Trial Title:
Ii-HANC Improving Incurable Head and Neck Cancer Healthcare Experiences
NCT ID:
NCT05714436
Condition:
Head and Neck Cancer
Conditions: Official terms:
Head and Neck Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Summary:
This research aims to improve experiences of patients with incurable head and neck cancer
(IHNC) by finding out the most pressing issues for them and developing solutions to
improve these.
Patients with IHNC have many complex needs and the level of support they require is often
greater than other illnesses. IHNC symptoms cause major changes to basic functions, such
as: being unable to talk; severe swallowing problems with a high choking risk; breathing
difficulties requiring a hole in the neck (tracheostomy). The manner of death can be
highly traumatic and frightening e.g. catastrophic bleeding from the neck. Despite this
poor outlook, little is known about patients' needs in the last year of life. However,
IHNC patients have more emergency hospital visits compared with other cancer groups.
Patients from poorer areas are more likely to die in hospital. Furthermore, head and neck
cancer (HNC) units are centralised, with access to specialist services dependent on where
the patient lives.
The researcher wishes to understand 'stress points' in the patients' journey, where
things do not go as planned, identify priorities for change and develop patient-led
solutions.
There are two main parts to this work, occurring over 21-months across Yorkshire,
Northwest and Northeast England.
1. A series of up to three interviews with approximately 25 IHNC patients and their
families, along with group discussions with healthcare workers involved in IHNC
care. These will explore how patients' needs and use of healthcare change over time.
2. Using interview and group discussion findings, the study team will hold a series of
workshops with patients, families, clinical service leaders, and healthcare workers.
The study team will identify priorities and develop ways to improve care
experiences.
The research is funded by the National Institute for Health Research (NIHR) Research for
Patient Benefit programme.
Detailed description:
STUDY DESIGN - A prospective longitudinal qualitative study across three regions of North
England, accompanied by co-design workshops which will utilise study findings to identify
priority areas for improving care for patients with incurable Head and Neck Cancer (HNC).
SETTING - Three HNC centres based in Northwest, Northeast and Yorkshire representing
areas of high incidence of HNC, diverse socioeconomic populations and heterogenous
geographical locations (main sites - Newcastle Upon Tyne Hospitals National Health
Service (NHS) Foundation Trust, Liverpool University Hospitals NHS Foundation Trust and
Sheffield Teaching Hospitals NHS Foundation Trust).
METHODS
Work package 1: Longitudinal qualitative study (months 1-18) This will comprise of
longitudinal interviews with patients and family carers (WP1a) and focus groups with
healthcare professionals (WP1b).
WP1a: Longitudinal interviews Rationale for study design: Previous qualitative HNC
studies all entailed participants being asked once about their experiences. Longitudinal
interviews shed light on how issues evolve over time and are particularly suitable when
there is an unpredictable disease trajectory; changing needs; and interactions with
healthcare services are varied and complex. They offer advantages over a single interview
or a comparison of 'snapshot' data at different stages in an illness. These include:
capturing change over time; facilitating more private, evolving accounts; and exploring
how external factors, such as the influence of healthcare services over the course of the
patient journey, affect needs and experiences. They can highlight shortcomings and allow
suggestions for improvements. Additionally, longitudinal interviews facilitate a
continuing relationship between the researcher and participant bringing personal
satisfaction to both parties as well as helping make any 'after-death' interviews with
family carers more acceptable. The feasibility and acceptability of longitudinal
interviews with people with incurable disease are demonstrated by Murray et al (2009).
They report on longitudinal interviews conducted with more than 150 palliative care
patients (including those with lung cancer, brain tumours, severe chronic obstructive
airways disease and advance cardiac failure).
Study population: Incurable HNC patients and/or their family carer.
Sampling: The study team will recruit a range (n=18-25) of HNC patients (+/- their family
carer) over an initial 7-months (aiming to conduct up to 60 interviews). Maximum variety
sampling will be undertaken using variables anticipated to experience differences in care
and outcomes e.g. age, gender, ethnicity, living alone, and postcode (to determine
distance from cancer centre and link to Index of Multiple Deprivation). A matrix will be
constructed with the selected variables and will be reviewed after each participant is
recruited to determine which groups have been 'captured' and to target further
recruitment to where 'gaps' exist. Liaison with clinical colleagues to highlight these
'gaps' will help direct ongoing recruitment.
