Colorectal Cancer Clinical Trial
— MINDOfficial title:
Psychological Predictors of Post-surgical Recovery in Colorectal Cancer Patients: a Pilot Cohort Study
NCT number | NCT03781193 |
Other study ID # | 1945 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | March 6, 2018 |
Est. completion date | July 6, 2019 |
This is an observation pilot trial aimed to study to the association between mindfulness and other psychological factors, including both protective and risk factors, with recovery of functional ability following colorectal cancer surgery.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | July 6, 2019 |
Est. primary completion date | March 6, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients > 18 years old (both males and females). - Patients diagnosed with colorectal cancer. - Patients scheduled for elective open or laparoscopic surgery for curative intent. Exclusion Criteria: - Patients unable to give the written informed consent. - Patients < 18 years old. - Patients undergoing surgery in emergency setting. - Patients with pre-operative evidence of metastatic cancer or colorectal cancer recurrence. - Pregnant or breastfeeding patients. - Any condition that, in the opinion of the investigator, can interfere with the study protocol (e.g. neuropsychiatric disorders or dementia). |
Country | Name | City | State |
---|---|---|---|
Italy | IRCCS Istituto Clinico Humanitas, Division of Colon and Rectal Surgery | Milan | MI |
Lead Sponsor | Collaborator |
---|---|
Istituto Clinico Humanitas |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Correlation between psychological predictors questionnaires outcome and length of hospital stay | Length of stay calculated in days from the day of surgery until the day of discharge | Post-operative day 7 | |
Primary | Correlation between psychological predictors questionnaires outcome and quality of life | Quality of Life will be assessed by using the European Organization for Research and Treatment of Cancer Quality of Life core Questionnaire (EORTC-QLQ-C30) and the European Organisation for Research and Treatment of Cancer Quality of life Questionnaire ColoRectal specific module (EORTC-QLQ-CR29) | Post-operative day 90 | |
Primary | Correlation between psychological predictors questionnaires outcome and quality of life | Quality of Life will be assessed by using the European Organization for Research and Treatment of Cancer quality of Life core Questionnaire (EORTC-QLQ-C30) and the European Organisation for Research and Treatment of Cancer Quality of life Questionnaire ColoRectal specific module (EORTC-QLQ-CR29) | Post-operative month 6 | |
Primary | Correlation between psychological predictors questionnaires outcome and quality of life | Quality of Life will be assessed by using the European Organization for Research and Treatment of Cancer Quality of Life core Questionnaire (EORTC-QLQ-C30) and the European Organisation for Research and Treatment of Cancer Quality of life Questionnaire ColoRectal specific module (EORTC-QLQ-CR29) | Post-operative month 12 |
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