Elsevier

European Journal of Cancer

Volume 130, May 2020, Pages 102-113
European Journal of Cancer

Original Research
Diagnosing deficits in quality of life and providing tailored therapeutic options: Results of a randomised trial in 220 patients with colorectal cancer

https://doi.org/10.1016/j.ejca.2020.01.025Get rights and content
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Highlights

  • Quality of life (QoL) may be seriously impaired in patients with colorectal cancer.

  • A clinical pathway with QoL diagnosis and QoL-oriented therapy was developed.

  • QoL diagnosis and therapy resulted in improved QoL at 12 months after surgery.

  • Results are compatible with a randomised trial enrolling breast cancer patients.

Abstract

Background

The implementation of quality of life (QoL) concepts in routine care, is still an open matter. We followed the Medical Research Council framework for complex interventions to implement a model of QoL diagnosis and therapeutic options, and investigated its effectiveness in patients with colorectal cancer.

Methods

This randomised, single-blind, multicentre, clinical trial enrolled patients diagnosed with primary colorectal cancer aged 18 years or older who were surgically treated in one of four recruiting hospitals in Germany. All patients received aftercare from one of 178 coordinating practitioners (CPs) who had access to 75 healthcare professionals providing tailored therapies. QoL was measured (EORTC QLQ-C30, QLQ-CR29) in all patients after surgery (baseline) and during aftercare (3, 6, 12, 18 months). 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 CP or standard postoperative care adhering to the German national guideline for colorectal cancer (control). The primary endpoint was the proportion of patients in each group with a need for QoL therapy 12 months after surgery. Analyses were done in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT02321813 and closed to accrual.

Findings

Between Jan 13, 2014, and Oct 28, 2015, 220 patients were enrolled and randomly assigned (n = 110 per group). At baseline (in hospital after surgery), a need for QoL therapy was diagnosed in 92/103 (89%) of intervention and 86/104 (83%) of control group patients. At 12 months (primary endpoint) the proportion of patients with a need for QoL therapy was 35/83 (42%; 95% CI 31–54%) in the intervention group versus 50/87 (57%; 95% CI: 46–68%) in the control group (p = 0·046, number needed to treat = 7; 95% CI 3–225).

Interpretation

Patients profited from the diagnosis of QoL deficits and tailored therapeutic options in their treatment of colorectal cancer. This trial confirmed the results of a previous RCT in breast cancer patients. The implementation of QoL concepts should become standard in treatment guidelines on cancer care.

Funding

Federal Ministry of Education and Research (BMBF; grant no. 01GY1339).

Clinical trial information

NCT02321813.

Keywords

Quality of life
Colorectal cancer
Definitive RCT
Complex intervention
Effectiveness of quality of life implementation

Cited by (0)

Prior presentation: Presented at the Annual Meeting of the American Society of Clinical Oncology, Chicago, IL, June 1–5, 2018.

1

The members of the collabration group “Regensburg QoL Study Group” are listed in Appendix.