Trial Title:
Personalised Cancer Care and Support: Identifying What Good Looks Like
NCT ID:
NCT05702684
Condition:
Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Other
Intervention:
Intervention type:
Other
Intervention name:
electronic Holistic Needs Assessment (eHNA)
Description:
eHNA to be completed within 31 days of diagnosis (standard care). ARC clinic previously
offered 6-24 months post-diagnosis.
Arm group label:
People living with colorectal cancer
Arm group label:
People living with treatable-but-not-curable cancer
Other name:
ARC clinic
Summary:
The overarching aim is to study the coproduction of personalised care in a digital age by
seeking to improve the experience of care and personalised care and support planning for
people who live with and beyond colorectal cancer. This study will assess digital health
contributions to personalised care and explore how to improve the quality of
collaborative digital care planning in cancer services. The electronic holistic needs
assessment (eHNA) developed by Macmillan Cancer Support
(macmillan.org.uk/healthcare-professionals/innovation-in-cancer-care/holistic-needs-asses
sment/sign-up-to-ehna) will be used as a case study to help advance this aspect of
healthcare improvement studies.
The primary objective is to gain a better understanding of how personalised care and
support planning in the form of the eHNA and consultation works (or not) from the
perspectives of people who are living with and beyond colorectal cancer, and clinicians.
The secondary objectives are to:
i. identify what good practice looks like for digital personalised care and support
planning in a specific tumour group (colorectal) and at a point in the cancer pathway
(within 31 days of diagnosis)
ii. explore if the ARC framework can be used to inform personalised cancer care and
support planning
The research will review current practice and focus on identifying what good looks like
for digital cancer care planning. It will go on to explore how what we know about LWBC
can be used to inform the co-design of digital care planning that better supports
personalised long-term cancer care. From the outset, this early work will help to inform
future issues around generalisability and scaling-up.
Detailed description:
The study will use two forms of data collection: 1) Video-Reflexive Ethnography (VRE) and
2) individual interviews with patient/clinician dyads from the ARC clinic.
1. Video-reflexive ethnography Video-reflexive ethnography (VRE) is a collaborative
participatory methodology used by researchers and participants, such as patients and
clinicians, to understand, reflect, and improve patient experience and clinicians'
work practices. Participants and researchers work together to engage with and
co-construct the research, that involves three sequential phases: i) field
observations of practice, ii) video recording of in-situ practice, and iii)
discussing edited footage with participants in video-reflexive sessions. The film is
a vital component of the process, and the critical appraisal gives participant
involvement in identifying/determining the focus based on the appraisal of the real
time or in-situ practice.
i) Field observations of practice Observations of practice will be undertaken at the
outset in order to capture everyday patient and staff practice and to map existing
eHNA/personalised care and support planning processes and interactions (i.e.,
delivery and content).
ii) Video recording of in-situ practice The research will focus on observing/filming
the two components of the eHNA process by following (the same) patient-staff dyads
(n=up to 15 in total across all sites) from eHNA tool to care plan. The sample size
is appropriate, in terms being able to answer the research question and the
methodological orientation of VRE and EBCD and the current debates on saturation.
Component 1: Observing (in-person or virtual) patients as they interact with the
eHNA
The eHNA tool is a patient-held self-assessment, so if the patient chooses to
complete the eHNA at home, the researcher will offer to host the session in-person
or virtually (i.e., using zoom or MS Teams, according to their preference). Virtual
observations describe a form of data collection when the researcher can witness an
event that is happening online and videoconferencing (i.e., zoom) has been rated as
an acceptable form of online qualitative data collection. Think aloud and
question-asking techniques will be used as patients interact with the eHNA to gather
user reasoning and feedback on experience as the intervention is happening. The
question-asking method goes one step further than the think-aloud method, in a way
that the researcher asks questions about the product being tested (eHNA tool). These
methods have been successfully used in previous studies that evaluate prototypes of
digital health systems. The participants do not have to tell the researcher anything
about their health concerns or their medical care if they do not want to.
Component 2: Observing (in-person or virtual) the care planning consultation with
patients and clinicians
With participant consent, the researcher will observe the care planning consultation
with the (same) patient and their clinician as they review the eHNA data, conduct
the care planning consultation, and complete a care plan. The observation will be
video and audio-recorded to capture the interaction and to provide an opportunity to
re-review the complexities of healthcare communication. The researcher's aim is to
be unobtrusive, but to learn about healthcare interactions and the practices and
tasks that each person is (or is not) involved in as part of personalised care and
support planning. The consultation forms a component of the eHNA process and is
offered to all patients as standard care. The consultation meeting is usually
organised by the clinician and conducted in a private 1:1 space. If the clinical
interaction is conducted virtually (i.e., a zoom consultation), the researcher will
join the meeting virtually. If the consultation is conducted by telephone, the
researcher will either join the meeting from the NHS Trust site and the consultation
will take place by speakerphone in a private room.
Alternatively, the researcher will join the meeting with the patient, according to
patient preference. The researcher will not speak during observations unless
participants have questions about the study.
iii) Video-reflexive sessions with a) patients, b) clinicians, and c) teams
The research team/chief investigator will edit clips from the two videos into a
short 5-10 minute film. Patients will be asked to attend a video-recorded reflexive
session to review the video footage and reflect on their eHNA and care planning
experience. They will be asked to reflect on what has gone well and what could be
improved. This session will take place at home or in a private room at the NHS Trust
site where the patient receives their care. If the patient chooses to have the
session at home, the researcher will offer to host the session in-person or
virtually (i.e., using zoom or MS Teams, according to their preference).
