Evidence map›Paper›PMID 37559004›Full record

Trial reportBMC cancer2023

Impact of web application support versus standard management on adherence with adjuvant hormone therapy in patients treated for breast cancer: the WEBAPPAC study.

François Gernier, Jean-Michel Grellard, Charlotte Dupont, Hervé Castel, Marie Fernette, François Lahaye, Rose-Marie Charles, Tiphaine Leroux, Céline Ory, Audrey Faveyrial and 14 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled TrialClinical Trial, Phase III
In one paragraph

Trial report in BMC cancer, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04554927 (Impact of Web Application Support Versus Standard Management on Compliance With Adjuvant Hormone Therapy at 18 Months in Patients Treated for Breast Cancer), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.5field-weighted citation impact, top 17% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04554927 naactive not recruitingnot on this map

Impact of Web Application Support Versus Standard Management on Compliance With Adjuvant Hormone Therapy at 18 Months in Patients Treated for Breast Cancer

TypeinterventionalSponsorCentre Francois BaclesseRan2020 to 2026Enrolled438ConditionsWeb-application, Breast Cancer, Hormono TherapyArmsWEB-Application, Standard accompaniment
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 6 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

24 authors at 1 institution in 2 countries.

François GernierClinical Research Department, Centre François Baclesse, 3 avenue du Général Harris, Caen, 14000, France. f.gernier@baclesse.unicancer.fr.
Jean-Michel GrellardClinical Research Department, Centre François Baclesse, 3 avenue du Général Harris, Caen, 14000, France.
Charlotte DupontBreast pathway nurse, Centre François Baclesse, Caen, France.
Hervé CastelClinical Research Department, Centre François Baclesse, 3 avenue du Général Harris, Caen, 14000, France.
Marie FernetteClinical Research Department, Centre François Baclesse, 3 avenue du Général Harris, Caen, 14000, France.
François LahayeBreast pathway nurse, Centre François Baclesse, Caen, France.
Rose-Marie CharlesBreast pathway nurse, Centre François Baclesse, Caen, France.
Tiphaine LerouxBreast pathway nurse, Centre François Baclesse, Caen, France.
Céline OryMedical Oncology Department, Centre François Baclesse, Caen, France.
Audrey FaveyrialMedical Oncology Department, Centre François Baclesse, Caen, France.
Adeline MorelMedical Oncology Department, Centre François Baclesse, Caen, France.
George EmileMedical Oncology Department, Centre François Baclesse, Caen, France.
Christelle LevyMedical Oncology Department, Centre François Baclesse, Caen, France.
Carine SeguraMedical Oncology Department, Centre François Baclesse, Caen, France.
Djelila AllouacheMedical Oncology Department, Centre François Baclesse, Caen, France.
Alison JohnsonMedical Oncology Department, Centre François Baclesse, Caen, France.
Julien GeffrelotMedical Oncology Department, Centre François Baclesse, Caen, France.
Katharina GunzerMedical Oncology Department, Centre François Baclesse, Caen, France.
Anaïs LelaidierNorth-West Canceropole Data Center, Centre François Baclesse, Caen, France.
Gilles GiraultComprehensive Cancer Centre F. Baclesse, Medical Library, Caen, France.
Coraline Dubot-PoitelonMedical Oncology Department, Centre François Baclesse, Caen, France.
Chankannira SanClinical Research Department, Centre François Baclesse, 3 avenue du Général Harris, Caen, 14000, France.
Justine LequesneClinical Research Department, Centre François Baclesse, 3 avenue du Général Harris, Caen, 14000, France.
Bénédicte ClarisseClinical Research Department, Centre François Baclesse, 3 avenue du Général Harris, Caen, 14000, France. b.clarisse@baclesse.unicancer.fr.
Centre François Baclesse · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNon-metastatic breast cancer treatment is mainly based on surgery, with or without chemotherapy, radiotherapy and/or hormone therapy. To reduce the risk of hormone receptor positive (HR+) disease recurrence, hormone therapy is prescribed for at least 5 years. It may induce adverse drug reactions (ADRs) as joint pain, sexual dysfunction, weight increase, fatigue, mood disorders and vasomotor symptoms. Around 30-40% of patients withhold hormone therapy within 5 years after initiation. Based on encouraging results of mobile health in patient follow-up, we developed a web-application addressed for breast cancer patients initiating adjuvant hormonal therapy and aimed to assess its impact on hormone therapy adherence, ADRs management, and health-related quality of life.

methodsThe WEBAPPAC trial is a randomized, open-label, prospective, single-center phase 3 study aiming to assess the interest of a web-application support as compared to standard management among breast cancer patients initiating hormone therapy. The main endpoint is the proportion of patients with hormone therapy adherence failure within 18 months after treatment start, in each arm. Eligible patients will be 1:1 randomized between the WEBAPPAC web-application support (experimental arm,) or standard support (control arm), with stratification on type of hormone therapy (Aromatase inhibitor or Tamoxifen). We plan to enroll 438 patients overall. Failure to hormone therapy will be assessed using the Morisky 8-item self-questionnaire (MMSA8), patient adherence logbook, and medical consultations. Secondary outcomes include hormone therapy adherence at 6 months, pain (Visual Analogue Scale and Brief Pain Inventory), quality of life (EORTC QLQ-C30 and BR23 self-questionnaires), anxiety and depression (Hospital and Depression Scale), and return to work and/or daily activities. The user experience with the WEBAPPAC web-application will be assessed using the System Usability Scale (SUS) questionnaire. DISCUSSION: Hormone therapy discontinuation or adherence failure in breast cancer patients may be indirectly related to an increased risk of recurrence. A better control of medication adherence, through the detection of side effects and some proposed actions trying to reduce them, appears therefore essential to limit the risk of disease recurrence. The WEBAPPAC web-application thus aims better monitoring and allowing higher level of responsiveness in case of ADRs, thus improving treatment adherence.

trial registrationNCT04554927, registered September 18, 2020. PROTOCOL VERSION: Version 2.1 dated from December 21, 2021.

Indexed as

Breast NeoplasmsAdjuvants, ImmunologicFemaleHormonesHumansMedication AdherenceNeoplasm Recurrence, LocalPainProspective StudiesQuality of LifeAdjuvants, ImmunologicHormonesAdherenceBreast cancerCancer survivorship care planHormone therapyQuality of lifeTelemedicine and mHealth

Identifiers

PMID37559004
PMCPMC10413707
OpenAlexW4385699261

What OpenQuestion holds

Textmetadata
LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.