- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06216834
Quality of Life and Psychosocial Status of Young-onset Patients With Rectal Cancer
January 11, 2024 updated by: Teng Qiong, Shandong Provincial Hospital
Quality of Life and Psychosocial Status of Young-onset Patients With Rectal Cancer After Surgery: a Cross-sectional Muti-questionnaire Survey
Colorectal cancer is one of the leading cancers worldwide.
Although the majority of CRC cases are typically diagnosed in individuals older than 50 years of age, recent international studies have highlighted the importance of younger adults (< 50) are gradually increasing.
Young cancer survivors often have poorer quality of life, disrupted social and sexual health, and increased mental health-related risks such as depression and anxiety.
Especially for patients with rectal cancer, patients may suffer from sexual dysfunction, urinary system problems and loss of normal bowel function after radical resection of rectal tumors, and some patients may also need to undergo ostomy, which may have adverse effects on the quality of life and mental health of patients after surgery.
Given that the incidence of colorectal cancer in young adults continues to rise worldwide, there is a need to better understand the impact of this particular disease on postoperative quality of life in young adults.
This study intends to retrospectively analyze the clinical characteristics of the patients, and further summarize the impact of rectal cancer surgery on the quality of life of patients through follow-up.
Study Overview
Detailed Description
Colorectal cancer (CRC) is the third most common malignancy worldwide and the second leading cause of cancer death.
The incidence of CRC has remained stable or declined in high-income countries over the past decade, possibly due to a series of screening and prevention measures aimed at people aged 50-70 years.
However, there is an increased incidence of rectal cancer in people younger than 50 years of age, which is known as young-onset RC (YO-RC).
By 2030, YO-RC is expected to account for 23% of rectal cancers.
In America, the proportion of people under 55 years of age newly diagnosed has increased from 11% in 1995 to 20% in 2019, and the incidence of RC in people under 50 years of age has increased by about 2% per year.
Due to the early detection of routine physical examination, advances in imaging, improved surgical techniques, and advances in chemoradiotherapy, colorectal cancer mortality is on a downward trend, with overall mortality declining by 57% from 1970 to 2020.
Therefore, those who are diagnosed with RC under the age of 50 are also called young-onset rectal cancer (YO-RC).
Prognostic analyses of YO-RC have been mixed, with some studies suggesting worse survival outcomes in younger patients, while others have shown no difference between younger and older patients.
In view of the difficulty of curing cancer and its complexity, traditional evaluation indicators such as survival time, remission period, treatment-related toxicity and tumor remission rate cannot comprehensively and accurately evaluate the medical outcome of cancer patients.
More and more people pay attention to the QOL of patients after treatment, which can comprehensively, objectively and truly evaluate the medical outcome from the perspective of patients.
Surgery is the basis of curative treatment for RC.
Problems that arise after RC surgery can impair quality of life (QOL), such as fatigue, abdominal pain, changes in bowel function, and decreased sexual function.
In addition, postoperative radiotherapy and chemotherapy can also reduce patients' QOL.
It is important to note that YO-RC patients may experience very different psychosocial status (PS) than older patients, with mental health issues such as anxiety and depression being more prominent.
At the same time, because YO-RC patients have higher requirements for postoperative QOL, it is necessary to adopt standardized quantitative scales to measure the postoperative situation of this group of people, so that clinicians can provide more effective interventions.
Here, we used the questionnaires, developed by the European Organization for Research and Treatment of Cancer (EORTC), to assess the QOL of patients with CRC.
Several standardized psychological and functional scales (previously applied to studies of other post-surgical tumors) were used to assess mental stress, body image anxiety, and work ability in patients after RC surgery.
This study is the first to evaluate the five-year QOL and PS in YO-RC patients after surgery using multiple questionnaires.
Based on our research results, the QOL and PS of patients can be better predicted, and then timely measures can be taken to help patients improve the QOL and relieve psychological pressure.
