Table 5. Inclusion and exclusion criteria for the longitudinal cohorts for the DOLORisk protocol.
Inclusion criteria | Exclusion criteria | |
---|---|---|
Chemotherapy | • ≥18 years.
• Diagnosed with high-risk colorectal cancer. • Planned adjuvant treatment with oxaliplatin and flourouracil (5-FU) or capecitabine (Pro 5-FU). |
• Known metastatic cancer.
• Previous treatment with chemotherapy. • Significant mental illness. • Alcohol abuse. • Known diabetes. • Significant neuropathic diseases. • Spinal cord stenosis. • Peripheral vascular diseases (Fontaine >2). • Chronic pain with a pain intensity on a 0-10 numeric rating scale >5. • Patients who do not speak, read or understand Danish. |
Thoracotomy | • ≥ 18 years.
• Scheduled for lung cancer resection performed via thoracoscopy and/or thoracotomy, including lobectomy, bilobectomy, pneumonectomy, resection of the tracheobronchial bifurcation, wedge resection, sleeve resection and combinations hereof. • Willingness and ability to comply with study procedures as judged by the site investigator/ manager. • Expected availability for follow-up throughout the study. |
• Mental incapacity or language barriers precluding
adequate understanding of study procedures. • Current alcohol or substance abuse according to the site investigator’s medical judgement. • Unsuitability for participation in the study for any other reason, e.g. due to a significant serious underlying condition (e.g. other cancer or AIDS), as determined by the site investigator/manager. ADDITIONALLY in FR: • Previous surgery on the same area. • Surgery targeting only the pleura or mediastinum. • Peripheral neurological pathology or central (brain damage, multiple sclerosis) susceptible to interfere with the evaluation of the post-operative pain. • History of significant mental illness: psychosis, severe depression having motivated a hospitalisation, suicide attempt. • Current major depressive episode at the time of the evaluation. • Abuse of drug or psychoactive substance during the last six months. • Patients participating in another protocol of biomedical research. |
Mastectomy | • Women ≥ 18 years.
• Scheduled for breast cancer resection performed via lumpectomy (partial or segmental mastectomy) or mastectomy with or without sentinel lymph node biopsy and axillary lymph node dissection, and any combinations hereof. • Affiliated to a social security scheme. • Danish/French language (read, written and spoken). • Willingness and ability to comply with study procedures as judged by the site investigator. • Expected availability for follow-up throughout the study. |
• Cognitive or psychological disorders incompatible with
the respect and/or the understanding of the protocol. • Current alcohol or substance abuse according to the site investigator's medical judgement. • Unsuitability for participation in the study for any other reason, e.g. due to a significant serious underlying condition (e.g. other cancer or AIDS), as determined by the site investigator. • Previous surgery on the same area. • Peripheral neurological pathology or central (brain damage, multiple sclerosis) susceptible to interfere with the evaluation of the post-operative pain. • History of significant mental illness: psychosis, severe depression having motivated a hospitalisation, suicide attempt. • Current major depressive episode at the time of assessment. • Abuse of drug or psychoactive substance during the last six months • Participating in another protocol of biomedical research. • Other cancer or AIDS. • Scheduled for bilateral mastectomy. • Presence of chronic pain before the breast cancer surgery. • Workplace accident, litigation or search for compensation. |