Recruitment: Potential participants will be identified through HNC and Specialist
Palliative Care Multi-disciplinary Team (MDT) meetings, outpatient clinics (both
face-to-face and virtual consultations), in-patient and community settings. Initial
approaches via local healthcare professionals will be tailored to each site.
Data collection: Participants will be invited to take part in 3 qualitative,
semi-structured interviews at 4 monthly intervals. Interviews (video, telephone or if
limited verbal communication, face-to-face or online written interviews) will be
conducted depending on COVID restrictions/participant preferences at a time and place of
their choice. Online written interviews use a shared document e.g., Google Docs, during
the online interview and enable the interview to be conducted in writing (if a potential
participant is unable to verbalise). Both the interviewer and interviewee will have
access to the shared document. Initially, an introductory paragraph from the topic guide
will be pasted into the online shared document by the interviewer. The interviewer will
then type in the first question and allow the interviewee to type their response.
The interview length will be determined by the patients' ability to participate, aiming
for approximately 45 minutes. Subsequent interviews will be approximately 30 minutes and
more focused on changes since the last interview. Interviews will be open and
conversational loosely following the topic guide (developed in collaboration with PPI
group), using a blended approach of interview techniques, with passive interviewing
allowing the participant space and time to tell their story (narrative), and more active
techniques, including appreciative inquiry employed. Interviews will be digitally
recorded, with the participants' consent, with field notes made to include any additional
comments or reflections by the researcher.
Baseline demographic data will be collected from the participant and will include age,
gender, ethnicity, postcode, and whether or not they live alone. Key clinical information
(collected via a standard form) will be obtained directly from clinical teams or from the
hospital records via members of the research team. The information will include date of
diagnosis, type of head and neck cancer, whether localised or metastatic disease, reason
for incurability of head and neck cancer.
With consent, and if preferred, patients will be asked if they wish to nominate a family
carer, either to support the interview process and participate in a joint interview
(representing a 'unit of care'); or to participate in an interview themselves if the
patient was unable to do so. The study team will sensitively discuss the uncertainty
about the future and the possibility, that if the patient became too unwell (or died),
advanced consent can be given for their family carer to be interviewed in their absence.
This approach has been used previously by the applicant team in palliative care studies
(Mayland). For patients who become too unwell (or die) during the course of the study,
their family carer will be approached to discuss whether they wish to participate in a
further interview.
Analysis: The interviews will be digitally recorded, transcribed verbatim by a
recommended University transcription service, and the transcripts will be anonymised.
Analysis will be supported using NVivo (qualitative data analysis software) and conducted
using a framework approach. Framework analysis facilitates both rigorous, transparent
data management but enables analysis to move backwards and forwards without losing sight
of the 'raw' data. The five stages are: familiarisation; identification of the thematic
framework; indexing; charting; and mapping and interpretation. The framework will be
developed from the principles of Picker's 'Patient Centred Care' but may include areas
beyond this to account for additional issues identified.
WP1b: On-line focus groups with healthcare professionals (HCP) (Months 13 & 14)
Rationale: Focus groups represent a type of group interview, bringing benefit from the
communication and interaction between research participants. Generally, they involve 6-10
people, and as multidisciplinary teams are involved in HNC care, represent an effective
way to seek views about our research aims compared with conducting individual interviews.
Through the COVID-19 pandemic, online methods of group discussion have become more viable
and offer advantages including: widening participation across larger geographical areas;
being more time-efficient for clinical staff; and reducing costs compared with
face-to-face meetings. However, it can be more challenging to manage discussions and
ensure engagement in online focus groups and it has been recommended to include no more
than five participants.
Study population: Healthcare professionals involved in the case of incurable HNC patients
over the last 12 months
Sampling: The study team aim to involve approximately 20 HCP. Up to 5 focus groups will
be conducted, each involving approximately 5 people. A purposive, snowball sampling
strategy will be used to gain views from different HCP perspectives, working within the
Northwest, Northeast and Yorkshire. The sample will be stratified to seek representatives
from the following groups: HNC multidisciplinary team member (surgeon, oncologist,
Clinical Nurse Specialist, allied health professionals); specialist palliative care
(SPC); and primary and community care (General Practitioners and District Nursing).
Recruitment: HCPs will be identified utilising a variety of different forums including:
- Newly established NIHR partnership project - PP-HANC network (which links the
Clinical Research Network areas of the North East and North Cumbria, Northwest Coast
and Yorkshire and Humber) including via social media.
- Regional HNC MDT meetings
- SPC MDT meetings
- Bulletins and email dissemination (within primary care and hospital trusts),
existing networks, and social media.
