Health TrialsbyHealthPanel

Safer Personalised Cancer Treatment Digital Follow-up

ConditionPatient Reported Outcome Measure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNordlandssykehuset HF

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Hematological cancer

Gynecological cancer

Trial design

Design model

Parallel

Treatments tested in this trial

  • Kaiku Health

    Device

    Digital follow-up with Kaiku Health as medical device

Treatment groups

900 Participants
are divided into 2 treatment groups
Group A: Digital follow-up with e-PROsActive comparator 1 intervention
Group B: Standard clinical follow-upNo intervention 0 interventions

Trial outcomes

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.

Time frame
3 years

Secondary outcomes

1

Overall survival

Implement personalised ePRO immunotherapy follow-up and investigate overall survival compared to standard of care from cancer diagnosis to death, and from start of immunotherapy treatment and intervention to death in the two comparing groups.

Time frame
3 years
2

Health related quality of life

Implement personalised ePRO immunotherapy follow-up and investigate QoL in intervention group by EORTC QLQ-C30 version 3.0 including global health status, functional scales (physical, role, emotional, cognitive, social) and symptom scales at baseline ( at start cancer treatment), 3, 6 and 12 months under cancer treatment. All of the scales and single-item measures range in score from 0 to 100. A high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL but a high score for a symptom scale represents a high level of symptomatology / problems. Firstly an estimate of the average of the items that contribute to the scale; this is the raw score. Then a linear transformation is used to standardise the raw score, so that scores range from 0 to 100; a higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms.

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nordlandssykehuset HF

Lead sponsor

University of Tromso

Collaborator

Helgeland Hospital Trust

Collaborator

University Hospital of North Norway

Collaborator

Source ClinicalTrials.gov
Apply now