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
Primary Purpose
Caregiver, Malignant Female Reproductive System Neoplasm
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Questionnaire Administration
Questionnaire Administration
Video
Sponsored by
About this trial
This is an interventional supportive care trial for Caregiver
Eligibility Criteria
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.
Sites / Locations
- M D Anderson Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Supportive Care (questionnaires, educational video)
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03037346
First Posted
January 27, 2017
Last Updated
September 27, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT03037346
Brief Title
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
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 17, 2017 (Actual)
Primary Completion Date
April 30, 2025 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caregiver, Malignant Female Reproductive System Neoplasm
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
734 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Supportive Care (questionnaires, educational video)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Complete questionnaires about MPOAD
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Video
Intervention Description
Watch educational video
Primary Outcome Measure Information:
Title
Proportion of patients who decline to participate in the study
Description
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.
Time Frame
Up to 3 months
Title
Proportion of patients who already have medical power of attorney (MPOAD) at consult
Description
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.
Time Frame
Up to 3 months
Title
Proportion of patients who completed MPOAD at the first social work counselor visit
Description
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.
Time Frame
Up to 3 months
Title
Proportion of participants who completed MPOAD after the first educational video
Description
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.
Time Frame
Up to 3 months
Title
Proportion of participants who completed MPOAD within 3 months after the educational video
Description
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.
Time Frame
Up to 3 months
Title
Willingness to participate in future advance care planning discussions
Description
Willingness to participate in future Advance Care Planning discussions for patients' values and goals important to MDM will be tabulated.
Time Frame
Up to 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donna S Zhukovsky
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mdanderson.org
Description
University of Texas MD Anderson Cancer Center Website
Learn more about this trial
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
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