Head CancerNCT06395805
Evaluation of Quality of Life and Self-assurance and Social Support Earned for Non-cellular Head Cancer
An observational study of Head Cancer, run by Andrzej Frycz Modrzewski Krakow University at 1 site in Poland.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Head Cancer
- What is being tested?
- BREF, ADL, AIS.
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 15 Jun 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- -clinical diagnosis of head cancer
- Study exclusion criteria:
- cranio-brain injuries and inflammatory brain diseases.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
St. Raphael's Hospital
Krakow, Lesserpoland, 30-693
Edyta Laska, Ph., +48692430150, elaska@afm.edu.pl
About this study
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
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
Read more
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 ?
- Conditions
- Head Cancer
- Being tested
- BREF, ADL, AIS.
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BREF, ADL, AIS.Diagnostic test
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start15 Jun 2023
- Primary completion15 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andrzej Frycz Modrzewski Krakow University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edyta Laska, Andrzej Frycz Modrzewski Krakow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06395805
- Sponsor's protocol ID
- 31/2023
- Status last verified
- Apr 2024
- First submitted
- 1 Jan 2024
- Last updated
- 2 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06395805
- Acronym / sponsor ID
- 31/2023
- Conditions
- Head Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Andrzej Frycz Modrzewski Krakow UniversityUniversity, hospital or other
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 15 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 2 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Family based
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- -clinical diagnosis of head cancer
- cranio-brain injuries and inflammatory brain diseases.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BREF, 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 | Diagnostic test | – |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head Cancer, run by Andrzej Frycz Modrzewski Krakow University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Edyta Laska, Ph. (+48692430150, elaska@afm.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2024.