Dataset Information

Evaluating a web- and telephone-based personalised exercise intervention for individuals living with metastatic prostate cancer (ExerciseGuide): protocol for a pilot randomised controlled trial.

ABSTRACT:

Introduction

Preliminary research has shown the effectiveness of supervised exercise-based interventions in alleviating sequela resulting from metastatic prostate cancer. Despite this, many individuals do not engage in sufficient exercise to gain the benefits. There are many barriers, which limit the uptake of face-to-face exercise in this population including lack of suitable facilities, remoteness, and access to experts, significant fatigue, urinary incontinence and motivation. Technology-enabled interventions offer a distance-based alternative. This protocol describes a pilot two-armed randomised controlled study that will investigate the feasibility and preliminary efficacy of an online exercise and behavioural change tool (ExerciseGuide) amongst individuals with metastatic prostate cancer.

Methods

Sixty-six participants with histologically diagnosed metastatic prostate cancer will be randomised into either the 8-week intervention or a wait-list control. The intervention arm will have access to a tailored website, remote supervision, and tele-coaching sessions to enhance support and adherence. Algorithms will individually prescribe resistance and aerobic exercise based upon factors such as metastasis location, pain, fatigue, confidence and current exercise levels. Behavioural change strategies and education on exercise benefits, safety and lifestyle are also tailored through the website. The primary outcome will be intervention feasibility (safety, usability, acceptability, and adherence). Secondary exploratory outcomes include changes in physical activity, quality of life, sleep, and physical function. Outcomes will be measured at baseline and week 9.

Discussion

The study aims to determine the potential feasibility of an online remotely monitored exercise intervention developed for individuals with metastatic prostate cancer. If feasible, this pilot intervention will inform the design and implementation of further distance-based interventions.

Trial registration

ANZCTR, ACTRN12614001268639 . Registered 10 December 2018, https://anzctr.org.au/ACTRN12618001979246.aspx.

SUBMITTER: Evans HEL

PROVIDER: S-EPMC7798256 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Evaluating a web- and telephone-based personalised exercise intervention for individuals living with metastatic prostate cancer (ExerciseGuide): protocol for a pilot randomised controlled trial.

Evans Holly E L HEL Forbes Cynthia C CC Galvão Daniel A DA Vandelanotte Corneel C Newton Robert U RU Wittert Gary G Chambers Suzanne S Vincent Andrew D AD Kichenadasse Ganessan G Brook Nicholas N Girard Danielle D Short Camille E CE

Pilot and feasibility studies 20210111 1

<h4>Introduction</h4>Preliminary research has shown the effectiveness of supervised exercise-based interventions in alleviating sequela resulting from metastatic prostate cancer. Despite this, many individuals do not engage in sufficient exercise to gain the benefits. There are many barriers, which limit the uptake of face-to-face exercise in this population including lack of suitable facilities, remoteness, and access to experts, significant fatigue, urinary incontinence and motivation. Technol ...[more]

PMID: 33431040

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Project description:BackgroundNHS Health Check is a primary prevention programme offering cardiovascular disease (CVD) risk assessment to adults in England aged 40-74. Uptake remains a challenge and invitation method is a strong predictor of uptake. There is evidence of low uptake when using invitation letters. Telephone invitations might increase uptake, but are not widely used. We explored the potential to improve uptake through personalising letters to patient's CVD risk, and to compare this with generic letters and telephone invitations.MethodsHEalth Check TRial (HECTR) was a three-arm randomised controlled trial in nine general practices in Staffordshire (UK). Eligible patients were randomised to be invited to a NHS Health Check using one of three methods: standard letter (control); telephone invitation; letter personalised to the patient's CVD risk. The primary outcome was attendance/non-attendance. Data were collected on a range of patient- and practice-level factors (e.g., patient socio-demographics, CVD risk, practice size, Health Checks outside usual working hours). Multi-level logistic regression estimated the marginal effects to explore whether invitation method predicted attendance. Invitation costs were collated from practices to estimate cost benefit.ResultsIn total, 4614 patients were included in analysis (mean age 50.2?± 8.0?yr.; 52.4% female). Compared with patients invited by standard letter (30.9%), uptake was significantly higher in those invited by telephone (47.6%, P <?.001), but not personalised letter (31.3%, p =?.812). In multi-level analysis, compared with the standard letter arm, likelihood of attendance was 18 percentage points higher in the telephone arm and 4 percentage points higher in the personalised letter arm. The effect of telephone calls appeared strongest in patients who were younger and had lower CVD risk. We estimated per 1000 patients invited, risk-personalised letters could result in 40 additional attended Health Checks (at no extra cost) and telephone invitations could result in 180 additional Health Checks at an additional cost of £240.ConclusionsTelephone invitations should be advocated to address the substantial deficit between current and required levels of NHS uptake, and could be targeted at younger and lower CVD risk adults. Risk-personalised letters should be explored further in a larger sample of high risk individuals.Trial registrationRegistration number: ISRCTN15840751 date of registration: 24/10/2017.

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Project description:BackgroundImproving retention within randomised controlled trials is important. The effectiveness of different strategies can be assessed using a Study Within A Trial (SWAT). Previous research has shown personalised text message reminders improve clinic attendance rates; however, the results are mixed on improving postal questionnaire return. This SWAT aims to assess whether personalised text message reminders improve completion rates for scheduled telephone follow-ups.MethodsThis SWAT is a two-arm, multi-centre randomised controlled trial with equal allocation. The host trial was the Melatonin for Anxiety prior to General anaesthesia In Children trial (ISRCTN 18296119), where the child's caregiver was to answer a scheduled telephone follow-up 14 days post-surgery; participants for the SWAT were therefore the caregiver. Text messages were sent 24-48 h before the scheduled call and the personalised version contained the first name of the caregiver which was omitted in the non-personalised version. The primary outcome was questionnaire completion rate, defined as the proportion of caregivers successfully contacted, and completed any of the questionnaires, over the telephone within the follow-up window (day 14 + 7 days).ResultsThe SWAT included 100 of the 110 (91%) participants randomised into the host trial. Randomisation within the SWAT was equal between non-personalised (n = 50) and personalised (n = 50) interventions. The overall questionnaire response rate was 73% with a difference between the two interventions of 68% in the non-personalised text message arm and 78% in the personalised text message arm. The adjusted absolute risk difference was 7.1% (95% confidence interval = -10.2%, 24.4%). There was no difference in either the time to response or the number of contact attempts between the two interventions.ConclusionsThere is some evidence that personalised text messages could be effective at increasing response rates when data is collected via telephone and in a population of caregivers for paediatric trial participants. However, similar SWATs have shown mixed results. Given the low-cost and low risks associated with personalising text message reminders, this SWAT could be implemented easily in other RCTs scheduling telephone follow-up appointments.Trial registrationISRCTN 18296119 , SWAT 35 (MRC Northern Ireland Network for Trials Methodology Network).

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Dataset Information

Evaluating a web- and telephone-based personalised exercise intervention for individuals living with metastatic prostate cancer (ExerciseGuide): protocol for a pilot randomised controlled trial.

Introduction

Methods

Discussion

Trial registration

Publications

Evaluating a web- and telephone-based personalised exercise intervention for individuals living with metastatic prostate cancer (ExerciseGuide): protocol for a pilot randomised controlled trial.

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