Adverse EventNCT02996201
Electronic Patient Reporting of Side Effects to Chemotherapy: A Cluster Randomized Controlled Trial
A study testing Completion of PRO-CTCAE items before consultation in people with Adverse Event and Cancer, Breast, run by Copenhagen University Hospital, Rigshospitalet.
Trial summary
The aim of this study is to determine whether the use of breast cancer patients' own electronic reporting of side effects to chemotherapy in a treatment setting has an impact on the handling of side effects and on the number of hospitalizations, febrile neutropenia and dose adjustments. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Adverse Event, Cancer, Breast, Chemotherapeutic Toxicity
- What is being tested?
- Completion of PRO-CTCAE items before consultation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Breast cancer patients starting adjuvant chemotherapy in the period November 1, 2015 - September 1, 2016 in Danish oncology clinics
Who cannot join
- More than six scheduled cycles of chemotherapy
- Not able to read and understand Danish language
About this study
Official title: Electronic Patient Reporting of Side Effects to Chemotherapy Among Breast Cancer Patients Using the Patient-Reported Outcomes Version of Common Terminology Criteria for Adverse Events (PRO-CTCAE): A Cluster Randomized Controlled Trial
The aim of this study is to determine whether the use of breast cancer patients' own electronic reporting of side effects to chemotherapy in a treatment setting has an impact on the handling of side effects and on the number of hospitalizations, febrile neutropenia and dose adjustments. We are using the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) for the patients' reporting of side effects.
- Being tested
- Completion of PRO-CTCAE items before consultation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Completion of PRO-CTCAE items before consultationOther
Patients report PRO-CTCAE symptoms on a tablet computer before each cycle of chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Electronic reporting of PRO-CTCAE items | Experimental | Patients report PRO-CTCAE symptoms on a tablet computer before each cycle of chemotherapy Receives: Other: Completion of PRO-CTCAE items before consultation |
| Standard practice | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose adjustments reported in the medication treatment sheet before each cycle of chemotherapy (5 time points with three weeks interval)
Measured: up to 18 weeks of treatment in the period betweeen November 1, 2015 and January 31, 2017
Secondary outcomes (6)
Number of hospitalizations reported in the medical record after each of the six cycles of chemotherapy
Measured: up to 18 weeks of treatment in the period betweeen November 1, 2015 and January 31, 2017
Febrile neutropenia reported in the medical record after each of the six cycles of chemotherapy
Measured: up to 18 weeks of treatment in the period betweeen November 1, 2015 and January 31, 2017
Detailed description of side effects in the medical record before start of chemotherapy and after each six cycles of chemotherapy
Measured: up to 18 weeks of treatment in the period betweeen November 1, 2015 and January 31, 2017
Handling of side effects documented in the medical record
Measured: up to 18 weeks of treatment in the period betweeen November 1, 2015 and January 31, 2017
Patients' experience of communication and handling of side effects measured in questionnaire survey and qualitative interviews
Measured: up to18 weeks of chemotherapy in the period November 1, 2015 - January 31, 2017
Patient and staff compliance as registerede by the software used
Measured: up to 18 weeks (November 1, 2015 - January 31, 2017)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2016 (estimated)
- Study startNov 2015
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Adverse EventStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Cancer Society
- Responsible party
- Principal investigator, Helle Pappot, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02996201
- Sponsor's protocol ID
- R113-A7084-14-S34
- Status last verified
- Oct 2017
- First submitted
- 4 Nov 2016
- Last updated
- 18 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Pappot H, Baeksted CW, Nissen A, Knoop A, Mitchell SA, Christensen J, Hjollund NH, Johansen C. Clinical effects of assessing electronic patient-reported outcomes monitoring symptomatic toxicities during breast cancer therapy: a nationwide and population-based study. Breast Cancer. 2021 Sep;28(5):1096-1099. doi: 10.1007/s12282-021-01244-x. Epub 2021 Apr 9.
PubMed 33837509Baeksted CW, Nissen A, Knoop AS, Pappot H. Patients' experience of communication and handling of symptomatic adverse events in breast cancer patients receiving adjuvant chemotherapy. Res Involv Engagem. 2019 Nov 20;5:36. doi: 10.1186/s40900-019-0171-1. eCollection 2019.
