Condition category
Cancer
Date applied
06/07/2020
Date assigned
30/07/2020
Last edited
30/07/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
The STAMINA study is looking at how men diagnosed with prostate cancer on hormones therapy (Androgen Deprivation Therapy [ADT]) can be supported to exercise, to improve and maintain their quality of life. Whilst ADT has proven anti-cancer benefits, it often causes deterioration in quality of life with side-effects of hot flushes, severe tiredness and sexual problems. ADT also increases the risks of dementia, diabetes and heart disease. Some ADT side-effects, including fatigue, can feel like recurrent cancer and cause understandable concern, leading to extra consultations/tests. Many treatments are suggested for these side-effects, but supervised exercise is the only supportive treatment proven to improve disease specific quality of life in men with prostate cancer on ADT. Exercise, therefore, is an important part of prostate cancer care and is recommended by the National Institute of Health and Clinical Excellence (NICE). Working in partnership with NHS Healthcare Professionals, a team of Exercise Professionals at Nuffield Health will deliver the STAMINA exercise programme over a 12-month period. The STAMINA exercise programme is based on the scientific evidence behind the NICE guidelines and this study will explore how to get the maximal benefit from these recommendations in men with prostate cancer on ADT. Also, men currently on ADT inform us they would welcome exercise with support embedded in their standard prostate cancer care rather than as an add-on. This study is part of a 5 year programme of work which means we have developed and tested the STAMINA exercise programme in smaller packages of work before we started this larger study.

Who can participate?
Men with prostate cancer can take part if the hospital where they receive treatment takes part in STAMINA, and if their clinical team feels they are eligible to take part.

What does the study involve?
Not all NHS hospitals taking part will deliver the full STAMINA exercise programme. Half of the NHS hospitals that are taking part in the study will be linked with a Nuffield Health gym to deliver the STAMINA exercise programme. These hospitals will be in the “intervention” group.
The other half of hospitals taking part in the study will continue to provide services in the same way as usual, optimised to promote exercise in accordance with NICE guidance. These hospitals will be in the “optimised usual care” group.
Which hospitals will be in the intervention group has been decided by chance (randomly). This means that neither the hospital, nor the researchers who run the study have influenced the groups. In this way, we can compare the two groups at the end of the study.
All participants will be asked to complete a questionnaire booklet at 5 time points over a maximum of 2 years. Participants who attend a hospital which is in the ‘intervention group’ will be contacted to discuss what the STAMINA supported exercise programme involves for them.

What are the possible benefits and risks of participating?
We hope that this study could improve quality of life for men with prostate cancer on ADT, but we cannot say that men who take part will definitely experience an improvement. We do not expect there will be any direct risks or disadvantages to taking part.

Where is the study run from?
The study is being organised and supervised by Sheffield Teaching Hospitals NHS Foundation Trust (UK). The study is coordinated by the Clinical Trials Research Unit at the University of Leeds (UK).

When is the study starting and how long is it expected to run for?
September 2018 to October 2023.

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
Prof Derek J Rosario, d.j.rosario@sheffield.ac.uk
STAMINA Senior Trial Manager, stamina@leeds.ac.uk


Lay summary under review with external organisation

Trial website

http://www.STAMINA.org.uk

Contact information

Type

Scientific

Primary contact

Prof Derek Rosario

ORCID ID

Contact details

Department of Urology
Royal Hallamshire Hospital
Glossop Road
Sheffield
S10 2JF
United Kingdom
+44 (0)114 226 1399
d.j.rosario@sheffield.ac.uk

Type

Public

Additional contact

Ms Petra Bijsterveld

ORCID ID

Contact details

STAMINA Senior Trial Manager
CTRU
University of Leeds
Leeds
LS2 9JT
United Kingdom
+44 (0)113 343 7589
STAMINA@leeds.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

CPMS 45624, IRAS 259674

Study information

Scientific title

Supported exercise TrAining for Men wIth prostate caNcer on Androgen deprivation therapy - the STAMINA programme

Acronym

STAMINA

Study hypothesis

The STAMINA programme is a 5 year programme grant for applied research funded by the NIHR. The aim is to determine whether an exercise intervention, embedded in routine NHS cancer care and supported by behaviour change, will confer long-term benefits in cancer-specific quality of life (QoL) and fatigue for men with prostate cancer (PCa) on Androgen Deprivation Therapy (ADT), and be cost effective when compared with optimised usual care. The STAMINA programme has a number of work packages.

*Please note*. This registration only pertains to work packages 4/5. All approvals for other work packages i.e. 1-3 have been sought elsewhere.

