A Study of the Correlation Between CRF, Survival and Physiological Factors in NSCLC Patients Under Chemotherapy

NCT03130192 | Unknown

• 1 other identifier: CSMUH01
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Worldwide, non-small cell lung cancer (NSCLC) is one of the most common causes of cancer mortality. Also, the first leading cause of death is lung cancer in Taiwan 2012. Most patients are diagnosed at advanced stages and their median survival with supportive care is only 3-6 months. The common regimens used on advanced NSCLC treatment consists of platinum-based doublet chemotherapy, the survival benefit of which is able to extend the survival to approximately 10 months. However, disease and treatment-related toxicities in cancer patients may result in fatigue and interfered quality of life (QoL). According to the others reports, eight QoL areas including physical functioning, fatigue, pain, and appetite loss have been showed a statistically significant association with survival rate of NSCLC patients. Cancer-related fatigue (CRF), an indicator of QoL, has been reported as the most frequent and distressing toxicity of lung cancer chemotherapy. Proposed criteria for CRF have been adopted for inclusion in the International Statistical Classification of Disease and Related Health Problems, Tenth Revision, Clinical Modification (ICD-10-CM). Therefore, more in-depth researches on CRF are needed in Taiwan. In addition, electrolyte disturbance like hyponatremia has been reported to be counted as one of the many contributing factors for fatigue in palliative care patients and associated with poorer overall survival rate (OS) in lung cancer. Thus, the correlation between CRF and electrolyte possibly would be a strong link for physician to improve the QoL and survival rate of NSCLC patients. The objective of this observational study is to evaluate the correlation between CRF, survival and physiological factors in NSCLC patients under chemotherapy. The study will compare the effect of QoL and CRF on survival with or without CRF treatment and investigate the correlation between the variation of CRF and physiological factors which have been examined and recorded on medical record under clinical practice. These results will supply physicians with more understanding about CRF, and help them to enhance the quality on lung cancer care to being perfected in the future.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Cancer-related fatigue evaluation by brief fatigue inventory-Taiwanese form (BFI-T)

  Change from baseline cancer-related fatigue at 6 chemotherapy cycles (24 weeks)

Secondary Outcomes (1)

• Quality of life assessments by functional assessment of cancer therapy-general 7 (FACT-G7)

  Change from baseline quality of life at 6 chemotherapy cycles (24 weeks)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Non-small cell lung cancer (NSCLC) patients with chemotherapy

You may qualify if:

• Patients who signed the informed consent form.
• Aged 20 years and older.
• Patients who have been given a diagnosis of stage II-IV NSCLC cancer.
• Patients who are under/ or scheduled for chemotherapy treatment.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
• Patients who are able to complete QoL questionnaires.

You may not qualify if:

• Patients have enrolled or have not yet completed other investigational drug trials within 30 days before screening.

Sponsors & Collaborators

• Chung Shan Medical University: lead

Study Sites (1)

Chung Shan Medical University Hospital

Taichung, Taiwan

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Shih-Ming Tsao, M.D., Ph.D.

CONTACT

886-4-24739595; tsmhwy@ms24.hinet.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Institutional review board

Study Record Dates

• First Submitted: March 26, 2017
• First Posted: April 26, 2017
• Study Start: December 22, 2016
• Primary Completion: June 7, 2021
• Study Completion: June 30, 2021
• Last Updated: April 17, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)