DistressPhase 2NCT00766883
Problem-Solving Education for Caregivers and Patients During Stem Cell Transplant
A Phase 2 study testing Problem Solving Education in people with Distress and Hematopoietic Stem Cell Transplantation, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
This study will examine the effectiveness of problem-solving education for patients who are undergoing a stem cell transplant and their caregivers. The emotional stress of transplant extends beyond patients to their caregivers; this study will identify the type of education that will be most helpful to transplant… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Distress, Hematopoietic Stem Cell Transplantation
- What is being tested?
- Problem Solving Education
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 195 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2008to 15 Dec 2010
- Phase
- Phase 2
- 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 caregiver(s) available and/or living with transplant recipient.
Show all 12Show fewer
- Caregiver(s) agrees to participate in the study.
- Caregiver(s):
- 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.
- Agrees to participate in the study.
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 Phase II Clinical Trial to Determine the Effectiveness of Problem Solving Education in Caregivers and Patients During Allogeneic HSCT
This study will examine the effectiveness of problem-solving education for patients who are undergoing a stem cell transplant and their caregivers. The emotional stress of transplant extends beyond patients to their caregivers; this study will identify the type of education that will be most helpful to transplant caregivers.
Adult patients undergoing stem cell transplant at the NIH s Clinical Center and their adult caregivers are eligible for this study. The caregiver must be caring for the patient from before hospital admission for the procedure until 6 weeks following the transplant. Both patient and caregiver must be able to read and speak English.
Read more
Patients and caregivers have three education sessions (in addition to the routine transplant education provided at the Clinical Center) and complete three study questionnaires as follows:
- Questionnaires: The questionnaires vary somewhat for patient and caregiver, but include information on demographics (e.g., sex, race, marital status, education level), distress, lifestyle, relationship with the caregiver/patient, confidence level, symptoms, pain, fatigue and sleep quality. Questionnaires are completed before the patient undergoes the transplant (and before attending any education sessions), before the patient is discharged from the hospital and 6 weeks after hospital discharge.
- Education sessions: The 60-minute sessions are designed to teach problem-solving strategies by looking at problems in a new way and learning effective communication skills. The sessions are conducted before the patient is discharged from the hospital, 1 week after discharge and 3 weeks after 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 individuals to successfully cope. Increased problem-solving skill has been shown to decrease psychological distress and may improve symptom distress and health related quality of life (QOL). The COPE (Creativity, Optimism, Planning, and Expert Information) problem-solving education (PSE) 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 our previous pilot study has been the only one done with patients and caregivers undergoing allogeneic HSCT.
Based on the findings from our pilot study and recent published reports, this study is designed to determine preliminary efficacy of problem solving education by increasing self-efficacy in caregivers during allogeneic HSCT. In addition, this study will explore factors associated with change in caregiver self-efficacy and distress such as demographics, clinical variables, mutuality, caregiver reaction, sleep quality, fatigue and health behaviors.
This is a phase two clinical trial applying a prospective 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 18 years old, able to read English and able to comprehend the investigational nature of the study. Patient volunteers must have at least one caregiver throughout the study period. A sample of at least 71 caregivers is needed to adequately evaluate the effectiveness of the PSE intervention. In order to achieve a sample of 71 caregivers 50 transplant patients will be recruited.
Each caregiver (and patient) will be scheduled for three individualized PSE intervention sessions (study intervention) in addition to the usual care group education. Three surveys will be administered to all study participants. The baseline questionnaires will be administered twice; once prior to allogeneic HSCT and again directly before the first PSE, at the time of initial discharge from the hospital. The post-intervention questionnaires will be administered 6 weeks post discharge. There will be no long term follow-up after the intervention period. Questionnaires include: Distress Thermometer, Family Caregiving Inventory Mutuality Scale, Health-Promoting Lifestyle Profile II, Cancer Self-Efficacy scale, Brief Symptom Inventory, Caregiver Reaction Assessment, Pittsburgh Sleep Quality Index and the Multidimensional Fatigue Symptom Inventory-Short Form. In addition, the subjects will participate in a semi-structured interview at the end of the study 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
- Distress, Hematopoietic Stem Cell Transplantation
- Being tested
- Problem Solving Education
- Keywords
- Allogeneic HSCT, Psychosocial Distress, Coping, Cognitive Behavior Therapy, Self Efficacy, Allogeneic Stem Cell Transplant
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.
To determine the effect of a PSE intervention on self-efficacy (a sense of control of oneself) in caregivers during the experience of an allogeneic HSCT.
Secondary outcomes (1)
To determine the effect of a PSE intervention on self-efficacy (a sense of control of oneself) in patients during the experience of an allogeneic HSCT.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2008 (estimated)
- Study start29 Sep 2008
- Primary completion15 Dec 2010
- Study completion15 Dec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DistressStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 195 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
- Margaret F Bevans, Ph.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00766883
- Sponsor's protocol ID
- 080220
- Other IDs
- 08-CC-0220
- Status last verified
- 28 Sep 2017
- First submitted
- 3 Oct 2008
- Last updated
- 17 Dec 2019
- 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 12430889Tabbara 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 12123398Thomas 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 10595811Sundaramurthi T, Wehrlen L, Friedman E, Thomas S, Bevans M. Hematopoietic Stem Cell Transplantation Recipient and Caregiver Factors Affecting Length of Stay and Readmission. Oncol Nurs Forum. 2017 Sep 1;44(5):571-579. doi: 10.1188/17.ONF.571-579.
