Anxiety DisorderNCT01341873
Nursing Intervention in Supporting Family Caregivers of Patients Undergoing Stem Cell Transplant
A study testing educational intervention, psychosocial support for caregiver and quality-of-life assessment in people with Anxiety Disorder and Depression, run by City of Hope Medical Center.
Trial summary
This randomized clinical trial studies nursing intervention in supporting family caregivers (FCs) of patients undergoing stem cell transplant. A nursing intervention may help prepare FCs support the recovery of the patients Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety Disorder, Depression, Fatigue
- What is being tested?
- educational intervention, psychosocial support for caregiver and quality-of-life assessment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2012to Oct 2016
- Phase
- Interventional
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The primary family caregiver as identified by a hematologic cancer patient who is scheduled for a single allogeneic bone marrow or stem cell transplant; the definition of a family caregiver for the purposes of this proposal refers to either a family member or friend that is identified by the patient as being the primary caregiver
- Living within a 50 mile radius of City of Hope
Who cannot join
- Caregivers who are unable to read English or Spanish consent forms
- Caregivers who live more than 50 miles from City of Hope
About this study
Official title: Nursing Intervention for Family Caregivers of HCT Patients
This randomized clinical trial studies nursing intervention in supporting family caregivers (FCs) of patients undergoing stem cell transplant. A nursing intervention may help prepare FCs support the recovery of the patients
Read the detailed description
PRIMARY OBJECTIVES:
- Test the effects of an advanced practice nursing (APN) intervention for family caregivers (FCs) of hematopoietic cell transplant (HCT) patients in the experimental group on FC quality of life, psychological distress, caregiver burden, caregiver skills preparedness as compared to FCs in the control group.
II. Describe self-care behaviors for FCs of HCT patients and compare them between the experimental and control groups.
III. Describe resource use by FCs comparing the experimental and control groups.
IV. Identify subgroups of FCs who benefit most from the family caregiver intervention (FCI) in relation to sociodemographic characteristics, caregiver health status, and patient characteristics.
SECONDARY OBJECTIVES:
- Describe family caregivers' satisfaction with the FCI.
OUTLINE: FCs are randomized to 1 of 2 groups.
GROUP I: FCs receive 4 sessions of an APN FCI beginning during the admission for transplant and continuing for up to 100 days after transplant.
GROUP II: FCs receive standard supportive care.
After completion of study, FCs are followed up at 3, 6, and 12 months.
- Conditions
- Anxiety Disorder, Depression, Fatigue
- Being tested
- educational intervention, psychosocial support for caregiver, quality-of-life assessment, questionnaire administration
- Medical subject headings
- Anxiety Disorders, Depression, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educational interventionOther
Also called intervention, educational
Undergo APN FCI
psychosocial support for caregiverOther
Undergo APN FCI
quality-of-life assessmentProcedure or surgery
Also called quality of life assessment
Ancillary studies
questionnaire administrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Group I (FCI) | Experimental | FCs receive 4 sessions of an APN FCI beginning during the admission for transplant and continuing for up to 100 days after transplant. Receives: Other: educational intervention; Other: psychosocial support for caregiver; Procedure: quality-of-life assessment; Other: questionnaire administration |
| Group II (control) | Other | FCs receive standard supportive care. Receives: Procedure: quality-of-life assessment; Other: questionnaire administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test the effects of an advanced practice nursing (APN) intervention for family caregivers (FCs) in the experimental group using questionnaires measuring quality of life and psychological distress as compared to the FCs in the control group.
Measured: 12 months after discharge
Test the effects of an advanced practice nursing (APN) intervention for family caregivers (FCs) in the experimental group using questionnaires measuring caregiver burden and skills preparedness as compared to the FCs in the control group.
