ISRCTN ISRCTN73441175
DOI https://doi.org/10.1186/ISRCTN73441175
IRAS number 333504
Secondary identifying numbers CCR 6037, CPMS 58211, IRAS 333504
Submission date
17/09/2024
Registration date
03/10/2024
Last edited
08/10/2024
Recruitment status
No longer recruiting
Overall study status
Ongoing
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
People living with HIV and anal cancer should get the care that meets all their needs. This does not always happen when services only focus on one health issue.
This new study will work with people living with HIV who are also being treated for anal cancer. This is to find out what matters most and how to improve cancer services.
We already know that people who get the care they need do better. They are more likely to take treatments and look after themselves. They are less likely to need extra hospital services.
People living with HIV are getting older and are more likely to get other illnesses that need treatment. They face stigma in society.
Although anal cancer is rare, HIV increases the risk and it occurs earlier. The incidence of anal cancer in the general population is 1.6 per 100,000 person-years. Among men who have sex with men and who are living with HIV, this is about 89 per 100,000 person-years.
Treatment is very effective but can also cause side effects that affect long-term quality of life. These affect the skin, bowel, bladder and sexual function. Cancer services do not always know how bad this impact is for people. This can mean that people suffer, often on their own, where better options could be available.
The researchers want to work in equal partnership with people living with HIV who have direct experience of treatment for anal cancer. This way of working is called co-production. The study aims to use co -production to design new models of care and support materials to make sure this group of patients gets the care that meets all their needs.

Who can participate?
Lived experience participants: People living with HIV, 18 years and above, who have had a diagnosis of anal cancer in the last 5 years. We would also like to hear from those who closely support them such as family members, partners or friends.
Stakeholder participants: Healthcare professionals with perspectives representative of different stages in the patient pathway. Representatives of relevant charities and advocacy groups that provide support for this group of patients

What does the study involve?
Interviews:
Lived experience participants will first be approached by their clinical team and referred to the research team who will take consent to conduct an interview. The interview will include questions about anal cancer treatment and its impact, coping strategies and support needs and what could be improved. Stakeholder participants will also take part in interviews in which they will be asked to share their perspectives on assessing needs and providing information and care for this group, identifying any areas that they believe require improvement.
Intervention Development Group Meetings:
The working group with both patient participants and healthcare staff/other stakeholders will meet three times and will work together to develop new models of care and support materials.
During the meetings, findings from the interviews will be presented and ideas for improvement sought from all members. Participants will discuss everyone’s ideas and work together to develop them until the final content for improved care during treatment is agreed. As the co-production progresses in these meetings new ways of working and resources, for example, patient information will be developed.

What are the possible benefits and risks of participating?
The study is not designed to provide participants with direct benefits. However, it may be rewarding for participants to work with others who have had similar experiences and be part of a project to design better care.
It is possible that the interviews may bring back bad memories for participants. There will be an option to stop at any time and participants will be signposted to information about support available within their hospital from the clinical team.

Where is the study run from?
The sponsor of this study is The Royal Marsden NHS Foundation Trust (UK).

When is the study starting and how long is it expected to run for?
April 2024 to March 2026

Who is funding the study?
This study is financially supported by National Institute for Health and Care Research (NIHR) (UK).

Who is the main contact?
Dr Emma Hainsworth, Emma.hainsworth@rmh.nhs.uk

Contact information

Prof Susanne Cruickshank
Principal Investigator

Applied Health Research Group
Royal Marsden Hospital, Fulham Road
London
SW3 6JJ
United Kingdom

ORCiD logoORCID ID 0000-0003-0204-4739
Phone +44 (0)20 7811 8516
Email susanne.cruickshank@rmh.nhs.uk
Dr Emma Hainsworth
Public, Scientific

Applied Health Research Group
Royal Marsden Hospital, Fulham Road
London
SW3 6JJ
United Kingdom

ORCiD logoORCID ID 0000-0003-3171-4201
Phone +44 (0)20 7811 8516
Email emma.hainsworth@rmh.nhs.uk

Study information

Study designQualitative exploratory methods following a three stage multi-method framework for the co-production and prototyping of interventions. Single centre with two PIC sites
Primary study designOther
Secondary study design
Study setting(s)Hospital
Study typeOther
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleLiving with HIV and treated for Anal Cancer: an exploratory study using a co-production approach to deliver person-centred care
Study acronymHIV-AC: Person-centred care
Study objectivesAim: To co-produce a feasible and acceptable complex intervention for improving experiences of care and health related quality of life for people living with HIV who receive pelvic chemoradiotherapy for anal cancer
Ethics approval(s)