PubMed 31832240
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electronic Patient Reporting of Side Effects to Chemotherapy Among Breast Cancer Patients Using the Patient-Reported Outcomes Version of Common Terminology Criteria for Adverse Events (PRO-CTCAE): A Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02996201
- Acronym / sponsor ID
- R113-A7084-14-S34
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Danish Cancer Society
- Study start
- Nov 2015 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 19 Dec 2016 (estimated)
- 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 aim of this study is to determine whether the use of breast cancer patients' own electronic reporting of side effects to chemotherapy in a treatment setting has an impact on the handling of side effects and on the number of hospitalizations, febrile neutropenia and dose adjustments. We are using the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) for the patients' reporting of side effects.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electronic reporting of PRO-CTCAE items | Experimental | Other: Completion of PRO-CTCAE items before consultationPatients report PRO-CTCAE symptoms on a tablet computer before each cycle of chemotherapy |
| Standard practice | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Breast cancer patients starting adjuvant chemotherapy in the period November 1, 2015 - September 1, 2016 in Danish oncology clinics
Key exclusion criteria (2 listed)
- More than six scheduled cycles of chemotherapy
- Not able to read and understand Danish language
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 |
|---|---|---|
| Completion of PRO-CTCAE items before consultationPatients report PRO-CTCAE symptoms on a tablet computer before each cycle of chemotherapy | Other | Electronic reporting of PRO-CTCAE items |
Primary outcome
Dose adjustments reported in the medication treatment sheet before each cycle of chemotherapy (5 time points with three weeks interval)
Time frame: up to 18 weeks of treatment in the period betweeen November 1, 2015 and January 31, 2017
6 secondary outcomes
Number of hospitalizations reported in the medical record after each of the six cycles of chemotherapy
Time frame: up to 18 weeks of treatment in the period betweeen November 1, 2015 and January 31, 2017
Febrile neutropenia reported in the medical record after each of the six cycles of chemotherapy
Time frame: up to 18 weeks of treatment in the period betweeen November 1, 2015 and January 31, 2017
Detailed description of side effects in the medical record before start of chemotherapy and after each six cycles of chemotherapy
Time frame: up to 18 weeks of treatment in the period betweeen November 1, 2015 and January 31, 2017
Handling of side effects documented in the medical record
Time frame: up to 18 weeks of treatment in the period betweeen November 1, 2015 and January 31, 2017
Patients' experience of communication and handling of side effects measured in questionnaire survey and qualitative interviews
Time frame: up to18 weeks of chemotherapy in the period November 1, 2015 - January 31, 2017
Patient and staff compliance as registerede by the software used
Time frame: up to 18 weeks (November 1, 2015 - January 31, 2017)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2017.
- Derived from this study: PubMed 33837509Pappot H, Baeksted CW, Nissen A, Knoop A, Mitchell SA, Christensen J, Hjollund NH, Johansen C. Clinical effects of assessing electronic patient-reported outcomes monitoring symptomatic toxicities during breast cancer therapy: a nationwide and population-based study. Breast Cancer. 2021 Sep;28(5):1096-1099. doi: 10.1007/s12282-021-01244-x. Epub 2021 Apr 9.
- Derived from this study: PubMed 31832240Baeksted CW, Nissen A, Knoop AS, Pappot H. Patients' experience of communication and handling of symptomatic adverse events in breast cancer patients receiving adjuvant chemotherapy. Res Involv Engagem. 2019 Nov 20;5:36. doi: 10.1186/s40900-019-0171-1. eCollection 2019.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Completion of PRO-CTCAE items before consultation in people with Adverse Event and Cancer, Breast, run by Copenhagen University Hospital, Rigshospitalet.
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 1 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: finished, as of the sponsor's last update on 18 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose adjustments reported in the medication treatment sheet before each cycle of chemotherapy (5 time points with three weeks interval) (time frame: up to 18 weeks of treatment in the period betweeen November 1, 2015 and January 31, 2017). 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 NCT02996201, which also lists 2 linked publications.
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 18 Oct 2017.