Direct Improvement of Quality of Life Using a Tailored Pathway With Quality of Life Diagnosis and Therapy: Randomised Trial in Colorectal Cancer Patients

Study Overview
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Brief Summary
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The purpose of the study is to determine whether a quality of life pathway with defined diagnostic and therapeutic options improves quality of life in colorectal cancer patients during follow-up.

Detailed Description
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There is a growing interest in using quality of life (QoL) data not only as relevant endpoint in clinical trials on cancer patients, but also in routine practice in order to improve patients' health during treatment. The investigators designed, implemented and evaluated an integrated quality of life diagnosis and therapy pathway (QoL pathway) for breast cancer patients (Klinkhammer-Schalke et al, 2008; 2012), guided by the UK Medical Research Council framework for developing and testing complex interventions. It could be demonstrated in a routine setting that breast cancer patients showed a benefit from tailored QoL diagnosis and therapy (Klinkhammer-Schalke et al, 2012). But there is also requirement for managing QoL deficits of patients with other cancers and to replicate findings of the previous trial. To achieve this aim, the QoL pathway has been modified for colorectal cancer patients. The Tumor Center Regensburg provides the infrastructure of the present project (quality circles, project groups). This is a two-arm randomised clinical trial with one intervention group and one control group. Patients' QoL is assessed with the EORTC QLQ-C30 and QLQ-CR29 at 0, 3, 6, 12, and 18 months after surgery. In intervention group results of the QoL-measure are transferred to a QoL-profile including 13 dimensions on scales of 0-100 (cutoff for diseased QoL <50). Three experts with varying professional background use the individual patient's QoL-profile and clinical and sociodemographic information in order to generate a QoL-report including therapy recommendation which is sent to the coordinating practitioner. Specific therapeutic options for the treatment of diseased QoL have been identified: pain therapy, psychotherapy, social support, nutrition counseling, stoma care, physiotherapy, fitness. To provide continuous medical education, quality circles for each therapy option have been founded. Coordinating practitioners receive a list with addresses of all quality circle members. In control group QoL is also measured but the coordinating practitioner neither receives a QoL-profile nor a QoL-report. The investigators expect that patients in the intervention group will experience a lower number of QoL-deficits (QoL < 50 points) in the first year after surgery compared with patients in the control group

Official Title
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Direct Improvement of Quality of Life Using a Tailored Pathway With Quality of Life Diagnosis and Therapy: Protocol of a Randomised Clinical Trial in Colorectal Cancer Patients

Conditions
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Quality of Life, Colorectal Neoplasms

Intervention / Treatment
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* Behavioral: quality of life pathway
* Other: placebo control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: primary colorectal cancer operated in one of four participating certified cancer centres for colorectal cancer (Krankenhaus Barmherzige Brüder, Department of Surgery, Regensburg; Germany; Caritas-Krankenhaus St. Josef, Department of Surgery, Regensburg; Germany; Klinikum Neumarkt., Department of Surgery, Neumarkt; Germany; Klinikum St. Elisabeth Straubing, Department of Surgery, Straubing, Germany), documented in a population-based cancer registry (Tumor Center Regensburg e.V.) informed consent. Exclusion Criteria: coordinating practitioner not implemented patient from district outside the study region (rural districts Regensburg, Neumarkt, Straubing, Straubing-Bogen, Kelheim, Schwandorf) patient unable to fill out the questionnaire for physical, psychological or language reasons (including dementia) age under 18 years pregnancy QoL clinician unavailable refusal to participate

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention group<br>In the quality of life pathway results of the quality of life (QoL) measure are transferred to a QoL-profile. Three experts with various professional background use the individual patient's QoL-profile and clinical and sociodemographic information in order to generate a QoL-report including therapy recommendation which is sent to the coordinating practitioner. Specific therapeutic options for the treatment of diseased QoL have been identified: pain therapy, psychotherapy, social support, nutrition counseling, stoma care, physiotherapy, fitness. To provide continuous medical education, quality circles for each therapy option haven been founded. Coordinating practitioners receive a list with addresses of all quality circle members. | Behavioral: quality of life pathway<br>* Quality of life measurement, diagnosis and tailored therapy (pain therapy, psychotherapy, social support, nutrition, stoma care, physiotherapy, fitness)<br>|
| Placebo Comparator: control group<br>In control group QoL is also measured but the coordinating practitioner neither receives a QoL-profile nor a QoL-report. | Other: placebo control<br>* Quality of life measurement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of patients in both groups with diseased quality of life (<50 points in at least one dimension) |  | 1 year after the date of primary surgery for colorectal cancer | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rates of patients with diseased quality of life in each dimension of the profile |  | 0 (0-2 days before clinical discharge), 3, 6, 12, and 18 months after primary surgery for colorectal cancer | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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quality of life, colorectal cancer, definitive RCT, complex intervention