About this trial
This clinical trial studies whether telephone-based coaching sessions, Talking About Cancer (TAC), work to improve engagement in advance care planning (ACP) in patients with cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and their support person. Participation in ACP, which includes having end of life (EOL) care conversations and completing advance directives (e.g., living will, health care proxy, do not resuscitate order), improves quality EOL care. Despite this, less than half of patients with advanced cancer have EOL care conversations or complete advance directives. TAC coaching sessions are delivered by a social worker over the phone. They are designed to help patients and their support person communicate about ACP, manage the distress these conversations can cause, and participate in the process of ACP with a clear action plan of having goals-of-care conversations and completing advance directives. This may be an effective way to improve ACP participation in advanced cancer patients and their support person.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
PATIENT: Current diagnosis of stage III or IV cancer
PATIENT: Able to provide informed consent
PATIENT: Fluent in English or Spanish
PATIENT: Have access to a telephone, computer, or mobile device
Disqualifiers
PATIENT: Too ill or weak to complete the interviews (as judged by the interviewer)
PATIENT: Receiving hospice at the time of enrollment
PATIENT: Younger than age 18
Trial design
Parallel
Treatments tested in this trial
Supportive Care
Other interventionAttend TAC telephone-based coaching sessions
Telephone-Based Intervention
BehavioralAttend TAC telephone-based coaching sessions
Survey Administration
Other interventionAncillary studies
Educational Intervention
Other interventionReceive an ACP brochure/handout
Treatment groups
Trial outcomes
Primary outcomes
Enrollment rate (Feasibility)
Feasibility will be examined using enrollment rates. Feasibility cutoffs will be based on prior research and include the following: ≥ 50% of eligible participants will enroll in the study. Low rates of enrollment, including missing data, will indicate low feasibility.
Intervention session completion rate (Feasibility)
Feasibility will be examined using enrollment and intervention completion rates as outcomes. Feasibility cutoffs will be based on prior research and include the following: ≥ 75% of Talking About Cancer sessions will be delivered with fidelity.
Acceptability of Intervention Measure (AIM) score (Acceptability)
To analyze intervention acceptability, will examine the median score for the AIM measure, with a median of \>= 4 indicating acceptability (on a 5-point Likert scale where 4=Agree and 5=Completely agree and higher scores indicate higher levels of acceptability).
Completion rate of study assessments (Feasibility of collecting primary and secondary outcomes)
Feasibility of the study collection procedures will be examined using study-related assessment completion rates and includes the following: ≥ 50% of enrolled patients will adhere to and complete assigned intervention components and study-related assessments.
Secondary outcomes
Completion of advance directives
Completion of advance directives will be assessed with questions that ask patients (caregivers) whether the patient has completed a do not resuscitate (DNR) order, living will or identified a health care proxy. This item is scored as having not advance directives (0) to all advance directives completed (3). In addition to the primary outcome of advance directives (0 to 3 score), will also examine each outcome separately (e.g., yes/no to completing a health care proxy) as secondary measures. Descriptive statistics will be run, including means and standard deviations for continuous data and frequencies and proportions for categorical data. Bivariate correlations will be run between demographics and clinical characteristics to determine if any are associated with the primary outcome at baseline.
Completion of do not resuscitate (DNR) order
Completion of advance directives will be assessed with questions that ask patients (caregivers) whether the patient has completed a DNR order. This item is scored as having not advance directives (0) to all advance directives completed (3). In addition to the primary outcome of advance directives (0 to 3 score), will also examine each outcome separately (e.g., yes/no to completing a health care proxy) as secondary measures. Descriptive statistics will be run, including means and standard deviations for continuous data and frequencies and proportions for categorical data.
Completion of living will
Completion of advance directives will be assessed with questions that ask patients (caregivers) whether the patient has completed a living will. This item is scored as having not advance directives (0) to all advance directives completed (3). In addition to the primary outcome of advance directives (0 to 3 score), will also examine each outcome separately (e.g., yes/no to completing a health care proxy) as secondary measures. Descriptive statistics will be run, including means and standard deviations for continuous data and frequencies and proportions for categorical data.
Identification of a health care proxy
Completion of advance directives will be assessed with questions that ask patients (caregivers) whether the patient has identified a health care proxy. This item is scored as having not advance directives (0) to all advance directives completed (3). In addition to the primary outcome of advance directives (0 to 3 score), will also examine each outcome separately (e.g., yes/no to completing a health care proxy) as secondary measures. Descriptive statistics will be run, including means and standard deviations for continuous data and frequencies and proportions for categorical data.
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