search
Back to results

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

Primary Purpose

Head and Neck Carcinoma

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Whole-Course Multidisciplinary Care Intervention
Sponsored by
West China Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Head and Neck Carcinoma focused on measuring Head and Neck Carcinoma, MDT, Whole-Course

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: The patient is willing and capable of signing the informed consent; Patient age ≥18 years; Non-metastatic head and neck tumors (including nasopharyngeal carcinoma) were confirmed by pathology; Patients need to receive postoperative adjuvant radiotherapy or radical radiotherapy; Expected survival ≥6 months; Baseline ECOG (Eastern Cooperative Oncology Group) score 0-3; Good cognitive and reading skills, able to complete the questionnaire survey. Exclusion Criteria: The patient has malignancies other than head and neck malignancies (except cured basal cell carcinoma of the skin or cervical carcinoma in situ); The patient had previously received radiotherapy; Previous history of mental illness or cognitive impairment (MMSE score < 27 points); 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. 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.; Pregnant women or lactating women.

Sites / Locations

  • West China Hospital, Sichuan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

standard care group

MDT care group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)
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

Full Information

First Posted
February 2, 2023
Last Updated
April 24, 2023
Sponsor
West China Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05828004
Brief Title
Effect of Whole-Course Multidisciplinary Care Intervention on Patients With Head and Neck Carcinoma
Official Title
Effect of an Oncology Nurse-Led Whole-Course Multidisciplinary Care Intervention on Patients With Head and Neck Carcinoma Receiving Radiotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 14, 2023 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West China Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Carcinoma
Keywords
Head and Neck Carcinoma, MDT, Whole-Course

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
242 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
standard care group
Arm Type
No Intervention
Arm Description
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
Arm Title
MDT care group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Whole-Course Multidisciplinary Care Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Radiotherapy interruption rate
Description
Interruption of radiotherapy was defined as the actual end date of radiotherapy minus the expected end date at least 5 days
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Quality of life score (EORTC QLQ C30)
Description
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)
Time Frame
once a week during radiotherapy;1, 2, 3 and 6 months after radiotherapy
Title
Quality of life score QLQ-HN35
Description
Quality of life score was calculated according to the European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire QLQ-HN35
Time Frame
once a week during radiotherapy;1, 2, 3 and 6 months after radiotherapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The patient is willing and capable of signing the informed consent; Patient age ≥18 years; Non-metastatic head and neck tumors (including nasopharyngeal carcinoma) were confirmed by pathology; Patients need to receive postoperative adjuvant radiotherapy or radical radiotherapy; Expected survival ≥6 months; Baseline ECOG (Eastern Cooperative Oncology Group) score 0-3; Good cognitive and reading skills, able to complete the questionnaire survey. Exclusion Criteria: The patient has malignancies other than head and neck malignancies (except cured basal cell carcinoma of the skin or cervical carcinoma in situ); The patient had previously received radiotherapy; Previous history of mental illness or cognitive impairment (MMSE score < 27 points); 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. 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.; Pregnant women or lactating women.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xingchen Peng, Ph.D
Phone
+8618980606753
Email
pxx2014@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xingchen Peng, Ph.D
Organizational Affiliation
West China Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
West China Hospital, Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xingchen Peng
Phone
+86 18980606753
Email
pxx2014@scu.edu.cn

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs