UMIN-CTR Clinical Trial

Public title

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

Acronym

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

Scientific Title

A Randomized Controlled Trial of a Mobile-based Empathic Communication Support Program to Promote Advance Care Planning Discussion Between Advanced Cancer Patients and Physicians

Scientific Title:Acronym

A Randomized Controlled Trial of a Mobile-based Empathic Communication Support Program to Promote Advance Care Planning Discussion Between Advanced Cancer Patients and Physicians

Region

Japan

Condition

Advanced Cancer

Classification by specialty

Medicine in general	Gastroenterology	Hepato-biliary-pancreatic medicine
Pneumology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

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

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Outcome assessment time points will be: T0 (baseline), T1 (visit 1 week or later after baseline), T2 (visit 1 week or later after T1), T3 (12 weeks after T1), and T4 (24 weeks after T1).

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 (T1). 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) (Fujimori et al., 2014). 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.

Key secondary outcomes

Secondary outcome measures:
1. Oncologists' communication behaviors at visit T1 are evaluated using the S, H, and A subscales of the SHARE manual. 2. The conversations between the participant and oncologists are coded and the communication behaviors are counted using a computer version of the Roter interaction process analysis system. 3. The number of conversations about ACP during the consultation is counted. 4. Psychological distress is obtained using The Hospital Anxiety and Depression Scale at all five scheduled visits. 5. Quality of life is obtained using The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 at T0, T2, T3, and T4. 6. Participants will be asked about their goals and the places where they would prefer to spend their final days at T0, T3, and T4. 7. The Patient Satisfaction Survey is conducted at T1. 8. The intervention's feasibility is evaluated according to the participants' assessment of the app's usability, the time taken for interventions, and app log records. 9. Medical care utilization is obtained from the electrical medical record of each participant at the 6-month follow-up. 10. The participant's medical and social background information includes cancer type, length of time since diagnosis, age, gender, educational background, employment history, financial status, marital status, household status, methods and times of hospital visits, and whether there is a family member or other person who can accompany them.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

No treatment

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

Concealment

Central registration

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

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 Question Prompt List(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.

Interventions/Control_2

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.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Patients with advance or recurrent cancer.

2) Patients who are judged by the attending physician to meet the Surprise Question tool (Bernacki et al., 2019; Moss et al., 2010).

3) Age 20 years or older.

4) 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.

5) Written consent to participate in the study must be obtained from the patient.

6) Able to read, write, and understand Japanese.

Key exclusion criteria

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

Target sample size

264

Name of lead principal investigator

1st name	Yosuke
Middle name
Last name	Uchitomi

Organization

National Cancer Center Hospital

Division name

Institute for Cancer Control

Zip code

104-0045

Address

5-1-1, Tsukiji, Chuo-ku, Tokyo

TEL

03-3547-5201

Email

yuchitom@ncc.go.jp

Name of contact person

1st name	Kyoko
Middle name
Last name	Obama

Organization

National Cancer Center Hospital

Division name

Institute for Cancer Control

Zip code

104-0045

Address

5-1-1, Tsukiji, Chuo-ku, Tokyo

TEL

03-3547-5201

Homepage URL

Email

kobama@ncc.go.jp

Institute

Group of Supportive Care and Survivorship Research, Institute for Cancer Control, National Cancer Center

Institute

Department

Personal name

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

National Cancer Center IRB

Address

5-1-1 Tsukiji Chuo-ku Tokyo

Tel

03-3547-5201

Email

irst@ml.res.ncc.go.jp

Secondary IDs

YES

Study ID_1

J-SUPPORT2104

Org. issuing International ID_1

Japan Supportive, Palliative and Psychosocial Oncology Group

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

国立がん研究センター中央病院（東京都）

Date of disclosure of the study information

2021

Year

08

Month

31

Day

URL releasing protocol

https://pubmed.ncbi.nlm.nih.gov/36977536/

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

264

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

Data obtained from this study may be used for secondary purposes at the request of the submitting publisher or other researchers in a form that is not linked to personal information.

IPD sharing Plan description

Recruitment status

Main results already published

Date of protocol fixation

2021

Year

07

Month

12

Day

Date of IRB

2021

Year

07

Month

20

Day

Anticipated trial start date

2021

Year

09

Month

06

Day

Last follow-up date

2023

Year

09

Month

30

Day

Date of closure to data entry

Date trial data considered complete

2023

Year

12

Month

28

Day

Date analysis concluded

2024

Year

06

Month

30

Day

Other related information

Registered date

2021

Year

08

Month

30

Day

Last modified on

2024

Year

06

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051726