An observational study in Quality of Life, Colorectal Cancer and Colorectal Neoplasms, sponsored by Tumor Center Regensburg. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-29.
Sponsored by Tumor Center Regensburg · Observational
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 208 is below the median of 250 across 1,226 observational studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Tumor Center Regensburg is the lead sponsor of 5 studies on the registry; none are open to participants now.
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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.
Exclusion Criteria:
In 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.
Behavioral: Quality of life diagnosis and therapy during the completed RCT DIQOL
In 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.
Quality of life measurement, diagnosis, and tailored therapy (pain therapy, psychotherapy, social support, nutrition, stoma care, physiotherapy, fitness)
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
Plan to share: Yes — Anonymized IPD that underlie the results in a publication are planned to be made available upon request of scientists.
This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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Tumor Center Regensburg