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

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

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.

Study Overview

• Status: Completed
• Conditions: Malignant Female Reproductive System Neoplasm; Caregiver
• Intervention / Treatment: Other: Questionnaire Administration; Other: Questionnaire Administration; Other: Video

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 731
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Questionnaire Administration; Ancillary studies; Other: Questionnaire Administration; Complete questionnaires about MPOAD; Other: Video; Watch educational video

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients who decline to participate in the study	Will be reported with 95% confidence intervals. Descriptive demographic and disease characteristics for patients who decline study participation but allow collection of demographic and disease characteristics will be compared to those of participating patients.	Up to 3 months
Proportion of patients who already have medical power of attorney (MPOAD) at consult	Will be reported with 95% confidence intervals. Baseline and changes in MPOA/primary family caregivers' knowledge, attitudes and beliefs about conditions for quality surrogate medical decision-making (MDM), in patients/primary family caregivers' self-efficacy and readiness for MPOA, and in patients/Primary family caregivers' knowledge of patients' values and goals for MDM, will be summarized and compared among the four patient groups: 1) had MPOAD at the consult already, 2) complete MPOAD at the first visit, 3) complete MPOAD after initial social work counselor visit and by 3 months, 4) do not complete MPOAD by 3 months, using Kruskal-Wallis test for continuous variables and either Chi-square test or Fisher's exact test for discrete variables, whenever appropriate. Univariate/multi-covariate logistic regression will be employed to evaluate the effect of potential factors on completion of MPOAD.	Up to 3 months
Proportion of patients who completed MPOAD at the first social work counselor visit	Will be reported with 95% confidence intervals. Baseline and changes in MPOA/primary family caregivers' knowledge, attitudes and beliefs about conditions for quality surrogate MDM, in patients/primary family caregivers' self-efficacy and readiness for MPOA, and in patients/Primary family caregivers' knowledge of patients' values and goals for MDM, will be summarized and compared among the four patient groups: 1) had MPOAD at the consult already, 2) complete MPOAD at the first visit, 3) complete MPOAD after initial social work counselor visit and by 3 months, 4) do not complete MPOAD by 3 months, using Kruskal-Wallis test for continuous variables and either Chi-square test or Fisher's exact test for discrete variables, whenever appropriate. Univariate/multi-covariate logistic regression will be employed to evaluate the effect of potential factors on completion of MPOAD.	Up to 3 months
Proportion of participants who completed MPOAD after the first educational video	Will be reported with 95% confidence intervals. Baseline and changes in MPOA/primary family caregivers' knowledge, attitudes and beliefs about conditions for quality surrogate MDM, in patients/primary family caregivers' self-efficacy and readiness for MPOA, and in patients/Primary family caregivers' knowledge of patients' values and goals for MDM, will be summarized and compared among the four patient groups: 1) had MPOAD at the consult already, 2) complete MPOAD at the first visit, 3) complete MPOAD after initial social work counselor visit and by 3 months, 4) do not complete MPOAD by 3 months, using Kruskal-Wallis test for continuous variables and either Chi-square test or Fisher's exact test for discrete variables, whenever appropriate. Univariate/multi-covariate logistic regression will be employed to evaluate the effect of potential factors on completion of MPOAD.	Up to 3 months
Proportion of participants who completed MPOAD within 3 months after the educational video	Will be reported with 95% confidence intervals. Baseline and changes in MPOA/primary family caregivers' knowledge, attitudes and beliefs about conditions for quality surrogate MDM, in patients/primary family caregivers' self-efficacy and readiness for MPOA, and in patients/Primary family caregivers' knowledge of patients' values and goals for MDM, will be summarized and compared among the four patient groups: 1) had MPOAD at the consult already, 2) complete MPOAD at the first visit, 3) complete MPOAD after initial social work counselor visit and by 3 months, 4) do not complete MPOAD by 3 months, using Kruskal-Wallis test for continuous variables and either Chi-square test or Fisher's exact test for discrete variables, whenever appropriate. Univariate/multi-covariate logistic regression will be employed to evaluate the effect of potential factors on completion of MPOAD.	Up to 3 months
Willingness to participate in future advance care planning discussions	Willingness to participate in future Advance Care Planning discussions for patients' values and goals important to MDM will be tabulated.	Up to 3 months

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Donna S Zhukovsky, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• University of Texas MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2017
• Primary Completion (Actual): December 16, 2024
• Study Completion (Actual): December 16, 2024

Study Registration Dates

• First Submitted: January 27, 2017
• First Submitted That Met QC Criteria: January 27, 2017
• First Posted (Estimated): January 31, 2017

Study Record Updates

• Last Update Posted (Actual): May 2, 2025
• Last Update Submitted That Met QC Criteria: April 30, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Genital Neoplasms, Female
• Other Study ID Numbers: 2016-0704 (Other Identifier: M D Anderson Cancer Center); NCI-2018-01745 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No