Head and Neck CancerEMPOWERNCT06170203
Evaluation of the Implementation of Personalised Follow-up in Head and Neck Cancer
An observational study of Head and Neck Cancer, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The NHS Long Term Plan for Cancer has set out the strategy to deliver personalised care to every patient treated for cancer (1) to improve experience and quality of life for patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Personalised Follow-up Pathway
- How many people
- 33 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Aug 2023to 10 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who have been treated for Head and Neck Cancer. Members of the MDT caring for patients who have been treated for HNC
Patient inclusion criteria
- Patients referred to the Head and Neck Cancer Personalised Follow Up clinic
- Patients who had oncological treatment for a Head and Neck cancer
- Patients who were treated with curative intent and who are disease free
- Patients who are at least 2 years post treatment completion
- Patients who have no risk factors of disease recurrence Staff Criteria
- Oncologists, surgeons, allied health practitioners, nurses, and support staff who provide care for patients with Head and Neck Cancer
- Willing to participate in a qualitative interview or focus group
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Laura Dean
London, E151gu
Laura Dean, +447391661798, laura.dean@gstt.nhs.uk
About this study
The NHS Long Term Plan for Cancer has set out the strategy to deliver personalised care to every patient treated for cancer (1) to improve experience and quality of life for patients. Personalised Follow-Up (PFU) focuses on the tailored needs of patients who have completed cancer treatment and PFU programmes have been established nationally for patients with breast and colorectal cancer. PFU for Head and Neck Cancer (HNC) services will be established nationally by 2024. Currently, there is a lack of evidence that measures prospectively the impact of PFU on patients and providers.
In January 2022, Guys and St. Thomas' NHS Foundation Trust initiated PFU for patients with HNC. For the first 2 years following treatment, patients treated curatively are followed up according to institutional protocol. At 2 years following completion of treatment, patients who remain disease free, have no significant risk factors for recurrence and no severe treatment-related toxicity are referred to the programme and discharged from routine oncology FU. Patients are reviewed in a nurse-led HNC PFU clinic where they receive personalised survivorship, health promotion and education in identifying signs of disease recurrence with information on the pathway to re-present directly to the services at Guy's Cancer.
This mixed methods research project will evaluate implementation factors of this new PFU programme whilst prospectively measuring its effectiveness. A hybrid type 2 implementation-effectiveness study design will be used to determine the value patients and health care providers (HCP). Semi-structured interviews and focus groups with patients and HCP will be undertaken to evaluate barriers and facilitators, safety, acceptability and user experience. Data will be collected over a 24 month period. All patients who are transferred to the PFU pathway will be eligible to participate, alongside HCP involved in delivering the service.
Read the detailed description
This mixed methods implementation science study aims to develop an understanding of the barriers and facilitators of a high level of fidelity that is sustainable for use by patients and health care providers.
Central to the construct of ethical research is the protection of participants' rights and prevention of harm. Participants should not feel coerced to participate and careful consideration has been given to the recruitment process to ensure informed consent. All participants will be provided with study information at least 10 days before written consent is obtained and verbal consent will be reconfirmed throughout the research process. Participation will be voluntary. Confidentiality of all information will be maintained in accordance with Caldicott Principles. Any patient-identifiable information and research data that is collected will be stored securely on a password-protected encrypted device, in accordance with General Data Protection Regulations. Research data will be collected on paper or electronic web based questionnaires and from qualitative interviews. Primary research data (eg. verbatim transcripts and tabulated data from individual questionnaire responses) will only be accessible to the research team, who are employed by the hospital site.
All patients within the PFU programme will be considered for inclusion within the research, however purposive sampling will be used to select patients for interview to ensure a range of patient demographics, treatments and clinical condition. The researcher will explain the study to patients and will provide a study information pack, including an introductory letter, information sheet and consent form. The researcher will contact the patient at least 48 hours after initial contact to explain the research further and to confirm if the patient would like to participate.
A Patient and Public Involvement (PPI) group comprised of patients and carers' who have received treatment for HNC, has been established to provide expert advice and act in partnership with the researchers with regards to all aspects of the project. PPI members meet bi-monthly to support pathway implementation and will co-design interview schedules to ensure they are participation friendly and ethically sound. PPI members will play a crucial role in ensuring the results of this research are provided with sensitivity to study participants and the wider public once the research is complete.
- Conditions
- Head and Neck Cancer
- Being tested
- Personalised Follow-up Pathway
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalised Follow-up PathwayOther
Discharge from routine oncology Follow-Up 2 years following radical treatment for a head and neck cancer
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of PFU pathway to patients with Head and Neck Cancer.
Semi structured interviews will be conducted with patients within the Personalised Follow Up Pathway to explore the acceptability of the pathway, the resources and the transition of care away from the 5 year follow up pathway
Measured: End of study, 12 months
Acceptability of PFU pathway to service providers within Head and Neck Cancer.
Semi structured interviews will be conducted with service providers within Head and Neck Cancer, to explore the acceptability of the pathway, the resources and the protocol.
Measured: End of study, 12 months
Safety of a Personalised Follow Up Pathway within Head and Neck Cancer
Clinical data will be collected with regards to any recurrent cancers that are diagnosed for patients within this pathway. Time from symptom recognition to clinical review and diagnosis will be monitored.
Measured: End of study, 12 months
Secondary outcomes (3)
Patient experience within the Personalised Follow Up Pathway.
Cross sectional patient surveys and semi-structured interviews will be conducted to explore the experience of patients within the Personalised Follow Up Pathway
Measured: End of study, 12 months
Service provider experience within the Personalised Follow Up Pathway.
Semi-structured interviews will be conducted to explore the experience of service providers within the Personalised Follow Up Pathway.
