Stem Cell TransplantNCT07107165
Psychosocial and Behavioral Intervention for Stem Cell Transplant Patients and Their Family Caregivers
A study testing Dyadic Problem Solving Training and Supportive Care in people with Stem Cell Transplant and Hematopoetic Stem Cell Transplant, run by University of Pittsburgh at 1 site in United States.
Trial summary
Adherence to the medical regimen after stem cell transplant is challenging for both patients and their family caregivers. The investigators propose a randomized clinical trial testing two brief psychosocial interventions to determine if either improves patient and family caregiver psychosocial and health-related… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stem Cell Transplant, Hematopoetic Stem Cell Transplant, Hematopoetic Stem Cell Transplantation
- What is being tested?
- Dyadic Problem Solving Training and Supportive Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2025to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Patient undergoing a stem cell transplant at the University of Pittsburgh Hillman Cancer Center
- 18 years or older
- having a family caregiver age 18 years or older also willing to participate in the study
- willing to accept randomization
Who cannot join
- Prior history of stem cell transplant
- Non-English speaking
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Pittsburgh Medical Center Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Donna Posluszny, PhD, 412-623-5966, poslusznydm@upmc.edu
Donna Posluszny, PhD
About this study
Official title: Adapting After Discharge From Allogeneic SCT: Partnering Together; Dyadic Intervention to Improve Patient-Family Caregiver Team-Based Management of the Medical Regimen After Allogeneic Hematopoietic Cell Transplantation
Adherence to the medical regimen after stem cell transplant is challenging for both patients and their family caregivers. The investigators propose a randomized clinical trial testing two brief psychosocial interventions to determine if either improves patient and family caregiver psychosocial and health-related outcomes.
Read the detailed description
The investigators propose a randomized controlled trial testing two brief, 4 session psychosocial interventions to help patients and family caregivers better manage the time period after hospital discharge from stem cell transplant. Patients and family caregivers will be randomized to either the skill learning intervention (n=52 patient-family caregiver dyads) or to the supportive care intervention (n=52 patient-family caregiver dyads). The intervention will be conducted via live video conferencing. Patients and family caregivers will complete questionnaires before the intervention and at 1-, 5-, 12-, 24 weeks afterwards. The investigators will determine whether the skills learning group has improved outcomes, including adherence to the medical regimen and perceived task efficacy.
- Conditions
- Stem Cell Transplant, Hematopoetic Stem Cell Transplant, Hematopoetic Stem Cell Transplantation
- Being tested
- Dyadic Problem Solving Training, Supportive Care
- Keywords
- stem cell transplant, hematopoietic stem cell transplant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dyadic Problem Solving TrainingBehavioural
Also called DPST
DPST consists of teaching the patient and family caregiver problem-solving skills that they can apply to help them manage the medical regimen after stem cell transplant.
Supportive CareBehavioural
Also called SC
Supportive Care consists of providing support to the patient and family caregiver as they manage the medical regimen after stem cell transplant
| Study group | Role | What they receive |
|---|---|---|
| Dyadic Problem Solving Training (DPST) | Experimental | DPST will teach problem solving skills to both the patient and family caregiver as they manage the medical regimen. Receives: Behavioral: Dyadic Problem Solving Training |
| Supportive Care | Active comparator | Supportive Care will provide support to both the patient and family caregiver as they manage the medical regimen. Receives: Behavioral: Supportive Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Habits Assessment - modified for stem cell transplant
Assess levels of adherence to the post-transplant multi-component medical regimen of 20 main tasks; each task marked as yes = 1/no=0 adherent. Tasks will be grouped and summed into categories including medication taking (3 items, range 0=low to 3 high), infection precautions (6 items; range 0=low to 6 high), catheter/port care (4 items, range 0=low to 4 = high), and lifestyle behaviors (7 items, range 0=low to 7=high). Higher scores indicate greater adherence.
Measured: 1-, 5-, 12- and 24-weeks post-intervention
Perceived task efficacy
Assesses perceptions of efficacy to complete tasks of the post-transplant multi-component medical regimen, 20 items rated on 1=low to 10=high scale, mean score will be used.
Measured: 1-, 5-, 12- and 24-weeks post intervention
Secondary outcomes (9)
Immunosuppressant blood levels
levels of immunosuppressant medication in patient's blood
Measured: 1-, 5-, 12- and 24-weeks post-intervention
Patient health care utilization
Counts of number of hospital readmissions, emergency room visits, and unplanned medical visits
Measured: continuous over 24 weeks post-intervention
Patient Health Questionnaire- 9
Assesses symptoms of depression, 9 items rated on 4-point scale from 0=not at all to 3=nearly every day. Sum and categorical classification will be used (score 10-14=moderate; score 15 and higher =severe.
