Colorectal CancerNCT06395766
Assessment of Quality of Life and Social Support Gained in Patients Before and After Colorectal Cancer Surgery
An observational study of Colorectal Cancer, run by Andrzej Frycz Modrzewski Krakow University at 1 site in Poland.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- BREF,MSPSS
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 15 May 2023to 31 Jul 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 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.
Who may be able to join
- clinical diagnosis of rectal cancer and right colon cancer
- laparoscopic surgery
- Study exclusion criteria:
- surgery by traditional method
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
John Grande Hospital of the Monastery of St. John of God
Krakow, Lesserpoland, 31-061
Edyta Laska, Ph., +48692430150, elaska@afm.edu.pl
About this study
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)
- 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
Read the detailed 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.
- Conditions
- Colorectal Cancer
- Being tested
- BREF,MSPSS
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BREF,MSPSSDiagnostic test
- 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
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 - 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."
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 May 2023
- Primary completion15 Jan 2024
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal 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
- NCT06395766
- Sponsor's protocol ID
- 30/2023
- Status last verified
- Apr 2024
- First submitted
- 1 Jan 2024
- Last updated
- 2 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
- 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)
- ClinicalTrials.gov ID
- NCT06395766
- Acronym / sponsor ID
- 30/2023
- Conditions
- Colorectal 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 May 2023 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 31 Jul 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.
- 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
Detailed 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.
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 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.
Key inclusion criteria (4 listed)
- clinical diagnosis of rectal cancer and right colon cancer
- laparoscopic surgery
- surgery by traditional method
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,MSPSS1. 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 | 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 - the original version on the MSPSS.
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. 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."
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.
- Individual participant dataSharing planned: No
Related trials for Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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 Colorectal 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 4 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 (+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 - the original version on the MSPSS. (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.