NCT06395766

Brief 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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 1, 2024

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2024

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 2, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

May 2, 2024

Status Verified

April 1, 2024

Enrollment Period

8 months

First QC Date

January 1, 2024

Last Update Submit

April 28, 2024

Conditions

Outcome Measures

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."

    12 months to 24 months

Interventions

BREF,MSPSSDIAGNOSTIC_TEST

1. abbreviated version of the quality of life assessment questionnaire - The World Health Organization Quality of Life (WHOQOL ) 2. the Zimet Multidimensional Scale of Perceived Social Support -. The original version on the MSPSS

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Each patient who is admitted to the surgical ward with a diagnosis of rectal cancer and cancer of the right side of the intestine and is qualified for laparoscopic surgery will receive written consent for the study and the processing of personal data, as well as information for the researcher with questionnaires, and then if he or she agrees in writing will be recruited for the study. The patient's personal data processing information will be retained for the study until its completion.

You may qualify if:

  • clinical diagnosis of rectal cancer and right colon cancer
  • laparoscopic surgery

You may not qualify if:

  • \- surgery by traditional method

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

John Grande Hospital of the Monastery of St. John of God

Krakow, Lesserpoland, 31-061, Poland

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 1, 2024

First Posted

May 2, 2024

Study Start

May 15, 2023

Primary Completion

January 15, 2024

Study Completion

July 31, 2024

Last Updated

May 2, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations