Evaluation of Quality of Life and Utilities Following Surgical Treatment of Stage I-IV Rectal Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

SUSPENDED

Total Enrollment

430 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-16

Study Completion Date

2030-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study evaluates quality of life and utilities following surgical treatment of stage I-IV rectal cancer. This study may help researches learn more about quality of life in patients who have or have had rectal cancer.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Relationship Between Quality of Life, Treatment Modalities, and Patient Treatment/Outcome Expectations

NCT00648635

Rectal Cancer

ACTIVE_NOT_RECRUITING

Active Surveillance and Chemotherapy Before Surgery in Treating Participants With Stage II-III Rectal Cancer

NCT03594630

Rectal Adenocarcinoma Stage II Rectal Cancer AJCC v8 Stage IIA Rectal Cancer AJCC v8 +6 more

RECRUITING EARLY_PHASE1

Involve-site Radiotherapy Combined With Chemotherapy and Immunotherapy as Neoadjuvant Treatment for Locally Advanced Rectal Cancer

NCT07161115

Rectal Adenocarcinoma

NOT_YET_RECRUITING PHASE2

Studying Biomarkers in Tumor Tissue and Blood Samples From Patients Undergoing Chemotherapy and Radiation Therapy for Stage II or Stage III Rectal Cancer That Can Be Removed By Surgery

NCT00960427

Colorectal Cancer

WITHDRAWN PHASE1

Cross-sectional Study of Anorectal Function and Quality of Life in Patients With Middle and Low Rectal Cancer

NCT04697303

Rectal Cancer

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

PRIMARY OBJECTIVE:

I. To assess post-treatment related health state utilities among patients with rectal cancer after treatment at 2 years.

SECONDARY OBJECTIVES:

I. To longitudinally compare the effects of treatment on quality of life and utilities among patients treated with or without (neo)adjuvant radiation therapy.

II. To characterize the impact of treatment on quality of life and utilities among patients with rectal cancer.

III. To assess changes in quality of life and utilities among patients treated for rectal cancer over time.

OUTLINE:

Patients complete quality of life questionnaires over 20-30 minutes at baseline, 6 and 12 months after surgery, and 2, 3, 4, and 5 years after surgery.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rectal Adenocarcinoma Stage I Rectal Cancer AJCC v8 Stage II Rectal Cancer AJCC v8 Stage IIA Rectal Cancer AJCC v8 Stage IIB Rectal Cancer AJCC v8 Stage IIC Rectal Cancer AJCC v8 Stage 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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Observational (questionnaire)

Patients complete quality of life questionnaires over 20-30 minutes at baseline, 6 and 12 months after surgery, and 2, 3, 4, and 5 years after surgery.

Quality-of-Life Assessment

Intervention Type OTHER

Complete quality of life questionnaire

Questionnaire Administration

Intervention Type OTHER

Complete quality of life questionnaire

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Quality-of-Life Assessment

Complete quality of life questionnaire

Intervention Type OTHER

Questionnaire Administration

Complete quality of life questionnaire

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Quality of Life Assessment

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patient has histologically proven adenocarcinoma of the rectum (stage I - IV) that is planned to be treated by surgical resection performed with curative intent, or who has already received surgical treatment
* Patient must sign an approved informed consent document and have the literary and physical ability to complete the questionnaire in English

Exclusion Criteria

* Patient has been treated with pelvic radiation therapy for a diagnosis other than rectal cancer
* Patient has a concurrent cancer diagnosis at the time of consent
* Patient has recurrent disease

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No