Mobile-based Empathic Communication Support Program to Promote Advance Care Planning Discussion in Advanced Cancer Patients

  • STATUS
    Recruiting
  • End date
    Sep 6, 2023
  • participants needed
    264
  • sponsor
    Yosuke Uchitomi
Updated on 6 October 2021

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 that is consistent with the patient's preferences based on the values and goals of the patient's life. ACP can improve outcomes for patients and caregivers; however, ACP rates remain low. One reason given might be the complexity of ACP in clinical practice.

A Question Prompt List (QPL) is a structured question list encouraging patients to ask their queries to physicians and promote discussion between patients and physicians during medical consultations. Our preliminary study found that face-to-face interventions by nurses or clinical psychologists using QPL about treatment and care, which is consistent with the patient's preferences based on the values and goals of the patient's life, after standard chemotherapy for patients with advanced cancer promoted more empathic 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, we developed a mobile-based empathic communication support program, including a QPL, to facilitate discussions about patients' values and goals with their physicians.

Purpose: This study examined whether a mobile-based empathic communication support program, which intends to promote ACP discussions in earlier stages of advanced cancer treatment, improves the empathic communication behaviors of patients with advanced cancer and their physicians.

Main contents of the intervention: Patients in the intervention group will be provided a mobile-based empathic communication support program-an application (app) on a mobile phone. The app comprises QPL (46 questions in eight categories) and questions about the patient preferred treatment and end-of-life based on the values and goals of the patient's life. After registering with the app, patients are first given a program overview and instructions for using the app. They can then proceed with the content themselves, at home or anywhere else, at any time. Between app registration and the next outpatient visit, the patient will be interviewed (by phone or in person) by a nurse or a clinical psychologist, who will help them prepare for the discussion with the physician and ask questions based on the patient's app responses for 30 minutes to an hour. During the outpatient visit, patients and their physicians will be provided feedback based on the interview.

Study subjects: In sum, 264 patients with advanced or recurrent cancer will be recruited, which will occur in 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 next 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 empathic 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 will be audio-recorded, and a third person's impression of the physician's communication behavior during the outpatient consultation will be scored on a 5-point scale from 0: not applicable at all to 4: strongly applicable. Scoring is conducted by multiple raters blinded to the assignment. Raters will be trained in conversation analysis with a manual, and inter-rater 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. We chose these outcomes for their comparability with previous studies.

Description

After obtaining written informed consent, patients who satisfy the criteria are assigned using a minimizing method to either an intervention or control group with stratification factors of the clinical department (respiratory medicine, gastroenterology, hepatobiliary medicine, and oncology), gender (male and female), and age (at age 64 years or younger/65 years or older). Within strata, patients will be randomized to the intervention arm and usual arm in 1:1.

Details
Condition Hospice Care, Advanced Cancer, Recurrent Carcinoma, Recurrent Cancer, cancer advanced
Treatment Mobile-based empathic communication support program to promote ACP discussion
Clinical Study IdentifierNCT05045040
SponsorYosuke Uchitomi
Last Modified on6 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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)
Age 20 years or older
PS: ECOG Performance status 0-2
(0) Fully active, able to carry on all pre-disease performance without
restriction. (1) Restricted in physically strenuous activity but ambulatory
and able to carry out work of a light or sedentary nature, e.g., light house
or office work. (2) Ambulatory and capable of all self-care but unable to
carry out 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
% of waking hours. (4) Completely disabled; cannot carry on any selfcare
totally confined to a bed or chair
Written consent to participate in the study must be obtained from the patient
Able to read, write, and understand Japanese

Exclusion Criteria

Patients who have been 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
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