The Influence of Anxiety and Depression on Survival in Nasopharyngeal Carcinoma Patients

Nasopharyngeal Carcinoma Clinical Trial

Official title:

The Influence of Anxiety and Depression on Survival in Nasopharyngeal Carcinoma Patients: a Prospective Observational Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03290001
• Other study ID #: anxiety and depression
• Status: Recruiting
• Phase: N/A
• First received: September 3, 2017
• Last updated: November 4, 2017
• Start date: August 20, 2017
• Est. completion date: September 20, 2022

Study information

• Verified date: November 2017
• Source: Sun Yat-sen University
• Contact: HaiQiang Mai
• Phone: 8620-8734-3380
• Email: maihq[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a prospective, observational cohort study aimed to explore the influence of anxiety and depression to long term survival in nasopharyngeal carcinoma patients.

Description:

Nasopharyngeal carcinoma (NPC) is endemic in Southern China and Southeast Asia. Radiotherapy (RT) and chemotherapy are the mainstays of therapy for NPC because these tumors are biologically highly radiosensitive and chemosensitive. Anxiety and depression symptoms were common psychological symptoms around the time of cancer diagnosis and were often persistent during cancer treatment. Psychological symptoms are associated with prolonged hospital stays, lower quality of life, and worse treatment adherence among patients with cancer. Depressive symptoms have been demonstrated to predict early mortality among patients with some kinds of cancer. But among NPC patients, the influence of anxiety and depression symptoms to long term survival have not be explored. Therefore, this prospective, observational cohort study aimed to explore the influence of anxiety and depression to long term survival in NPC patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: September 20, 2022
• Est. primary completion date: September 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III

• Age between 18-70

• Male and no pregnant female

• Patient have signed on the informed consent, and well understood the objective and procedure of this study

Exclusion Criteria:

• The presence of uncontrolled life-threatening illness

• Pregnancy or lactation

• Patient with severe medical condition

Related Conditions & MeSH terms

• Carcinoma
• Depression
• Nasopharyngeal Carcinoma
• Nasopharyngeal Neoplasms

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progress-free survival	Progress-free survival is calculated from the date of registration to the date of the first progress at any site.	3 years
Secondary	Anxiety related measure	Hospital Anxiety and Depression Scale (HADS) and Hamilton Anxiety Rating Scale (HAMA) will be used during the assessment.	Baseline, completion of radiation therapy (up to 12 weeks)
Secondary	Distress related measure	Hospital Anxiety and Depression Scale (HADS) and Hamilton Depression Rating Scale (HAMD) will be used during the assessment.	Baseline, completion of radiation therapy (up to 12 weeks)
Secondary	Overall Survival(OS)	The OS was defined as the duration from the date of registration assignment to the date of death from any cause or censored at the date of the last follow-up.	3 years
Secondary	Locoregional Relapse-Free Survival(LRFS)	The LRFS is evaluated and calculated from the date of registration until the day of first locoregional relapse or until the date of the last follow-up visit.	3 years
Secondary	Distant Metastasis-Free Survival (DMFS)	The DMFS is evaluated and calculated from the date of registration until the day of first distant metastases or until the date of the last follow-up visit.	3 years
Secondary	Complete Response (CR)	CR assessed by independent reviewers, according to the Modified Response Evaluation Criteria in Solid Tumors (RECIST) from the National Cancer Institute (NCI). Disease response evaluated after the completion of the treatment. Complete response defined as the complete disappearance of the target and non-target lesion(s) identified at baseline after radiological evaluation by Magnetic Resonance Imaging (MRI) only.	completion of radiation therapy (up to 12 weeks)
Secondary	Weight Loss	Weight loss was calculated as the relative percent of weight changes between weight measurement before and after the nasopharyngeal carcinoma treatment. Weight loss was calculated from the following formula:( pro-treatment body weight - post-treatment body weight)/ pro-treatment body weight.	Baseline, completion of radiation therapy (up to 12 weeks)