Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2025-12-25 @ 4:43 PM
Study NCT ID:
NCT06170203
Status:
RECRUITING
Last Update Posted:
2023-12-14
First Post:
2023-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Implementation of Personalised Follow-up in Head and Neck Cancer
Sponsor:
Guy's and St Thomas' NHS Foundation Trust
Organization:
Study Overview
Official Title:
Evaluation of the Implementation of Personalised Follow-up in Head and Neck Cancer
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EMPOWER
Brief 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. 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.
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: