Advanced Cancer
Conditions
Interventions
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 questi
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
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.
No Intervention: Usual care group Patients will
s situation.
Sponsors
Group of Supportive Care and Survivorship Research, Institute for Cancer Control, National Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactKyoko Obama
National Cancer Center Hospital Institute for Cancer Control
Outcome results
None listed