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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00895024
Other study ID # 2009-0031
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date April 2009
Est. completion date September 28, 2020

Study information

Verified date October 2020
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. examine cross-ethnic differences in the caregivers' quality of hospice care assessments. 2. investigate the association between parenteral hydration status of the patient and the quality of care assessments provided by the caregivers after death. 3. examine the association between levels of grief (as measured by the TRIG) and the quality of hospice care assessments provided by the caregiver.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 74
Est. completion date September 28, 2020
Est. primary completion date September 28, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Bereaved family caregivers who completed their participation in the parent protocol (2006-0494) and have lost their loved one within 3-23 months. 2. Caregivers who participated in the parent grant met the inclusion/exclusion criteria of the parent grant. Exclusion Criteria: 1. 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).

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Phone Interview/Questionnaire
35-minute questionnaire over the phone.

Locations

Country Name City State
United States University of Texas MD Anderson Cancer Center Houston Texas

Sponsors (2)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Survey assessment of cross-ethnic differences in caregivers' quality of hospice care 3-23 Months After Hospice Care
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