AzTrials
AzTrials

Quality of LifeDIQOLFollow-upNCT04930016

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

An observational study of Quality of Life and Colorectal Cancer, run by Tumor Center Regensburg at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Quality of life diagnosis and therapy during the completed RCT DIQOL
How many people
208 participants
Where
1 siteGermany
Study dates
14 Apr 2021to 7 Oct 2021
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • none -

Trial locations and contacts

1 site in 1 country.

Germany1 site

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

    Regensburg, Bavaria, 93053

Other trials in Germany

About this study

Official title: 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.

Read the 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.

Being tested
Quality of life diagnosis and therapy during the completed RCT DIQOL
Keywords
quality of life, colorectal cancer, complex intervention, survivorship, health services research
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Quality of life diagnosis and therapy during the completed RCT DIQOLBehavioural

    Quality of life measurement, diagnosis, and tailored therapy (pain therapy, psychotherapy, social support, nutrition, stoma care, physiotherapy, fitness)

Study groups in NCT04930016
Study groupRoleWhat they receive
Former DIQOL intervention groupIn 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.
Receives: Behavioral: Quality of life diagnosis and therapy during the completed RCT DIQOL
Former DIQOL control groupIn 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. need for QoL therapy of colorectal cancer survivors

    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

    Measured: >5 years after surgery for colorectal cancer

  2. specific need for QoL therapy of colorectal cancers survivors in specific QoL dimensions

    rates of patients with a need for QoL therapy in each single dimension of the QoL-profile more than 5 years after surgery

    Measured: >5 years after surgery for colorectal cancer

Secondary outcomes (4)

  1. overall survival

    survival after surgery for colorectal cancer

    Measured: surgery for colorectal cancer (01/2014-10/2015) up to 10/2021

  2. recurrence-free survival

    recurrence-free survival after surgery for colorectal cancer

    Measured: surgery for colorectal cancer (01/2014-10/2015) up to 10/2021

  3. aftercare of colorectal cancer survivors during the COVID-19 pandemic

    self-created questionnaire with quantitative questions asking whether and how the COVID-19 pandemic affected ´aftercare

    Measured: >5 years after surgery for colorectal cancer

  4. colorectal cancer survivors' recollections of their illness an therapy

    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

    Measured: >5 years after surgery for colorectal cancer

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2021
  2. Study start14 Apr 2021
  3. Primary completion7 Oct 2021
  4. Study completion7 Oct 2021

Resources

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
Cohort
Time perspective
Cross-sectional
Enrolment
208 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04930016
Sponsor's protocol ID
DIQOL_Follow-up_2021
Acronym
DIQOLFollow-up
Status last verified
Nov 2021
First submitted
10 Jun 2021
Last updated
29 Nov 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Anonymized IPD that underlie the results in a publication are planned to be made available upon request of scientists.

Publications

  • 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.

    PubMed 32179445

  • 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.

    PubMed 36782134

Questions about this trial

What is this clinical trial studying?

An observational study of Quality of Life and Colorectal Cancer, run by Tumor Center Regensburg at 1 site in Germany.

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 2 inclusion and 1 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: finished, as of the sponsor's last update on 29 Nov 2021. 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 Germany. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

need for QoL therapy of colorectal cancer survivors (time frame: >5 years after surgery for colorectal cancer). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04930016, which also lists 2 linked publications.

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 29 Nov 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in