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.
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
208
Quality of life measurement, diagnosis, and tailored therapy (pain therapy, psychotherapy, social support, nutrition, stoma care, physiotherapy, fitness)
Tumor Center Regensburg, Institute of Quality Management and Health Services Research of the University of Regensburg
Regensburg, Bavaria, Germany
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
Time frame: >5 years after surgery for colorectal cancer
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
Time frame: >5 years after surgery for colorectal cancer
overall survival
survival after surgery for colorectal cancer
Time frame: surgery for colorectal cancer (01/2014-10/2015) up to 10/2021
recurrence-free survival
recurrence-free survival after surgery for colorectal cancer
Time frame: surgery for colorectal cancer (01/2014-10/2015) up to 10/2021
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
Time frame: >5 years after surgery for colorectal cancer
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
Time frame: >5 years after surgery for colorectal cancer
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