Patient Reported Outcome MeasureSPecTNCT06476158
Safer Personalised Cancer Treatment Digital Follow-up
A study testing Kaiku Health in people with Patient Reported Outcome Measure, run by Nordlandssykehuset HF at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Reported Outcome Measure
- What is being tested?
- Kaiku Health
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jun 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Hematological cancer
- Gynecological cancer
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Nordlandssykehuset HF
Bodø, Nordland, 8092
Ellinor Haukland, MD, PhD, +4792267328, ellinor.haukland@nlsh.no
Siv Gyda Aanes, MD, +4790944580, siv.gyda.aanes@nlsh.no
About this study
Official title: Monitoring of Adverse Events Caused by Systemic Cancer Treatment. Identifying Adverse Events Related to Immunotherapy Treatment Before and After Implementation of Personalized Digital Patient Reported Outcomes
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:
Read more
- 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.
Read the detailed description
Cancer patients experience more frequently patient harm than other patients, mostly from systemic anticancer treatment. To reduce avoidable patient harm from modern cancer treatment such as immunotherapy and targeted therapies, precise and clinically relevant measurements are needed.
The study aims through three different sub-studies/ work pacages (WP) to develop electronic methods for measuring automatically injuries in cancer patients, and investigate if electronic patient follow-up (ePRO) can prevent injuries, affect quality of life and survival in patients receiving immunotherapy cancer treatment.
Research has shown that the recommended method for measuring patient harm and medication related adverse events is not specific or sensitive enough to detect cancer-related patient harm. In recent years, three patient harm measurement tools for cancer have been validated based on a manual retrospective review of the patient record. Based on existing technology and research, in WP1 the aim is to develop and validate a fully automatic patient harm measurement tool for retrospective detection of harm in cancer patients receiving immunotherapy. The development of the technological solution is done by Datavarehuset Helse Nord and SAS Institute in an already existing solution (Nordic Clinical Analytics Framework - NCAF) which is used daily in all health trusts in Helse Nord, Northern Norway.
In order to prevent avoidable patient harm and adverse events, it is important to involve the patient in their own treatment. Research on follow-up with ePRO revealed more side effects, increased quality of life and overall survival in cancer patients.
In WP2, the technology developed in WP1 is used to prospectively examine whether follow-up with ePRO compared to standard follow-up results in less adverse events. In WP3, quality of life and survival are investigated with ePRO follow-up compared to standard follow-up. WP1 is a retrospective diagnostic study. WP2 and 3 are clinical cohort studies where a prospective intervention group of cancer patients are followed with ePRO during immunotherapy treatment and compared with a retrospective group of cancer patients followed with standard clinical follow-up. WP2 investigates rates, severity and types of immunotherapy related adverse events in patients monitored with ePRO compared to standard follow-up. WP3 investigates quality of life in the ePRO cohort, and overall survival in patients monitored to standard follow-up.
When the study is completed in 2027, the intention is to have developed and validated an automatic measurement tool for the detection of cancer-related injuries for general use nationally and internationally, and new knowledge about how and if digital follow-up with ePRO can affect patient harm and adverse events, quality of life and survival.
The study contributes to new knowledge about measurement of patient injuries and digital follow-up of cancer patients during active treatment with immunotherapy as a new standard of care in our region.
Adverse events are an additional burden for seriously ill cancer patients. By measuring adverse events that occur in cancer patients, we recognize that these events happen and is a part of oncology that need to be taken to account for each individual patient. Knowledge of the occurrence of adverse events in each individual department will be able to say something about status in each department, so measures can be taken at a system level to improve patient safety and the quality of the health service.
The use of personalized ePRO gives the patient the opportunity to participate actively in the course of their illness, regardless of where and who the patient is. Increased involvement of the patient inthe patient journey has shown to provide increased empowerment, safety, better quality of life and possible increase survival in other studies. Follow-up with ePRO makes it easier for healthcare personnel to detect early signs of potential injuries so that measures can be initiated faster to mitigate potential harm.
- Conditions
- Patient Reported Outcome Measure
- Being tested
- Kaiku Health
- Keywords
- Adverse events, Patient reported outcome, Digital follow-up, Immunotherapy, Routine cancer care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kaiku HealthDevice
Digital follow-up with Kaiku Health as medical device
| Study group | Role | What they receive |
|---|---|---|
| Digital follow-up with e-PROs | Active comparator | Not described Receives: Device: Kaiku Health |
| Standard clinical follow-up | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Secondary outcomes (2)
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.
Measured: 3 years
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start1 Jun 2024
- Primary completion1 Jun 2025 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patient Reported Outcome MeasureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nordlandssykehuset HF
- Sponsor type
- University, hospital or other
- Collaborators
- University of Tromso, Helgeland Hospital Trust, University Hospital of North Norway
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06476158
- Sponsor's protocol ID
- HNF1626-22
- Acronym
- SPecT
- Status last verified
- Jun 2024
- First submitted
- 10 Jun 2024
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data are stored for 10 years after the research has concluded, in accordance with the Health Research Act. Identifiable data are destroyed after 10 years. Anonymized quantitative result data are further preserved, stored on a secure server at SIKT, the service provider for the knowledge sector, sikt.no, following their advice on anonymization. Anonymized quantitative result data are further preserved, stored on a secure server at SIKT, the service provider for the knowledge sector, sikt.no, following their advice on anonymization. This will make them searchable and accessible for secondary use in research, educational purposes and for replication and validation
Publications
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.
