Evaluation of Quality of Life and Self-assurance and Social Support Earned for Non-cellular Head Cancer

Head Cancer Clinical Trial

Official title:

Evaluation of Quality of Life and Self-assurance and Social Support Earned in Patients Before and After Operation for Non-cellular Head Cancer and Cancer in the First, Second and Third Stages of Advance

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06395805
• Other study ID #: 31/2023
• Status: Recruiting
• Start date: June 15, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Andrzej Frycz Modrzewski Krakow University
• Contact: Edyta Laska, Ph.
• Phone: +48692430150
• Email: elaska[@]afm.edu.pl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Research objectives: - To evaluate the quality of life of patients before and after surgery for benign head tumors ( meningiomas) and malignant tumors at stage I, II and III, to assess whether it depends on the size of the tumor, type of tumor, malignancy and its location - evaluation of the independence of patients before and after surgery for head tumors at different stages of the disease - benign tumors (meningiomas) and malignant tumors in stage I, II and III, evaluation of what factors affected the different independence of patients - Multidimensional evaluation of perceived social support of patients before and after surgery for head cancers - benign ( meningiomas) and malignant tumors in stage I, II and III, taking into account three sources of support: significant person, family and friends Scientific (research) problems: - What is the quality of life of patients before and after surgery for benign ( meningiomas) and malignant head cancers at stages I, II and III ? Is quality of life in patients with head cancer dependent on tumor size, malignancy, location or type of cancer ?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: June 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion criteria for the study:

-clinical diagnosis of head cancer

Study exclusion criteria:

• cranio-brain injuries and inflammatory brain diseases.

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Head Cancer

Intervention

Diagnostic Test:
• BREF, ADL, AIS.
abbreviated version of the quality of life assessment questionnaire - The World Health Organization Quality of Life (WHOQOL) -BREF scale I - ADL according to Lawton the AIS questionnaire the Zimet Multidimensional Scale of Perceived Social Support - the original version of the MSPSS

Locations

Country	Name	City	State
Poland	St. Raphael's Hospital	Krakow	Lesserpoland

Sponsors (1)

Lead Sponsor	Collaborator
Andrzej Frycz Modrzewski Krakow University

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life assessed using The World Health Organization Quality of Life (WHOQOL) scale. Social support assessed using Zimet's Multidimensional Perceived Social Support Scale. Patient self-efficacy as assessed by the Lawton I-ADL scale and AIS scale.	Quality of life assessed using The World Health Organization Quality of Life (WHOQOL-BREF) scale questionnaire which contains 26 questions analyzing four domains of life and separately perception of quality of life and self-assessment of health status.; It is used to assess the quality of life of both healthy and sick people in clinical practice and addresses the following domains of quality of life: somatic functioning, psychological functioning, social functioning and community functioning.; Social support assessed using Zimet's Multidimensional Perceived Social Support Scale - the original version on the MSPSS.; Patients' self-efficacy assessed by the I-ADL scale according to Lawton, where the patient answers nine questions regarding activities of daily living. Disease acceptance scale according to the AIS questionnaire, where the patient answers eight questions regarding their disease.	12 months to 24 months