Social Media-based Active Self-report on Incidence and Outcomes of Adverse Events in NK/TCL Patients

Sponsor

Rong Tao (Other)

Overall Status

Completed

CT.gov ID

NCT03079544

Collaborator

(none)

665

Enrollment

Locations

53.7

Actual Duration (Months)

332.5

Patients Per Site

6.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to collect data from patients by social media and self-report on the adverse events and outcomes happened with patients with extranodal natural killer/T-cell lymphoma, nasal type, who are treated outside of clinical trials in China.

Condition or Disease	Intervention/Treatment	Phase
Extranodal NK-T-Cell Lymphoma, Nasal Type	Combination Product: L-Asparaginase or or Pegaspargase containing chemotherapy

Detailed Description

Extranodal natural killer/T-cell lymphoma, nasal type, is a rare subtype of non-Hodgkin lymphoma with relatively high incidence in China. L-asparaginase based chemotherapy are widely used with Chinese patients and has been reported to improve overall response and prolonged the long-term survival in some clinical trials with very limited patients. However, most patients were treated out of clinical trials in China. Therefore the real incidence of adverse events and treatment outcomes are largely unknown. This study is designed to evaluate the incidence of adverse events and treatment outcomes by social media-based (www.house086.com, www.wechat.com) self-report from patients who are treated out of clinical trials.

Study Design

Study Type:

Observational

Actual Enrollment :

665 participants

Observational Model:

Case-Only

Time Perspective:

Other

Official Title:

Social Media-based Patient Education and Active Self-report on Incidence and Outcomes of Adverse Events in Natural Killer/T-cell Lymphoma (NK/TCL) Patients

Actual Study Start Date :

Mar 8, 2017

Actual Primary Completion Date :

Aug 30, 2021

Actual Study Completion Date :

Aug 30, 2021

Outcome Measures

Primary Outcome Measures

overall survival [2-year]
The overall survial time of patients will be measured since the initiation of treatment to death of any reason.

Secondary Outcome Measures

Treatment-Related Adverse Events as Assessed by CTCAE v4.0 [Day 1 of each course of chemotherapy and radiotherapy then every 3 months for 2 years]
Chemotherapy-related and radiotherapy-related toxicities and adverse events will be collected and graded by NCI CTCAE v4.0 criteria.
Progression free survival [2-year]
Progression free survival time is defined as the time from the initiation of treatment to the date on which disease "progresses" or the date on which the patient dies, from any cause.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Pathological diagnosis of extranodal natural killer/T-cell lymphoma, nasal type based on WHO 2008 classification of tumors of haematopoietic and lymphoid tissue.
Treated with at least one cycle of L-asparaginas or Pegaspargase based chemotherapy.
Signed Informed consent.

Exclusion Criteria:

patients who are enrolled in any other clinical trials.
Relapsed patients who were initially treated with non-L-asparaginas or non-pegaspargase based regimens.