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

NCT03037346 | Completed

• 2 other identifiers: 2016-0704NCI-2018-01745
• Study Type: interventional
• Target: 731
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Caregiver; Malignant Female Reproductive System Neoplasm

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (1)

Supportive Care (questionnaires, educational video)

EXPERIMENTAL

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; Other: Video

Interventions

Questionnaire Administration OTHER

Complete questionnaires about MPOAD

Supportive Care (questionnaires, educational video)

Video OTHER

Watch educational video

Supportive Care (questionnaires, educational video)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Without a MPOA or available family caregiver.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Interventions

Videotape Recording

Intervention Hierarchy (Ancestors)

Tape Recording; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture; Television

Study Officials

• Donna S Zhukovsky

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2017
• First Posted: January 31, 2017
• Study Start: July 17, 2017
• Primary Completion: December 16, 2024
• Study Completion: December 16, 2024
• Last Updated: May 2, 2025

Record last verified: 2025-04

Locations

US (1)