Impact of a Systematic Social Work Driven Approach on Medical Power of Attorney Documentation, Knowledge, Attitudes, and Beliefs in Participants With Stage I-IV Gynecological Cancers

NCT ID: NCT03037346

Last Updated: 2025-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

731 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-17

Study Completion Date

2024-12-16

Brief Summary

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This trial evaluates the impact of a systemic social work driven approach on medical power of attorney documentation, knowledge, attitudes, and beliefs in participants with stage I-IV gynecological cancers. Social work counseling and education may help increase the number of participants who complete medical power of attorney documents. Counseling and education may also affect attitudes about decision-making and willingness to take part in these conversations in participants with stage I-IV gynecological cancers and their family members and/or caregivers.

Detailed Description

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PRIMARY OBJECTIVES:

I. To evaluate medical power of attorney documents (MPOAD) completion rate after a systematic social work counseling and education clinical process.

SECONDARY OBJECTIVES:

I. To determine change in medical power of attorney (MPOA)/primary family caregivers' knowledge, attitudes and beliefs about conditions for quality surrogate medical decision-making (MDM).

II. To determine change in MPOA/primary family caregivers' knowledge of patients' values and goals for MDM.

III. Evaluate patients' and MPOA/primary family caregivers' willingness to participate in future advance care planning discussions to discuss patients' values and goals important to MDM.

IV. Evaluate predictors of patient subgroups most likely to respond to the social work counseling and education clinical process.

V. Explore aspects of the Spanish language version of the advance care planning engagement survey to inform future validation studies.

OUTLINE:

Participants (patients and family caregiver/MPOA) complete questionnaires about knowledge, attitudes, and beliefs of MPOAD. Participants without a MPOAD watch a 4-minute educational video about the importance of the role of MPOA.

After completion of intervention, participants are followed up at 3 months.

Conditions

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Caregiver Malignant Female Reproductive System Neoplasm

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Supportive Care (questionnaires, educational video)

Participants (patients and family caregiver/MPOA) complete questionnaires about knowledge, attitudes, and beliefs of MPOAD. Participants without a MPOAD watch a 4-minute educational video about the importance of the role of MPOA.

Group Type EXPERIMENTAL

Questionnaire Administration

Intervention Type OTHER

Complete questionnaires about MPOAD

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Video

Intervention Type OTHER

Watch educational video

Interventions

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Questionnaire Administration

Complete questionnaires about MPOAD

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Video

Watch educational video

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* PATIENTS
* Diagnosis of invasive gynecologic malignancy stages 1-4.
* New patient in the Gynecologic Oncology Center.
* Adequate capacity to understand and complete MPOAD in the opinion of the study investigator or research assistant.
* Able to speak and understand English and/or Spanish.
* Provision of Institutional Review Board (IRB)-approved informed consent.
* Available MPOA or primary family caregiver who consents to study participation.
* FAMILY CAREGIVER/MPOA
* MPOA or if none documented in electronic health record (EHR), primary family caregiver, as designated by the patient.
* Permission to contact provided by patient.
* Adequate capacity to understand and complete study measures in the opinion of the study investigator or research assistant.
* Provision of IRB-approved informed consent.

Exclusion Criteria

* Without a MPOA or available family caregiver.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Donna S Zhukovsky

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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M D Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Related Links

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http://www.mdanderson.org

University of Texas MD Anderson Cancer Center Website

Other Identifiers

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NCI-2018-01745

Identifier Type: REGISTRY

Identifier Source: secondary_id

2016-0704

Identifier Type: OTHER

Identifier Source: secondary_id

2016-0704

Identifier Type: -

Identifier Source: org_study_id

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