Within these forums, the contact details for the research team and the Participant
Information Sheet will be disseminated. Interested, eligible people will be invited to
contact the research team. Alternatively, with verbal consent, their contact details can
be forwarded to the research team via one of the study's collaborators.
Data collection: The focus groups will be conducted on-line, via a University of
Sheffield approved video-conferencing system and recorded. The focus group sessions will
last up to 90 minutes and loosely follow a topic guide.
Analysis: With consent, the focus groups will be digitally recorded, and field notes
taken. The focus groups will be transcribed verbatim by a recommended University
transcription service, and the transcripts will be anonymised. Analysis will be supported
using NVivo and will use a similar framework to the patient interviews, being mindful of
any new factors discussed not previously mentioned by patients and family carers. Any
identifiable data will be removed from the analysis. Pattern-matching across the patient
and HCP coding matrix will identify areas of congruence and incongruence.
Work package 2: Co-design workshops (months 18-20) Design: The study team will follow the
co-design approach of O'Brien and colleagues to integrate scientific evidence, expert
knowledge and experience, and stakeholder involvement to start the process of
prioritising and developing innovative solutions and interventions to help improve
experiences with healthcare services for those with incurable HNC. A hybrid approach will
be used incorporating initial 'virtual' information exchange meetings lasting
approximately 60 minutes. Then, two face-to-face co-design workshops (unless these need
adaptations due to COVID restrictions) will be conducted, lasting approximately 3 hours.
Outcomes: Initial logic model; list of innovative solutions; decision about priority
areas for intervention development.
Stakeholders: Approximately 15 stakeholders as well as project team members and three PPI
representatives from our existing group.
Individuals with 'lived experience' (n=5-8). In addition to three PPI representatives,
the study team will involve HNC patients and those who have been involved in caring for
someone with HNC (family and friends). They will be approached using a variety of routes
including current study participants, existing contacts through HNC support groups and
charities (e.g., Swallows), our NIHR Partnership project (PP-HANC), and our HCP co-leads
(Mayland, Patterson) and clinical colleagues. Healthcare professionals, commissioners and
service leads (n=5-8). The study team will include a diverse group and approach HCP,
commissioners, and service leads involved in the funding and provision of care for
incurable HNC patients. Healthcare professionals who work within the community (GPs,
community nurses, SPC professionals) and hospital setting (oncologists, allied health
professionals, clinical nurse specialists) will be considered. In addition to the
approaches listed above, stakeholders will be contacted through current linkages with our
NIHR Partnership project (PP-HANC), Cancer Alliances, the emerging Integrated Care
Systems, and partnerships such as the Liverpool Head and Neck Centre.
Methods Invitation: Those interested will be approached using both verbal and written
means. With permission, they will be contacted by the researcher to have the opportunity
to ask questions/have further discussions. Consent will be obtained for participation in
the three co-design workshops. If the participant wishes to proceed, they will be sent a
link to an online consent form. Prior to first workshop, the research team will confirm
the participant has read the Participant Information Sheet and completed the online
consent form. If the consent form has not been received by the time of the initial
meeting, recorded verbal consent will be obtained. A copy of the agreed consent form will
be sent to the participant and the verbal recording of consent will be stored separately
to the main interview recording. Permission to audio-record the meetings and co-design
workshops will be obtained. These will not be transcribed but will form an additional
account of the workshops.
Initial information exchange meetings (month 18) Purpose: To build relationships and
present an overview of the study; provide opportunity for participants to share their
experiences and how they relate to the preliminary study findings; outline the purpose of
the co-design workshops.
Setting: The initial information exchange meetings will be held online.
Outcomes: Key stakeholders informed about subsequent co-design workshops; increased
awareness of local contextual differences and lived experiences.
Methods: Two group meetings will be conducted virtually - one for those with lived
experience and one for other stakeholders. By having initial meetings in a smaller
format, this supports the sharing of lived experiences, local contextual differences and
enables these to influence and shape the subsequent iterative work. A summary of our
preliminary qualitative interview and focus group findings will be presented and details
about the processes used in subsequent workshops.
Co-design workshop 1 (month 19) Purpose: To identify and prioritise 'stress-points' in
the system, where things need to be improved, and generate initial ideas for solutions.
Outcomes: Collation of workshop ideas to help identify the initial elements of a
preliminary logic model.
Setting: The workshop will take place in-person in a location accessible to all
stakeholders.