PubMed 41367243
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring of Adverse Events Caused by Systemic Cancer Treatment. Identifying Adverse Events Related to Immunotherapy Treatment Before and After Implementation of Personalized Digital Patient Reported Outcomes
- ClinicalTrials.gov ID
- NCT06476158
- Acronym / sponsor ID
- SPecT / HNF1626-22
- Conditions
- Patient Reported Outcome Measure
- Keywords
- Adverse events, Patient reported outcome, Digital follow-up, Immunotherapy, Routine cancer care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Nordlandssykehuset HFUniversity, hospital or other
- Collaborators
- University of Tromso, Helgeland Hospital Trust, University Hospital of North Norway
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 26 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cancer patients experience more frequently patient harm than other patients, mostly from systemic anticancer treatment. To reduce avoidable patient harm from modern cancer treatment such as immunotherapy and targeted therapies, precise and clinically relevant measurements are needed.
The study aims through three different sub-studies/ work pacages (WP) to develop electronic methods for measuring automatically injuries in cancer patients, and investigate if electronic patient follow-up (ePRO) can prevent injuries, affect quality of life and survival in patients receiving immunotherapy cancer treatment.
Research has shown that the recommended method for measuring patient harm and medication related adverse events is not specific or sensitive enough to detect cancer-related patient harm. In recent years, three patient harm measurement tools for cancer have been validated based on a manual retrospective review of the patient record. Based on existing technology and research, in WP1 the aim is to develop and validate a fully automatic patient harm measurement tool for retrospective detection of harm in cancer patients receiving immunotherapy. The development of the technological solution is done by Datavarehuset Helse Nord and SAS Institute in an already existing solution (Nordic Clinical Analytics Framework - NCAF) which is used daily in all health trusts in Helse Nord, Northern Norway.
In order to prevent avoidable patient harm and adverse events, it is important to involve the patient in their own treatment. Research on follow-up with ePRO revealed more side effects, increased quality of life and overall survival in cancer patients.
In WP2, the technology developed in WP1 is used to prospectively examine whether follow-up with ePRO compared to standard follow-up results in less adverse events. In WP3, quality of life and survival are investigated with ePRO follow-up compared to standard follow-up. WP1 is a retrospective diagnostic study. WP2 and 3 are clinical cohort studies where a prospective intervention group of cancer patients are followed with ePRO during immunotherapy treatment and compared with a retrospective group of cancer patients followed with standard clinical follow-up. WP2 investigates rates, severity and types of immunotherapy related adverse events in patients monitored with ePRO compared to standard follow-up. WP3 investigates quality of life in the ePRO cohort, and overall survival in patients monitored to standard follow-up.
When the study is completed in 2027, the intention is to have developed and validated an automatic measurement tool for the detection of cancer-related injuries for general use nationally and internationally, and new knowledge about how and if digital follow-up with ePRO can affect patient harm and adverse events, quality of life and survival.
The study contributes to new knowledge about measurement of patient injuries and digital follow-up of cancer patients during active treatment with immunotherapy as a new standard of care in our region.
Adverse events are an additional burden for seriously ill cancer patients. By measuring adverse events that occur in cancer patients, we recognize that these events happen and is a part of oncology that need to be taken to account for each individual patient. Knowledge of the occurrence of adverse events in each individual department will be able to say something about status in each department, so measures can be taken at a system level to improve patient safety and the quality of the health service.
The use of personalized ePRO gives the patient the opportunity to participate actively in the course of their illness, regardless of where and who the patient is. Increased involvement of the patient inthe patient journey has shown to provide increased empowerment, safety, better quality of life and possible increase survival in other studies. Follow-up with ePRO makes it easier for healthcare personnel to detect early signs of potential injuries so that measures can be initiated faster to mitigate potential harm.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Digital follow-up with e-PROs | Active comparator | Device: Kaiku Health |
| Standard clinical follow-up | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Hematological cancer
- Gynecological cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kaiku HealthDigital follow-up with Kaiku Health as medical device | Device | Digital follow-up with e-PROs |
Primary outcome
Incidence and severity of immunotherapy related adverse events (irAEs)
Time frame: 3 years
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.
2 secondary outcomes
Overall survival
Time frame: 3 years
Health related quality of life
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Derived from this study: PubMed 41367243Aanes 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.
- Individual participant dataSharing planned: Yes. All data are stored for 10 years after the research has concluded, in accordance with the Health Research Act. Identifiable data are destroyed after 10 years. Anonymized quantitative result data are further preserved, stored on a secure server at SIKT, the service provider for the knowledge sector, sikt.no, following their advice on anonymization. Anonymized quantitative result data are further preserved, stored on a secure server at SIKT, the service provider for the knowledge sector, sikt.no, following their advice on anonymization. This will make them searchable and accessible for secondary use in research, educational purposes and for replication and validation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kaiku Health in people with Patient Reported Outcome Measure, run by Nordlandssykehuset HF at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ellinor C Haukland, MD, Phd (+4792267328, ellinor.haukland@nlsh.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of immunotherapy related adverse events (irAEs) (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06476158, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2024.