Measured: 12 months after discharge
Through the use of questionnaires, comparison of self-care behaviors for FCs of Hematopoietic Cell Transplant (HCT) patients between the experimental and control groups
Measured: 12 months after discharge
Through the use of questionnaires, comparison of resource use between the experimental and control groups
Measured: 12 months after discharge
Through the use of questionnaires, identification of subgroups of FCs who benefit most from the Family Care Intervention (FCI) in relation to sociodemographic characteristics, caregiver health status, and patient characteristics
Measured: 12 months after discharge
Secondary outcomes (1)
Through the use of questionnaires, measure FCs satisfaction with the FCI
Measured: 12 months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2011 (estimated)
- Study startMay 2012
- Primary completionOct 2016 (estimated)
Why it stopped: The protocol was not funded by the NCI
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by City of Hope Medical 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Marcia Grant, RN, DNSC, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01341873
- Sponsor's protocol ID
- 10235
- Other IDs
- NCI-2011-00574
- Status last verified
- Apr 2012
- First submitted
- 21 Apr 2011
- Last updated
- 23 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nursing Intervention for Family Caregivers of HCT Patients
- ClinicalTrials.gov ID
- NCT01341873
- Acronym / sponsor ID
- 10235
- Conditions
- Anxiety Disorder, Depression, Fatigue
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The protocol was not funded by the NCI
- Enrolment
- 0 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2012
- Primary completion
- Oct 2016 (estimated)
- First posted
- 26 Apr 2011 (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 randomized clinical trial studies nursing intervention in supporting family caregivers (FCs) of patients undergoing stem cell transplant. A nursing intervention may help prepare FCs support the recovery of the patients
Detailed description
PRIMARY OBJECTIVES:
- Test the effects of an advanced practice nursing (APN) intervention for family caregivers (FCs) of hematopoietic cell transplant (HCT) patients in the experimental group on FC quality of life, psychological distress, caregiver burden, caregiver skills preparedness as compared to FCs in the control group.
II. Describe self-care behaviors for FCs of HCT patients and compare them between the experimental and control groups.
III. Describe resource use by FCs comparing the experimental and control groups.
IV. Identify subgroups of FCs who benefit most from the family caregiver intervention (FCI) in relation to sociodemographic characteristics, caregiver health status, and patient characteristics.
SECONDARY OBJECTIVES:
- Describe family caregivers' satisfaction with the FCI.
OUTLINE: FCs are randomized to 1 of 2 groups.
GROUP I: FCs receive 4 sessions of an APN FCI beginning during the admission for transplant and continuing for up to 100 days after transplant.
GROUP II: FCs receive standard supportive care.
After completion of study, FCs are followed up at 3, 6, and 12 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (FCI) | Experimental | Other: educational intervention, Other: psychosocial support for caregiver, Procedure: quality-of-life assessment, Other: questionnaire administrationFCs receive 4 sessions of an APN FCI beginning during the admission for transplant and continuing for up to 100 days after transplant. |
| Group II (control) | Other | Procedure: quality-of-life assessment, Other: questionnaire administrationFCs receive standard supportive care. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The primary family caregiver as identified by a hematologic cancer patient who is scheduled for a single allogeneic bone marrow or stem cell transplant; the definition of a family caregiver for the purposes of this proposal refers to either a family member or friend that is identified by the patient as being the primary caregiver
- Living within a 50 mile radius of City of Hope
Key exclusion criteria (2 listed)
- Caregivers who are unable to read English or Spanish consent forms
- Caregivers who live more than 50 miles from City of Hope
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 |
|---|---|---|
| educational interventionAlso: intervention, educationalUndergo APN FCI | Other | Group I (FCI) |
| psychosocial support for caregiverUndergo APN FCI | Other | Group I (FCI) |
| quality-of-life assessmentAlso: quality of life assessmentAncillary studies | Procedure or surgery | Group I (FCI), Group II (control) |
| questionnaire administrationAncillary studies | Other | Group I (FCI), Group II (control) |
Primary outcome
Test the effects of an advanced practice nursing (APN) intervention for family caregivers (FCs) in the experimental group using questionnaires measuring quality of life and psychological distress as compared to the FCs in the control group.
Time frame: 12 months after discharge
Test the effects of an advanced practice nursing (APN) intervention for family caregivers (FCs) in the experimental group using questionnaires measuring caregiver burden and skills preparedness as compared to the FCs in the control group.
Time frame: 12 months after discharge
Through the use of questionnaires, comparison of self-care behaviors for FCs of Hematopoietic Cell Transplant (HCT) patients between the experimental and control groups
Time frame: 12 months after discharge
Through the use of questionnaires, comparison of resource use between the experimental and control groups
Time frame: 12 months after discharge
Through the use of questionnaires, identification of subgroups of FCs who benefit most from the Family Care Intervention (FCI) in relation to sociodemographic characteristics, caregiver health status, and patient characteristics
Time frame: 12 months after discharge
1 secondary outcome
Through the use of questionnaires, measure FCs satisfaction with the FCI
Time frame: 12 months after discharge
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2012.
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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.
Marcia Grant, RN, DNSC principal investigator
City of Hope Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing educational intervention, psychosocial support for caregiver and quality-of-life assessment in people with Anxiety Disorder and Depression, run by City of Hope Medical Center.
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 2 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: withdrawn, as of the sponsor's last update on 23 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Test the effects of an advanced practice nursing (APN) intervention for family caregivers (FCs) in the experimental group using questionnaires measuring quality of life and psychological distress as compared to the FCs in the control group. (time frame: 12 months after discharge). The study lists 5 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 23 Apr 2012.