Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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

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.

Condition or disease
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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Influence of Anxiety and Depression on Survival in Nasopharyngeal Carcinoma Patients: a Prospective Observational Cohort Study
Actual Study Start Date : August 20, 2017
Estimated Primary Completion Date : September 20, 2022
Estimated Study Completion Date : September 20, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
University hospital
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03290001


Contacts
Layout table for location contacts
Contact: HaiQiang Mai 8620-8734-3380 maihq@sysucc.org.cn

Locations
Layout table for location information
China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Linquan Tang    8620-8734-3380    tanglq@sysucc.org.cn   
Contact: Liping Chen    8620-8734-3380    chenlp@sysucc.org.cn   
Sponsors and Collaborators
Sun Yat-sen University

Layout table for additonal information
Responsible Party: Hai-Qiang Mai,MD,PhD, Deputy Director of the Department of Nasopharyngeal Carcinoma, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03290001     History of Changes
Other Study ID Numbers: anxiety and depression
First Posted: September 21, 2017    Key Record Dates
Last Update Posted: November 7, 2017
Last Verified: November 2017

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Nasopharyngeal Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Carcinoma
Depression
Behavioral Symptoms
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases