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

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

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

Study Overview

• Status: Unknown
• Conditions: Nasopharyngeal Carcinoma

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: HaiQiang Mai; Phone Number: 8620-8734-3380; Email: maihq@sysucc.org.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Sun Yat-Sen University Cancer Center
      • Contact: Linquan Tang; Phone Number: 8620-8734-3380; Email: tanglq@sysucc.org.cn
      • Contact: Liping Chen; Phone Number: 8620-8734-3380; Email: chenlp@sysucc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

University hospital

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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
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
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
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)
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)

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2017
• Primary Completion (Anticipated): September 20, 2022
• Study Completion (Anticipated): September 20, 2022

Study Registration Dates

• First Submitted: September 3, 2017
• First Submitted That Met QC Criteria: September 18, 2017
• First Posted (Actual): September 21, 2017

Study Record Updates

• Last Update Posted (Actual): November 7, 2017
• Last Update Submitted That Met QC Criteria: November 4, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Nasopharyngeal Neoplasms; Carcinoma; Nasopharyngeal Carcinoma
• Other Study ID Numbers: anxiety and depression

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No