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Preparing Patients and Family Caregivers for Medical Decision Making

This study is currently recruiting participants.
Verified October 2017 by M.D. Anderson Cancer Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT03037346
First Posted: January 31, 2017
Last Update Posted: October 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
  Purpose

The goal of this research study is to learn how well MD Anderson helps patients and their families select and prepare an MPOA. Researchers want to find out if social work counseling and education help to increase the number of patients who complete MPOA documents. They also want to study how counseling and education affects attitudes about medical decision-making, and willingness to take part in these kinds of conversations for patients and their family members and/or caregivers.

This is an investigational study. Reviewing your medical record and completing a set of surveys at your new patient appointment and again 3 months later is the only part of this study that is considered investigational.

Up to 180 patient and caregiver pairs will take part in this study. All will be enrolled at MD Anderson.


Condition Intervention
Malignant Neoplasms of Female Genital Organs Behavioral: Questionnaires Behavioral: Surveys

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Preparing Patients and Family Caregivers for Medical Decision Making: Evaluating the Impact of a Systematic Social Work Driven Approach on Medical Power of Attorney Documentation, Knowledge, Attitudes and Beliefs

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Percentage of Participants Completing Medical Power of Attorney Documents (MPOAD) Within 3 Months After the First New Patient Encounter [ Time Frame: 3 months ]

Estimated Enrollment: 560
Actual Study Start Date: July 17, 2017
Estimated Study Completion Date: July 2022
Estimated Primary Completion Date: July 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Participant - Medical Power of Attorney
Questionnaires and surveys completed at new patient appointment and 3 months later during follow-up.
Behavioral: Questionnaires

Participants: 3 questionnaires completed at new patient visit that should take about 15 minutes to complete.

Questionnaires also completed 3 months later that should take about 17 minutes to complete.

Family/Caregiver: 7 questionnaires completed at new patient visit that should take about 8 minutes total to complete.

Another questionnaire completed 3 months later that should take about 2 minutes to complete.

Behavioral: Surveys
Participants: 8 surveys completed at new patient visit that should take about 23 minutes total to complete.
Experimental: Family/Caregiver - Medical Power of Attorney
Questionnaires completed at at new patient appointment and 3 months later.
Behavioral: Questionnaires

Participants: 3 questionnaires completed at new patient visit that should take about 15 minutes to complete.

Questionnaires also completed 3 months later that should take about 17 minutes to complete.

Family/Caregiver: 7 questionnaires completed at new patient visit that should take about 8 minutes total to complete.

Another questionnaire completed 3 months later that should take about 2 minutes to complete.


  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. [Patients] Diagnosis of invasive gynecologic malignancy stages 1-4
  2. [Patients] New patient in the Gynecologic Oncology Center
  3. [Patient] Adequate capacity to understand and complete MPOAD in the opinion of the study investigator or research assistant
  4. [Patients] Able to speak and understand English and/or Spanish
  5. [Patients] age 18 or older
  6. [Patients] Provision of IRB-approved informed consent
  7. [Patients] Available MPOA or primary family caregiver who consents to study participation
  8. [Family Caregiver/MPOA] MPOA or if none documented in EHR, primary family caregiver, as designated by the patient
  9. [Family Caregiver/MPOA] Permission to contact provided by patient
  10. [Family Caregiver/MPOA] Adequate capacity to understand and complete study measures in the opinion of the study investigator or research assistant
  11. [Family Caregiver/MPOA] Age 18 years or older
  12. [Family Caregiver/MPOA] Provision of IRB-approved informed consent

Exclusion Criteria:

  1. [Patients] who are obtaining a second opinion and do not plan on receiving ongoing care at MD Anderson Cancer Center
  2. [Patients] without a MPOA or available family caregiver
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03037346


Contacts
Contact: Donna Zhukovsky, MD 713-792-6085 CR_Study_Registration@mdanderson.org

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Clinical Research Operations       CR_Study_Registration@mdanderson.org   
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Donna Zhukovsky, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03037346     History of Changes
Other Study ID Numbers: 2016-0704
Fred #40242 ( Other Grant/Funding Number: Institutional Research Grant (IRG) )
First Submitted: January 27, 2017
First Posted: January 31, 2017
Last Update Posted: October 9, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Malignant neoplasms of female genital organs
Invasive gynecologic malignancy
Medical Power of Attorney Documents
MPOAD
Questionnaires
Surveys

Additional relevant MeSH terms:
Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site