Metastatic adenocarcinoma of the colon or rectum Cancer
Conditions
Interventions
Decision aids (DAs) are a tool used to improve communicating information between health providers and patients, and to involve patients in decisions about their health care.
Stratifie
oncologists and patients are informed of the randomization arm only when patients receive the DA. Those receiving DA are counselled not to share it with others in the waiting room to avoid contaminati
Sponsors
Ministry of Health
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age between 21 and 75 years 2. Confirmed diagnosis of metastatic adenocarcinoma of the colon or rectum 3. Patient or companion must be able to read and write 4. Written informed consent is obtained from each patient
Exclusion criteria
Exclusion criteria: 1. Not candidate for chemotherapy because of medical reason or very poor performance status 2. Illiterate patient and companion have uncontrolled psychiatric condition or any other condition that impairs ability to decision making (e.g. dysphasia, deafness etc) 3. Life expectancy less than 6 weeks 4. Patients were excluded if they had previously received chemotherapy for metastatic colorectal cancer (adjuvant chemotherapy permitted), cognitive impairment with patient and companion, severe comorbid illness, or extreme anxiety or distress, as assessed by the treating physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient understanding of prognostic, treatment information and satisfaction with decision-making, assessed using a questionnaire that covers various content areas regarding colorectal cancer metastases, e.g., the natural history of colorectal cancer, the risk of cancer recurrence and, what chemotherapy is and how it is given, and the benefits and risks associated with chemotherapy. Each item on the questionnaire consists of a statement followed by a true/false/unsure response. A scoring instrument is used as the percentage of correct responses from 0–10. Measured immediately after the consultation and after 1 and 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Patient satisfaction with decision-making using the effective decision-making subscale of the Decisional Conflict Instrument at baseline, 1 and 6 months 2. Patient anxiety measured using Generalized Anxiety Disorder Scale (GAD-7) at baseline, 1 and 6 months 3. Patient understanding based on mCRC standard prognosis and treatment information at baseline and 1 month 4. Physician satisfaction measured using a combination of two surveys (pretrial survey) | — |
Countries
Saudi Arabia
Outcome results
None listed