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

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ClinicalTrials.gov Identifier: NCT03290001
Recruitment Status : Recruiting
First Posted : September 21, 2017
Last Update Posted : November 7, 2017
Sponsor:
Information provided by (Responsible Party):
Hai-Qiang Mai,MD,PhD, Sun Yat-sen University

Tracking Information
First Submitted Date September 3, 2017
First Posted Date September 21, 2017
Last Update Posted Date November 7, 2017
Actual Study Start Date August 20, 2017
Estimated Primary Completion Date September 20, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 18, 2017)
Progress-free survival [ Time Frame: 3 years ]
Progress-free survival is calculated from the date of registration to the date of the first progress at any site.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03290001 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: September 18, 2017)
  • Anxiety related measure [ Time Frame: Baseline, completion of radiation therapy (up to 12 weeks) ]
    Hospital Anxiety and Depression Scale (HADS) and Hamilton Anxiety Rating Scale (HAMA) will be used during the assessment.
  • Distress related measure [ Time Frame: Baseline, completion of radiation therapy (up to 12 weeks) ]
    Hospital Anxiety and Depression Scale (HADS) and Hamilton Depression Rating Scale (HAMD) will be used during the assessment.
  • Overall Survival(OS) [ Time Frame: 3 years ]
    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.
  • Locoregional Relapse-Free Survival(LRFS) [ Time Frame: 3 years ]
    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.
  • Distant Metastasis-Free Survival (DMFS) [ Time Frame: 3 years ]
    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.
  • Complete Response (CR) [ Time Frame: completion of radiation therapy (up to 12 weeks) ]
    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.
  • Weight Loss [ Time Frame: Baseline, completion of radiation therapy (up to 12 weeks) ]
    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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Influence of Anxiety and Depression on Survival in Nasopharyngeal Carcinoma Patients
Official Title The Influence of Anxiety and Depression on Survival in Nasopharyngeal Carcinoma Patients: a Prospective Observational Cohort Study
Brief 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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population University hospital
Condition Nasopharyngeal Carcinoma
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 18, 2017)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 20, 2022
Estimated Primary Completion Date September 20, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: HaiQiang Mai 8620-8734-3380 maihq@sysucc.org.cn
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03290001
Other Study ID Numbers anxiety and depression
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Hai-Qiang Mai,MD,PhD, Sun Yat-sen University
Study Sponsor Sun Yat-sen University
Collaborators Not Provided
Investigators Not Provided
PRS Account Sun Yat-sen University
Verification Date November 2017