Advanced Cancer
Conditions
Brief summary
To develop an educational patient decision aid for advanced cancer patients to prepare them to have conversations with their clinicians about treatment options (Treatments in Advanced cancer - Decision Aid, TA-DA).
Detailed description
Primary Objectives: The study objective is to develop an educational patient DA (Treatments in Advanced cancer - Decision Aid, TA-DA) to assist patients, their caregivers, and clinicians to make an informed decision about third-line or beyond palliative systemic therapy for advanced cancer. To fulfill the study's objectives, we will complete 3 study parts: Using qualitative methods, explore the decision-making needs of patients with advanced cancer, their caregivers, and clinicians, about third-line or beyond palliative systemic therapy; identify initial preferences and recommendations to inform the design of the educational patient DA in Part II. Following a user-centered design approach, develop and measure the acceptability of an educational patient DA to promote shared decision making among patients with advanced cancer, their caregivers, and clinicians, about third-line or beyond palliative systemic therapy. Conduct a pilot RCT to estimate the effect of the educational patient DA (TA-DA) on patient's knowledge of their treatment options. Secondary Objectives: Examine the impact of the educational patient DA (TA-DA) on patients' illness understanding (Prigerson's items), preparation for decision making (PrepDM Scale), decisional conflict (Decisional Conflict Scale \[DCS\]), quality of the shared decision-making process (SDM Process Scale), decisional regret (decisional regret scale), therapeutic alliance (The Human Connection Scale \[THC\]), anxiety (Generalized Anxiety Disorder 7 \[GAD-7\]), final treatment choice, and end-of-life care outcomes (e.g., systemic therapy use in last month of life). Examine the impact of the educational patient DA (TA-DA) on caregivers' knowledge of the patient's treatment options, illness understanding (Prigerson's items), preparation for decision making (PrepDM Scale), decisional conflict (DCS), quality of the shared decision- making process (SDM Process Scale), therapeutic alliance (THC Scale), and anxiety (GAD-7). Examine the acceptability (Ottawa Acceptability Scale) of the educational patient DA (TA-DA) among patients, caregivers, and oncologists in the educational patient DA group. Examine the acceptability (modified Acceptability of Intervention Measure \[AIM\]), appropriateness (Intervention Appropriateness Measure \[IAM\]), and feasibility (Feasibility of Intervention Measure \[FIM\]) of the educational patient DA (TA-DA) among clinicians in the educational patient DA group. Exploratory Objective: 2.3.1. (Part III) Examine the impact of the educational patient DA (TA-DA) on the concordance between patient-caregiver dyads for knowledge of the patient's treatment options, illness understanding (Prigerson's items), preparation for decision making (PrepDM Scale), decisional conflict (DCS), quality of the shared decision-making process (SDM Process Scale), therapeutic alliance (THC Scale), and anxiety (GAD-7).
Interventions
OTHERCommunication
Participants meet with clinician
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Clinicians (Part I/II/III): MD Anderson medical oncologists and APPs who provide care to patients with advanced cancer 2. Patients (Part I/II/III): Age 18 or over * Diagnosis of advanced cancer (i.e., metastatic, relapsed, and/or incurable disease as defined by the treating oncologist) who has received at least 2 lines of palliative systemic therapy\* * Patient-rated ECOG performance status of 1-3 for Part I/II and 2-3 for Part III * Able to make treatment decisions based on the clinical judgement of the oncology team * English speaking * patient has started, is receiving, and/or has completed second-line palliative systemic therapy or beyond 3. Caregivers (Part I/II/III): * Age 18 or older * Currently a primary caregiver to a patient who satisfies the patient eligibility criteria listed above * For the study purposes, a primary caregiver is defined as: * someone who provides physical, emotional, decisional and/or logistical assistance to the patient regularly (e.g. daily, weekly); * can be a family member, friend, or other individual in a close relationship with the patient; * must be identified by the patient and self-identify as the primary person providing caregiving support to the patient * Able to provide informed consent and participate in the study * English speaking
Exclusion criteria
Any patient who meets any of the following criteria will be excluded from participation in this study: * (Part I/II/III): Diagnosis of cognitive impairment or dementia requiring a surrogate decision maker as determined by the clinical team * (Part III only): Participants in Part I and II
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Adverse Events (AEs) | Through study completion; an average of 1 year | Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 |
Countries
United States
Contacts
CONTACTDavid Hui, MD
PRINCIPAL_INVESTIGATORDavid Hui, MD
M.D. Anderson Cancer Center
Outcome results
None listed