Post Hematopoietic Stem Cell TransplantationNCT02928185
Adaptation of Skills Training Manuals for Patients Receiving Hematopoietic Stem Cell Transplantation and Their Caregivers
An observational study of Post Hematopoietic Stem Cell Transplantation, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to see what the patients perceptions are of the Coping Together manuals during the first 100 days after their Hematopoietic Stem Cell Transplantation (HSCT), and if they would make any changes to Coping Together manuals for future patients, caregivers and couples that use these manuals… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post Hematopoietic Stem Cell Transplantation
- What is being tested?
- semi-structured interviews
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2016to 7 Oct 2025
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Hematopoietic Stem Cell Transplantation and Their Caregivers at MSKCC
Who may be able to join
- Part 1
- HSCT Patients
- Admission to the MSKCC Adult BMT service for an outpatient HSCT for a hematologic malignancy
- HSCT procedure scheduled within two months of consent
- ≥18 years old
- Ability to read, speak and understand English
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- Able to give written informed consent
- Physically and cognitively able to participate in the study as determined by the investigators HSCT CGs
- ≥18 years old
- Ability to read, speak and understand English
- Able to give written informed consent
- Physically and cognitively able to participate in the study as determined by the investigators
- HSCT Dyads
- In addition to meeting the inclusion criteria for HSCT Patients and HSCT CGs above, both parties must provide mutual agreement to participate as a dyad.
- HSCT Clinicians
- Member of MSKCC BMT patient care team for at least one year
- Part 2
- HSCT Patients
- Same as Part 1 HSCT Patients HSCT CGs
- Same as Part 1 HSCT CGs HSCT Dyads
- Same as Part 1 HSCT Dyads
Who cannot join
- Part 1 HSCT Patients
- Physically and cognitively unable to participate in the study as determined by the investigators HSCT CGs
- Inability to complete role responsibilities 24 hours per day for at least 50% of time (50 days)
- Physically and cognitively unable to participate in the study as determined by the investigators HSCT Dyads
- Participants must not meet the exclusion criteria for HSCT Patients and HSCT CGs above.
- Patients or CGs who are participating in this study as individuals HSCT Clinicians
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- There are no exclusion criteria
- Part 2 HSCT Patients
- Same as Part 1 HSCT Patients HSCT CGs
- Same as Part 1 HSCT CGs HSCT Dyads
- Same as Part 1 Dyads
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Adaptation of Coping Together, Self-directed Coping Skills Training Manuals for Patients and Caregivers in the Context of Hematopoietic Stem Cell Transplantation
The purpose of this study is to see what the patients perceptions are of the Coping Together manuals during the first 100 days after their Hematopoietic Stem Cell Transplantation (HSCT), and if they would make any changes to Coping Together manuals for future patients, caregivers and couples that use these manuals after their HSCT. The investigators would also like to see what is the caregiver's perception of this intervention, and to see if they have any suggestions for changes. If the caregiver is interested in providing feedback, they will sign a separate consent form.
Read the detailed description
A two-part, qualitative descriptive design will be employed to systematically adapt the Coping Together manuals based on recommendations of HSCT patients, CGs, dyads and clinicians (for Phase 1 only). For this study, CG is defined as spouse, partner, family member, friend, colleague, or neighbor who can, but do not necessarily live together, and provide uncompensated care. A dyad is defined as a combination of a patient and their designated CG. Dyads can review the Coping Together manuals individually or jointly, but will be interviewed together.
Part 1 will capture diverse perspectives of HSCT patients, CGs, dyads and clinicians using individual (patients, CGs, clinicians) and dyadic (dyads) interviews for the preliminary adaptation of the Coping Together manuals.
Part 2 will explore the experiences of HSCT patients, CGs and dyads with HSCT CT, which will be the HSCT-modified version of the Coping Together manuals, using individual (patients, CGs) and dyadic (dyads) interviews to refine the HSCT CT manuals.
- Being tested
- semi-structured interviews
- Keywords
- training manuals, patients and caregivers, 16-1334
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
semi-structured interviewsBehavioural
| Study group | Role | What they receive |
|---|---|---|
| HSCT patients | Individual/dyadic semi-structured interviews between Day +100 to +130 Receives: Behavioral: semi-structured interviews | |
| HSCT care givers | Individual/dyadic semi-structured interviews between Day +100 to +130 Receives: Behavioral: semi-structured interviews | |
| HSCT dyads | Individual/dyadic semi-structured interviews between Day +100 to +130 Receives: Behavioral: semi-structured interviews | |
| HSCT Clinicians | Can include: MD, RN, SW, PharmD and Nutritionist. Individual semi-structured interviews after 14 days to review the Coping Together manuals Receives: Behavioral: semi-structured interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
finalize the preliminary adaptation of the manuals
Socio-demographic characteristics will be summarized with descriptive statistics (frequencies, percentages, means, standard deviations) using IBM SPSS® Statistics, Version 22.
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 posted10 Oct 2016 (estimated)
- Study start13 Sep 2016
- Primary completion7 Oct 2025
- Study completion7 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Hematopoietic Stem Cell TransplantationStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- City University of New York
- Responsible party
- Sponsor
- Investigators
- Tammy Son, BS, MS, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02928185
- Sponsor's protocol ID
- 16-1334
- Status last verified
- Oct 2025
- First submitted
- 6 Oct 2016
- Last updated
- 9 Oct 2025
- Results posted
- No
Publications
Son T, Lambert S, Jakubowski A, DiCicco-Bloom B, Loiselle CG. Adaptation of Coping Together - a self-directed coping skills intervention for patients and caregivers in an outpatient hematopoietic stem cell transplantation setting: a study protocol. BMC Health Serv Res. 2018 Aug 29;18(1):669. doi: 10.1186/s12913-018-3483-1.
PubMed 30157867
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation of Coping Together, Self-directed Coping Skills Training Manuals for Patients and Caregivers in the Context of Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT02928185
- Acronym / sponsor ID
- 16-1334
- Keywords
- training manuals, patients and caregivers, 16-1334
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- City University of New York
- Study start
- 13 Sep 2016 (actual)
- Primary completion
- 7 Oct 2025 (actual)
- Study completion
- 7 Oct 2025 (actual)
- First posted
- 10 Oct 2016 (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.
The purpose of this study is to see what the patients perceptions are of the Coping Together manuals during the first 100 days after their Hematopoietic Stem Cell Transplantation (HSCT), and if they would make any changes to Coping Together manuals for future patients, caregivers and couples that use these manuals after their HSCT. The investigators would also like to see what is the caregiver's perception of this intervention, and to see if they have any suggestions for changes. If the caregiver is interested in providing feedback, they will sign a separate consent form.
Detailed description
A two-part, qualitative descriptive design will be employed to systematically adapt the Coping Together manuals based on recommendations of HSCT patients, CGs, dyads and clinicians (for Phase 1 only). For this study, CG is defined as spouse, partner, family member, friend, colleague, or neighbor who can, but do not necessarily live together, and provide uncompensated care. A dyad is defined as a combination of a patient and their designated CG. Dyads can review the Coping Together manuals individually or jointly, but will be interviewed together.
Part 1 will capture diverse perspectives of HSCT patients, CGs, dyads and clinicians using individual (patients, CGs, clinicians) and dyadic (dyads) interviews for the preliminary adaptation of the Coping Together manuals.
Part 2 will explore the experiences of HSCT patients, CGs and dyads with HSCT CT, which will be the HSCT-modified version of the Coping Together manuals, using individual (patients, CGs) and dyadic (dyads) interviews to refine the HSCT CT manuals.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HSCT patients | – | Behavioral: semi-structured interviewsIndividual/dyadic semi-structured interviews between Day +100 to +130 |
| HSCT care givers | – | Behavioral: semi-structured interviewsIndividual/dyadic semi-structured interviews between Day +100 to +130 |
| HSCT dyads | – | Behavioral: semi-structured interviewsIndividual/dyadic semi-structured interviews between Day +100 to +130 |
| HSCT Clinicians | – | Behavioral: semi-structured interviewsCan include: MD, RN, SW, PharmD and Nutritionist. Individual semi-structured interviews after 14 days to review the Coping Together manuals |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Hematopoietic Stem Cell Transplantation and Their Caregivers at MSKCC
Key inclusion criteria (21 listed)
- Part 1
- HSCT Patients
- Admission to the MSKCC Adult BMT service for an outpatient HSCT for a hematologic malignancy
- HSCT procedure scheduled within two months of consent
- ≥18 years old
Key exclusion criteria (11 listed)
- Part 1 HSCT Patients
- Physically and cognitively unable to participate in the study as determined by the investigators HSCT CGs
- Inability to complete role responsibilities 24 hours per day for at least 50% of time (50 days)
- Physically and cognitively unable to participate in the study as determined by the investigators HSCT Dyads
- Participants must not meet the exclusion criteria for HSCT Patients and HSCT CGs above.
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 interviews | Behavioural | HSCT Clinicians, HSCT care givers, HSCT dyads, HSCT patients |
Primary outcome
finalize the preliminary adaptation of the manuals
Time frame: 1 year
Socio-demographic characteristics will be summarized with descriptive statistics (frequencies, percentages, means, standard deviations) using IBM SPSS® Statistics, Version 22.
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 9 Oct 2025.
- Derived from this study: PubMed 30157867Son T, Lambert S, Jakubowski A, DiCicco-Bloom B, Loiselle CG. Adaptation of Coping Together - a self-directed coping skills intervention for patients and caregivers in an outpatient hematopoietic stem cell transplantation setting: a study protocol. BMC Health Serv Res. 2018 Aug 29;18(1):669. doi: 10.1186/s12913-018-3483-1.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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.
Tammy Son, BS, MS, PhD principal investigator
Memorial Sloan Kettering Cancer Center
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 Post Hematopoietic Stem Cell Transplantation, run by Memorial Sloan Kettering Cancer Center 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 21 inclusion and 11 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 9 Oct 2025. 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?
finalize the preliminary adaptation of the manuals (time frame: 1 year). 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 NCT02928185, which also lists 1 linked publication.
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 9 Oct 2025.