Evidence map›Paper›PMID 33407782›Full record

Trial reportTrials2021

An exercise trial for adults undergoing neoadjuvant chemoradiotherapy for rectal cancer proves not feasible: recommendations for future trials.

Jennifer Brunet, Jenson Price, Céline Delluc

Registry-linked trialOpen access · goldAbstract readClinical TrialLetter
In one paragraph

Trial report in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03049124 (Exercise for Adults Diagnosed With Rectal Cancer), which is not on this map. Cited by 5 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 3 pooled it
0.3field-weighted citation impact, top 44% 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.

NCT03049124 nawithdrawnnot on this map

Exercise for Adults Diagnosed With Rectal Cancer: A Feasibility Study

TypeinterventionalSponsorUniversity of OttawaRan2017 to 2019Enrolled0ConditionsRectal CancerArmsExercise
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 3 syntheses or guidelines pooled it, 6 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Article
  5. 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

3 authors at 2 institutions in 1 country.

Jennifer BrunetSchool of Human Kinetics, University of Ottawa, 125 University Private, Montpetit Hall, Room 339, Ottawa, Ontario, K1N 6N5, Canada. jennifer.brunet@uottawa.ca.ORCID http://orcid.org/0000-0003-3242-5444
Jenson PriceSchool of Human Kinetics, University of Ottawa, 125 University Private, Montpetit Hall, Room 339, Ottawa, Ontario, K1N 6N5, Canada.
Céline DellucInstitut du savoir Montfort, Hôpital Montfort, Ottawa, Ontario, Canada.
University of Ottawa · CAMontfort Hospital · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe aim of this paper is to share the methodological problems of an unsuccessful prospective single-arm feasibility trial conducted to evaluate the safety and feasibility of a 12-week progressive exercise intervention for adults undergoing neoadjuvant chemoradiotherapy for rectal cancer, as well as offer recommendations for future trials.

methodsThe initial plan was to recruit adults diagnosed with rectal cancer and scheduled for neoadjuvant chemoradiotherapy over a 12-month period. The exercise intervention was to consist of supervised exercise sessions delivered three times per week by a trained exercise specialist. Feasibility (i.e., recruitment, adherence, and compliance rates) and safety (i.e., adverse events) were to be assessed throughout the trial, and patient-reported and physical health outcomes were to be assessed pre- and post-intervention. After 8 months of open recruitment, we had been unable to successfully enroll patients into our trial. We therefore modified our eligibility criteria to increase the number of patients that could be recruited into our trial, and in turn increase our recruitment rate. We also amended our recruitment procedures to ensure we could reach patients who were either awaiting treatment, receiving treatment, or had completed treatments in the past 5 years. In doing so, we added a research objective, namely to determine the optimal timing of conducting an exercise intervention with adults diagnosed with rectal cancer (i.e., during neoadjuvant treatment, after surgery, during adjuvant treatment, or post-treatment).

resultsMany problems continued to hinder the progress of our trial, particularly the low recruitment rate and the failure to enroll the required sample size that would make our results reliable.

conclusionThis led us to conclude that our trial was not feasible and that it is advisable to consider some elements carefully (e.g., recruitment strategies, communication, and trial location) before designing and conducting future trials. If one or more of these elements still proves to be problematic, trial results risk being compromised and alternative approaches should be considered.

trial registrationClinicalTrials.gov NCT03049124 . Registered on 02 September 2017.

Indexed as

Neoadjuvant TherapyRectal NeoplasmsAdultChemoradiotherapyExerciseHumansProspective StudiesFeasibilityMethodologyRecruitmentRetention

Identifiers

PMID33407782
PMCPMC7789730
OpenAlexW3119946814

What OpenQuestion holds

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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.