Empathetic Communication Facilitation Program for Early Initiation of End-of-life Discussions

NCT05045040 | Completed DMC

• 2 other identifiers: J-SUPPORT210420EA1010
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

Brief Summary

Background: The National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology: palliative care recommends discussing advance care planning (ACP) when patients' estimated life expectancy is reduced from a year to months. Discussions about ACP focus on communication among patients, their caregivers, and healthcare providers to achieve cancer-related treatment and care consistent with the patient's preferences based on their values and goals. ACP can improve outcomes for patients and caregivers; however, provision of ACP to patients remain low. This may be because of the complexity of ACP in clinical practice. A Question Prompt List (QPL) is a structured question list encouraging patients to put forward their queries to physicians and promote discussion between patients and physicians during medical consultations. Our preliminary study found that for patients with advanced cancer after standard chemotherapy, face-to-face interventions by nurses or clinical psychologists using a QPL about treatment and care, which is consistent with the patient's preferences based on their values and goals promoted empathetic communication between patients and their physicians. In recent years, however, ensuring adequate time during outpatient visits has become difficult due to increased numbers of outpatients and shortages of corresponding medical personnel. Therefore, intervention methods not restricted by location or time are needed. Thus, the investigators develop a mobile-based empathetic communication support program, including a QPL, to facilitate discussions about patients' values and goals with their physicians. Purpose: This study examines whether a mobile-based empathetic communication support program, which intends to promote ACP discussions in earlier stages of advanced cancer treatment, improves such communication behaviors of patients with advanced cancer and their physicians. Main contents of the intervention: Patients in the intervention group are provided a mobile-based empathetic communication support program-a mobile application (app). The app comprises a QPL (46 questions in eight categories) and questions about the patient's preferred treatment and end-of-life care based on their values and goals. After registering on the app, patients are first given a program overview and instructions for using the app. Then, they proceed with the content themselves, at home or anywhere else, at any time. Between app registration and the next outpatient visit, the patient is interviewed (by phone or in person) by a nurse or a clinical psychologist, who helps them prepare for the discussion with the physician and asks questions based on the patient's app responses for 30 minutes to an hour. During the outpatient visit, patients and their physicians are provided feedback based on the interview. Study participants: Overall, 264 patients with advanced or recurrent cancer are recruited from four departments (respiratory medicine, gastroenterology, hepatobiliary medicine, and oncology) in the outpatient clinic of the National Cancer Center Hospital, Japan. Outcome measurement: The primary outcome of this trial is the Reassurance and Emotional support score of physician behavior measured using the SHARE model at the first visit after the intervention. SHARE is a conceptual communication skills model comprising 26 items and four subscales, categorized as S: Supportive environment, H: How to deliver bad news, A: Additional information, and RE: Reassurance and Emotional support. Reassurance and Emotional support assesses physicians' behavior in providing reassurance and addressing patients' emotions with empathetic responses (e.g., remaining silent out of concern for patient's feelings or accepting patient's expression of emotions). The conversation between patients and the physicians is audio-recorded, and a third person's impression of the physician's communication behavior during the outpatient consultation is scored on a 5-point scale from 0: not applicable at all to 4: strongly applicable. Scoring will be conducted by multiple raters blinded to the assignment. Raters are trained in conversation analysis with a manual, and inter- and intra-rater agreements will be checked in advance. Secondary outcomes are as follows: 1) the patient-physician behavioral assessment based on the conversation analysis manual, 2) number of conversations about ACP, 3) psychological distress, 4) quality of life, 5) medical care use, 6) app use, 7) feasibility of intervention program, 8) patients' satisfaction of the consultation, 9) care goals, and 10) preferred place for future care. The investigators chose these outcomes for their comparability with previous studies.

Conditions

End of Life Care; Advanced Cancer; Recurrent Cancer

Keywords

Advance Care Planning; Communication; Decision Making; Neoplasms; Palliative Care

Outcome Measures

Primary Outcomes (1)

• Oncologists' communication behaviors - RE subscale (reassurance and emotional support) from the SHARE scoring manual

  SHARE comprises 26 items and four subscales categorized as S: Supportive environment, H: How to deliver bad news, A: Additional information, and RE: Reassurance and Emotional support. The investigators focus on RE, which assesses oncologists' behavior in providing reassurance and their empathetic responses to participants' emotions. Patient-physician conversation is audio-recorded, and a third person's impression of the physician's communication behavior is scored on a five-point scale (0: not applicable at all, 4: strongly applicable). Higher score indicates better communication behavior. References: A randomized controlled trial with a cluster of oncologists evaluating of an integrated communication support program for oncologists, caregivers, and patients with rapidly progressing advanced cancer on patient-centered conversation: J-SUPPORT 1704 study. ASCO Annual Meeting; 2021. J Clin Oncol. Fujimori M, et al. Palliat Support Care 2014;12(5):379-86.

  The first post-baseline visit (up to 4 weeks)

Secondary Outcomes (25)

• The score of oncologists' communication behaviors - S, H, and A subscales from the SHARE scoring manual

  The first post-baseline visit (up to 4 weeks)

• Communication behaviors between participants and oncologists

  The first post-baseline visit (up to 4 weeks)

• Number of ACP-related topics in the consultation

  The first post-baseline visit (up to 4 weeks)

• Psychological distress

  Baseline, The first post-baseline visit (up to 4 weeks), the second post-baseline visit (up to 4 weeks from the previous visit), 12 weeks after the baseline, and 24 weeks after the baseline

• Quality of life measured by the EORTC-QLQ-C30

  Baseline, the second post-baseline visit (up to 4 weeks from the previous visit), 12 weeks after the baseline, and 24 weeks after the baseline

Study Arms (2)

Mobile-based empathetic communication support program group

EXPERIMENTAL

Patients are provided a mobile-based empathetic communication support program to promote ACP discussion for patients with advanced cancer and physicians. The experimental group also receives the usual care as is standard practice.

