development of an educational patient decision aid (treatments in advanced cancer - decision aid, ta-da) to promote shared decision making for third-line or beyond palliative systemic therapy

Conditions: Advanced Cancer

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).

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).

Eligibility criteria:
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 2 or greater * 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