Advanced CancerNCT00895024
Caregiver Assessments of the Quality of Home Hospice Care
An observational study of Advanced Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The Objectives are to administer the Family Evaluation of Hospice Care (FEHC) questionnaire and The Texas Revised Inventory of Grief (TRIG) to caregivers previously enrolled into the parent grant and conduct supplemental analyses to: 1. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- Phone Interview/Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to 28 Sep 2020
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Bereaved family caregivers who completed their participation in the UT MDACC parent protocol (2006-0494) and have lost their loved one within 3-23 months. Caregivers who participated in the parent grant met the inclusion/exclusion criteria of the parent grant.
Who may be able to join
- Bereaved family caregivers who completed their participation in the parent protocol (2006-0494) and have lost their loved one within 3-23 months.
- Caregivers who participated in the parent grant met the inclusion/exclusion criteria of the parent grant.
Who cannot join
- Bereaved family caregivers who did not complete their participation in the parent protocol or any other caregiver who was never enrolled in the parent protocol (2006-0494).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Caregiver Assessments of the Quality of Home Hospice Care: A Comparison Across 3 Ethnic Groups (A Preliminary Study)
The Objectives are to administer the Family Evaluation of Hospice Care (FEHC) questionnaire and The Texas Revised Inventory of Grief (TRIG) to caregivers previously enrolled into the parent grant and conduct supplemental analyses to:
- examine cross-ethnic differences in the caregivers' quality of hospice care assessments.
- investigate the association between parenteral hydration status of the patient and the quality of care assessments provided by the caregivers after death.
- examine the association between levels of grief (as measured by the TRIG) and the quality of hospice care assessments provided by the caregiver.
Read the detailed description
After the death of their loved-ones, caregivers will be asked to report on the care received by their care recipient and the quality of practical and emotional care provided to them by hospice by completing the 25-minute FEHC questionnaire over the phone. Caregivers will also be asked 16 additional questions to assess their attitudes and beliefs about hydration at the end of life, and a brief questionnaire to assess past and current levels of grief (TRIG). The additional questions on hydration and grief can easily be completed in less than 10 minutes over the phone. The entire interview should take no more than 35 minutes to complete.
Bereaved caregivers who have participated in the parent grant and have lost their loved one within 3-23 months will be mailed a letter from Drs. Bruera and Torres inviting them to participate in the voluntary supplemental after-death survey. The letter will include a brief description of the research study and appropriate contact information for the caregiver to call if she/he is interested in participating. The letters then will be followed up by a phone call from Dr. Torres to verify receipt of the letter. If the caregivers express their interest in participating in the study, they will be asked a few screening questions over the phone to verify their eligibility. Once found eligible for the study, a telephone verbal consent will be obtained.
Dr. Isabel Torres will conduct the phone interviews with 128 primary caregivers who had previously completed the parent grant protocol.
- Conditions
- Advanced Cancer
- Being tested
- Phone Interview/Questionnaire
- Keywords
- Caregiver, Questionnaire, Home Hospice Care, Family Evaluation of Hospice Care, FEHC, The Texas Revised Inventory of Grief, TRIG, Cross-ethnic differences, Parenteral Hydration, Grief
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phone Interview/QuestionnaireBehavioural
Also called Survey
35-minute questionnaire over the phone.
| Study group | Role | What they receive |
|---|---|---|
| Caregivers | Not described Receives: Behavioral: Phone Interview/Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survey assessment of cross-ethnic differences in caregivers' quality of hospice care
Measured: 3-23 Months After Hospice Care
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2009 (estimated)
- Study startApr 2009
- Primary completion28 Sep 2020
- Study completion28 Sep 2020
Why it stopped: PRMS No Slow Accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Lorna H. McNeill, MPH, PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00895024
- Sponsor's protocol ID
- 2009-0031
- Status last verified
- Oct 2020
- First submitted
- 5 May 2009
- Last updated
- 29 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caregiver Assessments of the Quality of Home Hospice Care: A Comparison Across 3 Ethnic Groups (A Preliminary Study)
- ClinicalTrials.gov ID
- NCT00895024
- Acronym / sponsor ID
- 2009-0031
- Conditions
- Advanced Cancer
- Keywords
- Caregiver, Questionnaire, Home Hospice Care, Family Evaluation of Hospice Care, FEHC, The Texas Revised Inventory of Grief, TRIG, Cross-ethnic differences
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PRMS No Slow Accrual
- Enrolment
- 74 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2009 (actual)
- Primary completion
- 28 Sep 2020 (actual)
- Study completion
- 28 Sep 2020 (actual)
- First posted
- 7 May 2009 (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.
