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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 264
- 试验地点
- 2
- 主要终点
- Oncologists' communication behaviors - RE subscale (reassurance and emotional support) from the SHARE scoring manual
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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-
- •(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.
排除标准
- •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
结局指标
主要结局
Oncologists' communication behaviors - RE subscale (reassurance and emotional support) from the SHARE scoring manual
时间窗: The first post-baseline visit (up to 4 weeks)
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.
次要结局
- Participants' care goals(Baseline, 12 weeks after the baseline, and 24 weeks after the baseline)
- Medical care utilization: ICU admission(24 weeks after the baseline)
- Medical care utilization: use of end-of-life care consultations(24 weeks after the baseline)
- Age in years(Baseline)
- Employment(Baseline)
- Financial status(Baseline)
- Length of time since diagnosis in months(Baseline)
- 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))
- Medical care utilization: the presence or absence of anticancer treatment and a reason for treatment termination if it is discontinued(24 weeks after the baseline)
- 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)
- Participant satisfaction with their oncologists' consultation(The first post-baseline visit (up to 4 weeks))
- Feasibility of the intervention(The first post-baseline visit (up to 4 weeks))
- 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)
- Participants' preferred places for spending their final days(Baseline, 12 weeks after the baseline, and 24 weeks after the baseline)
- Cancer type(Baseline)
- Medical care utilization: unscheduled outpatient visits(24 weeks after the baseline)
- Medical care utilization: hospitalization(24 weeks after the baseline)
- Medical care utilization: use of palliative care services(24 weeks after the baseline)
- Educational background(Baseline)
- Sex(Baseline)
- Methods of hospital visits(Baseline)
- Family member(Baseline)
- Times of hospital visits in min(Baseline)
研究者
Yosuke Uchitomi
Chief of Innovation Center for Supportive, Palliative and Psychosocial Care, National Cancer Center Hospital
National Cancer Center, Japan