A randomized controlled study on the effect of cognitive behavioral therapy on adverse reactions to chemoradiotherapy in locoregional advanced head and neck squamous cell carcinoma

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300079205

Enrollment

Unknown

Registered

2023-12-27

Start date

2024-01-01

Completion date

Unknown

Last updated

2024-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

head and neck squamous cell carcinoma

Interventions

Cognitive behavioral therapy group:Cognitive behavioral therapy combined with chemoradiotherapy

Conventional health education Group:Conventional health education combined with chemoradiotherapy

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) histopathologically confirmed locally advanced head and neck squamous cell carcinoma (including oral cancer, oropharyngeal cancer, hypopharyngeal cancer, and laryngeal cancer in this study), excluding nasopharyngeal cancer. 2) Chemoradiotherapy as the standard treatment plan (locally advanced head and neck cancer that cannot be operated or does not wish to be operated on). AJCC staging is stage III-IVb, specifically including: (a) oral cancer: T3N0, T1-3N1-3, T4aN0-3; (b.) Oral and pharyngeal cancer (P16 positive or negative): T1-2N1, T3-4aN0-1, T1-4aN2-3 (c.) Hypopharyngeal cancer: T1N1-3, T2-3N0-3, T4aN0-3; (d.) Glottic laryngeal cancer: T3-4aN0-3, supraglottic laryngeal cancer: T1-2N1-3, T3N0-3, T4aN0-3. 3) At least one measurable lesion (MRI or spiral CT scan = 10mm, meeting RECIST 1.1 criteria); 4) Karnofsky physical status = 70; 5) Normal liver and kidney function and hematopoietic function; 6) Hospital Anxiety and Depression Scale (HADS) score<11 points; 7) Patients can participate in cognitive-behavioral therapy; 8) All participants provided written informed consent. .

Exclusion criteria

Exclusion criteria: 1) A history of prior radiation therapy; 2) secondary primary malignant tumor; 3) Pregnance or lactating ; 4) mental health conditions (such as suicidal,tendency).

Design outcomes

Primary

Measure	Time frame
= Level 3 treatment-related adverse reactions;	—

Secondary

Measure	Time frame
Overall survival rate;Hospital Anxiety and Depression Scale (HADS) ;Quality of life;Local recurrence free survival rate;Progression-free survival;Distant metastasis free survival rate ;	—

Countries

China

Contacts

Public ContactLiu Feng

Hu'nan Cancer Hospital

liufeng820111@163.com+86 186 1398 5727

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026