The Objectives are to administer the Family Evaluation of Hospice Care (FEHC) questionnaire and The Texas Revised Inventory of Grief (TRIG) to caregivers previously enrolled into the parent grant and conduct supplemental analyses to:
- examine cross-ethnic differences in the caregivers' quality of hospice care assessments.
- investigate the association between parenteral hydration status of the patient and the quality of care assessments provided by the caregivers after death.
- examine the association between levels of grief (as measured by the TRIG) and the quality of hospice care assessments provided by the caregiver.
Detailed description
After the death of their loved-ones, caregivers will be asked to report on the care received by their care recipient and the quality of practical and emotional care provided to them by hospice by completing the 25-minute FEHC questionnaire over the phone. Caregivers will also be asked 16 additional questions to assess their attitudes and beliefs about hydration at the end of life, and a brief questionnaire to assess past and current levels of grief (TRIG). The additional questions on hydration and grief can easily be completed in less than 10 minutes over the phone. The entire interview should take no more than 35 minutes to complete.
Bereaved caregivers who have participated in the parent grant and have lost their loved one within 3-23 months will be mailed a letter from Drs. Bruera and Torres inviting them to participate in the voluntary supplemental after-death survey. The letter will include a brief description of the research study and appropriate contact information for the caregiver to call if she/he is interested in participating. The letters then will be followed up by a phone call from Dr. Torres to verify receipt of the letter. If the caregivers express their interest in participating in the study, they will be asked a few screening questions over the phone to verify their eligibility. Once found eligible for the study, a telephone verbal consent will be obtained.
Dr. Isabel Torres will conduct the phone interviews with 128 primary caregivers who had previously completed the parent grant protocol.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Caregivers | – | Behavioral: Phone Interview/Questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Bereaved family caregivers who completed their participation in the UT MDACC parent protocol (2006-0494) and have lost their loved one within 3-23 months. Caregivers who participated in the parent grant met the inclusion/exclusion criteria of the parent grant.
Key inclusion criteria (2 listed)
- Bereaved family caregivers who completed their participation in the parent protocol (2006-0494) and have lost their loved one within 3-23 months.
- Caregivers who participated in the parent grant met the inclusion/exclusion criteria of the parent grant.
Key exclusion criteria (1 listed)
- Bereaved family caregivers who did not complete their participation in the parent protocol or any other caregiver who was never enrolled in the parent protocol (2006-0494).
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 |
|---|---|---|
| Phone Interview/QuestionnaireAlso: Survey35-minute questionnaire over the phone. | Behavioural | Caregivers |
Primary outcome
Survey assessment of cross-ethnic differences in caregivers' quality of hospice care
Time frame: 3-23 Months After Hospice Care
Results and safety
The study was stopped early (reason given: PRMS No Slow Accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2020.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Lorna H. McNeill, MPH, PHD principal investigator
M.D. Anderson Cancer Center
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 Advanced Cancer, run by M.D. Anderson Cancer Center 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 2 inclusion and 1 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: stopped early, as of the sponsor's last update on 29 Oct 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?
The study was stopped early (reason given: PRMS No Slow Accrual). Results are not available in the source record.
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?
Survey assessment of cross-ethnic differences in caregivers' quality of hospice care (time frame: 3-23 Months After Hospice Care). 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 29 Oct 2020.