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Electronic Patient Reporting of Side Effects to Chemotherapy: A Cluster Randomized Controlled Trial

NCT ID: NCT02996201

Last Updated: 2017-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2017-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Adverse Event Cancer, Breast Chemotherapeutic Toxicity Patient Outcomes Assessments

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Electronic reporting of PRO-CTCAE items

Patients report PRO-CTCAE symptoms on a tablet computer before each cycle of chemotherapy

Group Type EXPERIMENTAL

Completion of PRO-CTCAE items before consultation

Intervention Type OTHER

Patients report PRO-CTCAE symptoms on a tablet computer before each cycle of chemotherapy

Standard practice

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Completion of PRO-CTCAE items before consultation

Patients report PRO-CTCAE symptoms on a tablet computer before each cycle of chemotherapy

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Breast cancer patients starting adjuvant chemotherapy in the period November 1, 2015 - September 1, 2016 in Danish oncology clinics

Exclusion Criteria

* More than six scheduled cycles of chemotherapy
* Not able to read and understand Danish language
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Danish Cancer Society

OTHER

Sponsor Role collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Helle Pappot

Chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type DERIVED
PMID: 33837509 (View on PubMed)

Baeksted 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.

Reference Type DERIVED
PMID: 31832240 (View on PubMed)

Other Identifiers

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R113-A7084-14-S34

Identifier Type: -

Identifier Source: org_study_id