PubMed 28820507
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Trial to Determine the Effectiveness of Problem Solving Education in Caregivers and Patients During Allogeneic HSCT
- ClinicalTrials.gov ID
- NCT00766883
- Acronym / sponsor ID
- 080220
- Conditions
- Distress, Hematopoietic Stem Cell Transplantation
- Keywords
- Allogeneic HSCT, Psychosocial Distress, Coping, Cognitive Behavior Therapy, Self Efficacy, Allogeneic Stem Cell Transplant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 29 Sep 2008
- Primary completion
- 15 Dec 2010 (actual)
- Study completion
- 15 Dec 2010 (actual)
- First posted
- 6 Oct 2008 (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 examine the effectiveness of problem-solving education for patients who are undergoing a stem cell transplant and their caregivers. The emotional stress of transplant extends beyond patients to their caregivers; this study will identify the type of education that will be most helpful to transplant caregivers.
Adult patients undergoing stem cell transplant at the NIH s Clinical Center and their adult caregivers are eligible for this study. The caregiver must be caring for the patient from before hospital admission for the procedure until 6 weeks following the transplant. Both patient and caregiver must be able to read and speak English.
Patients and caregivers have three education sessions (in addition to the routine transplant education provided at the Clinical Center) and complete three study questionnaires as follows:
- Questionnaires: The questionnaires vary somewhat for patient and caregiver, but include information on demographics (e.g., sex, race, marital status, education level), distress, lifestyle, relationship with the caregiver/patient, confidence level, symptoms, pain, fatigue and sleep quality. Questionnaires are completed before the patient undergoes the transplant (and before attending any education sessions), before the patient is discharged from the hospital and 6 weeks after hospital discharge.
- Education sessions: The 60-minute sessions are designed to teach problem-solving strategies by looking at problems in a new way and learning effective communication skills. The sessions are conducted before the patient is discharged from the hospital, 1 week after discharge and 3 weeks after 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 individuals to successfully cope. Increased problem-solving skill has been shown to decrease psychological distress and may improve symptom distress and health related quality of life (QOL). The COPE (Creativity, Optimism, Planning, and Expert Information) problem-solving education (PSE) 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 our previous pilot study has been the only one done with patients and caregivers undergoing allogeneic HSCT.
Based on the findings from our pilot study and recent published reports, this study is designed to determine preliminary efficacy of problem solving education by increasing self-efficacy in caregivers during allogeneic HSCT. In addition, this study will explore factors associated with change in caregiver self-efficacy and distress such as demographics, clinical variables, mutuality, caregiver reaction, sleep quality, fatigue and health behaviors.
This is a phase two clinical trial applying a prospective 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 18 years old, able to read English and able to comprehend the investigational nature of the study. Patient volunteers must have at least one caregiver throughout the study period. A sample of at least 71 caregivers is needed to adequately evaluate the effectiveness of the PSE intervention. In order to achieve a sample of 71 caregivers 50 transplant patients will be recruited.
Each caregiver (and patient) will be scheduled for three individualized PSE intervention sessions (study intervention) in addition to the usual care group education. Three surveys will be administered to all study participants. The baseline questionnaires will be administered twice; once prior to allogeneic HSCT and again directly before the first PSE, at the time of initial discharge from the hospital. The post-intervention questionnaires will be administered 6 weeks post discharge. There will be no long term follow-up after the intervention period. Questionnaires include: Distress Thermometer, Family Caregiving Inventory Mutuality Scale, Health-Promoting Lifestyle Profile II, Cancer Self-Efficacy scale, Brief Symptom Inventory, Caregiver Reaction Assessment, Pittsburgh Sleep Quality Index and the Multidimensional Fatigue Symptom Inventory-Short Form. In addition, the subjects will participate in a semi-structured interview at the end of the study 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
- Treatment
- 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 (12 listed)
- 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 caregiver(s) available and/or living with transplant recipient.
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
To determine the effect of a PSE intervention on self-efficacy (a sense of control of oneself) in caregivers during the experience of an allogeneic HSCT.
1 secondary outcome
To determine the effect of a PSE intervention on self-efficacy (a sense of control of oneself) in patients during the experience of an allogeneic 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 17 Dec 2019.
- 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 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.
- 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.
- Derived from this study: PubMed 28820507Sundaramurthi T, Wehrlen L, Friedman E, Thomas S, Bevans M. Hematopoietic Stem Cell Transplantation Recipient and Caregiver Factors Affecting Length of Stay and Readmission. Oncol Nurs Forum. 2017 Sep 1;44(5):571-579. doi: 10.1188/17.ONF.571-579.
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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.
Margaret F Bevans, Ph.D. 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?
A Phase 2 study testing Problem Solving Education in people with Distress and Hematopoietic Stem Cell 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 12 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 17 Dec 2019. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
To determine the effect of a PSE intervention on self-efficacy (a sense of control of oneself) in caregivers during the experience of an allogeneic HSCT.. 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 NCT00766883, which also lists 4 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 17 Dec 2019.