Evidence map›Paper›PMID 27194552›Full record

Trial reportAnnals of surgical oncology2016

The MELFO-Study: Prospective, Randomized, Clinical Trial for the Evaluation of a Stage-adjusted Reduced Follow-up Schedule in Cutaneous Melanoma Patients-Results after 1 Year.

Samantha Damude, Josette E H M Hoekstra-Weebers, Anne Brecht Francken, Sylvia Ter Meulen, Esther Bastiaannet, Harald J Hoekstra

Abstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Annals of surgical oncology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 4 pooled it
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 4 syntheses or guidelines pooled it.

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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

6 authors.

Samantha DamudeDepartment of Surgical Oncology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
Josette E H M Hoekstra-WeebersWenckebach Institute, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
Anne Brecht FranckenDepartment of Surgical Oncology, Isala, Zwolle, The Netherlands.
Sylvia Ter MeulenDepartment of Dermatology, Netherlands Cancer Institute/Antoni van Leeuwenhoek, Amsterdam, The Netherlands.
Esther BastiaannetDepartment of Surgical Oncology, University of Leiden, University Medical Center Leiden, Leiden, The Netherlands.
Harald J HoekstraDepartment of Surgical Oncology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands. h.j.hoekstra@umcg.nl.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundGuidelines for evidence-based follow-up in melanoma patients are not available. This study examined whether a reduced follow-up schedule affects: patient-reported outcome measures, detection of recurrences, and follow-up costs.

methodsThis multicenter trial included 180 patients treated for AJCC stage IB-II cutaneous melanoma, who were randomized in a conventional follow-up schedule group (CSG, 4 visits first year, n = 93) or experimental follow-up schedule group (ESG, 1-3 visits first year, n = 87). Patients completed the State-Trait Anxiety Inventory, cancer worry scale, impact of events scale, and a health-related quality of life questionnaire (HRQoL, RAND-36). Physicians registered clinicopathologic features and the number of outpatient clinic visits.

resultsSociodemographic and illness-related characteristics were equal in both groups. After 1-year follow-up, the ESG reported significantly less cancer-related stress response symptoms than the CSG (p = 0.01), and comparable anxiety, mental HRQoL, and cancer-related worry. Mean cancer-related worry and stress response symptoms decreased over time (p < 0.001), whereas mental HRQoL increased over time (p < 0.001) in all melanoma patients. Recurrence rate was 9 % in both groups, mostly patient-detected and not physician-detected (CSG 63 %, ESG 43 %, p = 0.45). Hospital costs of 1-year follow-up were reduced by 45 % in the ESG compared to the CSG.

conclusionsThis study shows that the stage-adjusted, reduced follow-up schedule did not negatively affect melanoma patients' mental well-being and the detection of recurrences compared with conventional follow-up as dictated by the Dutch guideline, at 1 year after diagnosis. Additionally, reduced follow-up was associated with significant hospital cost reduction.

Indexed as

AdultAftercareAgedAged, 80 and overAnxietyAppointments and SchedulesFemaleHospital CostsHumansLymphatic MetastasisMaleMelanomaMiddle AgedNeoplasm Recurrence, LocalNeoplasm StagingPractice Guidelines as Topic

Identifiers

PMID27194552
PMCPMC4972865

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Registered trials

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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.