Colorectal cancer Cancer
Conditions
Interventions
Within the study a number of patients will be asked to use the PEPA within their personal care setting. Furthermore, it is envisaged to involve not only the NCT but also selected general practitioners
Sponsors
University Hospital Heidelberg - Department of General Practice and Health Services Research
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Inclusion criterial for patients: 1.1. Patients eligible for participation in the pre-implementation and implementation study have to be diagnosed with colorectal cancer (ICD-10: C18, C19, C20) 1.2. They either should be receiving chemotherapy with curative approach at the NCT after their primary surgery (at least for 2 months remains) or chemotherapy after relapse with symptom relieving approach at the NCT as well 1.3. The participants must be 18 years of age or older and their disease status has to be classified with UICC-stadium III-IV If the recruitment of a sufficient number of colorectal cancer patients should not be possible, the inclusion of other cancer diagnoses such as gallbladder ICD-10: C23.9, C24.0, C 24.1) or stomach (ICD-10: C16) will be envisaged. Within the pre-implementation study also patients with diabetes mellitus type 2 (ICD-10: E11) are possible participants for the usability test because of their chronic disease. 2. Inclusion criteria for health care professionals: The group of health care professionals is sub-classified into: 2.1. Clinicians of the NCT, 2.2. Other HCP’s like nursing staff, social worker, stoma-therapists, nutritionists that are connected to the NCT as well as 2.3. General practitioners (GP’s) according to German regulations and their 2.4. Medical assistants. To be eligible for participation in the study the clinicians and other HCP’s of the NCT have to cooperate closely with the included patients with colorectal cancer during their treatment at the NCT. The GP’s can be both, single and group practices. For the implementation study they have to be the attending physician of the included patients with colorectal cancer and they should have their practices in a distance of 20 to 30 km to the NCT. Additionally the GP’s have to have an internet access in their practices and an option to scan documents. 3. Inclusion criteria for stakeholder: To be eligible for participation in the study, the stakeholders have to be directly affected by or involved in the implementation process of a PEPA. The final selection of the stakeholder is based on: 3.1. Relevant organizations for the implementation process 3.2. The position/reputation of specific actors and 3.3. The potential influence and participation that actors have by relevant decision making and general acting concerning the implementation process of a PEPA
Exclusion criteria
Exclusion criteria: 1. Patients, who do not fulfill the inclusion criteria will be excluded 2. Additional exclusion criteria are: 2.1. Severe acute psychiatric disorders (for example, schizophrenia, schizotypal and delusional disorders) 2.2. Dementia 2.3. Mental and behavioural disorders due to psychoactive substance use 2.4. Insurmountable language and communication problems and emergent cases HCP’s (health care professionals) and stakeholders, who do not fulfill the inclusion criteria will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 03/05/2016: Patient self-efficacy, German version of the Cancer Behaviour Inventory – Brief Version (CBI-B-G) at Baseline and after 12 weeks Previous primary outcome measures: Patient self-efficacy, measured using the Communication and Attitudinal Self-Efficacy scale for cancer (CASE-cancer) at Baseline and after 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 03/05/2016: 1. Control Preference, measured using the Control Preference Scale at Baseline and after 12 weeks 2. Psychosocial distress, measured using the Distress Thermometer at Baseline and after 12 weeks 3. Utilization of medical services, measured using the Mannheimer Modul Ressourcenverbrauch at Baseline and after 12 weeks 4. Involvement in care, measured using the Patients’ perceived involvement in care (PICS) at Baseline and after 12 weeks 5. Usability of PEPA-prototype, measured using the System Usability Scale (SUS) at Baseline and after 12 weeks Previous secondary outcome measures: 1. Control Preference, measured using the Control Preference Scale at Baseline and after 12 weeks 2. Psychosocial distress, measured using the Distress Thermometer at Baseline and after 12 weeks 3. Quality of life, measured using the EQ-5D index at Baseline and after 12 weeks 4. Hope, measured using the Herth Hope Index (HHI) at Baseline and after 12 weeks 5. Depression severity, measured using the Whooley Depression Scale at Baseline and after 12 weeks 6. Utilization of medical services, measured using the Mannheimer Modul Ressourcenverbrauch at Baseline and after 12 weeks 7. Involvement in care, measured using the Patients‘ perceived involvement in care (PICS) at Baseline and after 12 weeks 8. Usability of PEPA-prototype, measured using the System Usability Scale (SUS) at Baseline and after 12 weeks | — |
Countries
Germany
Outcome results
None listed