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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06395766
Other study ID # 30/2023
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 15, 2023
Est. completion date July 31, 2024

Study information

Verified date April 2024
Source Andrzej Frycz Modrzewski Krakow University
Contact Edyta Laska
Phone +48692430150
Email elaska@afm.edu.pl
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

- evaluation of the quality of life of patients before and after laparoscopic surgery for rectal cancer and cancer of the right part of the intestine at different stages of the disease, whether it depends on the size of the tumor, neoadjuvant treatment, type of cancer and its location - Multidimensional assessment of perceived social support (considering three sources of support: significant person, family and friends) of patients before and after laparoscopic surgery for rectal cancer and cancer of the right part of the intestine, whether it depends on the stage of the disease, the location of the tumor lesion and the treatment undertaken


Description:

Specific scientific objectives: - To evaluate the quality of life of patients before and after laparoscopic surgery for rectal cancer and right-sided colon cancer at different stages of disease, whether it depends on tumor size, neoadjuvant treatment, type of cancer and its location - Multidimensional evaluation of perceived social support (considering three sources of support: significant person, family and friends) of patients before and after laparoscopic surgery for rectal cancer and cancer of the right part of the intestine, whether it depends on the stage of the disease, the location of the tumor lesion and the treatment undertaken Scientific (research) problems: - What is the quality of life of patients before surgery, and what is the quality of life after laparoscopic surgery for rectal cancer and cancer of the right side of the intestine at different stages of oncological disease? Does quality of life depend on the size of the tumor, location, advancement or type of treatment undertaken? - How do patients rate the received social support both before and after laparoscopic surgery for rectal cancer and right colon cancer ? - Did the obtained social support in the patient at each stage of the disease ( before surgery, after surgery) depend on the advancement of the oncological lesion, the location of the tumor lesion and the treatment undertaken ? 2 Methodology of the study The study will be carried out at the General Surgery Clinical Department of the John Grande Hospital of the Order of St. John of God in Krakow after obtaining permission from the facility's management. Each patient qualified for laparoscopic surgery for rectal cancer and cancer of the right side of the intestine who simultaneously agreed to participate in the study anonymously was included in the study group.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date July 31, 2024
Est. primary completion date January 15, 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion criteria for the study: - clinical diagnosis of rectal cancer and right colon cancer - laparoscopic surgery Study exclusion criteria: - surgery by traditional method

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
BREF,MSPSS
abbreviated version of the quality of life assessment questionnaire - The World Health Organization Quality of Life (WHOQOL ) the Zimet Multidimensional Scale of Perceived Social Support -. The original version on the MSPSS

Locations

Country Name City State
Poland John Grande Hospital of the Monastery of St. John of God 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 - 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."
12 months to 24 months
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