Assessment of Quality of Life and Social Support Gained in Patients Before and After Colorectal Cancer Surgery

Colorectal Cancer Clinical Trial

Official title:

Assessment of Quality of Life and Social Support Gained in Patients Before and After Laparoscopic Surgery for Cancer of the Rectum and Cancer of the Right Part of the Intestine (Cecum, Ascending Colon)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06395766
• Other study ID #: 30/2023
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

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