Work package 4 overview: Building on outputs from preceding work packages as part of the programme grant, and drawing on the MRC framework for complex interventions, Work Package 4 (WP4) will conduct a definitive, pragmatic cluster randomised controlled trial, evaluating the clinical and cost-effectiveness of the STAMINA intervention compared to optimised usual cancer care, in men with prostate cancer, incorporating an internal pilot phase to ensure acceptable recruitment, follow-up and intervention adherence rates.

Work Package 5 overview: A parallel, mixed methods process evaluation will be conducted based on the framework of Linnan and Steckler and informed by the Medical Research Council (MRC) guidance for process evaluation of complex interventions. The acceptability of the intervention is a key aspect for the process evaluation to explore but it is not an explicit element of the Linnan and Steckler framework. We will therefore include an assessment of acceptability following Sekhons framework.

Ethics approval

Approved 09/07/2020, West of Scotland Research Ethics Service (Ward 11, Dykebar Hospital,
Grahamston Road, Paisley, PA2 7DE, UK; +44 (0)141 314 0212; WosRec1@ggc.scot.nhs.uk), ref: 20/WS/0069

Study design

Cluster randomized controlled trial and qualitative assessment

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Prostate Cancer

Intervention

STAMINA WP4&WP5 is a definitive, multi-centre, two arm, cluster randomised controlled trial with an internal pilot), including a cost-effectiveness analysis (WP4)and an embedded process evaluation (WP5).

The study aims to recruit 1100 participants (550 optimised usual care and 550 STAMINA lifestyle intervention), from approx. 44 NHS sites considered to be within a reasonable distance of travel for the patient of a participating community-based exercise facility (i.e Nuffield Health (NH)).
In intervention sites, Healthcare Professionals (HCPs) involved in the Prostate Cancer (PCa) care pathway, will receive specialised training to provide patient facing behavioural support for initiating and maintaining exercise, and undertake a clinical review upon completion of the exercise prescription. The intervention will be predominantly delivered in NH exercise facilities by STAMINA trained Exercise Professionals (EP).
Participants in the optimised usual care arm will receive unrestricted usual care as provided by cancer care services, including cancer-specific information leaflets that promote exercise in accordance with NICE guidelines.

Eligible NHS sites (clusters) will be randomly allocated on a 1:1 basis to either the STAMINA lifestyle intervention, or optimised Usual Care, by the statistician at the Clinical Trial Research Unit (CTRU). Stratification will ensure the treatment groups are well balanced for the following characteristics: regional cancer centre vs District General Hospital and the number of men started on ADT per year (<50 vs. >=50). Cluster randomisation is appropriate as the intervention is delivered at a service level, involving training of clinical and exercise teams and with the aim of minimising contamination between the groups.

Following randomisation, sites will open to participant recruitment, with individual participants consenting to trial data collection ahead of registration. Wherever practicable recruiting researchers will not be aware of site allocation, with HCPs supporting NHS intervention activity following participant registration. We will regularly monitor for selection bias by i) reviewing monthly numbers and proportions of eligible men screened, consented and recruited by treatment arm and by site, checking for imbalance; ii) monitoring recruited participant characteristics (e.g. disease status, age etc.) by treatment arm.

Patients will be approached at their routine clinic visit by a trained STAMINA member of their health care team who will introduce the STAMINA trial and determine if the patient is interested in participating. Verbal consent will be sought from the patient for their contact details to be forwarded to a member of the central research team. The central research team member will further discuss the trial and agree and obtain consent (over the telephone) from the participant to collect data for trial purposes. Eligibility to enter the trial will be assessed at this point. Following consent and confirmation of eligibility, participants will be registered into the trial. Participants in the optimised usual care arm will be followed up as part of their routine clinic visits, (no extra visits for research purposes). Participants who attend a hospital which is in the ‘intervention group’ will be contacted to discuss what the STAMINA supported exercise programme involves for them.

The primary outcomes for the trial are whether the STAMINA lifestyle intervention, improves participant cancer-specific quality of life for men with PCa,(measured using FACT-P at twelve months post registration) and whether there is a reduction in cancer-specific fatigue (measured using FACT-F at twelve months post registration). The trial outcome data will be collected using self-report postal/online questionnaires based on participant preference at three, six, and twelve months (with additional collection at twenty-four months for those recruited early to the trial). Additional supplementary support will be available via postal/telephone/online/text reminders as required. Intervention data will be collected by the care providers (NH and NHS – EP/HCP) on those patients in the intervention arm to assess adherence. Recordings of the intervention participants’ reviews with the community clinical exercise professionals will be made at induction, 3, 6, and 12 months. Safety data will be collected by care providers in accordance with the protocol.

