Clinical trial NCT05045040: Empathetic Communication Facilitation Program for Early Initiation of End-of-life Discussions
Official title: Effectiveness of a Facilitating Program Utilizing a Mobile Application for Initiating Advanced Care Planning Discussions Between Patients with Advanced Cancer and Healthcare Providers: Protocol for a Randomized Controlled Trial (J-SUPPORT 2104)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End of Life Care
Advanced Cancer
Recurrent Cancer
Keywords: Advance Care Planning
Communication
Decision Making
Neoplasms
Palliative Care
Lead sponsor: National Cancer Center, Japan
Sponsor class: OTHER_GOV
First posted: 2021-09-16
Enrollment: 264
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed 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 are randomized to the intervention arm and the control arm in a 1:1 ratio.

Eligibility criteria: 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).
* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Oncologists' communication behaviors - RE subscale (reassurance and emotional support) from the SHARE scoring manual
timeFrame: The first post-baseline visit (up to 4 weeks)
Secondary outcomes:
measure: The score of oncologists' communication behaviors - S, H, and A subscales from the SHARE scoring manual
timeFrame: The first post-baseline visit (up to 4 weeks)
measure: Communication behaviors between participants and oncologists
timeFrame: The first post-baseline visit (up to 4 weeks)
measure: Number of ACP-related topics in the consultation
timeFrame: The first post-baseline visit (up to 4 weeks)
measure: Psychological distress
timeFrame: 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
measure: Quality of life measured by the EORTC-QLQ-C30
timeFrame: 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
measure: Participants' care goals
timeFrame: Baseline, 12 weeks after the baseline, and 24 weeks after the baseline
measure: Participants' preferred places for spending their final days
timeFrame: Baseline, 12 weeks after the baseline, and 24 weeks after the baseline
measure: Participant satisfaction with their oncologists' consultation
timeFrame: The first post-baseline visit (up to 4 weeks)
measure: Feasibility of the intervention
timeFrame: The first post-baseline visit (up to 4 weeks)
measure: Medical care utilization: the presence or absence of anticancer treatment and a reason for treatment termination if it is discontinued
timeFrame: 24 weeks after the baseline
measure: Medical care utilization: unscheduled outpatient visits
timeFrame: 24 weeks after the baseline
measure: Medical care utilization: hospitalization
timeFrame: 24 weeks after the baseline
measure: Medical care utilization: ICU admission
timeFrame: 24 weeks after the baseline
measure: Medical care utilization: use of end-of-life care consultations
timeFrame: 24 weeks after the baseline
measure: Medical care utilization: use of palliative care services
timeFrame: 24 weeks after the baseline
measure: Cancer type
timeFrame: Baseline
measure: Length of time since diagnosis in months
timeFrame: Baseline
measure: Age in years
timeFrame: Baseline
measure: Sex
timeFrame: Baseline
measure: Educational background
timeFrame: Baseline
measure: Employment
timeFrame: Baseline
measure: Financial status
timeFrame: Baseline
measure: Family member
timeFrame: Baseline
measure: Methods of hospital visits
timeFrame: Baseline
measure: Times of hospital visits in min
timeFrame: Baseline
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: National Cancer Center Hospital, National Cancer Center
state: Chuo-ku
Study officials:
affiliation: National Cancer Center, Japan
name: Yosuke Uchitomi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.