Nasopharyngeal CarcinomaNCT06572293
Effect of Nurse-Led Individualized Follow-Up Intervention on Patients With Nasopharyngeal Carcinoma
A study testing Nurse-led intervention in people with Nasopharyngeal Carcinoma, run by Fujian Cancer Hospital.
Trial summary
The incidence of nasopharyngeal carcinomas (NPCs) is highly unbalanced around the globe, primarily concentrated in East and Southeast Asia.There is no well-conducted, larger randomized controlled trials (RCT) outlining a gold standard for follow-up programs ensuring early detection of recurrence, good management of… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- Nurse-led intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- Nov 2024to Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to provide informed consent;
- Have completed radiotherapy treatment for loco-regional nasopharyngeal carcinoma without clinical sign of distance metastatis;
- Aged 18 years and above;
- Expected survival ≥6 months;
- Read, understand Chinese characters and speak Mandarin.
Who cannot join
- Previous history of other malignancies, mental illness or cognitive impairment (MMSE score < 27 points);
- Unstable medical or psychiatric conditions
- Inability to communicate effectively in mandarin
- Pregnant women or lactating women.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Nurse-Led Individualized Follow-Up Intervention Versus Regular Physician-Led Visits in Nasopharyngeal Carcinoma: A Phase III Randomized, Controlled Trial
The incidence of nasopharyngeal carcinomas (NPCs) is highly unbalanced around the globe, primarily concentrated in East and Southeast Asia.There is no well-conducted, larger randomized controlled trials (RCT) outlining a gold standard for follow-up programs ensuring early detection of recurrence, good management of symptoms and cost-effectiveness. The primary aim of this randomised, controlled trial is to test whether a nurse-led individually tailored symptom management program will significantly reduce reported symptoms among NPC patients following primary treatment compared to physician-led scheduled follow-up. Additionally, the investigators will assess patient activation (self-management), anxiety, depression, fear of recurrence, work abilities, recurrence times, changes in health behavior, and health care utilization and costs for the two arms of the study.
A nurse-led education program focused on symptom management is provided to patients, along with an electronic platform to report symptoms to nurses and support in symptom management.
Read the detailed description
It is planned to recruit 250 primary NPC patients from Fujian Cancer Hospital's Oncology Departments during an 18-month period, after completing the chemoradiotherapy for NPC. You will participate in a five-year study in which you are randomly assigned to either the nurse-led intervention or the physician-led intervention. Regardless of group assignment, you will follow the national nasopharyngeal carcinoma screening program.
Both the control and intervention arms will use questionnaires, clinical databases, and national registers to collect data for 5 years after inclusion both in the control and intervention groups. The primary and secondary outcomes are measured using questionnaires in both groups, whereas Patient Reported Outcomes (PRO) are collected only in the intervention group. Relapsed patients will not be asked to complete the remaining outcome questionnaires or PROs since they quit the follow-up program to pursue recurrent treatment. If PROs reveal a need, or if the patient requires consultation, the nurse or project physician will be consulted.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Nurse-led intervention
- Keywords
- Nasopharyngeal Carcinoma, Nurse-Led Individualized Follow-Up, post-radiotherapy
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-led interventionBehavioural
Nurse-led intervention involves patient education, collecting Patient Reported Outcomes (PRO) and evaluating them by specialists nurses, as well as navigating patients to services that can assist with their symptoms. During three-five planned appointments, the nurse will talk with you about adjusting to life after complete the radiotherapy of nasopharyngeal carcinoma, including symptoms of relapse and how to deal with them.In the first year, PROs will be collected every six months on recurrences and late effects, and thereafter every 12 months. PRO will be administered to patients for three years after the nurse appointments are finalized.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Nurse-led follow-up Receives: Behavioral: Nurse-led intervention |
| Control | No intervention | Physician-led follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life score (EORTC QLQ C30)
Quality of life score was calculated according to the European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 (EORTC QLQ C30), the range is 0-100, higher scores mean a worse outcome.
Measured: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months
Quality of life score QLQ-HN35
Quality of life score was calculated according to the European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire QLQ-HN35, the range is 0-100, higher scores mean a worse outcome.
Measured: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months
Secondary outcomes (6)
Changes in knowledge, skill, and confidence for self-management
Patient Activation Measure (PAM), interval-level scale from 0-100 that correlates to one of four levels of patient activation. PAM Levels 1 and 2 indicate lower patient activation, while PAM Levels 3 and 4 indicate higher patient activation.
Measured: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months
Changes in anxiety
Generalized Anxiety Disorder (GAD-7),the range is 7-28, higher scores mean a worse outcome.
Measured: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months
Changes in self-management
The Health Education Impact Questionnaire (heiQ), the range is 40-160, higher scores mean a better outcome.
Measured: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months
Changes in fear of recurrence
Concerns About Recurrence Questionnaire (CARQ-4),the range is 0-40, and a higher score represents higher fear of recurrence.
