities to promote adaptive strategies.
- Conditions
- Social Adaptation
- Being tested
- Semi structured personal interview
- Keywords
- Blood and Marrow Transplant (BMT)
- Medical subject headings
- Social Adjustment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi structured personal interviewProcedure or surgery
A trained research assistant will conduct in-person, in-depth semi-structured interviews at a location of the participants choosing. Participants will be asked to discuss their experiences with cancer, focusing especially on how their cancer affected their (1) work/education (2) relationships with their family (spouse, children, parents, siblings and other relatives) (3) their other social relationships
| Study group | Role | What they receive |
|---|---|---|
| autologous BMT recipients | Lymphoma patients who received an autologous BMT as adults Receives: Procedure: Semi structured personal interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specific aspects of social adaptation, such as social connectedness, occupational outcomes and family relationships in lymphoma patients after autologous blood or marrow transplantation (BMT)
Measured: 1 year
Social adaptation variation with time lapsed since BMT and with the life stage as determined by patient's age
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2010 (estimated)
- Study startNov 2009
- Primary completionNov 2010
- Study completion28 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social AdaptationStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Family based
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karen Cook, Principal investigator, Stanford UniversityKate Tierney, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01165788
- Sponsor's protocol ID
- BMT216
- Other IDs
- SU-07092010-6496
- Status last verified
- Nov 2017
- First submitted
- 16 Jul 2010
- Last updated
- 2 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Adaptation in Long Term Survivors of Blood and Marrow Transplantation
- ClinicalTrials.gov ID
- NCT01165788
- Acronym / sponsor ID
- BMT216
- Conditions
- Social Adaptation
- Keywords
- Blood and Marrow Transplant (BMT)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- 28 Jun 2017 (actual)
- First posted
- 20 Jul 2010 (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.
- To explore specific aspects of social adaptation such as social connectedness, occupational outcomes and family relationships in lymphoma patients after autologous blood or marrow transplantation (BMT).
- To investigate how social adaptation varies with time lapsed since BMT and with the life stage as determined by patient?s age. Understanding both the positive and negative aspects of cancer and cancer therapy leads to opportunities to promote adaptive strategies.
Study design
- Observational model
- Family based
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| autologous BMT recipients | – | Procedure: Semi structured personal interviewLymphoma patients who received an autologous BMT as adults |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be identified from the comprehensive database of the Blood and Marrow Transplant Division of Stanford Hospitals \& Clinics. We will target lymphoma patients who received an autologous BMT as adults (18 years or older). We estimate there are ~580 surviving who are between 2 and 22 years post-BMT.
Key inclusion criteria (4 listed)
- Lymphoma patients treated with blood and marrow transplantation at Stanford University Medical Center
- Age > 18 years at the time of transplant
- English speaking
- Willingness to sign a written informed consent document
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semi structured personal interviewA trained research assistant will conduct in-person, in-depth semi-structured interviews at a location of the participants choosing. Participants will be asked to discuss their experiences with cancer, focusing especially on how their cancer affected their (1) work/education (2) relationships with their family (spouse, children, parents, siblings and other relatives) (3) their other social relationships | Procedure or surgery | autologous BMT recipients |
Primary outcome
Specific aspects of social adaptation, such as social connectedness, occupational outcomes and family relationships in lymphoma patients after autologous blood or marrow transplantation (BMT)
Time frame: 1 year
Social adaptation variation with time lapsed since BMT and with the life stage as determined by patient's age
Time frame: 1 year
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 2 Dec 2017.
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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.
Karen Cook principal investigator
Stanford University
Kate Tierney principal investigator
Stanford University
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 Social Adaptation, run by Stanford University 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 4 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 2 Dec 2017. 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?
Specific aspects of social adaptation, such as social connectedness, occupational outcomes and family relationships in lymphoma patients after autologous blood or marrow transplantation (BMT) (time frame: 1 year). 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?
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 2 Dec 2017.