Methods: Prior to the workshops, the study team will generate a series of vignettes from
our interview findings that stakeholders can engage with to stimulate discussion. The
vignettes will represent personas (representing a different HNC patient) with specific
characteristics, circumstances and challenges reflecting real life experiences relating
to healthcare service use that arose from the interviews and focus groups. The vignettes
will be informed by PPI engagement (month 16), clinical experiences and our systematic
reviews. Within the co-design workshop, discussion about the vignettes will be based
around the principles of 'Patient Centered Care' and how well or not each of these are
addressed. Stakeholders will work collaboratively and iteratively to discuss key issues
and the potential reasoning. Ideas will be generated about what would be useful and/or
needed to achieve patient-centered care and experience. The research team have excellent
facilitation and communication skills to ensure all voices are heard. Following the
workshop, the research team will use the ideas and discussion, to begin the process of
identifying the initial elements of a logic model (contextual issues, mechanism,
outcomes) mapping the issues across the incurable HNC patient journey.
Co-design workshop 2 (month 20) Purpose: To present initial elements of a logic model; To
generate potential solutions and consider interventions in the context of barriers,
facilitators, strengths and weaknesses
Outcome: List of potential solutions and priority areas for intervention development;
Refined logic model
Setting: The workshop will take place in-person in a location accessible to all
stakeholders.
Methods: Key stakeholders will be provided with the ideas about potential solutions and
the initial elements of a logic model. Using the principles of the 'Six Hats Exercise',
participants will be invited to discuss the barriers, facilitators, strengths and
weaknesses from different perspectives (i.e. each 'hat' will represent different people,
such as a person with HNC, family member, oncologist to help consider other viewpoints).
Further discussion will draw together priority areas for intervention development and the
elements of a refined logic model (resources, activities, contextual issues, mechanisms,
outputs and outcomes).
Next steps: Following the co-design workshops, the research team will bring together the
findings into a refined logic model and the potential areas for future intervention
development (in keeping with the Medical Research Council guidance). This will inform a
follow-on grant application, seeking to develop, optimize and conduct initial feasibility
testing for an intervention to improve experiences for those with incurable HNC and their
families.
Criteria for eligibility:
Study pop:
Patients with Head and Neck Cancer and their carers/ family. Healthcare Professionals
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- INTERVIEWS WITH PATIENTS AND CARERS
- Have a clinical diagnosis of incurable HNC where the intent of any treatment is
palliative, including those with:
- incurable primary HNC
- recurrent or persistent HNC not amenable for further curative treatment
- metastatic disease
- other co-morbidities (including a concurrent primary cancer at another
site) meaning curative treatment is either not advised by the MDT or
reflected by the patients' choice
- Are >= 18 years old
- Able to give informed consent
- Reside within the networks covered by the three chosen HNC centres
- Or are/was a family carer (>= 18 years old) to someone participating in the
study.
FOCUS GROUPS WITH HEALTHCARE PROFESSIONALS
- Any HCP who has been involved in the case of incurable HNC patients over the last 12
months
- Works clinically within the regions of the Northwest, Northeast or Yorkshire (in
keeping with the Clinical Research Network areas of the North East and North
Cumbria, Northwest Coast and Yorkshire and Humber https://local.nihr.ac.uk/lcrn/).
- Are >= 18 years old
- Able to give informed consent
- Able to participate in an online focus group, when required.
Exclusion Criteria:
- INTERVIEWS WITH PATIENTS AND CARERS
- Unable to provide fully informed written consent FOCUS GROUPS WITH HEALTHCARE
PROFESSIONALS
- Unable to provide informed consent
- Unable to participate in an online focus group, when required.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Sheffield Teaching Hospitals NHS Foundation Trust
Address:
City:
Sheffield
Zip:
S10 2JF
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Sarah Birchall, MSc
Phone:
0114 271 1658
Phone ext:
11658
Email:
sarah.birchall4@nhs.net
Start date:
April 19, 2023
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Sheffield Teaching Hospitals NHS Foundation Trust
Agency class:
Other
Collaborator:
Agency:
University of Sheffield
Agency class:
Other
Collaborator:
Agency:
University of Newcastle Upon-Tyne
Agency class:
Other
Collaborator:
Agency:
University of Liverpool
Agency class:
Other
Collaborator:
Agency:
Lancaster University
Agency class:
Other
Source:
Sheffield Teaching Hospitals NHS Foundation Trust
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05714436
