Evidence map›Paper›PMID 30352568›Full record

ArticleBMC cancer2018

Protocol for a phase III RCT and economic analysis of two exercise delivery methods in men with PC on ADT.

Shabbir M H Alibhai, Paul Ritvo, Daniel Santa Mina, Catherine Sabiston, Murray Krahn, George Tomlinson, Andrew Matthew, Himu Lukka, Padraig Warde, Sara Durbano and 2 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC cancer, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02834416 (A Randomized Control Trial), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–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.

NCT02834416 phase3completednot on this map

A Randomized Control Trial (RCT) and Economic Analysis of Two Exercise Delivery Methods in Men With Prostate Cancer on ADT

TypeinterventionalSponsorUniversity Health Network, TorontoRan2016 to 2020Enrolled38ConditionsProstate CancerArmsSupervised Group Exercise, Home Based Exercise
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Variability and limitations in home-based exercise program descriptions in oncology: a scoping review.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2020
    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

12 authors.

Shabbir M H AlibhaiUniversity Health Network, Toronto, ON, M5G 2C4, Canada. shabbir.alibhai@uhn.ca.ORCID http://orcid.org/0000-0001-7815-6046
Paul RitvoCancer Care Ontario, Toronto, ON, M5G 2L3, Canada.
Daniel Santa MinaUniversity Health Network, Toronto, ON, M5G 2C4, Canada.
Catherine SabistonUniversity of Toronto, Toronto, ON, M5S 2J7, Canada.
Murray KrahnUniversity Health Network, Toronto, ON, M5G 2C4, Canada.
George TomlinsonUniversity Health Network, Toronto, ON, M5G 2C4, Canada.
Andrew MatthewUniversity Health Network, Toronto, ON, M5G 2C4, Canada.
Himu LukkaThe Juravinski Cancer Centre, Hamilton, ON, L8V 5C2, Canada.
Padraig WardeUniversity Health Network, Toronto, ON, M5G 2C4, Canada.
Sara DurbanoUniversity Health Network, Toronto, ON, M5G 2C4, Canada.
Meagan O'NeillUniversity Health Network, Toronto, ON, M5G 2C4, Canada.
S Nicole Culos-ReedUniversity of Calgary, Calgary, AB, T2N 1N4, Canada.

Funding

Canadian Institutes of Health Research MOP130252
6 · The paper itself

Abstract

backgroundAndrogen deprivation therapy (ADT) is commonly used to treat prostate cancer. However, side effects of ADT often lead to reduced quality of life and physical function. Existing evidence demonstrates that exercise can ameliorate multiple treatment-related side effects for men on ADT, yet adherence rates are often low. The method of exercise delivery (e.g., supervised group in-centre vs. individual home-based) may be important from clinical and economic perspectives; however, few studies have compared different delivery models. Additionally, long-term exercise adherence and an understanding of predictors of adherence are critical to achieving sustained benefits, but such data are lacking. The primary aim of this multi-centre phase III non-inferiority randomized controlled trial is to determine whether a home-based delivery model is non-inferior to a group-based delivery model in terms of benefits in fatigue and fitness in this population. Two other key aims include examining cost-effectiveness and long-term adherence.

methodsMen diagnosed with prostate cancer of any stage, starting or continuing on ADT for at least 6 months, fluent in English, and living close to a study centre are eligible. Participants complete five assessments over 12 months (baseline and every 3 months during the 6-month intervention and 6-month follow-up phases), including a fitness assessment and self-report questionnaires. Biological outcomes are collected at baseline, 6, and 12 months. A total of 200 participants will be randomized in a 1:1 fashion to supervised group training or home-based training supported by smartphones, health coaches, and Fitbit technology. Participants are asked to complete 4 to 5 exercise sessions per week, incorporating aerobic, resistance and flexibility training. Outcomes include fatigue, quality of life, fitness measures, body composition, biological outcomes, and program adherence. Cost information will be obtained using patient diary-based self-report and utilities via the EQ-5D. DISCUSSION: To disseminate publicly funded exercise programs widely, clinical efficacy and cost-effectiveness have to be demonstrated. The goals of this trial are to provide these data along with an increased understanding of adherence to exercise among men with prostate cancer receiving ADT.

trial registrationThe trial has been registered at clinicaltrials.gov (Registration # NCT02834416 ). Registration date was June 2, 2016.

Indexed as

Exercise TherapyAndrogen AntagonistsClinical Trials, Phase III as TopicCost-Benefit AnalysisEquivalence Trials as TopicHumansMaleProstatic NeoplasmsRandomized Controlled Trials as TopicTreatment OutcomeAndrogen AntagonistsAndrogen deprivation therapyCost-effectivenessExerciseFatiguePatient adherencePhysical fitnessProstate cancerQuality of lifeRandomized controlled trial

Identifiers

PMID30352568
PMCPMC6199786

What OpenQuestion holds

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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.