Study Type
Observational
Enrollment (Estimated)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shandong
-
Jinan, Shandong, China, 250000
- Recruiting
- Shandong Provincial Hospital
-
Contact:
- Qiong Teng, MD
- Phone Number: 18755138389
- Email: tengqiong2021@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Young patients undergoing radical resection for rectal cancer
Description
Inclusion Criteria:
- 1. Preoperative colonoscopy and pathological examination were performed to confirm the pathological diagnosis of rectal cancer; 2. Abdominal and pelvic CT examination and MRI examination were performed before operation to carefully evaluate the extent of tumor invasion and whether there was distant metastasis. 3. The patient's clinical data (contact information, age, gender, hospitalization record, colonoscopy report, postoperative pathological report, operation record, informed consent) were recorded comprehensively; 4. Patients with R0 resection; 5. The patients are more than 18 years old and less than 50 years old.
Exclusion Criteria:
- 1. Patients with other malignant tumors; 2. Previous history of other malignant tumors; 3. Patients with inflammatory gastrointestinal disease; 4. Emergency surgery; 4. Patients with preoperative mental illness or cognitive impairment.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality-of-life scores
Time Frame: From September 2023 to September 2024
|
patients' quality of life after surgery
|
From September 2023 to September 2024
|
psychosocial status
Time Frame: From September 2023 to September 2024
|
patients' psychosocial status after surgery
|
From September 2023 to September 2024
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2023
Primary Completion (Estimated)
September 1, 2024
Study Completion (Estimated)
October 1, 2024
Study Registration Dates
First Submitted
January 11, 2024
First Submitted That Met QC Criteria
January 11, 2024
First Posted (Actual)
January 22, 2024
Study Record Updates
Last Update Posted (Actual)
January 22, 2024
Last Update Submitted That Met QC Criteria
January 11, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SWYX:NO.2023-546
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Rectal Cancer
-
Ohio State University Comprehensive Cancer CenterNovartis Pharmaceuticals; National Comprehensive Cancer NetworkCompletedStage IIA Rectal Cancer | Stage IIB Rectal Cancer | Stage IIC Rectal Cancer | Stage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Recurrent Rectal CancerUnited States
-
M.D. Anderson Cancer CenterRecruitingEvaluation of Quality of Life and Utilities Following Surgical Treatment of Stage I-IV Rectal CancerStage III Rectal Cancer AJCC v8 | Stage IIIA Rectal Cancer AJCC v8 | Stage IIIB Rectal Cancer AJCC v8 | Stage IIIC Rectal Cancer AJCC v8 | Stage IV Rectal Cancer AJCC v8 | Stage IVA Rectal Cancer AJCC v8 | Stage IVB Rectal Cancer AJCC v8 | Stage IVC Rectal Cancer AJCC v8 | Rectal Adenocarcinoma | Stage... and other conditionsUnited States
-
OHSU Knight Cancer InstituteNatera, Inc.RecruitingEstablishing a ctDNA Biomarker to Improve Organ Preserving Strategies in Patients With Rectal CancerStage III Rectal Cancer AJCC v8 | Stage IIIA Rectal Cancer AJCC v8 | Stage IIIB Rectal Cancer AJCC v8 | Stage IIIC Rectal Cancer AJCC v8 | Rectal Adenocarcinoma | Stage IIA Rectal Cancer AJCC v8 | Stage IIB Rectal Cancer AJCC v8 | Stage II Rectal Cancer AJCC v8 | Stage IIC Rectal Cancer AJCC v8United States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingStage III Rectal Cancer AJCC v8 | Stage IIIA Rectal Cancer AJCC v8 | Stage IIIB Rectal Cancer AJCC v8 | Stage IIIC Rectal Cancer AJCC v8 | Rectal Adenocarcinoma | Stage IIA Rectal Cancer AJCC v8 | Stage IIB Rectal Cancer AJCC v8 | Stage II Rectal Cancer AJCC v8 | Stage IIC Rectal Cancer AJCC v8United States
