Clinical trial NCT05386225: Individualized Follow-Up for Head and Neck Cancer
Official title: Individualized Follow-Up for Head and Neck Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Head and Neck Cancer
Keywords: Follow-Up Care
Follow-Up Studies
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Betaalbaar Beter (VGZ)
First posted: 2022-05-23
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Detailed description: Background of the study:

Head and Neck Cancer (HNC) patients are currently enrolled in routine follow-up by medical specialists (standardized follow-up) for five years after primary treatment, according to the Dutch guideline Head and Neck Tumors. Similar recommendations are described in guidelines from the US and UK. The purposes for aftercare following cancer treatment as stated by the Health Council of the Netherlands are to address the effects of the disease and treatment itself, to detect new cancer manifestations, and to evaluate medical procedures to improve the quality of care.

The majority of HNC recurrences occur in the first 1.5-two years after treatment, and most of them cause clinical symptoms.It has not been proven that patients with recurrent disease discovered in the asymptomatic phase have better treatment options and life expectancy than patients who experience symptoms at the time of discovery.

Detecting second primary tumors (SPT) is an extra argument for routine follow-up as HNC patients are at greater risk of developing second primary cancers. SPTs are known to negatively affect overall long-term survival, especially those found outside the head and neck area. However, the way in which control visits are performed, namely physical examination of the head and neck, does not aim to identify SPTs elsewhere in the body. Because the incidence of SPTs remains stable over the years after treatment, detecting them would require life-long follow-up through diagnostic imaging.

Many patients express the concern that their cancer will progress or recur after treatment, also known as fear of cancer recurrence (FCR). FCR has a major impact on quality of life. It is not clear whether routine control visits exacerbate or relieve FCR, although previous research suggests that patient-led follow-up, in which prescheduled visits are replaced by patient-education and access to care by self-referral, does not influence FCR. Furthermore, patients have reported being anxious before scheduled control visits.

Overall, de-intensifying routine follow-up after primary HNC treatment seems to be sensible in the light of discovering recurrent or new cancers and will probably not affect FCR. However, reducing the frequency of prescheduled control visits for all HNC patients may deny the varying needs of individual patients. These needs include receiving more information about the treatment trajectory and being more involved in the decision-making process. Therefore, we have implemented a novel decision-aided follow-up program that allows HNC patients to choose between continuing standardized follow-up with prescheduled control visits, and individualized follow-up with symptom-based visits.

Objective of the study:

The aim of this project is to evaluate implementing the choice for individualized follow-up after head and neck cancer treatment at the Radboudumc and Rijnstate, the preferred partner of the Radboudumc regarding head and neck oncology. It will be investigated to what extent it is feasible to offer patients the choice for individualized follow-up, 1.5 years after completion of treatment. In addition, insight into (cost-)effectiveness is explored.

Primary research question: What is the feasibility of offering head and neck cancer patients the choice between standardized and individualized follow-up in a shared-decision making process supported by a decision-aid after completing 1.5 years of standardized follow-up?

Secondary research questions:

1. How many patients choose individualized follow-up after completing 1.5 years of standardized follow-up if they are supported by a decision-aid and their treating physician in a shared-decision-making process?
2. To what extent do patients who choose individualized follow-up differ from patients who choose standardized follow-up, based on gender, age, educational level, or other patient- or tumor characteristics?
3. What are patients' experiences with the choice in terms of the decision-making-process and decisional regret?
4. What are physicians' experiences with the choice in terms of the decision-making-process?
5. What is the effect of this choice on fear of cancer recurrence and other quality of life outcome measures?
6. What is the difference in costs between standardized and individualized follow-up?
7. Is there a difference in timing and manner of detection of recurrences between patients who opted for standardized and individualized follow-up? We hypothesize that giving patients the choice between standardized and individualized follow-up is feasible and has a positive effect on FCR, while maintaining QoL and reducing medical costs. We do not expect to diagnose less recurrences or second primary tumors in patients who opted for individualized follow-up.

Study design:

This is an observational study (prospective cohort study) to evaluate offering a choice for individualized follow-up after treatment for HNC in Radboudumc and Rijnstate.

Study population:

Patients with a primary malignancy in the head and neck region (nose, nasopharynx, nasopharynx, oral cavity, pharynx, larynx) who have undergone treatment with curative intent.

Introducing individualized follow-up:

All head and neck cancer patients who are enrolled in standardized follow-up will be informed on the choice between standardized and individualized follow-up directly after treatment. Patients who have completed 1.5 years of standardized follow-up will be asked to make a choice between continuing standardized follow-up or switching to individualized follow-up. Patients will gain access to our online decision-aid to support the decision-making process. Their treating physician will explain all the details during a decision-making consult, after which a decision is made.

Including participants:

Patients who are eligible to participate in this study will be scheduled for an outpatient visit with an independent researcher 1.5 years after treatment, regardless of their choice for standardized or individualized follow-up. The researcher will explain the study and study-goals. Another appointment will be scheduled two weeks later to answer possible questions and, if the patient is willing to participate, obtain informed consent.

Ethical aspects:

We expect that patients who are given the opportunity to choose their own form of follow-up will not regret their decision. Nevertheless, participants always have the option to withdraw their decision at any time during the study, and afterwards. Participants in this study will not receive any special compensation or reward.

Data management:

All participants who have given informed consent are assigned an identification code. The identification code is copied on the code list. Identifiable data of the included study participants are kept in the code list (name, address, telephone number, medical file number (MDN), etc.). No traceable data are recorded in the electronic database (Castor EDC), only the participant's identification code. The code list is kept in a separate and secured digital environment.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Follow-up decision
timeFrame: Baseline
measure: Demand - assessed by the reach
timeFrame: 1.5 years
measure: Acceptability - assessed by the SUS
timeFrame: Baseline
measure: Tailored decision aid - usability
timeFrame: Baseline
measure: Tailored decision aid - use and added value
timeFrame: Baseline
measure: Tailored decision aid - implementation in clinical practice
timeFrame: 1.5 years
Secondary outcomes:
measure: Quality of life - Fear of cancer recurrence
timeFrame: Baseline
measure: Quality of life - EORTC QLQ C-30
timeFrame: Baseline
measure: Quality of life - EORTC QLQ-H&N35
timeFrame: Baseline
measure: Quality of life - EQ-5D-5L
timeFrame: Baseline
measure: Quality of life - Fear of cancer recurrence
timeFrame: 1.5 years
measure: Quality of life - QLQ C-30
timeFrame: 1.5 years
measure: Quality of life - QLQ-H&N35
timeFrame: 1.5 years
measure: Quality of life - EQ-5D-5L
timeFrame: 1.5 years
measure: Shared decision making for patients
timeFrame: Baseline (after decision making consult)
measure: Shared decision making for physicians
timeFrame: Baseline (after decision making consult)
measure: Decisional conflict
timeFrame: Baseline
measure: Decisional regret
timeFrame: 1.5 years
measure: Practicality - Medical consumption
timeFrame: Baseline
measure: Practicality Medical consumption
timeFrame: 1.5 years
measure: Practicality - Productivity loss
timeFrame: Baseline
measure: Practicality - Productivity loss
timeFrame: 1.5 years
measure: Practicality - outpatients visits and tests
timeFrame: 1.5 years
Other outcomes:
measure: Sociodemographic and basic clinical characteristics - input variables
timeFrame: Baseline
measure: Oncological outcomes
timeFrame: 1.5 years
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Center
state: Gelderland
Study officials:
affiliation: Radboud University Medical Center
name: Robert P Takes, Prof
role: PRINCIPAL_INVESTIGATOR
References: