Quality of Life and Survival of Patients With Colorectal Cancer 5 Years After Surgery - Follow-up of the RCT DIQOL (DIQOLFollow-up)

November 25, 2021 updated by: Prof. Dr. Monika Klinkhammer-Schalke, Tumor Center Regensburg

Quality of Life and Survival of Patients With Colorectal Cancer 5 Years After Surgery and Their Aftercare Situation During the COVID-19 Pandemic - Long-term Follow-up of the Randomized Trial DIQOL

This observational follow-up study of the randomized trial (RCT) DIQOL investigates long-term effects of an intervention with quality of life (QoL) diagnosis and therapy on present QoL, survival, and recurrence-free survival of colorectal cancer survivors more than 5 years after surgery.

Moreover, patients' experiences with aftercare for colorectal cancer during the COVID-19 pandemic and their recollections of their illness and therapy are examined.

Study Overview

Detailed Description

In a complex intervention a clinical pathway with quality of life (QoL) diagnosis and tailored therapy had been developed for patients with colorectal cancer and its effectiveness was evaluated in a randomized trial (RCT DIQOL, NCT02321813, Klinkhammer-Schalke et al, 2020). In the RCT DIQOL a total of 220 patients were randomised (1:1) into two groups: a care pathway, including QoL-profiles consisting of 13 QoL scales plus specific therapeutic recommendations forwarded to the patient's doctor (intervention) or standard postoperative care (control). QoL was measured (EORTC QLQ-C30, QLQ-CR29) in all patients after surgery and during aftercare (3, 6, 12, 18 months postoperatively). A need for QoL therapy was defined as a score <50 points on at least one QoL scale. It was demonstrated that the proportion of patients with a need for QoL therapy was significantly lower in intervention group patients at 12 months after surgery (primary endpoint).

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.

Study Type

Observational

Enrollment (Actual)

208

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

    • Bavaria
      • Regensburg, Bavaria, Germany, 93053
        • Tumor Center Regensburg, Institute of Quality Management and Health Services Research of the University of Regensburg

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Former participants of the RCT DIQOL with a primary diagnosis of colorectal cancer between 01/2014 and 10/2015 who had been surgically treated in one of four participating certified centers for colorectal cancer (Krankenhaus Barmherzige Brüder Regensburg, Germany; Caritas-Krankenhaus St. Josef Regensburg, Germany; Klinikum Neumarkt, Germany; Klinikum St. Elisabeth Straubing, Germany). Originally, 220 patients were included in the RCT DIQOL. Of the 220 participants who were included in the RCT 12 patients refused participation during the trial so that the final sample for the follow-up study encompasses 208 patients. The questionnaire is mailed to survivors of this cohort. Overall survival and recurrence-free surival will be analzyed in all 208 former study participants.

Description

Inclusion Criteria:

  • former participants of the RCT DIQOL with a primary diagnosis of colorectal cancer between 01/2014 and 10/2015 who did not refuse to participate during the RCT
  • informed consent

Exclusion Criteria:

- none -

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
need for QoL therapy of colorectal cancer survivors
Time Frame: >5 years after surgery for colorectal cancer
proportion of patients in both groups with a need for QoL therapy (<50 points in at least one dimension) more than 5 years after surgery
>5 years after surgery for colorectal cancer
specific need for QoL therapy of colorectal cancers survivors in specific QoL dimensions
Time Frame: >5 years after surgery for colorectal cancer
rates of patients with a need for QoL therapy in each single dimension of the QoL-profile more than 5 years after surgery
>5 years after surgery for colorectal cancer

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: surgery for colorectal cancer (01/2014-10/2015) up to 10/2021
survival after surgery for colorectal cancer
surgery for colorectal cancer (01/2014-10/2015) up to 10/2021
recurrence-free survival
Time Frame: surgery for colorectal cancer (01/2014-10/2015) up to 10/2021
recurrence-free survival after surgery for colorectal cancer
surgery for colorectal cancer (01/2014-10/2015) up to 10/2021
aftercare of colorectal cancer survivors during the COVID-19 pandemic
Time Frame: >5 years after surgery for colorectal cancer
self-created questionnaire with quantitative questions asking whether and how the COVID-19 pandemic affected ´aftercare
>5 years after surgery for colorectal cancer
colorectal cancer survivors' recollections of their illness an therapy
Time Frame: >5 years after surgery for colorectal cancer
self-created questionnaire with three qualitative questions asking for worst experiences during the colorectal cancer episode, positive aspects of the illness, and any advice survivors would give to newly diagnosed patients
>5 years after surgery for colorectal cancer

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Monika Klinkhammer-Schalke, MD, Prof., Tumor Center Regensburg
  • Principal Investigator: Patricia Lindberg-Scharf, PhD, Tumor Center Regensburg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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)

April 14, 2021

Primary Completion (Actual)

October 7, 2021

Study Completion (Actual)

October 7, 2021

Study Registration Dates

First Submitted

June 10, 2021

First Submitted That Met QC Criteria

June 10, 2021

First Posted (Actual)

June 18, 2021

Study Record Updates

Last Update Posted (Actual)

November 29, 2021

Last Update Submitted That Met QC Criteria

November 25, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized IPD that underlie the results in a publication are planned to be made available upon request of scientists.

IPD Sharing Time Frame

6 months after date of publication until 60 months after date of publication

IPD Sharing Access Criteria

Data will be made available to other scientists upon request for nonprofit research. The contact address is monika.klinkhammer-schalke@ur.de. Scientists are required to send their predefined statistical analysis plan. Together with the scientific review board of the Tumor Center Regensburg a decision will be made based on the quality and usefulness of planned statistical analysis. In case of a positive decision the scientist is required to sign a contract for data usage before receiving anonymized IPD.

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 Quality of Life

Clinical Trials on Quality of life diagnosis and therapy during the completed RCT DIQOL

Subscribe