Family CaregiversPhase 1NCT00423774
Education Program to Manage Emotional Stress of Stem Cell Transplant Recipients and Their Caregivers
A Phase 1 study testing Problem-Solving Education in people with Family Caregivers and Bone Marrow Transplantation, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
his study will evaluate a series of problem-solving education sessions for patients undergoing a stem cell transplant and their family caregivers. The emotional stress of transplant extends beyond patients to their families, especially caregivers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Family Caregivers, Bone Marrow Transplantation
- What is being tested?
- Problem-Solving Education
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jan 2007to 1 Dec 2008
- Phase
- Phase 1
- 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
Who may be able to join
- Patients: Receiving their first allogeneic HSCT at the CC, 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.
- Adult family member serves as primary caregiver throughout study period.
- Family caregiver agrees to participate in the study.
Show all 14Show fewer
- Family Caregiver (FC):
- 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.
- Adult family member who meets the patient inclusion criteria.
- Family member (patient) agrees to participate in the study.
- Intends to serve as primary caregiver throughout study period
- If the FC changes during the study, the PSE intervention will continue as scheduled with the new FC, however, FC data will no longer be collected and will be excluded from the analyses.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: A Feasibility Study to Test an Individualized Dyadic Problem-Solving Education Intervention to Improve Problem-Solving Skills of Patients and Family Caregivers During Allogeneic HSCT
his study will evaluate a series of problem-solving education sessions for patients undergoing a stem cell transplant and their family caregivers. The emotional stress of transplant extends beyond patients to their families, especially caregivers. Little is known about managing the emotional distress associated with stem cell transplant or the support and education most helpful to caregivers of stem cell recipients.
Patients undergoing a stem cell transplant and their family caregivers may be eligible for this study. All participants must be 18 years of age and older.
Read more
Patients and their caregivers receive routine treatment-specific education from transplant team members. This study adds a series of educational sessions focusing on problem-solving skills. In addition to the study education, participants do the following:
- Complete a 130-item questionnaire when they consent to participate in the study.
- Complete a 60-item questionnaire and attend a 60-minute face-to-face education session before the transplant.
- Complete a 40-item questionnaire and attend a 60-minute face-to-face education session before hospital discharge.
- Complete the same 40-item questionnaire and attend a 60-minute face-to-face education session 2 weeks after hospital discharge.
- Attend a 30-minute face-to-face education session 4 weeks after hospital discharge.
- Complete a 60-item questionnaire 6 weeks after hospital discharge.
Read the detailed description
Allogeneic hematopoietic stem cell transplantation (HSCT) generates multiple symptoms and problems that can vary in complexity. Although it seems evident that patients and caregivers experience clinically significant levels of psychological distress, few intervention studies have been explored to address this concern in this population.
Problem-solving is an essential skill for patients and caregivers. Increased problem-solving skill has been shown to decrease psychological distress and may improve symptom distress and health related QOL. The COPE (Creativity, Optimism, Planning, Expert Information) problem-solving education intervention has demonstrated benefit and has been reported as a positive therapy by cancer patients and their families. Only one study has reported the application of this intervention in the acute care setting and no study has been done with patients undergoing allogeneic HSCT.
This study will evaluate the feasibility of conducting an individualized dyadic problem-solving education (PSE) intervention in patients and family caregivers experiencing allogeneic HSCT. In addition, this study will explore the effect of a PSE intervention on problem-solving skills in patients and family caregivers experiencing allogeneic HSCT. Moreover, this study will explore the relationship of baseline psychological distress and family functioning to change in problem-solving skills following a PSE intervention.
This is a single group, mixed-methods, repeated measure design. Subjects will be accrued to this protocol if they agree to participation in an allogeneic HSCT at the Clinical Center, NIH, are greater than or equal to 18 years old, able to read English and able to comprehend the investigational nature of the study. Patient volunteers must have an adult family member to serve as their primary caregiver throughout the study period. A sample of 20 subjects (10 patient/family caregiver dyads) will be recruited to capture the essence of the experience and adequately evaluate the feasibility of the intervention in this sample.
