CaregiverNCT03037346
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
A study testing Questionnaire Administration and Video in people with Caregiver and Malignant Female Reproductive System Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caregiver, Malignant Female Reproductive System Neoplasm
- What is being tested?
- Questionnaire Administration and Video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 731 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2017to 16 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- Without a MPOA or available family caregiver.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate medical power of attorney documents (MPOAD) completion rate after a systematic social work counseling and education clinical process.
SECONDARY OBJECTIVES:
- 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.
- 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.
- Being tested
- Questionnaire Administration, Video
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire AdministrationOther
Complete questionnaires about MPOAD
Questionnaire AdministrationOther
Ancillary studies
VideoOther
Watch educational video
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Questionnaire Administration; Other: Video |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study start17 Jul 2017
- Primary completion16 Dec 2024
- Study completion16 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CaregiverStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 731 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Donna S Zhukovsky, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03037346
- Sponsor's protocol ID
- 2016-0704
- Other IDs
- NCI-2018-01745, 2016-0704
- Status last verified
- Apr 2025
- First submitted
- 27 Jan 2017
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03037346
- Acronym / sponsor ID
- 2016-0704
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 731 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 17 Jul 2017 (actual)
- Primary completion
- 16 Dec 2024 (actual)
- Study completion
- 16 Dec 2024 (actual)
- First posted
- 31 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To evaluate medical power of attorney documents (MPOAD) completion rate after a systematic social work counseling and education clinical process.
SECONDARY OBJECTIVES:
- 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.
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive Care (questionnaires, educational video) | Experimental | Other: Questionnaire Administration, Other: VideoParticipants (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (1 listed)
- Without a MPOA or available family caregiver.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire AdministrationComplete questionnaires about MPOAD | Other | Supportive Care (questionnaires, educational video) |
| Questionnaire AdministrationAncillary studies | Other | Supportive Care (questionnaires, educational video) |
| VideoWatch educational video | Other | Supportive Care (questionnaires, educational video) |
Primary outcome
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donna S Zhukovsky principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire Administration and Video in people with Caregiver and Malignant Female Reproductive System Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who decline to participate in the study (time frame: Up to 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2025.