Clips from the three videos (i) patient as they interact with the eHNA tool, ii)
care planning consultation, iii) patient reflexive session will then be edited into
one short film by the research team. The edited film will be shared with the paired
clinician to allow them to also reflect on what went well and on what could be
improved, and to learn from the experience in a clinician reflexive session. All
video clips intended for the team reflexivity sessions will be shared with the
patient/clinician to ensure they are happy for the chosen clips to be shown. In this
way, the patient/clinician can also be involved in identifying topics for analysis
and selecting the clips to be shown to teams. The edited video provides a
concentrated focus to generate conversation and to gain in-depth insight into
experiences of practice. In this way, VRE works as a catalyst for healthcare
practice change. The researcher is also actively involved in the process as a
co-creator, that is, leading the editing of video clips and facilitating the
reflexive sessions. The staff and team reflexive sessions will last approximately
60-90 minutes and will take place either face-to-face at the NHS Trust site where
the clinician/team works or online, depending on preference. The session will be led
by a researcher and will be audio-recorded in order to capture all experiences,
views, and ideas accurately. Before all reflexivity sessions, the edited clips are
reviewed by those featured in footage and the specific time and place for the
reflexivity sessions are decided in negotiation with the participants. The focus of
the clinician/team reflexive sessions is for staff to learn from each other (with
the help of VRE), to identify strengths of practice as well as opportunities for
improvement.
2. Individual interviews with patient/clinician dyads from the ARC clinic (in-person or
virtual depending on participant preference and/or covid-19 regulations)
Interview data meets the research aim by capturing perspectives, attitudes, and values in
relation to personalised care and support planning. Semi-structured individual interviews
will explore experiences of attending/working in the ARC clinic, perspectives on the
value of the ARC clinic intervention, areas for improvement, and will allow for overall
reflection of being involved in the ARC clinic project/their experience of care. As this
is an investigative study, individuals will be encouraged to tell their own story and to
share their views, attitudes, experiences, and perceptions in an open way. Patients (n=5)
and clinicians (n=3) will be interviewed separately and not together as a pair.
Criteria for eligibility:
Study pop:
The study will focus on colorectal (including metastatic disease but not end of life)
cancer. This group of patients have immediate needs (i.e., body image, disruption in
life), and require ongoing treatment (up to 15 years of treatment options). This tumour
group also has a fairly equal age and gender distribution and is underrepresented in
research (Sun et al., 2021). Changes to colorectal cancer care delivery during the
COVID-19 pandemic have also shown to increase healthcare inequalities (Ip et al., 2022).
The study will focus on the eHNA process at diagnosis (within 31 days of diagnosis)
because this is already a focus for services in terms of meeting NHS England key
performance indicators.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
Patients
1. Patients (who are living with and beyond colorectal cancer) who have agreed to
complete the eHNA intervention within 31 days of diagnosis OR patients who received
the ARC clinic HNA intervention.
2. Over 18 years of age
3. Speak a conversational level of English Patients will be sampled purposively to
ensure a range of experiences. Patients will be sampled on ethnicity, gender, age,
time since diagnosis, socio-economic status, and digital maturity, so that findings
can also be used to explore and address cancer inequalities.
Paired clinicians
1. Clinicians (e.g., CNS, AHP, cancer support worker) who work in cancer services and
provide the eHNA/ARC intervention to (the recruited) patients who are living with
colorectal cancer.
2. Over the age of 18
3. Speak a conversational level of English.
Team members
1. Clinicians (e.g., CNS, AHP, cancer support worker) who work in the colorectal cancer
team or who work in close liaison with the colorectal cancer team and are
responsible for providing the eHNA and care planning consultation.
2. Over the age of 18
3. Speak a conversational level of English.
Exclusion Criteria:
Patients
1. Patients (who are living with and beyond cancer) who are receiving treatment but who
have not agreed to complete an eHNA /patients who did not attend the ARC clinic.
2. Under 18 years of age
3. Do not speak a conversational level of English
4. Patients who lack capacity to consent
Patients that are approached to take part in the study but who do not want to participate
will automatically be excluded from the project. Insufficient ability to understand/speak
English is an exclusion criterion for this study because the research uses audio
recordings of verbal conversation and relies on understanding of written study materials
in order to ensure informed consent. Participants with a low level of literacy (but with
adequate conversational level of English) can be supported by having the researcher read
out the participant information sheet and consent form, and to check for understanding.
Paired Clinicians 1. Clinicians who do not provide the eHNA intervention /ARC
intervention to patients who are living with and beyond cancer.
Team members
1. Clinicians (e.g., CNS, AHP, cancer support worker) who do not work in the colorectal
cancer team or in close liaison with the colorectal cancer team.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Guy's & St Thomas' NHS Foundation Trust
Address:
City:
London
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
June Allen
Start date:
July 31, 2023
Completion date:
January 9, 2025
Lead sponsor:
Agency:
King's College London
Agency class:
Other
Source:
King's College London
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05702684