Measured: baseline and 1-,5-,12-, and 24-weeks post-intervention
Generalized Anxiety Disorder - 7
Assesses symptoms of anxiety, 7 items rated from 0=not at all to 3=nearly every day. Sum and category will be used (score 10-14 = moderate; score 15 or higher = severe)
Measured: baseline and 1-, 5-, 12-, and 24-weeks post-intervention
Dyadic Adjustment Scale - modified
Assess relationship quality, 9 items rated from 1=not at all to 5 = often; range 9-45; sum will be used. Higher scores indicate greater relationship quality.
Measured: baseline and 1-, 5-, 12-, 24-weeks post-intervention
Task Responsibility
Rating of whether the patient was mostly responsible, the caregiver was mostly responsible, or the patient and caregiver had equal responsibility in making sure each task of the post-transplant multi-component medical regimen is completed. Levels of each of the three choices will be tabulated. The highest level will dictate the categorical score (patient mostly responsible; caregiver mostly responsible; patient and caregiver equally responsible).
Measured: 1-, 5-, 12-, and 24-weeks post-intervention
Caregiver Reaction Assessment
Assesses burden in caregivers, 24 items rated on a 1=low to 5=high; range = 24-120; sum will be used.
Measured: 1-, 5-, 12-, 24- weeks
Cancer and Treatment Distress Scale
Assess distress specific to cancer, 35 items are rated from 0=none to 3=severe; range = 0-105; sum score will be used.
Measured: baseline and 1-, 5-, 12-, 24-weeks post-intervention
PROMIS - 16 v2.1
Assesses overall health-related quality of life and functioning, 16 items rated from 1=low to 5 = high; higher scores indicate greater health-related quality of life; sum will be used.
Measured: baseline and 1-, 5-, 12-, and 24-weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start1 Jul 2025
- Primary completionJun 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stem Cell TransplantStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Donna Posluszny, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07107165
- Sponsor's protocol ID
- STUDY25020163
- Other IDs
- R01CA268004
- Status last verified
- Mar 2026
- First submitted
- 17 Jul 2025
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study database will be reviewed to ensure that no identifying information of any type is contained therein. A downloadable, de-identified data set and data dictionary will be made available electronically from the PI after the request is reviewed by the research team for scientific merit and requestors provide evidence to the PI that (a) their plan for the use of such data has been approved by their institution's Institutional Review Board or its equivalent, and (b) they have completed NIH requirements for training in research integrity and human subjects protection.
Publications
Posluszny DM, Bovbjerg DH, Syrjala KL, Agha M, Dew MA. Correlates of anxiety and depression symptoms among patients and their family caregivers prior to allogeneic hematopoietic cell transplant for hematological malignancies. Support Care Cancer. 2019 Feb;27(2):591-600. doi: 10.1007/s00520-018-4346-3. Epub 2018 Jul 19.
PubMed 30022348Posluszny DM, Bovbjerg DH, Syrjala KL, Agha M, Farah R, Hou JZ, Raptis A, Im AP, Dorritie KA, Boyiadzis MM, Dew MA. Rates and Predictors of Nonadherence to the Post-Allogeneic Hematopoietic Cell Transplantation Medical Regimen in Patients and Caregivers. Transplant Cell Ther. 2022 Mar;28(3):165.e1-165.e9. doi: 10.1016/j.jtct.2021.11.020. Epub 2021 Dec 4.
PubMed 34875403
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting After Discharge From Allogeneic SCT: Partnering Together; Dyadic Intervention to Improve Patient-Family Caregiver Team-Based Management of the Medical Regimen After Allogeneic Hematopoietic Cell Transplantation
- ClinicalTrials.gov ID
- NCT07107165
- Acronym / sponsor ID
- STUDY25020163
- Conditions
- Stem Cell Transplant, Hematopoetic Stem Cell Transplant, Hematopoetic Stem Cell Transplantation
- Keywords
- stem cell transplant, hematopoietic stem cell transplant
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 6 Aug 2025 (actual)
- 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.
Adherence to the medical regimen after stem cell transplant is challenging for both patients and their family caregivers. The investigators propose a randomized clinical trial testing two brief psychosocial interventions to determine if either improves patient and family caregiver psychosocial and health-related outcomes.
