Trial reportTrials2017
The effects of exercise on the quality of life of patients with breast cancer (the UMBRELLA Fit study): study protocol for a randomized controlled trial.
Trial report in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.
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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
12 citing papers in PubMed.
- Trial
- Effects of exercise in breast cancer patients: implications of the trials within cohorts (TwiCs) design in the UMBRELLA Fit trial.Breast cancer research and treatment · 2021Trial
- Understanding the unmet needs of patients with brain metastases referred for stereotactic radiotherapy and their caregivers: A prospective cohort study.Neuro-oncology practice · 2026Article
- Tailored guidance to apply the Estimand framework to Trials within Cohorts (TwiCs) studies.Global epidemiology · 2024Article
- Randomised trials conducted using cohorts: a scoping review.BMJ open · 2024Article
- The Trial within Cohorts (TwiCs) study design in oncology: experience and methodological reflections.BMC medical research methodology · 2023Article
- Article
- Circulating tumor DNA guided adjuvant chemotherapy in stage II colon cancer (MEDOCC-CrEATE): study protocol for a trial within a cohort study.BMC cancer · 2020Article
- Obstructions and the Recognition of Cancer Inpatient Physical Activity Based on Exercise Experience.International journal of environmental research and public health · 2020Article
- Article
- Breast Cancer Survivors' Experiences With an Activity Tracker Integrated Into a Supervised Exercise Program: Qualitative Study.JMIR mHealth and uHealth · 2019Article
- Protocol for the development of a CONSORT extension for RCTs using cohorts and routinely collected health data.Research integrity and peer review · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundMeta-analyses of randomized controlled trials (RCTs) have shown that exercise has beneficial effects on quality of life (QoL) in patients with breast cancer. However, these effects were often small. Blinding in an exercise trial is not possible, which has the possible disadvantage of difficult accrual, drop-out after randomization to control and contamination between study groups (controls adopting the behaviour of the intervention group). The cohort multiple randomized controlled trial (cmRCT) is an alternative for conventional RCTs and has the potential to overcome these disadvantages.
methodsThis cmRCT will be performed within the Utrecht cohort for Multiple BREast cancer intervention studies and Long-term evaLuAtion (UMBRELLA). Patients with breast cancer who visit the radiotherapy department of the University Medical Center Utrecht are asked to participate in UMBRELLA. Patients give consent for collection of medical information, providing patient-reported outcomes through regular questionnaires and randomization into future intervention studies. Patients who fulfill the UMBRELLA Fit study eligibility criteria (12 to 18 months post inclusion in UMBRELLA, low physical activity level) will be randomly allocated to the intervention or control group (1:1 ratio). Patients randomized to the intervention group will be offered a 12-week exercise programme. The control group will not be informed. Regular cohort measurements will be used for outcome assessment. Feasiblity (including participation, contamination, generalizability and retention) of the cmRCT design and effects of the intervention on QoL will be evaluated. DISCUSSION: We will examine the feasibility of the cmRCT design in exercise-oncology research and compare this with conventional RCTs. Furthermore, the effectiveness of an exercise intervention on the QoL of patients with breast cancer in the short term (6 months) and long term (24 months) will be studied.
trial registrationNetherlands Trial Register, NTR5482/NL.52062.041.15 . Retrospectively registered on 7 December 2015.
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