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI)WithdrawnStage IIA Rectal Cancer | Stage IIB Rectal Cancer | Stage IIC Rectal Cancer | Stage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Rectal AdenocarcinomaUnited States
-
OHSU Knight Cancer InstituteOregon Health and Science University; Taiho Pharmaceutical Co., Ltd.RecruitingStage III Rectal Cancer AJCC v8 | Stage IIIA Rectal Cancer AJCC v8 | Stage IIIB Rectal Cancer AJCC v8 | Stage IIIC Rectal Cancer AJCC v8 | Rectal Adenocarcinoma | Stage IIA Rectal Cancer AJCC v8 | Stage IIB Rectal Cancer AJCC v8United States
-
Jonsson Comprehensive Cancer CenterNatera, Inc.; The Joseph Drown FoundationRecruitingStage III Rectal Cancer AJCC v8 | Stage IIIA Rectal Cancer AJCC v8 | Stage IIIB Rectal Cancer AJCC v8 | Stage IIIC Rectal Cancer AJCC v8 | Rectal Adenocarcinoma | Stage IIA Rectal Cancer AJCC v8 | Stage IIB Rectal Cancer AJCC v8 | Stage II Rectal Cancer AJCC v8 | Stage IIC Rectal Cancer AJCC v8 | Locally...United States
-
Case Comprehensive Cancer CenterCompletedStage IIA Rectal Cancer | Stage IIB Rectal Cancer | Stage IIC Rectal Cancer | Stage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Stage IIIA Colon Cancer | Stage IIIB Colon Cancer | Stage IIIC Colon Cancer | Recurrent Colon Cancer | Recurrent Rectal Cancer | Stage IVA Colon Cancer | Stage IVA Rectal Cancer and other conditionsUnited States
-
City of Hope Medical CenterWithdrawnRecurrent Rectal Cancer | Stage I Rectal Cancer | Stage II Rectal Cancer | Stage III Rectal Cancer
-
National Cancer Institute (NCI)TerminatedMetastatic Rectal Adenocarcinoma | Rectal Adenocarcinoma | Stage III Rectal Cancer AJCC v7 | Stage IIIA Rectal Cancer AJCC v7 | Stage IIIB Rectal Cancer AJCC v7 | Stage IIIC Rectal Cancer AJCC v7 | Stage IV Rectal Cancer AJCC v7 | Stage IVA Rectal Cancer AJCC v7 | Stage IVB Rectal Cancer AJCC v7 | Locally...United States
Clinical Trials on No intervention
-
Wave NeuroscienceCompletedAutistic DisorderUnited States
-
University of Alabama at BirminghamCompletedInflammatory Bowel Diseases | Colorectal Cancer | Diverticular Diseases | Social BehaviorUnited States
-
Janssen Research & Development, LLCCompletedLupus Erythematosus, Systemic | Lupus Erythematosus, Cutaneous | Lupus Erythematosus, DiscoidUnited States, Poland
-
Hospital Universitario La Paz3MVX CCB and Agaplesion Markus Krankenhaus, Frankfurt a.M., Germany.; Department...RecruitingEmbolism | Atrial Fibrillation | Arrhythmia | Stroke, Acute | Stroke Sequelae | AblationSpain
-
Southern California College of Optometry at Marshall...Ohio State University; University of Houston; Alcon Research; University of Waterloo and other collaboratorsCompletedContact Lens Complication | Contact Lens Acute Red Eye | Contact Lens Related Corneal Infiltrate (Disorder) | Contact Lens-Induced Corneal Fluorescein StainingUnited States, Canada
-
Case Western Reserve UniversityAmerican UniversityNot yet recruitingNutrition, Healthy
-
University of Dublin, Trinity CollegeCompleted
-
Hôpital Necker-Enfants MaladesUnknown
-
China Medical University HospitalUnknownIntention to Stay, Turnover Behavior