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

April 28, 2024 updated by: Edyta Laska, Andrzej Frycz Modrzewski Krakow University

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

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 ?

Study Overview

Status

Recruiting

Conditions

Head Cancer

Intervention / Treatment

Diagnostic test: BREF, ADL, AIS.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Edyta Laska, Ph.
Phone Number: +48692430150
Email: elaska@afm.edu.pl

Study Locations

Poland
- Lesserpoland
  - Krakow, Lesserpoland, Poland, 30-693
    - Recruiting
    - St. Raphael's Hospital
    - Contact:
      
      Edyta Laska, Ph.
      
      Phone Number: +48692430150
      
      Email: elaska@afm.edu.pl

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

Each patient who is admitted to the surgical ward with a diagnosis of head cancer will be qualified for surgery will be given written consent for the study and the processing of personal data, as well as information for the researcher with questionnaires, and then give written consent will be recruited for the study. The patient's personal data processing information will be retained for the study until its completion.

Description

Inclusion criteria for the study:

-clinical diagnosis of head cancer

Study exclusion criteria:

- cranio-brain injuries and inflammatory brain diseases.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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. Time Frame: 12 months to 24 months	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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Andrzej Frycz Modrzewski Krakow University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2023

Primary Completion (Estimated)

June 15, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

January 1, 2024

First Submitted That Met QC Criteria

April 28, 2024

First Posted (Actual)

May 2, 2024

Study Record Updates

Last Update Posted (Actual)