Participants and personnel delivering the intervention will not be blind to the treatment allocation. Outcome assessment using self-report methods is planned to reduce the risk of assessment bias. Supplementary follow-up support (i.e. via telephone) will be performed blinded to treatment allocation, whenever practicable to reduce the risk of assessment bias, for study participants requiring these methods.

A process evaluation is embedded into this trial to describe the intervention implementation, uptake, experience by providers and recipients, and fidelity in delivery. We will conduct one to one interviews (telephone or face to face) and focus groups (choice depending on interviewee preference and feasibility) with a purposive sample of up to: 20 intervention study participants, 6 control arm participants; 10 carers; 20 exercise professionals, 10 health care professionals, and 10 other stakeholders. A topic guide will be used to guide the interviews. Audio recordings of review sessions between participants and exercise professionals will be rated against a checklist for delivery of behaviour change techniques and general patient-centred approach. Theoretical Domains Framework questionnaires will be given to Health Care Professionals and Exercise Professionals to complete.

Intervention type

Other

Phase

Drug names

Primary outcome measure

1. Disease-specific quality of life at 12 months post registration measured by the Functional Assessment of Cancer Therapy – Prostate (FACT-P)
2. Fatigue at 12 months post registration measured by the Functional Assessment of Cancer Therapy - Fatigue (FACT-F)

Secondary outcome measures

1. Physical, social, emotional and function wellbeing is measured using FACT-P at 3, 6 and 12 months post-registration
2. Cancer specific fatigue is measured using FACT-F at 3, 6 and 12 months post-registration
3. Leisure time physical activity measured using Godin Questionnaire at 3, 6 and 12 months
4. Fear of Cancer Recurrence is measured using FCR4 and FCR7 at 3, 6 and 12 months
5. Functional capacity and body composition is measured using blood pressure, chair sit-to-stand, waist and hip circumference and body mass at 3, 6 and 12 months
6. Adverse event rates and their severity are measured using a Safety Case Report Form
7. Cost-effectiveness is assessed using incremental cost effectiveness ratios (ICERs)
8. Quality-adjusted life year (QUALYs) is derived from the EQ-5D-5L at 3, 6, 12 and 24 months

Overall trial start date

01/09/2018

Overall trial end date

31/10/2023

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Men with prostate cancer on ADT or due to start ADT within the next twelve weeks
2. Willing and able to provide informed consent

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

Planned Sample Size: 1,100; UK Sample Size: 1,100

Participant exclusion criteria

1. Proven metastatic castrate resistant prostate cancer (mCRPC) on imaging
2. Unstable angina
3. Uncontrolled hypertension and/or diabetes mellitus
4. Recent myocardial infarction (within past 6 months)
5. Unable to provide informed consent (e.g. lacking capacity)
6. Painful or unstable bony metastases
7. Inability to read or speak English to an appropriate level is an exclusion criteria, to ensure safe compliance with the exercise programme
8. Fixed output pacemakers
9. Any other absolute contraindication to exercise as defined by clinical guidance, e.g. ACPICR standards
10. Unable to complete study assessments
11. Participation in other lifestyle intervention trials for PCa
12. Estimated life expectancy of less than 12 months for reasons unrelated to PCa diagnosis

Recruitment start date

01/11/2020

Recruitment end date

01/04/2022

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Northern General Hospital
Sheffield Teaching Hospitals NHS Foundation Trust Herries Road
Sheffield
S5 7AU
United Kingdom

Sponsor information

Organisation

Sheffield Teaching Hospitals NHS Foundation Trust

Sponsor details

Northern General Hospital
Herries road
Sheffield
S5 7AU
United Kingdom
+44 (0)1142 265945
sth.researchadministration@nhs.net

Sponsor type

Hospital/treatment centre

Website

http://www.sth.nhs.uk/

Funders

Funder type

Government

Funder name

NIHR Central Commissioning Facility (CCF); Grant Codes: RP-PG-1016-20007

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

National Institute for Health Research (NIHR) (UK)

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from CTRU-DataAccess@leeds.ac.uk Data will be shared according to a controlled access approach. Data will only be shared for participants who have given consent to use of their data for secondary research. Requests will be reviewed by relevant stakeholders. No data will be released before an appropriate agreement is in place setting out the conditions of release.

Intention to publish date

31/10/2024

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

06/07/2020: Trial’s existence confirmed by National Institute for Health Research (NIHR).