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

Colorectal Cancer Clinical Trial

— DIQOLFollow-up  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04930016
• Other study ID #: DIQOL_Follow-up_2021
• Status: Completed
• Start date: April 14, 2021
• Est. completion date: October 7, 2021

Study information

• Verified date: November 2021
• Source: Tumor Center Regensburg
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: October 7, 2021
• Est. primary completion date: October 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 -

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Quality of Life
• Survivorship

Intervention

Behavioral:
• 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)

Locations

Country	Name	City	State
Germany	Tumor Center Regensburg, Institute of Quality Management and Health Services Research of the University of Regensburg	Regensburg	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Tumor Center Regensburg

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Klinkhammer-Schalke M, Steinger B, Koller M, Zeman F, Fürst 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	>5 years after surgery for colorectal cancer
Primary	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	>5 years after surgery for colorectal cancer
Secondary	overall survival	survival after surgery for colorectal cancer	surgery for colorectal cancer (01/2014-10/2015) up to 10/2021
Secondary	recurrence-free survival	recurrence-free survival after surgery for colorectal cancer	surgery for colorectal cancer (01/2014-10/2015) up to 10/2021
Secondary	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	>5 years after surgery for colorectal cancer
Secondary	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	>5 years after surgery for colorectal cancer