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

NCT07141407 | Recruiting

• 3 other identifiers: RG1125666NCI-2025-05520FHIRB0020936
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Advanced Malignant Solid Neoplasm; Hematopoietic and Lymphatic System Neoplasm

Outcome Measures

Primary Outcomes (4)

• 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.

  At 6-weeks post-randomization

• 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.

  At 6-weeks post-randomization

• 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).

  At 6-weeks post-randomization

• 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.

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

Secondary Outcomes (11)

• Completion of advance directives

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

• Completion of do not resuscitate (DNR) order

  At baseline, 6-weeks post-randomization, 12-weeks post-randomization

• Completion of living will

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

• Identification of a health care proxy

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

• Advance care planning (ACP) conversations

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

Study Arms (2)

Arm I (TAC sessions)

EXPERIMENTAL

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.

Other: Supportive Care; Behavioral: Telephone-Based Intervention; Other: Survey Administration

Arm II (enhanced usual care)

ACTIVE COMPARATOR

Participants receive an ACP brochure/handout on study.

Other: Survey Administration; Other: Educational Intervention

Interventions

Telephone-Based Intervention BEHAVIORAL

Attend TAC telephone-based coaching sessions

Arm I (TAC sessions)

Survey Administration OTHER

Ancillary studies

Arm I (TAC sessions); Arm II (enhanced usual care)

Educational Intervention OTHER

Receive an ACP brochure/handout

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Arm II (enhanced usual care)

Supportive Care OTHER

Attend TAC telephone-based coaching sessions

Also known as: Supportive Therapy, Symptom Management, Therapy, Supportive

Arm I (TAC sessions)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead

Study Sites (3)

Providence Regional Cancer Partnership

Everett, Washington, 98201, United States

RECRUITING

Skagit Regional Health Cancer Care Center

Mount Vernon, Washington, 98274, United States

RECRUITING

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

RECRUITING

MeSH Terms

Interventions

Palliative Care; Early Intervention, Educational; Educational Status; Methods

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Child Health Services; Community Health Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques

Study Officials

• Megan Shen, PhD

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Megan Shen, PhD

CONTACT

206-667-4172; mshen2@fredhutch.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: The study project coordinator will oversee randomization and the research coordinator conducting assessments will remain blind to the condition to which the participant is assigned.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: August 26, 2025
• Study Start: April 8, 2026
• Primary Completion (Estimated): October 12, 2026
• Study Completion (Estimated): December 14, 2026
• Last Updated: May 29, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)