Evaluation of the Implementation of Personalised Follow-up in Head and Neck Cancer

NCT06170203 | Unknown

• 1 other identifier: 320336
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (3)

• 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

  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.

  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.

  End of study, 12 months

Secondary Outcomes (3)

• Patient experience within the Personalised Follow Up Pathway.

  End of study, 12 months

• Service provider experience within the Personalised Follow Up Pathway.

  End of study, 12 months

• Sustainability of the Personalised Follow Up Pathway

  End of study, 12 months

Interventions

Personalised Follow-up Pathway OTHER

Discharge from routine oncology Follow-Up 2 years following radical treatment for a head and neck cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead

Study Sites (1)

Laura Dean

London, E151gu, United Kingdom

RECRUITING

Related Publications (1)

• 1. NHS England. The NHS Long Term Plan. (2019) https://www.longtermplan.nhs.uk

  BACKGROUND

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Central Study Contacts

Laura Dean

CONTACT

+447391661798; laura.dean@gstt.nhs.uk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: December 14, 2023
• Study Start: August 8, 2023
• Primary Completion: September 10, 2024
• Study Completion: September 10, 2024
• Last Updated: December 14, 2023

Record last verified: 2023-12

Locations

GB (1)