Measured: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months
Changes in Depression
The Patient Health Questionnaire (PHQ-9),the range is 0-27, higher scores mean a worse outcome.
Measured: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months
Changes in work ability
Work Ability Index (WAI), range 7-49, a higher score indicated better work ability
Measured: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study startNov 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by Fujian Cancer HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Qiaojuan Guo, Fujian Cancer Hospital
- Investigators
- Qiaojuan Guo, Dr., Principal investigator, Fujian Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06572293
- Sponsor's protocol ID
- 2024-6-6
- Status last verified
- Oct 2024
- First submitted
- 31 Jul 2024
- Last updated
- 16 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nurse-Led Individualized Follow-Up Intervention Versus Regular Physician-Led Visits in Nasopharyngeal Carcinoma: A Phase III Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT06572293
- Acronym / sponsor ID
- 2024-6-6
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- Nasopharyngeal Carcinoma, Nurse-Led Individualized Follow-Up, post-radiotherapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- Nov 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 27 Aug 2024 (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 incidence of nasopharyngeal carcinomas (NPCs) is highly unbalanced around the globe, primarily concentrated in East and Southeast Asia.There is no well-conducted, larger randomized controlled trials (RCT) outlining a gold standard for follow-up programs ensuring early detection of recurrence, good management of symptoms and cost-effectiveness. The primary aim of this randomised, controlled trial is to test whether a nurse-led individually tailored symptom management program will significantly reduce reported symptoms among NPC patients following primary treatment compared to physician-led scheduled follow-up. Additionally, the investigators will assess patient activation (self-management), anxiety, depression, fear of recurrence, work abilities, recurrence times, changes in health behavior, and health care utilization and costs for the two arms of the study.
A nurse-led education program focused on symptom management is provided to patients, along with an electronic platform to report symptoms to nurses and support in symptom management.
Detailed description
It is planned to recruit 250 primary NPC patients from Fujian Cancer Hospital's Oncology Departments during an 18-month period, after completing the chemoradiotherapy for NPC. You will participate in a five-year study in which you are randomly assigned to either the nurse-led intervention or the physician-led intervention. Regardless of group assignment, you will follow the national nasopharyngeal carcinoma screening program.
Both the control and intervention arms will use questionnaires, clinical databases, and national registers to collect data for 5 years after inclusion both in the control and intervention groups. The primary and secondary outcomes are measured using questionnaires in both groups, whereas Patient Reported Outcomes (PRO) are collected only in the intervention group. Relapsed patients will not be asked to complete the remaining outcome questionnaires or PROs since they quit the follow-up program to pursue recurrent treatment. If PROs reveal a need, or if the patient requires consultation, the nurse or project physician will be consulted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Nurse-led interventionNurse-led follow-up |
| Control | No intervention | –Physician-led follow-up |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Able to provide informed consent;
- Have completed radiotherapy treatment for loco-regional nasopharyngeal carcinoma without clinical sign of distance metastatis;
- Aged 18 years and above;
- Expected survival ≥6 months;
- Read, understand Chinese characters and speak Mandarin.
Key exclusion criteria (4 listed)
- Previous history of other malignancies, mental illness or cognitive impairment (MMSE score < 27 points);
- Unstable medical or psychiatric conditions
- Inability to communicate effectively in mandarin
- Pregnant women or lactating women.
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 |
|---|---|---|
| Nurse-led interventionNurse-led intervention involves patient education, collecting Patient Reported Outcomes (PRO) and evaluating them by specialists nurses, as well as navigating patients to services that can assist with their symptoms. During three-five planned appointments, the nurse will talk with you about adjusting to life after complete the radiotherapy of nasopharyngeal carcinoma, including symptoms of relapse and how to deal with them.In the first year, PROs will be collected every six months on recurrences and late effects, and thereafter every 12 months. PRO will be administered to patients for three years after the nurse appointments are finalized. | Behavioural | Intervention |
Primary outcome
Quality of life score (EORTC QLQ C30)
Time frame: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months
Quality of life score was calculated according to the European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 (EORTC QLQ C30), the range is 0-100, higher scores mean a worse outcome.
Quality of life score QLQ-HN35
Time frame: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months
Quality of life score was calculated according to the European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire QLQ-HN35, the range is 0-100, higher scores mean a worse outcome.
6 secondary outcomes
Changes in knowledge, skill, and confidence for self-management
Time frame: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months
Changes in anxiety
Time frame: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months
Changes in self-management
Time frame: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months
Changes in fear of recurrence
Time frame: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months
Changes in Depression
Time frame: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months
Changes in work ability
Time frame: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
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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.
Qiaojuan Guo, Dr. principal investigator
Fujian Cancer Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-led intervention in people with Nasopharyngeal Carcinoma, run by Fujian Cancer Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. 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: opening soon, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ziyi Wu, Dr. (8618150833735, wuziyi@fjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life score (EORTC QLQ C30) (time frame: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Oct 2024.