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

Caregiver Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03037346
• Other study ID #: 2016-0704
• Secondary ID: NCI-2018-0174520
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 17, 2017
• Est. completion date: April 30, 2025

Study information

• Verified date: April 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 734
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Caregiver
• Genital Neoplasms, Female
• Malignant Female Reproductive System Neoplasm

Intervention

Other:
• Questionnaire Administration
Complete questionnaires about MPOAD
• Questionnaire Administration
Ancillary studies
• Video
Watch educational video

Locations

Country	Name	City	State
United States	M D 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	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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

External Links

•   University of Texas MD Anderson Cancer Center Website