Measured: End of study, 12 months
Sustainability of the Personalised Follow Up Pathway
Semi structured interviews will be conducted with patients and staff to explore the barriers and facilitators that will influence the sustainability of this pathway, within the institution
Measured: End of study, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start8 Aug 2023
- Primary completion10 Sep 2024 (estimated)
- Study completion10 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06170203
- Sponsor's protocol ID
- 320336
- Acronym
- EMPOWER
- Status last verified
- Dec 2023
- First submitted
- 28 Nov 2023
- Last updated
- 14 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
1. NHS England. The NHS Long Term Plan. (2019) https://www.longtermplan.nhs.uk
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Implementation of Personalised Follow-up in Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT06170203
- Acronym / sponsor ID
- EMPOWER / 320336
- Conditions
- Head and Neck Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- 8 Aug 2023 (actual)
- Primary completion
- 10 Sep 2024 (estimated)
- Study completion
- 10 Sep 2024 (estimated)
- First posted
- 14 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The NHS Long Term Plan for Cancer has set out the strategy to deliver personalised care to every patient treated for cancer (1) to improve experience and quality of life for patients. Personalised Follow-Up (PFU) focuses on the tailored needs of patients who have completed cancer treatment and PFU programmes have been established nationally for patients with breast and colorectal cancer. PFU for Head and Neck Cancer (HNC) services will be established nationally by 2024. Currently, there is a lack of evidence that measures prospectively the impact of PFU on patients and providers.
In January 2022, Guys and St. Thomas' NHS Foundation Trust initiated PFU for patients with HNC. For the first 2 years following treatment, patients treated curatively are followed up according to institutional protocol. At 2 years following completion of treatment, patients who remain disease free, have no significant risk factors for recurrence and no severe treatment-related toxicity are referred to the programme and discharged from routine oncology FU. Patients are reviewed in a nurse-led HNC PFU clinic where they receive personalised survivorship, health promotion and education in identifying signs of disease recurrence with information on the pathway to re-present directly to the services at Guy's Cancer.
This mixed methods research project will evaluate implementation factors of this new PFU programme whilst prospectively measuring its effectiveness. A hybrid type 2 implementation-effectiveness study design will be used to determine the value patients and health care providers (HCP). Semi-structured interviews and focus groups with patients and HCP will be undertaken to evaluate barriers and facilitators, safety, acceptability and user experience. Data will be collected over a 24 month period. All patients who are transferred to the PFU pathway will be eligible to participate, alongside HCP involved in delivering the service.
Detailed description
This mixed methods implementation science study aims to develop an understanding of the barriers and facilitators of a high level of fidelity that is sustainable for use by patients and health care providers.
Central to the construct of ethical research is the protection of participants' rights and prevention of harm. Participants should not feel coerced to participate and careful consideration has been given to the recruitment process to ensure informed consent. All participants will be provided with study information at least 10 days before written consent is obtained and verbal consent will be reconfirmed throughout the research process. Participation will be voluntary. Confidentiality of all information will be maintained in accordance with Caldicott Principles. Any patient-identifiable information and research data that is collected will be stored securely on a password-protected encrypted device, in accordance with General Data Protection Regulations. Research data will be collected on paper or electronic web based questionnaires and from qualitative interviews. Primary research data (eg. verbatim transcripts and tabulated data from individual questionnaire responses) will only be accessible to the research team, who are employed by the hospital site.
All patients within the PFU programme will be considered for inclusion within the research, however purposive sampling will be used to select patients for interview to ensure a range of patient demographics, treatments and clinical condition. The researcher will explain the study to patients and will provide a study information pack, including an introductory letter, information sheet and consent form. The researcher will contact the patient at least 48 hours after initial contact to explain the research further and to confirm if the patient would like to participate.
A Patient and Public Involvement (PPI) group comprised of patients and carers' who have received treatment for HNC, has been established to provide expert advice and act in partnership with the researchers with regards to all aspects of the project. PPI members meet bi-monthly to support pathway implementation and will co-design interview schedules to ensure they are participation friendly and ethically sound. PPI members will play a crucial role in ensuring the results of this research are provided with sensitivity to study participants and the wider public once the research is complete.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have been treated for Head and Neck Cancer. Members of the MDT caring for patients who have been treated for HNC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalised Follow-up PathwayDischarge from routine oncology Follow-Up 2 years following radical treatment for a head and neck cancer | Other | – |
Primary outcome
Acceptability of PFU pathway to patients with Head and Neck Cancer.
Time frame: End of study, 12 months
Semi structured interviews will be conducted with patients within the Personalised Follow Up Pathway to explore the acceptability of the pathway, the resources and the transition of care away from the 5 year follow up pathway
Acceptability of PFU pathway to service providers within Head and Neck Cancer.
Time frame: End of study, 12 months
Semi structured interviews will be conducted with service providers within Head and Neck Cancer, to explore the acceptability of the pathway, the resources and the protocol.
Safety of a Personalised Follow Up Pathway within Head and Neck Cancer
Time frame: End of study, 12 months
Clinical data will be collected with regards to any recurrent cancers that are diagnosed for patients within this pathway. Time from symptom recognition to clinical review and diagnosis will be monitored.
3 secondary outcomes
Patient experience within the Personalised Follow Up Pathway.
Time frame: End of study, 12 months
Service provider experience within the Personalised Follow Up Pathway.
Time frame: End of study, 12 months
Sustainability of the Personalised Follow Up Pathway
Time frame: End of study, 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2023.
- Background1. NHS England. The NHS Long Term Plan. (2019) https://www.longtermplan.nhs.uk
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laura Dean (+447391661798, laura.dean@gstt.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of PFU pathway to patients with Head and Neck Cancer. (time frame: End of study, 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06170203, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2023.