Safer Personalised Cancer Treatment Digital Follow-up

NCT06476158 | Recruiting

• 1 other identifier: HNF1626-22
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to investigate patient harm/ adverse events, overall survival and health related quality of life under treatment with immunotherapy medication in cancer patients when they are followed up by a personalized digital program where the patients report symptoms directly to health care personnel. The main questions the clinical trial aims to answer are:

• How often and how severe are immunotherapy related adverse events/ side effects when patients are followed up by a digital personalized patient-reporting system compared to standard follow-up?
• How are life quality and survival affected for patients followed up by a digital personalized patient-reporting system compared to follow-up standard follow-up?? Participants under immunotherapy cancer treatment will be followed up by a digital patient reporting program in one group, and compared to a group of cancer patients receiving the same treatment, but with standard follow-up without a digital program in another group. Researchers will compare the two groups to see if there any differences in how many patients who develop immunotherapy related patient harm and how long the patients live.

Conditions

Patient Reported Outcome Measure

Keywords

Adverse events; Patient reported outcome; Digital follow-up; Immunotherapy; Routine cancer care

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of immunotherapy related adverse events (irAEs)

  Incidence of irAEs per 100 patients and per patient, and severity of irAEs graded by Common Terminology Critera for Adverse Events (CTCAE) 0-5 where 0 is no harm, and 5 is death. Consequence of the irAEs are graded by National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) Index category E-I where E is an error contributing to or resulted in temporary harm and required intervention. I is the maximum value, where an error occurred that may have contributed to or resulted in a patient death.

  3 years

Secondary Outcomes (2)

• Overall survival

  3 years

• Health related quality of life

  3 years

Study Arms (2)

Digital follow-up with e-PROs

ACTIVE COMPARATOR

Device: Kaiku Health

Standard clinical follow-up

NO INTERVENTION

Interventions

Kaiku Health DEVICE

Digital follow-up with Kaiku Health as medical device

Digital follow-up with e-PROs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Above 18 years of age
• Cancer diagnosis as primary or secondary diagnosis according to the ICD-10 classification
• Receiving immunotherapy as systemic anticancer treatment reported with ATC codes for medications.

You may not qualify if:

• Hematological cancer
• Gynecological cancer

Sponsors & Collaborators

• Nordlandssykehuset HF: lead
• University of Tromso: collaborator
• Helgeland Hospital Trust: collaborator
• University Hospital of North Norway: collaborator

Study Sites (1)

Nordlandssykehuset HF

Bodø, Nordland, 8092, Norway

RECRUITING

Related Publications (1)

• Aanes SG, Nieder C, Bates DW, Wiig S, Haukland EC. Consequences of adverse events in cancer immunotherapy combinations - a comprehensive real-world analysis. Immunotherapy. 2025 Nov;17(16):1177-1187. doi: 10.1080/1750743X.2025.2600847. Epub 2025 Dec 10.

  PMID: 41367243 DERIVED

Central Study Contacts

Ellinor C Haukland, MD, Phd

CONTACT

+4792267328; ellinor.haukland@nlsh.no

Siv Gyda Aanes, MD

CONTACT

+4790944580; siv.gyda.aanes@nlsh.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A retrospective quantitative approach will be used to develop and validate new technology and methods since there is a need to control and check the outcomes, before we use an ambi-directional cohort study design to see how the new technology and methods perform in clinical practice on real world data.

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: June 26, 2024
• Study Start: June 1, 2024
• Primary Completion: June 1, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 26, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 2024 - 2034
• Access Criteria: Open access

Locations

NO (1)