Clinical trial NCT04930016: Quality of Life and Survival of Patients With Colorectal Cancer 5 Years After Surgery - Follow-up of the RCT DIQOL
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Quality of Life
Colorectal Cancer
Colorectal Neoplasms
Survivorship
Keywords: quality of life
colorectal cancer
complex intervention
survivorship
health services research
Lead sponsor: Tumor Center Regensburg
Sponsor class: OTHER
First posted: 2021-06-18
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

Brief 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.

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.

Eligibility criteria: 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 -

Primary outcomes:
measure: need for QoL therapy of colorectal cancer survivors
timeFrame: >5 years after surgery for colorectal cancer
measure: specific need for QoL therapy of colorectal cancers survivors in specific QoL dimensions
timeFrame: >5 years after surgery for colorectal cancer
Secondary outcomes:
measure: overall survival
timeFrame: surgery for colorectal cancer (01/2014-10/2015) up to 10/2021
measure: recurrence-free survival
timeFrame: surgery for colorectal cancer (01/2014-10/2015) up to 10/2021
measure: aftercare of colorectal cancer survivors during the COVID-19 pandemic
timeFrame: >5 years after surgery for colorectal cancer
measure: colorectal cancer survivors' recollections of their illness an therapy
timeFrame: >5 years after surgery for colorectal cancer
Other outcomes:
Locations:
city: Regensburg
country: Germany
facility: Tumor Center Regensburg, Institute of Quality Management and Health Services Research of the University of Regensburg
state: Bavaria
Study officials:
affiliation: Tumor Center Regensburg
name: Monika Klinkhammer-Schalke, MD, Prof.
role: STUDY_CHAIR
affiliation: Tumor Center Regensburg
name: Patricia Lindberg-Scharf, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.