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

Official title

Community-Engaged Pilot Testing of Talking About Cancer (TAC) to Improve Engagement in Advance Care Planning

Overview

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.

Detailed description

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Participants attend Talking About Cancer (TAC) telephone-based coaching sessions (2 sessions) designed to support participants in communicating about advance care planning (ACP), managing distress around ACP conversations, engaging in the process of ACP, and completing advance directives over 45-60 minutes each once a week (QW) for 2 weeks.

ARM II: Participants receive an ACP brochure/handout on study.

After completion of study intervention, participants are followed up at 6- and 12-weeks post-randomization.

Interventions

• Other Supportive Care
  Attend TAC telephone-based coaching sessions
• Behavioral Telephone-Based Intervention
  Attend TAC telephone-based coaching sessions
• Other Survey Administration
  Ancillary studies
• Other Educational Intervention
  Receive an ACP brochure/handout

Primary outcome measures

• Enrollment rate (Feasibility) [Time frame: At 6-weeks post-randomization]
• Intervention session completion rate (Feasibility) [Time frame: At 6-weeks post-randomization]
• Acceptability of Intervention Measure (AIM) score (Acceptability) [Time frame: At 6-weeks post-randomization]
• Completion rate of study assessments (Feasibility of collecting primary and secondary outcomes) [Time frame: At baseline, 6-weeks post- randomization, and 12-weeks post-randomization]

Secondary outcome measures (11)

• Completion of advance directives [Time frame: At baseline, 6-weeks post-randomization, and 12-weeks post-randomization]
• Completion of do not resuscitate (DNR) order [Time frame: At baseline, 6-weeks post-randomization, 12-weeks post-randomization]
• Completion of living will [Time frame: At baseline, 6-weeks post-randomization, and 12-weeks randomization]
• Identification of a health care proxy [Time frame: At baseline, 6-weeks post-randomization, and 12-weeks post-randomization]
• Advance care planning (ACP) conversations [Time frame: At baseline, 6-weeks post-randomization, and 12-weeks post-randomization]
• Level of engagement in ACP [Time frame: At baseline, 6-weeks post-randomization, and 12-weeks post-randomization]
• Readiness to engage in ACP [Time frame: At baseline, 6-weeks post-randomization, and 12-weeks post-randomization]
• Self-efficacy for treatment decision-making [Time frame: At baseline, 6-weeks post-randomization, and 12-weeks post-randomization]
• Psychological distress [Time frame: At baseline, 6-weeks post-randomization, and 12-weeks post-randomization]
• Prognostic understanding [Time frame: At baseline, 6-weeks post-randomization, and 12-weeks post-randomization]
• Support person [caregiver] burden [Time frame: At baseline, 6-weeks post-randomization, and 12-weeks post-randomization]

Eligibility criteria

Inclusion criteria

• 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
• CAREGIVER (SUPPORT PERSON): Person patient indicates provides support
• CAREGIVER (SUPPORT PERSON): English or Spanish speaking
• CAREGIVER (SUPPORT PERSON): 18 years of age or older
• CAREGIVER (SUPPORT PERSON): Able to provide informed consent

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

United States · 3 centers

• Providence Regional Cancer Partnership — Everett
• Skagit Regional Health Cancer Care Center — Mount Vernon
• Fred Hutch/University of Washington Cancer Consortium — Seattle

Identifiers

NCT: NCT07141407 · RG1125666 · NCI-2025-05520 · FHIRB0020936

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