Detailed description
The investigators propose a randomized controlled trial testing two brief, 4 session psychosocial interventions to help patients and family caregivers better manage the time period after hospital discharge from stem cell transplant. Patients and family caregivers will be randomized to either the skill learning intervention (n=52 patient-family caregiver dyads) or to the supportive care intervention (n=52 patient-family caregiver dyads). The intervention will be conducted via live video conferencing. Patients and family caregivers will complete questionnaires before the intervention and at 1-, 5-, 12-, 24 weeks afterwards. The investigators will determine whether the skills learning group has improved outcomes, including adherence to the medical regimen and perceived task efficacy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dyadic Problem Solving Training (DPST) | Experimental | Behavioral: Dyadic Problem Solving TrainingDPST will teach problem solving skills to both the patient and family caregiver as they manage the medical regimen. |
| Supportive Care | Active comparator | Behavioral: Supportive CareSupportive Care will provide support to both the patient and family caregiver as they manage the medical regimen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient undergoing a stem cell transplant at the University of Pittsburgh Hillman Cancer Center
- 18 years or older
- having a family caregiver age 18 years or older also willing to participate in the study
- willing to accept randomization
Key exclusion criteria (2 listed)
- Prior history of stem cell transplant
- Non-English speaking
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 |
|---|---|---|
| Dyadic Problem Solving TrainingAlso: DPSTDPST consists of teaching the patient and family caregiver problem-solving skills that they can apply to help them manage the medical regimen after stem cell transplant. | Behavioural | Dyadic Problem Solving Training (DPST) |
| Supportive CareAlso: SCSupportive Care consists of providing support to the patient and family caregiver as they manage the medical regimen after stem cell transplant | Behavioural | Supportive Care |
Primary outcome
Health Habits Assessment - modified for stem cell transplant
Time frame: 1-, 5-, 12- and 24-weeks post-intervention
Assess levels of adherence to the post-transplant multi-component medical regimen of 20 main tasks; each task marked as yes = 1/no=0 adherent. Tasks will be grouped and summed into categories including medication taking (3 items, range 0=low to 3 high), infection precautions (6 items; range 0=low to 6 high), catheter/port care (4 items, range 0=low to 4 = high), and lifestyle behaviors (7 items, range 0=low to 7=high). Higher scores indicate greater adherence.
Perceived task efficacy
Time frame: 1-, 5-, 12- and 24-weeks post intervention
Assesses perceptions of efficacy to complete tasks of the post-transplant multi-component medical regimen, 20 items rated on 1=low to 10=high scale, mean score will be used.
9 secondary outcomes
Immunosuppressant blood levels
Time frame: 1-, 5-, 12- and 24-weeks post-intervention
Patient health care utilization
Time frame: continuous over 24 weeks post-intervention
Patient Health Questionnaire- 9
Time frame: baseline and 1-,5-,12-, and 24-weeks post-intervention
Generalized Anxiety Disorder - 7
Time frame: baseline and 1-, 5-, 12-, and 24-weeks post-intervention
Dyadic Adjustment Scale - modified
Time frame: baseline and 1-, 5-, 12-, 24-weeks post-intervention
Task Responsibility
Time frame: 1-, 5-, 12-, and 24-weeks post-intervention
Caregiver Reaction Assessment
Time frame: 1-, 5-, 12-, 24- weeks
Cancer and Treatment Distress Scale
Time frame: baseline and 1-, 5-, 12-, 24-weeks post-intervention
PROMIS - 16 v2.1
Time frame: baseline and 1-, 5-, 12-, and 24-weeks post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Background: PubMed 30022348Posluszny DM, Bovbjerg DH, Syrjala KL, Agha M, Dew MA. Correlates of anxiety and depression symptoms among patients and their family caregivers prior to allogeneic hematopoietic cell transplant for hematological malignancies. Support Care Cancer. 2019 Feb;27(2):591-600. doi: 10.1007/s00520-018-4346-3. Epub 2018 Jul 19.
- Background: PubMed 34875403Posluszny DM, Bovbjerg DH, Syrjala KL, Agha M, Farah R, Hou JZ, Raptis A, Im AP, Dorritie KA, Boyiadzis MM, Dew MA. Rates and Predictors of Nonadherence to the Post-Allogeneic Hematopoietic Cell Transplantation Medical Regimen in Patients and Caregivers. Transplant Cell Ther. 2022 Mar;28(3):165.e1-165.e9. doi: 10.1016/j.jtct.2021.11.020. Epub 2021 Dec 4.
- Individual participant dataSharing planned: Yes. The study database will be reviewed to ensure that no identifying information of any type is contained therein. A downloadable, de-identified data set and data dictionary will be made available electronically from the PI after the request is reviewed by the research team for scientific merit and requestors provide evidence to the PI that (a) their plan for the use of such data has been approved by their institution's Institutional Review Board or its equivalent, and (b) they have completed NIH requirements for training in research integrity and human subjects protection.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dyadic Problem Solving Training and Supportive Care in people with Stem Cell Transplant and Hematopoetic Stem Cell Transplant, run by University of Pittsburgh 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 2 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: looking for participants now, as of the sponsor's last update on 1 Apr 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Donna Posluszny, PhD (412-623-5966, poslusznydm@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Habits Assessment - modified for stem cell transplant (time frame: 1-, 5-, 12- and 24-weeks post-intervention). 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 NCT07107165, which also lists 2 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 1 Apr 2026.