DIQOLFollow-up: Quality of Life and Survival of Patients With Colorectal Cancer 5 Years After Surgery - Follow-up of the RCT DIQOL
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Former DIQOL intervention group 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
Quality of life measurement, diagnosis, and tailored therapy (pain therapy, psychotherapy, social support, nutrition, stoma care, physiotherapy, fitness)
|
| Former DIQOL control group 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. |
Outcome Measures
Primary Outcome Measures
- need for QoL therapy of colorectal cancer survivors [>5 years after surgery for colorectal cancer]
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
- specific need for QoL therapy of colorectal cancers survivors in specific QoL dimensions [>5 years after surgery for colorectal cancer]
rates of patients with a need for QoL therapy in each single dimension of the QoL-profile more than 5 years after surgery
Secondary Outcome Measures
- overall survival [surgery for colorectal cancer (01/2014-10/2015) up to 10/2021]
survival after surgery for colorectal cancer
- recurrence-free survival [surgery for colorectal cancer (01/2014-10/2015) up to 10/2021]
recurrence-free survival after surgery for colorectal cancer
- aftercare of colorectal cancer survivors during the COVID-19 pandemic [>5 years after surgery for colorectal cancer]
self-created questionnaire with quantitative questions asking whether and how the COVID-19 pandemic affected ´aftercare
- colorectal cancer survivors' recollections of their illness an therapy [>5 years after surgery for colorectal cancer]
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
Eligibility Criteria
Criteria
Inclusion Criteria:
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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 -
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tumor Center Regensburg, Institute of Quality Management and Health Services Research of the University of Regensburg | Regensburg | Bavaria | Germany | 93053 |
Sponsors and Collaborators
- Tumor Center Regensburg
Investigators
- Study Chair: Monika Klinkhammer-Schalke, MD, Prof., Tumor Center Regensburg
- Principal Investigator: Patricia Lindberg-Scharf, PhD, Tumor Center Regensburg
Study Documents (Full-Text)
None provided.More Information
Publications
- DIQOL_Follow-up_2021