Approved 03/09/2024, West of Scotland Research Ethics Service (Ward 11, Dykebar Hospital Grahamston Road, Paisley, PA2 7DE, United Kingdom; +44 141 314 0213; WoSREC5@ggc.scot.nhs.uk), ref: 24/WS/0114

Health condition(s) or problem(s) studiedPeople living with HIV and treated for anal cancer
InterventionObservational study
This study uses a co-production methodology in which a person-centred intervention will be developed by researchers alongside stakeholders to align research and service development and increase research impact. Co-production involves the equitable engagement of partners all the way through the research process emphasising power sharing, reciprocity and mutual learning. A three stage multi-method framework for co-producing and prototyping interventions has been developed.
Stage 1: Data will be collected by evidence review, observation and in-depth interviews with lived experience participants (n=20) and stakeholders (n=15) involved in their care and support. Deliverable Stage 1: A rich and detailed description of the experiences of people living with HIV undergoing treatment for anal cancer - drawn from patient participant accounts, interviews with relevant stakeholders and focused observation of the clinical setting. A long list of priority needs during and after treatment will also be produced. The outcomes from all methods will feed into stage 2, the co-production of the intervention.

Stage 2: Three Intervention Development Meetings will be held made up of patients and stakeholders. The findings of Stage 1 will be discussed and appropriate intervention content will be co-produced along with associated resources using an action research cycle. Deliverable Stage 2: A draft intervention and associated resources will be produced

Stage 3: During the final prototype phase, two separate meetings of clinical staff (n= 10) and patient participants (n=5) will provide final feedback and comments before the final prototype is developed.  Deliverable Stage 3: A pilot intervention and associated resources will be produced.
Intervention typeOther
Primary outcome measureThe development of a pilot person-centred intervention, associated resources and guidance on delivery methods using interviews and focus group discussions with patients and stakeholders, guided by a co-production approach
Secondary outcome measuresA rich and detailed description of the experiences of people living with HIV and undergoing treatment for anal cancer drawn from patient and stakeholder interviews
Overall study start date01/04/2024
Completion date01/03/2026

Eligibility

Participant type(s)Patient, Health professional, Carer, Other
Age groupAdult
Lower age limit18 Years
Upper age limit90 Years
SexBoth
Target number of participantsLived experience participants n=20. Stakeholder participants n=15
Key inclusion criteriaLived Experience participants:
1. HIV positive
2. Anal cancer diagnosis within the last 5 years
3. 18 years and upwards
4. Has received pelvic chemoradiotherapy for anal cancer

Stakeholder participants
1. Healthcare professionals of all disciplines involved in the care and support of people living with HIV who are being treated for anal cancer
2. Members of charitable organisations and advocacy groups with relevant knowledge
Key exclusion criteriaLived experience participants:
1. Has received surgery alone or laser ablation for early-stage anal cancer/anal intraepithelial neoplasia
Date of first enrolment04/10/2024
Date of final enrolment31/07/2025

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

The Royal Marsden Hospital
Fulham Road
London
SW3 6JJ
United Kingdom

Sponsor information

Royal Marsden NHS Foundation Trust
Hospital/treatment centre

Royal Marsden Hospital, Fulham Road
London
SW3 6JJ
England
United Kingdom

Phone +44 2031865416
Email mark.brandon-grove@rmh.nhs.uk
Website http://www.royalmarsden.nhs.uk/pages/home.aspx
ROR logo "ROR" https://ror.org/0008wzh48

Funders

Funder type

Government

National Institute for Health and Care Research
Government organisation / National government
Alternative name(s)
National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location
United Kingdom

Results and Publications

Intention to publish date01/03/2027
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planPlanned publication in a peer-reviewed journal
Development of infographics and webcasts to be utilised by community organisations, relevant charities and advocacy groups
IPD sharing planThe datasets generated during and/or analysed during the current study are not expected to be made available due to the challenges of anonymising qualitative data and the risk of identifying study participants

Editorial Notes

08/10/2024: Internal review.
17/09/2024: Trial's existence confirmed by West of Scotland Research Ethics Service.