Each dyad will be scheduled for four individualized PSE intervention sessions (study intervention) in addition to the usual care group education. Study questionnaires will be administered twice prior to allogeneic HSCT, at 2 time points during the intervention period, and at the end of the study. As a feasibility study, there will be no long term follow-up after the intervention period. Questionnaires include: Brief Symptom Inventory-18, Problem-Solving Inventory-Revised, Symptom Distress Scale, and the Family Adaptability-Cohesion Evaluation Scale-IV. In addition, the dyad will participate in a semi-structured interview at the end of each intervention session and the interventionist will complete a log that tracks subject attendance, session length, and discrepancy between planned and actual session date and time. Quantitative and qualitative analysis techniques will be used in this study.
- Conditions
- Family Caregivers, Bone Marrow Transplantation
- Being tested
- Problem-Solving Education
- Keywords
- Allogeneic Hematopoietic Stem Cell Transplant, Psychological Distress, Coping, Cognitive Behavior Therapy, Bone Marrow Transplant, Coping Skills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Problem-Solving EducationBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Participation themes and implementation variances
Secondary outcomes (1)
Problem solving skills in patient and caregiver
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2007 (estimated)
- Study start11 Jan 2007
- Primary completion1 Dec 2008
- Study completion1 Dec 2008
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 Family CaregiversStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00423774
- Sponsor's protocol ID
- 070067
- Other IDs
- 07-CC-0067
- Status last verified
- 28 Sep 2010
- First submitted
- 17 Jan 2007
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Goldman JM, Horowitz MM. The international bone marrow transplant registry. Int J Hematol. 2002 Aug;76 Suppl 1:393-7. doi: 10.1007/BF03165291.
PubMed 12430889Thomas ED, Blume KG. Historical markers in the development of allogeneic hematopoietic cell transplantation. Biol Blood Marrow Transplant. 1999;5(6):341-6. doi: 10.1016/s1083-8791(99)70010-8. No abstract available.
PubMed 10595811Tabbara IA, Zimmerman K, Morgan C, Nahleh Z. Allogeneic hematopoietic stem cell transplantation: complications and results. Arch Intern Med. 2002 Jul 22;162(14):1558-66. doi: 10.1001/archinte.162.14.1558.
PubMed 12123398
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study to Test an Individualized Dyadic Problem-Solving Education Intervention to Improve Problem-Solving Skills of Patients and Family Caregivers During Allogeneic HSCT
- ClinicalTrials.gov ID
- NCT00423774
- Acronym / sponsor ID
- 070067
- Conditions
- Family Caregivers, Bone Marrow Transplantation
- Keywords
- Allogeneic Hematopoietic Stem Cell Transplant, Psychological Distress, Coping, Cognitive Behavior Therapy, Bone Marrow Transplant, Coping Skills
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 11 Jan 2007
- Primary completion
- 1 Dec 2008 (actual)
- Study completion
- 1 Dec 2008 (actual)
- First posted
- 18 Jan 2007 (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.
his study will evaluate a series of problem-solving education sessions for patients undergoing a stem cell transplant and their family caregivers. The emotional stress of transplant extends beyond patients to their families, especially caregivers. Little is known about managing the emotional distress associated with stem cell transplant or the support and education most helpful to caregivers of stem cell recipients.
Patients undergoing a stem cell transplant and their family caregivers may be eligible for this study. All participants must be 18 years of age and older.
Patients and their caregivers receive routine treatment-specific education from transplant team members. This study adds a series of educational sessions focusing on problem-solving skills. In addition to the study education, participants do the following:
- Complete a 130-item questionnaire when they consent to participate in the study.
- Complete a 60-item questionnaire and attend a 60-minute face-to-face education session before the transplant.
- Complete a 40-item questionnaire and attend a 60-minute face-to-face education session before hospital discharge.
