Tokyo, Sept. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062741) titled 'A Randomized Controlled Trial of a Combined Life Review and Serious Illness Conversation Intervention to Improve Spiritual Well-being in People with Advanced Cancer' on Aug. 31.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -but assessor(s) are blinded
Control - Active
Primary Sponsor:
Institute - Kyoto University
Condition:
Condition - Patients with end-stage GI cancer
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - To determine whether a two-step communication intervention integrating LIM and SICG improves spiritual well-being (SWB) at 12 weeks compared with usual care among patients with advanced gastrointestinal cancer initiating first-line palliative chemotherapy.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Step 1 Life Review Interview Method (LIM)
A nurse conducts a LIM interview to help the patient reflect on their life experiences and articulate their values, meaning, and beliefs.
Step 2 Serious Illness Conversation Guide (SICG)
A conversation involving the patient, family members, and a nurse is conducted using the SICG to discuss future care and treatment in light of the patient's values.
Follow-up
Brief telephone follow-ups are conducted at 12 and 24 weeks after the intervention to support ongoing conversations about care consistent with the patient's values.
Interventions/Control_2 - Participants receive usual care provided by their treating physician and nurse. In addition, brief telephone follow-up is conducted at the same time points as in the intervention group.
Eligibility:
Age-lower limit - 20
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1. Patients diagnosed with metastatic or recurrent gastrointestinal cancer that is not amenable to curative treatment.
2. Histologically confirmed gastric, esophageal, biliary tract, pancreatic, or colorectal cancer (any histological subtype).
3. Patients who have initiated first-line palliative chemotherapy at Kyoto University Hospital within 6 weeks (42 days) and are able to attend outpatient visits.
4. Patients who have been informed of their diagnosis and the palliative intent of treatment by their treating physician.
5. Age more than or equal to 20 years at the time of consent.
6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
7. Written informed consent obtained from the patient.
Key exclusion criteria - 1. Patients with clinically significant distress, defined as a score of more than or equal to 4 on the distress scale and more than or equal to 3 on the impact scale of the Distress and Impact Thermometer (DIT).
2. Patients who have already experienced a structured conversation with their treating physician or nurse covering illness understanding, prognostic information sharing, clarification of personal values, and discussion of preferred medical care and treatment before enrollment in this study.
3. Patients who are unable to have a family member or other significant person accompany them to discussions regarding medical care or treatment decisions with their physician or nurse.
4. Patients with significant cognitive impairment, including evident cognitive impairment, attention deficits, or memory impairment.
5. Patients who are unable to communicate, read, or write in Japanese.
6. Patients whom the treating physician judges to be inappropriate for participation in this study for any other reason.
Target Size - 70
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 08 Month 06 Day
Date of IRB - 2026 Year 08 Month 06 Day
Anticipated trial start date - 2026 Year 10 Month 26 Day
Last follow-up date - 2027 Year 11 Month 01 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069693
Disclaimer: Curated by HT Syndication.
