Clinical trial 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
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
Overall status: COMPLETED
Phase: NA
Conditions: Caregiver
Malignant Female Reproductive System Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-01-31
Enrollment: 731
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Proportion of patients who decline to participate in the study
timeFrame: Up to 3 months
measure: Proportion of patients who already have medical power of attorney (MPOAD) at consult
timeFrame: Up to 3 months
measure: Proportion of patients who completed MPOAD at the first social work counselor visit
timeFrame: Up to 3 months
measure: Proportion of participants who completed MPOAD after the first educational video
timeFrame: Up to 3 months
measure: Proportion of participants who completed MPOAD within 3 months after the educational video
timeFrame: Up to 3 months
measure: Willingness to participate in future advance care planning discussions
timeFrame: Up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Donna S Zhukovsky
role: PRINCIPAL_INVESTIGATOR
References: