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NCT Number: NCT03037346

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

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.

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Key information

Conditions

Caregiver Malignant Female Reproductive System Neoplasm

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Questionnaire Administration

Other

Complete questionnaires about MPOAD

video

Other

Watch educational video

Primary outcomes

  1. Proportion of patients who decline to participate in the study

    Time frame: Up to 3 months

    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.

  2. Proportion of patients who already have medical power of attorney (MPOAD) at consult

    Time frame: Up to 3 months

    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.

  3. Proportion of patients who completed MPOAD at the first social work counselor visit

    Time frame: Up to 3 months

    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.

  4. Proportion of participants who completed MPOAD after the first educational video

    Time frame: Up to 3 months

    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.

  5. Proportion of participants who completed MPOAD within 3 months after the educational video

    Time frame: Up to 3 months

    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.

  6. Willingness to participate in future advance care planning discussions

    Time frame: Up to 3 months

    Willingness to participate in future Advance Care Planning discussions for patients' values and goals important to MDM will be tabulated.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2024
Study completion
2024
First posted
Jan 31, 2017
Registry last updated
May 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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