Effect of Whole-Course Multidisciplinary Care Intervention on Patients With Head and Neck Carcinoma

Head and Neck Carcinoma Clinical Trial

Official title:

Effect of an Oncology Nurse-Led Whole-Course Multidisciplinary Care Intervention on Patients With Head and Neck Carcinoma Receiving Radiotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05828004
• Other study ID #: 2022-1831
• Status: Completed
• Phase: N/A
• Start date: January 14, 2023
• Est. completion date: December 1, 2023

Study information

• Verified date: December 2023
• Source: West China Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Radiotherapy is one of the main treatments for head and neck Carcinoma. The incidence of radiotherapy-related adverse events is greater than 90%, and severe adverse events may lead to the interruption of radiotherapy.

Interruption of radiotherapy on the one hand affects the efficacy of tumor treatment, on the other hand seriously affects the quality of life of patients.

Investigators intend to conduct a randomized, controlled clinical study of multidisciplinary nutritional and psychological care for patients receiving radiotherapy for head and neck carcinoma, with a view to reducing the rate of radiotherapy interruption and improving the quality of life of patients with radiotherapy for head and neck carcinoma through a whole-course multidisciplinary care model.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 226
• Est. completion date: December 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. The patient is willing and capable of signing the informed consent;

2. Patient age =18 years;

3. Non-metastatic head and neck tumors (including nasopharyngeal carcinoma) were confirmed by pathology;

4. Patients need to receive postoperative adjuvant radiotherapy or radical radiotherapy;

5. Expected survival =6 months;

6. Baseline ECOG (Eastern Cooperative Oncology Group) score 0-3;

7. Good cognitive and reading skills, able to complete the questionnaire survey.

Exclusion Criteria:

1. The patient has malignancies other than head and neck malignancies (except cured basal cell carcinoma of the skin or cervical carcinoma in situ);

2. The patient had previously received radiotherapy;

3. Previous history of mental illness or cognitive impairment (MMSE score < 27 points);

4. There are contraindications to radiotherapy for head and neck, such as grade 3 or 4 suppression of bone marrow function and active head and neck infection.

5. The presence of uncontrolled systemic diseases that seriously affect the quality of life, such as poorly controlled diabetes, heart failure (NYHA grade III-IV), interstitial lung disease, etc.;

6. Pregnant women or lactating women.

Related Conditions & MeSH terms

• Carcinoma
• Head and Neck Carcinoma

Intervention

Behavioral:
• Whole-Course Multidisciplinary Care Intervention
On the basis of standard treatment, all patients were evaluated by senior practice nurses in the Department of Oncology in person at the time of enrollment (before radiotherapy) and once every week during radiotherapy, and once in person/over the phone at 1, 2, 3, and 6 months after radiotherapy.

Locations

Country	Name	City	State
China	West China Hospital, Sichuan University	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiotherapy interruption rate	Interruption of radiotherapy was defined as the actual end date of radiotherapy minus the expected end date at least 5 days	5 days
Secondary	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)	once a week during radiotherapy;1, 2, 3 and 6 months after radiotherapy
Secondary	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	once a week during radiotherapy;1, 2, 3 and 6 months after radiotherapy