Quality of Life and Survival of Patients With Colorectal Cancer 5 Years After Surgery - Follow-up of the RCT DIQOL
NCT ID: NCT04930016
Last Updated: 2021-11-29
Study Results
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.
COMPLETED
208 participants
OBSERVATIONAL
2021-04-14
2021-10-07
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Moreover, patients' experiences with aftercare for colorectal cancer during the COVID-19 pandemic and their recollections of their illness and therapy are examined.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Until now, it is unclear whether there are also long-term benefits of QoL diagnosis and therapy. Therefore, the aim of this observational, cross-sectional follow-up study of the RCT DIQOL is to investigate long-term effects of the intervention on present QoL (EORTC QLQ-C30, QLQ-CR29), overall survival, and recurrence-free survival more than 5 years after surgery by comparing former intervention and control group patients. Moreover, participants will be asked for their experiences during aftercare in relation of the COVID-19 pandemic and for their recollection of their illness and therapy. Data are collected via questionnaire.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
CROSS_SECTIONAL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Former DIQOL intervention group
In the present follow-up study no interventions are administered. This group encompasses patients who had been part of the intervention group of the completed RCT DIQOL with the following intervention: Patients answered QoL questionnaires after surgery and at 3, 6, 12, and 18 months postoperatively. Results were transferred to a QoL-profile consisting of 13 QoL scales. Three experts with various professional background used the individual patient's QoL-profile and clinical and sociodemographic information to generate a QoL-report including therapy recommendations which was sent to the patient's doctor. Specific therapeutic options for the treatment of QoL had been defined: pain therapy, psychotherapy, social support, nutrition counseling, stoma care, physiotherapy, and fitness.
Quality of life diagnosis and therapy during the completed RCT DIQOL
Quality of life measurement, diagnosis, and tailored therapy (pain therapy, psychotherapy, social support, nutrition, stoma care, physiotherapy, fitness)
Former DIQOL control group
In the present follow-up study no interventions are administered. This group encompasses patients who had been part of the control group of the completed RCT DIQOL: Patients answered QoL questionnaires after surgery and at 3, 6, 12, and 18 months postoperatively but their doctor neither received a QoL-profile nor a QoL-report.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Quality of life diagnosis and therapy during the completed RCT DIQOL
Quality of life measurement, diagnosis, and tailored therapy (pain therapy, psychotherapy, social support, nutrition, stoma care, physiotherapy, fitness)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* informed consent
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Tumor Center Regensburg
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Prof. Dr. Monika Klinkhammer-Schalke
Director of the Tumor Center Regensburg
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Monika Klinkhammer-Schalke, MD, Prof.
Role: STUDY_CHAIR
Tumor Center Regensburg
Patricia Lindberg-Scharf, PhD
Role: PRINCIPAL_INVESTIGATOR
Tumor Center Regensburg
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Tumor Center Regensburg, Institute of Quality Management and Health Services Research of the University of Regensburg
Regensburg, Bavaria, Germany
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Klinkhammer-Schalke M, Steinger B, Koller M, Zeman F, Furst A, Gumpp J, Obermaier R, Piso P, Lindberg-Scharf P; Regensburg QoL Study Group. Diagnosing deficits in quality of life and providing tailored therapeutic options: Results of a randomised trial in 220 patients with colorectal cancer. Eur J Cancer. 2020 May;130:102-113. doi: 10.1016/j.ejca.2020.01.025. Epub 2020 Mar 13.
Volkel V, Steinger B, Koller M, Klinkhammer-Schalke M, Lindberg-Scharf P. Colorectal cancer survivors' long-term recollections of their illness and therapy up to seven years after enrolment into a randomised controlled clinical trial. BMC Cancer. 2023 Feb 13;23(1):149. doi: 10.1186/s12885-023-10604-z.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DIQOL_Follow-up_2021
Identifier Type: -
Identifier Source: org_study_id