- Complete the same 40-item questionnaire and attend a 60-minute face-to-face education session 2 weeks after hospital discharge.
- Attend a 30-minute face-to-face education session 4 weeks after hospital discharge.
- Complete a 60-item questionnaire 6 weeks after hospital discharge.
Detailed description
Allogeneic hematopoietic stem cell transplantation (HSCT) generates multiple symptoms and problems that can vary in complexity. Although it seems evident that patients and caregivers experience clinically significant levels of psychological distress, few intervention studies have been explored to address this concern in this population.
Problem-solving is an essential skill for patients and caregivers. Increased problem-solving skill has been shown to decrease psychological distress and may improve symptom distress and health related QOL. The COPE (Creativity, Optimism, Planning, Expert Information) problem-solving education intervention has demonstrated benefit and has been reported as a positive therapy by cancer patients and their families. Only one study has reported the application of this intervention in the acute care setting and no study has been done with patients undergoing allogeneic HSCT.
This study will evaluate the feasibility of conducting an individualized dyadic problem-solving education (PSE) intervention in patients and family caregivers experiencing allogeneic HSCT. In addition, this study will explore the effect of a PSE intervention on problem-solving skills in patients and family caregivers experiencing allogeneic HSCT. Moreover, this study will explore the relationship of baseline psychological distress and family functioning to change in problem-solving skills following a PSE intervention.
This is a single group, mixed-methods, repeated measure design. Subjects will be accrued to this protocol if they agree to participation in an allogeneic HSCT at the Clinical Center, NIH, are greater than or equal to 18 years old, able to read English and able to comprehend the investigational nature of the study. Patient volunteers must have an adult family member to serve as their primary caregiver throughout the study period. A sample of 20 subjects (10 patient/family caregiver dyads) will be recruited to capture the essence of the experience and adequately evaluate the feasibility of the intervention in this sample.
Each dyad will be scheduled for four individualized PSE intervention sessions (study intervention) in addition to the usual care group education. Study questionnaires will be administered twice prior to allogeneic HSCT, at 2 time points during the intervention period, and at the end of the study. As a feasibility study, there will be no long term follow-up after the intervention period. Questionnaires include: Brief Symptom Inventory-18, Problem-Solving Inventory-Revised, Symptom Distress Scale, and the Family Adaptability-Cohesion Evaluation Scale-IV. In addition, the dyad will participate in a semi-structured interview at the end of each intervention session and the interventionist will complete a log that tracks subject attendance, session length, and discrepancy between planned and actual session date and time. Quantitative and qualitative analysis techniques will be used in this study.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients: Receiving their first allogeneic HSCT at the CC, 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.
- Adult family member serves as primary caregiver throughout study period.
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 |
|---|---|---|
| Problem-Solving Education | Behavioural | – |
Primary outcome
Participation themes and implementation variances
1 secondary outcome
Problem solving skills in patient and caregiver
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 Jul 2017.
- Background: PubMed 12430889Goldman JM, Horowitz MM. The international bone marrow transplant registry. Int J Hematol. 2002 Aug;76 Suppl 1:393-7. doi: 10.1007/BF03165291.
- Background: PubMed 10595811Thomas ED, Blume KG. Historical markers in the development of allogeneic hematopoietic cell transplantation. Biol Blood Marrow Transplant. 1999;5(6):341-6. doi: 10.1016/s1083-8791(99)70010-8. No abstract available.
- Background: PubMed 12123398Tabbara IA, Zimmerman K, Morgan C, Nahleh Z. Allogeneic hematopoietic stem cell transplantation: complications and results. Arch Intern Med. 2002 Jul 22;162(14):1558-66. doi: 10.1001/archinte.162.14.1558.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Problem-Solving Education in people with Family Caregivers and Bone Marrow Transplantation, 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 14 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 Jul 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Participation themes and implementation variances. 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 NCT00423774, 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 2 Jul 2017.