Telephone-Based Coaching Sessions (TAC) to Improve Advance Care Planning Participation in Advanced Cancer Patients and Their Support Person

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFred Hutchinson Cancer Center

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Supportive Care

    Other intervention

    Attend TAC telephone-based coaching sessions

  • Telephone-Based Intervention

    Behavioral

    Attend TAC telephone-based coaching sessions

  • Survey Administration

    Other intervention

    Ancillary studies

  • Educational Intervention

    Other intervention

    Receive an ACP brochure/handout

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Arm I (TAC sessions)Experimental treatment 3 interventions
Group B: Arm II (enhanced usual care)Active comparator 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
At 6-weeks post-randomization
2

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.

Time frame
At 6-weeks post-randomization
3

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).

Time frame
At 6-weeks post-randomization
4

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.

Time frame
At baseline, 6-weeks post- randomization, and 12-weeks post-randomization

Secondary outcomes

1

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.

Time frame
At baseline, 6-weeks post-randomization, and 12-weeks post-randomization
2

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.

Time frame
At baseline, 6-weeks post-randomization, 12-weeks post-randomization
3

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.

Time frame
At baseline, 6-weeks post-randomization, and 12-weeks randomization
4

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.

Time frame
At baseline, 6-weeks post-randomization, and 12-weeks post-randomization

Other outcomes

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