Individualized Follow-Up for Head and Neck Cancer

NCT05386225 | Unknown

• 1 other identifier: 112491
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study evaluates offering Head and Neck Cancer (HNC) patients a choice between standardized and individualized follow-up after HNC treatment. Following treatment, the patient will be educated about self-examination of the head and neck and which physical symptoms require a follow-up visit. After completing 1.5 years of uncomplicated guideline-prescribed follow-up, patients will be offered the option to switch to individualized follow-up through a tailored decision aid. Standardized follow-up entails continuing the guideline-prescribed follow-up schedule until five years after treatment. Individualized follow-up consists of follow-up visits based on symptoms and other needs at the patient's initiative. We hypothesize that giving patients the choice between standardized and individualized follow-up is feasible and saves costs while maintaining quality of life.

Conditions

Head and Neck Cancer

Keywords

Follow-Up Care; Follow-Up Studies

Outcome Measures

Primary Outcomes (6)

• Follow-up decision

  The type of follow-up that was chosen (standardized or individualized) will be distracted from the electronical patient record.

  Baseline

• Demand - assessed by the reach

  Number of patients who received the decision-aid and the choice for follow-up in our clinical practice divided by the number of patients eligible to use the decision-aid and thus make a choice between the two follow-up programs.

  1.5 years

• Acceptability - assessed by the SUS

  The use of the decision-aid will be evaluated using the System Usability Scale (SUS): 10 items giving a global view of subjective assessments of usability of the decision-aid on a 5-point scale from strongly disagree (1) to strongly agree (5). A higher score means higher usability. 10 self-constructed questions about the presentation, actual use, and perceived added value are added to the questionnaire.

  Baseline

• Tailored decision aid - usability

  The use of a tailored decision aid to support the decision making process will be evaluated using the System Usability Scale (SUS): 10 items giving a global view of subjective assessments of usability of the decision-aid on a 5-point scale from strongly disagree (1) to strongly agree (5).

  Baseline

• Tailored decision aid - use and added value

  The use of a tailored decision aid to support the decision making process will be evaluated by a self-constructed questionnaire consisting of 10 additional questions about the presentation, actual use, and the perceived added value of the decision aid from a patient perspective. A higher score means higher usability.

  Baseline

• Tailored decision aid - implementation in clinical practice

  The use of a tailored decision aid from a physician perspective will be evaluated by an adjusted version of the MIDI questionnaire to measure determinants associated with successful implementation of the decision aid. In general, a higher score means higher (expected) use in clinical practice.

  1.5 years

Secondary Outcomes (17)

• Quality of life - Fear of cancer recurrence

  Baseline

• Quality of life - EORTC QLQ C-30

  Baseline

• Quality of life - EORTC QLQ-H&N35

  Baseline

• Quality of life - EQ-5D-5L

  Baseline

• Quality of life - Fear of cancer recurrence

  1.5 years

Other Outcomes (2)

• Sociodemographic and basic clinical characteristics - input variables

  Baseline

• Oncological outcomes

  1.5 years

Study Arms (2)

Standardized follow-up

Participants who chose to continue guideline-prescribed, standardized follow-up one year after HNC treatment.

Individualized follow-up

Participants who chose to switch to individualized follow-up one year after HNC treatment. Follow-up visits will only be scheduled based on clinical symptoms and questions, initiated by the patient.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants will be selected from the Radboud University Medical Center, which is one of eight specialized head and neck oncology care centers in the Netherlands, and their preferred partner Rijnstate Ziekenhuis in Arnhem, The Netherlands.

You may qualify if:

• Malignant tumor of the head and neck
• First primary HNC
• Participant was treated with curative intent
• Participant has completed one year of uncomplicated routine follow-up
• Treating physician supports the possible choice for patient-led follow-up

You may not qualify if:

• Malignant tumors of salivary glands
• Participant is cognitively impaired
• Participant is unable to read or write in Dutch

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Betaalbaar Beter (VGZ): collaborator

Study Sites (1)

Radboud University Medical Center

Nijmegen, Gelderland, 6525 GA, Netherlands

RECRUITING

Related Publications (1)

• van de Weerd C, van Tol-Geerdink JJ, van den Broek GB, Kaanders JHAM, Marres HAM, Hermens RPMG, Takes RP. Individualised follow-up for head and neck cancer-design of a prospective cohort study to assess its feasibility. BMJ Open. 2022 Dec 29;12(12):e068750. doi: 10.1136/bmjopen-2022-068750.

  PMID: 36581428 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Robert P Takes, Prof

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cecile van de Weerd, MD

CONTACT

0031243614933; cecile.vandeweerd@radboudumc.nl

Study Design

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

Study Record Dates

• First Submitted: May 6, 2022
• First Posted: May 23, 2022
• Study Start: September 1, 2022
• Primary Completion: October 1, 2024
• Study Completion: December 1, 2024
• Last Updated: May 22, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will become available after publication of the manuscript describing the results of this study. The exact date and duration of data availability have not been established yet.
• Access Criteria: Criteria for access have to be discussed by the authors.

Locations

NL (1)