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RecruitingNCT06395831Updated May 2, 2024

Assessment of Quality of Life and Independence, as Well as Received Social Support for Spinal Cancer.

An observational study in Spinal Canal Tumors, 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

  • Started Jun 2023; still recruiting 3 years 4 months later.
Study type
Observational
Model
Family-based
Time perspective
Prospective
Enrollment
100
Sex
All
01

Study summary

  • Evaluation of the quality of life of patients before and after surgery for benign and malignant spinal cancers, assessing whether it depends on the size of the tumor, type of cancer, malignancy and its location
  • evaluation of patients' independence before and after surgery for benign and malignant spinal tumors, evaluation of what factors influenced patients' different independence
  • multidimensional assessment of perceived social support of patients before and after surgery for benign and malignant spinal cancers, taking into account three sources of support: significant person, family and friends
Read the detailed description

RESEARCH PROJECT DESCRIPTION, RESEARCH METHODOLOGY:

Research objectives:

  • To evaluate the quality of life of patients before and after surgery for benign and malignant spinal cancers, to assess whether it depends on the size of the tumor, type of cancer, malignancy and its location
  • evaluation of patients' independence before and after surgery for benign and malignant spinal tumors, assessment of what factors influenced patients' different independence
  • multidimensional evaluation of perceived social support of patients before and after surgery for benign and malignant spinal cancers, 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 and malignant spinal cancers ? Is the quality of life in patients with spinal cancer dependent on tumor size, malignancy, location or type of cancer ?
  • How do patients rate their independence both before and after surgery for spinal cancers at different stages of the disease?
  • How do patients with spinal cancer at different stages of the disease rate the social support they received both before and after surgery?
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Conditions studied

  • Spinal Canal Tumors

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03

In context

Spinal Cord Neoplasms

105 studies on the registry are indexed under Spinal Cord Neoplasms; 27 are open to participants now.

This study's planned enrollment of 100 is below the median of 150 across 31 observational studies indexed under Spinal Cord Neoplasms.

Browse Spinal Cord 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.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Each patient who is admitted to the surgical ward with a diagnosis of spinal 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 will then give written consent and 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 spinal cancer

Study exclusion criteria:

-inflammatory and disc disease of the spinal column

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

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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 - the original version on the MSPSS.

    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. The Multidimensional Scale of Perceived Social Support takes into account the multidimensionality of perceived social support, considering three primary sources of support: significant other, family and friends. The scale consists of 12 statements, which the subject addresses using a seven-point Likert scale, where 1 means "strongly disagree" and 7 means "strongly agree."

    Time frame: 12 months to 24 months

07

Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2023 to primary completion in Jan 2024, 7 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 1, 2024
First posted
May 2, 2024
StartActual
Jun 15, 2023
Primary completionActual
Jan 15, 2024
CompletionEst.
Jul 31, 2024
Last update
May 2, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
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 ↗
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Registry details

Key details

Study ID
NCT06395831
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
Jan 15, 2024
Completion
Jul 31, 2024 (estimated)
Last update
May 2, 2024

Study contacts

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

Oversight

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

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