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

• Sponsor: West China Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05828004
• Collaborator: (none)
• Enrollment: 242
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 8.5
• Patients Per Site Per Month: 28.4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Carcinoma	Behavioral: Whole-Course Multidisciplinary Care Intervention	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 242 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Effect of an Oncology Nurse-Led Whole-Course Multidisciplinary Care Intervention on Patients With Head and Neck Carcinoma Receiving Radiotherapy
• Actual Study Start Date: Jan 14, 2023
• Anticipated Primary Completion Date: Sep 30, 2023
• Anticipated Study Completion Date: Sep 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: standard care group The standard care group is the routine care group, that is, under the current standard antitumor treatment and follow-up mode, the patients independently decided whether to carry out nutritional and psychological intervention after the advice from the medical care department of oncology
Experimental: MDT care group The MDT care group is the whole-course multidisciplinary care intervention group, which is conducted by a multidisciplinary team composed of the oncology department, nutrition department, mental health center and rehabilitation department.	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.

Outcome Measures

Primary Outcome Measures

1. Radiotherapy interruption rate [5 days]

   Interruption of radiotherapy was defined as the actual end date of radiotherapy minus the expected end date at least 5 days

Secondary Outcome Measures

1. Quality of life score (EORTC QLQ C30) [once a week during radiotherapy;1, 2, 3 and 6 months after radiotherapy]

   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)

2. Quality of life score QLQ-HN35 [once a week during radiotherapy;1, 2, 3 and 6 months after radiotherapy]

   Quality of life score was calculated according to the European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire QLQ-HN35

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	West China Hospital, Sichuan University	Chengdu	Sichuan	China	610041

Sponsors and Collaborators

• West China Hospital

Investigators

• Principal Investigator: Xingchen Peng, Ph.D, West China Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xingchen Peng, PhD, Professor, West China Hospital
• ClinicalTrials.gov Identifier: NCT05828004
• Other Study ID Numbers: 2022-1831
• First Posted: Apr 25, 2023
• Last Update Posted: Apr 25, 2023
• Last Verified: Apr 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Xingchen Peng, PhD, Professor, West China Hospital: Head and Neck Carcinoma; MDT; Whole-Course
• Additional relevant MeSH terms: Carcinoma

Study Results

No Results Posted as of Apr 25, 2023