Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06395805
Other study ID # 31/2023
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT00318890 - Cisplatin and Docetaxel Plus Docetaxel and Radiotherapy With Amifostine for Squamous Cell Carcinoma of the Head and Neck Phase 1/Phase 2
Recruiting NCT05420948 - A Study of Pembrolizumab in Combination With Chemotherapy for Head and Neck Cancer Phase 2
Completed NCT00798655 - Trial of Postoperative Radiation, Cisplatin, and Panitumumab in Locally Advanced Head and Neck Cancer Phase 2
Completed NCT02714920 - DNA Repair Enzyme Signature in Head and Neck Cancer (CHEMRAD) N/A
Completed NCT01194466 - Transcutaneous Electrical Nerve Stimulation (TENS) and Head and Neck Cancer Pain (HNC) (TENS & HNC) N/A
Recruiting NCT05549414 - Pivotal Study of Proton Radiotherapy Treatments Using Fixed Beam Chair-Based Delivery System N/A
Recruiting NCT04750434 - PET MRI as a Staging Tool for Head and Neck Cancer
Withdrawn NCT05472506 - Oral AHR Antagonist in Combination With Nivolumab in Patients With PD-1 Resistant Metastatic or Recurrent Head and Neck Cancer Phase 1
Not yet recruiting NCT04261179 - Study Comparing Lymphoseek® vs. Albumin Nanocolloid in Head and Neck, Melanoma and Breast Cancer Phase 4
Recruiting NCT04673981 - Neurosensorial Disorder and Pain in Oral Cavity and Oropharynx Cancer Traited Patients (OCAPA) N/A
Not yet recruiting NCT05946577 - Association Between Tinnitus and Hearing Loss in Locally Advanced Head and Neck Cancer Treated by Radiotherapy Alone or With Chemotherapy: a Prospective and Multicenter Study
Completed NCT02738268 - Laser Therapy for the Prevention of Radiodermatitis in Head and Neck Patients N/A
Recruiting NCT04722523 - A Study of Cemiplimab With Chemotherapy and Immunotherapy in People With Head and Neck Cancer Phase 1
Enrolling by invitation NCT04905030 - Education, Immigration and HPV Vaccination: an Informational Randomized Trial N/A
Recruiting NCT03809208 - Birinapant and Intensity Modulated Re-Irradiation Therapy for Local-Regionally Recurrent Head and Neck Squamous Cell Carcinoma Phase 1