Behavioral: Mobile-based empathetic communication support program to promote ACP discussion

Usual care group

NO INTERVENTION

Patients receive the usual care. The usual care includes routine medical treatment and care by physicians, nurses, pharmacists, and others as well as support from the palliative care team and others as per the patient's situation.

Interventions

Mobile-based empathetic communication support program to promote ACP discussion BEHAVIORAL

Patients in the intervention group are provided a mobile-based empathic communication support program-an app on a mobile phone. The app comprises a QPL (46 questions in eight categories) and questions about the patient's preferred treatment and end-of-life care based on their values and goals. Then, they proceed with the content themselves, at home or anywhere, at any time. Between app registration and the next outpatient visit, the patient is interviewed (by phone or in person) by a nurse or a clinical psychologist, who helps them prepare for the discussion with the physician and asks questions based on the patient's app responses for 30 minutes to an hour. During the outpatient visit, feedback is provided to patients and their physicians based on the interview. The duration between the start of app use and the next consultation is a minimum of one week and a maximum of four weeks.

Mobile-based empathetic communication support program group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with unresectable (Union for International Cancer Control, UICC stage III or IV) or recurrent cancer.
• Patients who are judged by the attending physician to meet the Surprise Question tool (Bernacki et al., 2019; Moss et al., 2010).
• Patients aged 20 years or older.
• Patients who have an ECOG Performance status 0-2.
• (0) Fully active and able to carry on all pre-disease performance without restriction. (1) Restricted in physically strenuous activity but ambulatory and able to engaged in light or sedentary work, e.g., light house or office work. (2) Ambulatory and capable of all self-care but unable to engage in any work activities; up and about more than 50% of waking hours. (3) Capable of only limited self-care; confined to a bed or chair for more than 50% of waking hours. (4) Completely disabled; cannot carry on any selfcare; completely confined to a bed or chair
• Patients who have provided written consent to participate in the study
• Patients who are able to read, write, and understand Japanese.

You may not qualify if:

• Patients judged by the attending physician to have a serious cognitive decline, such as delirium or dementia
• Patients with an estimated prognosis of three or fewer months
• Patients who are otherwise judged by the attending physician to be unsuitable for this study
• Patients who are in the middle of other psychological or communication support protocol interventions at the time of enrollment

Sponsors & Collaborators

• Yosuke Uchitomi: lead

Study Sites (1)

National Cancer Center Hospital, National Cancer Center

Tokyo, Chuo-ku, 1040045, Japan

Location

Related Publications (4)

• Fujimori M, Shirai Y, Asai M, Akizuki N, Katsumata N, Kubota K, Uchitomi Y. Development and preliminary evaluation of communication skills training program for oncologists based on patient preferences for communicating bad news. Palliat Support Care. 2014 Oct;12(5):379-86. doi: 10.1017/S147895151300031X. Epub 2013 Nov 4.

  PMID: 24182602 BACKGROUND

• Bernacki R, Paladino J, Neville BA, Hutchings M, Kavanagh J, Geerse OP, Lakin J, Sanders JJ, Miller K, Lipsitz S, Gawande AA, Block SD. Effect of the Serious Illness Care Program in Outpatient Oncology: A Cluster Randomized Clinical Trial. JAMA Intern Med. 2019 Jun 1;179(6):751-759. doi: 10.1001/jamainternmed.2019.0077.

  PMID: 30870563 BACKGROUND

• Moss AH, Lunney JR, Culp S, Auber M, Kurian S, Rogers J, Dower J, Abraham J. Prognostic significance of the "surprise" question in cancer patients. J Palliat Med. 2010 Jul;13(7):837-40. doi: 10.1089/jpm.2010.0018.

  PMID: 20636154 BACKGROUND

• Obama K, Fujimori M, Okamura M, Kadowaki M, Ueno T, Boku N, Mori M, Akechi T, Yamaguchi T, Oyamada S, Okizaki A, Miyaji T, Sakurai N, Uchitomi Y. Effectiveness of a facilitation programme using a mobile application for initiating advance care planning discussions between patients with advanced cancer and healthcare providers: protocol for a randomised controlled trial (J-SUPPORT 2104). BMJ Open. 2023 Mar 28;13(3):e069557. doi: 10.1136/bmjopen-2022-069557.

  PMID: 36977536 DERIVED

MeSH Terms

Conditions

Recurrence; Communication; Neoplasms

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Yosuke Uchitomi, MD, PhD

  National Cancer Center, Japan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief of Innovation Center for Supportive, Palliative and Psychosocial Care, National Cancer Center Hospital

Study Record Dates

• First Submitted: August 24, 2021
• First Posted: September 16, 2021
• Study Start: September 6, 2021
• Primary Completion: February 15, 2023
• Study Completion: August 8, 2023
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Prior to public release, individual requests will be handled on a case-by-case basis.
• Access Criteria: Undecided

Locations

JP (1)