Caregiver Burden and Distress in Hematopoeitic Stem Cell Transplant

An observational study of Depression and Anxiety, run by Northside Hospital, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to examine the impact that serving as a caregiver for a patient undergoing hematopoietic stem cell transplant has on the caregiver. This will include looking at the caregiver's level of burden, depression, anxiety, somatic symptoms, fatigue and overall distress. Read more about this study

Who is it for?: Any age
Conditions the study is for: Depression, Anxiety, Fatigue
How many people: 100 participants
Where: 1 siteUnited States
Study dates: 19 Apr 2010to 30 Mar 2018
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: The study population will be an autologous patient and their caregiver and an allogeneic patient and their caregiver

Who may be able to join

Patient:
Any patient undergoing autologous or allogeneic HSCT at The Blood and Marrow Transplant Program at Northside Hospital
Patients must have a single primary caregiver
Patients must be willing to comply with all assessments as outlined in the protocol
Patients must be willing to sign informed consent
Caregiver:

Show all 9Show fewer

Must be the primary caregiver for an autologous or allogenic HSCT patient at the Blood and Marrow Transplant Program at Northside Hospital
Caregiver must be willing to comply will all assessments as outlined in the protocol
Caregiver must be willing to sign consent

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

Northside Hospital
Atlanta, Georgia, 30342

Other trials in United States

About this study

Official title: The Impact of Hematopoeitic Stem Cell Transplantation on Primary Caregiver Level of Burden and Distress

Conditions: Depression, Anxiety, Fatigue, Distress
Keywords: HSCT, Caregiver, Caregiver Burden, Allogeneic Transplant, Autologous Transplant, Hematopoietic Stem Cell Transplantation
Medical subject headings: Depression, Anxiety Disorders, Fatigue, Caregiver Burden

What is being measured

The primary outcome is the main question the study is designed to answer.

Brief Symptom Inventory and Burden Interview
Brief Symptom Inventory (BSI) measures overall distress. Scores can range from 0-72 with the higher score representing a higher level of distress. Each question is 0-4 with 4 being higher levels of distress. Clinically significant level of distress is 25+. Burden Interview is scored on a continuum. No clinically range, but higher scores mean higher feelings of burden. Scores range from 0-88.
Time frame: BSI scores and Burden scores were compared in caregivers of HSCT patients at preBMT and post BMT (30 days and 1 year).
Measured: Baseline, Day 30 & 1 year

Secondary outcomes (4)

Patient Distress, Fatigue & Pain Scores
BSI scale 0-72 with the higher score representing higher distress Brief Fatigue inventory 0-90 with the higher score representing higher fatigue Brief Pain inventory 0-120 with the higher score representing higher pain
Measured: Baseline, Day 30 & 1 year
Overall Patient Survival
Number of patients who are alive at 1 year
Measured: Pre-transplant to 1 year post-transplant
Common Characteristics of Caregivers
12 demographic characteristics were collected. If common characteristics were found then it would have been analyzed for correlation with caregiver burden and distress
Measured: Baseline
Length of Patient Hospitalization
Measured: pretransplant to 1 year post-transplant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Apr 201030 Mar 2018

First posted10 Mar 2010 (estimated)
Study start19 Apr 2010
Primary completion29 Sep 2017
Study completion30 Mar 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for DepressionStudies 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: Observational
Observational model: Other
Time perspective: Prospective
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01084694
Sponsor's protocol ID: NSH 888
Status last verified: Jan 2020
First submitted: 9 Mar 2010
Last updated: 7 Jan 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Impact of Hematopoeitic Stem Cell Transplantation on Primary Caregiver Level of Burden and Distress
ClinicalTrials.gov ID: NCT01084694
Acronym / sponsor ID: NSH 888
Conditions: Depression, Anxiety, Fatigue, Distress
Keywords: HSCT, Caregiver, Caregiver Burden, Allogeneic Transplant, Autologous Transplant, Hematopoietic Stem Cell Transplantation
Study type: Observational
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Northside Hospital, Inc.University, hospital or other
Study start: 19 Apr 2010 (actual)
Primary completion: 29 Sep 2017 (actual)
Study completion: 30 Mar 2018 (actual)
First posted: 10 Mar 2010 (estimated)
Results: Posted 3 Dec 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Other
Time perspective: Prospective

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: The study population will be an autologous patient and their caregiver and an allogeneic patient and their caregiver

Key inclusion criteria (9 listed)

Any patient undergoing autologous or allogeneic HSCT at The Blood and Marrow Transplant Program at Northside Hospital
Patients must have a single primary caregiver
Patients must be willing to comply with all assessments as outlined in the protocol
Patients must be willing to sign informed consent
Must be the primary caregiver for an autologous or allogenic HSCT patient at the Blood and Marrow Transplant Program at Northside Hospital

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.

Primary outcome

Brief Symptom Inventory and Burden Interview
Time frame: Baseline, Day 30 & 1 year
Brief Symptom Inventory (BSI) measures overall distress. Scores can range from 0-72 with the higher score representing a higher level of distress. Each question is 0-4 with 4 being higher levels of distress. Clinically significant level of distress is 25+. Burden Interview is scored on a continuum. No clinically range, but higher scores mean higher feelings of burden. Scores range from 0-88. Time frame: BSI scores and Burden scores were compared in caregivers of HSCT patients at preBMT and post BMT (30 days and 1 year).

4 secondary outcomes

Patient Distress, Fatigue & Pain Scores
Time frame: Baseline, Day 30 & 1 year
Overall Patient Survival
Time frame: Pre-transplant to 1 year post-transplant
Common Characteristics of Caregivers
Time frame: Baseline
Length of Patient Hospitalization
Time frame: pretransplant to 1 year post-transplant

Results and safety

Results posted to the registry on 3 Dec 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patients Undergoing Autologous Transplant	50	44
Patients Undergoing Allogeneic Transplant	50	30

Primary outcome: Brief Symptom Inventory and Burden Interview

Time frame: Baseline, Day 30 & 1 year. Mean (Full Range). Unit: units on a scale

Measure	Autologous Transplant Recipients n = 44	Allogeneic Transplant Recipients n = 30
Baseline BSI	6.2 (0 to 32)	6.1 (0 to 32)
Day 30 BSI	6 (0 to 34)	5.9 (0 to 32)
1 year BSI	5.3 (0 to 39)	5.2 (0 to 39)
Baseline Burden	13.4 (0 to 39)	13.1 (0 to 39)
Day 30 Burden	18.1 (0 to 36)	17.9 (0 to 35)
1 year Burden	18 (0 to 37)	18 (0 to 36)

Population analysed: 74 caregivers met criteria for analysis

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patients Undergoing Autologous Transplant	0 of 50 (0%)	0 of 50 (0%)	8 of 50
Patients Undergoing Allogeneic Transplant	0 of 50 (0%)	0 of 50 (0%)	12 of 50
Caregivers for Patients Undergoing Autologous Transplant	0 of 50 (0%)	0 of 50 (0%)	0 of 50
Caregivers for Patients Undergoing Allogeneic Transplants	0 of 50 (0%)	0 of 50 (0%)	0 of 50

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Dawn Speckhart, PhD principal investigator

Northside Hospital

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 Depression and Anxiety, run by Northside Hospital, Inc. 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 9 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 7 Jan 2020. 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?

Yes. Results are posted in the registry (first posted 3 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Brief Symptom Inventory and Burden Interview (time frame: Baseline, Day 30 & 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 NCT01084694.

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 7 Jan 2020.