Mobile-based Empathic Communication Support Program to Promote Advance Care Planning Discussion in Advanced Cancer Patients
Study Details
Study Description
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 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 will be randomized to the intervention arm and usual arm in 1:1.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Mobile-based empathic communication support program group Patients will be provided an mobile-based empathic communication support program to promote ACP discussion for advanced cancer patients and physicians. The experimental group will also receive the usual care as is standard practice. |
Behavioral: Mobile-based empathic communication support program to promote ACP discussion
Patients in the intervention group will be provided a mobile-based empathic communication support program- an 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. They can then proceed with the content themselves, at home or anywhere, 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 by 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 a feedback 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.
|
| No Intervention: Usual care group Patients will 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. |
Outcome Measures
Primary Outcome Measures
- Oncologists' communication behaviors [The first post-baseline visit (up to 4 weeks)]
The primary outcome is the Reassurance and Emotional support score of physician behavior measured using the SHARE model. SHARE 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 or accepting patients' expression of 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. Scoring is conducted by multiple raters blinded to the assignment. Raters are trained in conversation analysis, and inter-rater and intra-rater agreements are checked in advance.
Secondary Outcome Measures
- Patient-physician behavioral assessment [The first post-baseline visit (up to 4 weeks)]
Patient-physician behavioral assessment based on the conversation analysis manual (Roter's Interaction Analysis System, RIAS)
- Number of conversations about ACP with physicians during the consultation [The first post-baseline visit (up to 4 weeks)]
Number of conversations about ACP (prognosis, palliative care, remaining anticancer treatment, end-of-life treatment and recuperation issues, and preparation for the future) with physicians during the consultation will assessed based on a conversation analysis manual.
- 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]
The HADS (Hospital Anxiety and Depression Scale) is a 14-item self-administered questionnaire that measures psychological distress in patients. It includes subscales for depression (7 items) and anxiety (7 items). Responses are selected from four options and scores range from 0 to 21 for each subscale. The cut-off scores are 4/5 points on the depression scale, 7/8 points on the anxiety scale, and 10/11 points on a total score. Higher scores suggest the possibility of having symptoms.
- Quality of life scored by the EORTC-QLQ-C30 scale [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]
The European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire (EORTC-QLQ-C30) is an integrated system for assessing the health-related quality of life (QoL) of cancer patients. The QLQ-C30 includes functional scales, symptom scales, and a global health status/QoL scale. The scales and single-item measures have a score range of 0 to 100. A high scale score represents a higher response level.
- Anti-cancer drug administration [24 weeks after the baseline]
Administration of oral or intravenous(IV) anticancer drugs on the day of the survey.
- Specialist palliative care use [24 weeks after the baseline]
Obtain from the electronic medical record whether or not specialized palliative care is being used.
- Only if deceased: Oral or IV anticancer drugs within 14 days prior to death [24 weeks after the baseline]
Obtain from the electronic medical record whether oral or IV anticancer drugs were administered within 14 days prior to death.
- Only if deceased: Initiation of new oral or IV anticancer drugs within 30 days prior to death [24 weeks after the baseline]
Obtain from the electronic medical record whether new oral or IV anticancer drugs were started within 30 days prior to death.
- Only if deceased: Emergency visits except palliative care within 30 days prior to death [24 weeks after the baseline]
Obtain from electronic medical records on emergency visits within 30 days prior to death.
- Only if deceased: use of palliative care within 30 days prior to death [24 weeks after the baseline]
Obtain from the electronic medical record whether specialist palliative care has been used within 30 days prior to death.
- Time spent using the application [24 weeks after the baseline]
Patient's application usage time, as retrieved from the application's data usage log.
- Time spent in an intervention interview [The first post-baseline visit (up to 4 weeks)]
Time spent in intervention interviews by phone or in person.
- Patients'satisfaction of the intervention program [The first post-baseline visit (up to 4 weeks)]
Five questions were asked to rate the intervention program on an 11-point scale from 0 (not applicable) to 10 (applicable). The higher the score, the more useful the intervention was. Were you able to organize the questions you wanted to ask? Did you understand how to use the application and could you actually use it? Did you find the application useful? Was it easy to implement the application? Was the phone call and interview support helpful?
- Patients' satisfaction of the consultation [The first post-baseline visit (up to 4 weeks)]
The Client Satisfaction Questionnaire is a scale to measure patient satisfaction of the consultation, comprising five items: needs addressed, active involvement in the interaction, information received, emotional support received, and interaction in general. Each item is rated on an 11-point scale from 0 (not satisfied at all) to 10 (very satisfied). Total satisfaction is obtained by summing the answers to the five questions.
- Care goals [Baseline, 12 weeks after the baseline, and 24 weeks after the baseline]
The instruction is as follows: "The following is a list of common examples of goals for treatment and living when it becomes difficult to continue with the cancer treatment. Please choose one that is closest to your thoughts." The options for treatment goals are as follows: I would like to receive treatment to relieve my symptoms, without any cancer treatment, so that I can live a peaceful life. I would like to receive less burdensome cancer treatment to alleviate symptoms so that I can continue my daily living as much as possible. I would like to receive cancer treatment even if it is somewhat burdensome so that I can finish important events or things that I have to do. I would like to receive all the cancer treatment I can, no matter what the burden, so that I can live as long as possible.
- Preferred place for future care [Baseline, 12 weeks after the baseline, and 24 weeks after the baseline]
The options for where they want to spend time in the future are as follows: (1) their homes, (2) a nearby hospital, (3) a palliative care hospital or ward, (4) the hospital where they are receiving treatment, and (5) others.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Patients with unresectable (Union for International Cancer Control, UICC stage III or
- 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 50% 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | National Cancer Center Hospital, National Cancer Center | Tokyo | Chuo-ku | Japan | 1040045 |
Sponsors and Collaborators
- Yosuke Uchitomi
Investigators
- Principal Investigator: Yosuke Uchitomi, MD, PhD, National Cancer Center, Japan
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- J-SUPPORT2104
- 20EA1010