NCT06395805

Brief 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 ?

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 1, 2024

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 2, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

May 2, 2024

Status Verified

April 1, 2024

Enrollment Period

1 year

First QC Date

January 1, 2024

Last Update Submit

April 28, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

BREF, ADL, AIS.DIAGNOSTIC_TEST

1. abbreviated version of the quality of life assessment questionnaire - The World Health Organization Quality of Life (WHOQOL) -BREF 2. scale I - ADL according to Lawton 3. the AIS questionnaire 4. the Zimet Multidimensional Scale of Perceived Social Support - the original version of the MSPSS

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • clinical diagnosis of head cancer

You may not qualify if:

  • \- cranio-brain injuries and inflammatory brain diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Raphael's Hospital

Krakow, Lesserpoland, 30-693, Poland

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Central Study Contacts

Edyta Laska, Ph.

CONTACT

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 1, 2024

First Posted

May 2, 2024

Study Start

June 15, 2023

Primary Completion

June 15, 2024

Study Completion

December 31, 2024

Last Updated

May 2, 2024

Record last verified: 2024-04

Locations