Trial reportTrials2023
Recruiting women with ductal carcinoma in situ to a randomised controlled trial: lessons from the LORIS study.
Trial report in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
What it found
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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.
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.
Who cites it
8 citing papers in PubMed, 15 citations in OpenAlex.
- Prognostic Implications of Calcification and Surgery Type by Estrogen Receptor and HER2 Status in Ductal CarcinomaJournal of breast cancer · 2026Article
- Is axillary surgery still justified in DCIS diagnosed via vacuum-assisted biopsy?World journal of surgical oncology · 2025Article
- Mammography screening and incidence of ductal carcinoma in situ of the breast in Italy: an age-period-cohort analysis.International journal of epidemiology · 2025Article
- Risk perception of patients with ductal carcinomaHistology and histopathology · 2025Review
- Review
- Defining precancer: a grand challenge for the cancer community.Nature reviews. Cancer · 2024Review
- Survival outcomes after omission of surgery for ductal carcinoma in situ.NPJ breast cancer · 2024Article
- Radiology for Ductal Carcinoma In Situ of the Breast: Updates on Invasive Cancer Progression and Active Monitoring.Korean journal of radiology · 2024Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 4 institutions in 1 country.
Funding
Abstract
backgroundThe LOw RISk DCIS (LORIS) study was set up to compare conventional surgical treatment with active monitoring in women with ductal carcinoma in situ (DCIS). Recruitment to trials with a surveillance arm is known to be challenging, so strategies to maximise patient recruitment, aimed at both patients and recruiting centres, were implemented.
methodsWomen aged ≥ 46 years with a histologically confirmed diagnosis of non-high-grade DCIS were eligible for 1:1 randomisation to either surgery or active monitoring. Prior to randomisation, all eligible women were invited to complete: (1) the Clinical Trials Questionnaire (CTQ) examining reasons for or against participation, and (2) interviews exploring in depth opinions about the study information sheets and film. Women agreeing to randomisation completed validated questionnaires assessing health status, physical and mental health, and anxiety levels. Hospital site staff were invited to communication workshops and refresher site initiation visits to support recruitment. Their perspectives on LORIS recruitment were collected via surveys and interviews.
resultsEighty percent (181/227) of eligible women agreed to be randomised. Over 40% of participants had high anxiety levels at baseline. On the CTQ, the most frequent most important reasons for accepting randomisation were altruism and belief that the trial offered the best treatment, whilst worries about randomisation and the influences of others were the most frequent most important reasons for declining. Most women found the study information provided clear and useful. Communication workshops for site staff improved knowledge and confidence but only about half said they themselves would join LORIS if eligible. The most common recruitment barriers identified by staff were low numbers of eligible patients and patient preference.
conclusionsRecruitment to LORIS was challenging despite strategies aimed at both patients and site staff. Ensuring that recruiting staff support the study could improve recruitment in similar future trials.
trial registrationISRCTN27544579, prospectively registered on 22 May 2014.
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What OpenQuestion holds
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.