Tokyo, June 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061544) titled 'Telehealth in specialist palliative care in patients with advanced lung cancer: A randomized controlled trial' on June 1.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - Nagoya University
Condition:
Condition - Advanced Lung Cancer (advanced non-small-cell or advanced small-cell lung cancer)
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the efficacy of a telehealth palliative care intervention compared with usual care in improving quality of life (FACT-L total score) at 12 weeks in patients with advanced lung cancer.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Patients in the intervention group will receive telehealth palliative care consultations at baseline and at 4, 8, and 12 weeks.
Interventions/Control_2 - Patients will receive standard oncological care from their treating physicians. Access to face-to-face specialist palliative care at their own institution is not restricted if deemed necessary by the treating physician or requested by the patient.
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - -Aged 18 years or older.
-Currently receiving anti-cancer therapy* at a participating institution.
* Including cytotoxic chemotherapy, targeted therapy, and immune checkpoint inhibitors.
-Estimated life expectancy of at least 6 months, as determined by the treating physician.
-Diagnosed with advanced* non-small cell lung cancer (NSCLC) or advanced* small cell lung cancer (SCLC).
* Definition of advanced disease: NSCLC (Stage III/IV) not eligible for curative-intent treatment (surgery or radiotherapy); or SCLC (extensive-stage, limited-stage ineligible for radiotherapy, or recurrent disease).
-Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3.
-Able to communicate and respond to questions in Japanese.
Key exclusion criteria - -Prior receipt of specialist palliative care.*
*Defined as having two or more previous visits to a palliative care outpatient clinic.
-Inability to operate a tablet or similar device, lack of a home internet connection, or difficulty accessing the standardized online platform for online palliative care consultations, as determined by the treating physician.
-Considered unsuitable for study participation by the treating physician due to psychiatric condition or cognitive function.
Target Size - 90
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 04 Month 30 Day
Anticipated trial start date - 2026 Year 07 Month 01 Day
Last follow-up date - 2027 Year 07 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069520
Disclaimer: Curated by HT Syndication.