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RecruitingNCT06395805Updated May 2, 2024

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

An observational study in Head Cancer, sponsored by Andrzej Frycz Modrzewski Krakow University. Recruiting at 1 site in Poland. Per ClinicalTrials.gov, last updated 2024-05-02.

Sponsored by Andrzej Frycz Modrzewski Krakow University · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2024, 2 years 3 months ago, but the record still lists the study as recruiting.
  • Started Jun 2023; still recruiting 3 years 3 months later.
Study type
Observational
Model
Family-based
Time perspective
Prospective
Enrollment
100
Sex
All
01

Study 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 ?
02

Conditions studied

  • Head Cancer
03

In context

Head and Neck Neoplasms

2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.

This study's planned enrollment of 100 is close to the median of 100 across 441 observational studies indexed under Head and Neck Neoplasms.

Browse Head and Neck Neoplasms studies →

Lead sponsor

Andrzej Frycz Modrzewski Krakow University is the lead sponsor of 12 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
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.

Eligibility criteria

Inclusion criteria for the study:

-clinical diagnosis of head cancer

Study exclusion criteria:

  • cranio-brain injuries and inflammatory brain diseases.
05

Study design

Observational model
Family-based
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testBREF, ADL, AIS.

    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

06

What researchers measure

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.

    Time frame: 12 months to 24 months

07

Study locations

1 of 1 sites recruiting
  • St. Raphael's Hospital
    Krakow, Lesserpoland 30-693, Poland
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06395805
Lead sponsor
Andrzej Frycz Modrzewski Krakow University
Responsible party
Edyta Laska (Principal Investigator, Andrzej Frycz Modrzewski Krakow University) — Principal investigator
First posted
May 2, 2024
Start date
Jun 15, 2023
Primary completion
Jun 15, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
May 2, 2024

Study contacts

Edyta Laska, Ph.
Contact
elaska@afm.edu.pl
+48692430150

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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