Colorectal CancerMINDNCT03781193
Psychological Predictors in Colorectal Cancer Surgery Recovery
An observational study of Colorectal Cancer, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Questionnaires administration, Five Facet Mindfulness Questionnaire (FFMQ) and Langer Mindfulness Scale (LMS)
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 6 Mar 2018to 6 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Colorectal cancer patients scheduled for elective curative colorectal surgery.
Who may be able to join
- Patients > 18 years old (both males and females).
- Patients diagnosed with colorectal cancer.
- Patients scheduled for elective open or laparoscopic surgery for curative intent.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Istituto Clinico Humanitas, Division of Colon and Rectal Surgery
Milan, MI, 20089
Annalisa Maroli, PhD, 0282247776, annalisa.maroli@humanitas.it
About this study
Official title: Psychological Predictors of Post-surgical Recovery in Colorectal Cancer Patients: a Pilot Cohort Study
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.
Read the detailed description
Preliminary evidence suggests that there are multiple variables that may influence the functional recovery following colorectal cancer surgery, some of which deal with the psychological domain. Distress and depression can negatively affect the perceptions of functional ability, while resilience and effective coping styles promote a better psychological adaptation to challenging situations. Furthermore, psychosocial prehabilitation and interventions have been proposed as a feasible and cost-effective way to positively influence the recovery after surgery in association with the Enhanced Recovery After Surgery (ERAS) protocol.
In particular, mindfulness is proved to be associated with higher quality of life in different medical conditions, including oncological patients and has been also associated with improved clinical outcomes.
The aim of the study is to investigate the association of mindfulness and other psychological predictors with functional and quality of life outcomes in patients undergoing colorectal surgery for oncological condition.
- Conditions
- Colorectal Cancer
- Being tested
- Questionnaires administration, Five Facet Mindfulness Questionnaire (FFMQ), Langer Mindfulness Scale (LMS), Cognitive Flexibility Scale (CFS), Life Orientation Test (LOT)
- Keywords
- mindfulness, Psychological predictors, Colorectal surgery, ERAS
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaires administrationOther
Psychological and quality of life questionnaires
Five Facet Mindfulness Questionnaire (FFMQ)Other
FFMQ is a 39-item measure consisting of five subscales (observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience).
Langer Mindfulness Scale (LMS)Other
The LMS Tis a 21-item questionnaire, assessing four domains associated with mindful thinking: novelty-seeking, engagement, novelty producing, and flexibility.
Cognitive Flexibility Scale (CFS)Other
The CFS is 12-item self-report test assessing awareness.
Life Orientation Test (LOT)Other
The LOT is a 10-item, self-administered scale assessing generalized expectancies for positive versus negative outcomes.
Mini Locus of Control test (MLS)Other
The MLS is a 6-item questionnaire that includes 3 factors : chance, powerful others, and internality.
Hospital Anxiety and Depression Scale (HADS)Other
The HADS is a 14-items rated on a four-point Likert scale. The questionnaire was designed to screen for the presence and severity of depression (HADS-D) and anxiety (HADS-A) in people with a physical symptomatology
Perceived Stress Scale (PSS)Other
The PSS is 14-item self-report tool commonly used to provide a global measure of perceived stress in daily life.
Toronto Alexithymia Scale (TAS)Other
The TSA is a 20-item scale that evaluates the three components of alexithymia: difficulty to identify feelings and distinguish between feelings and bodily sensations of emotional arousal difficulty, describing feelings to others, and a cognitive style that is literal, utilitarian, and externally oriented.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Post-operative day 7
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)
Measured: Post-operative day 90
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)
Measured: Post-operative month 6
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)
Measured: Post-operative month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start6 Mar 2018
- Primary completion6 Mar 2019 (estimated)
- Study completion6 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonino Spinelli, MD, PhD, Principal investigator, Istituto Clinico Humanitas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03781193
- Sponsor's protocol ID
- 1945
- Acronym
- MIND
- Status last verified
- Dec 2018
- First submitted
- 14 Dec 2018
- Last updated
- 20 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Predictors of Post-surgical Recovery in Colorectal Cancer Patients: a Pilot Cohort Study
- ClinicalTrials.gov ID
- NCT03781193
- Acronym / sponsor ID
- MIND / 1945
- Conditions
- Colorectal Cancer
- Keywords
- mindfulness, Psychological predictors, Colorectal surgery, ERAS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 6 Mar 2018 (actual)
- Primary completion
- 6 Mar 2019 (estimated)
- Study completion
- 6 Jul 2019 (estimated)
- First posted
- 19 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Preliminary evidence suggests that there are multiple variables that may influence the functional recovery following colorectal cancer surgery, some of which deal with the psychological domain. Distress and depression can negatively affect the perceptions of functional ability, while resilience and effective coping styles promote a better psychological adaptation to challenging situations. Furthermore, psychosocial prehabilitation and interventions have been proposed as a feasible and cost-effective way to positively influence the recovery after surgery in association with the Enhanced Recovery After Surgery (ERAS) protocol.
In particular, mindfulness is proved to be associated with higher quality of life in different medical conditions, including oncological patients and has been also associated with improved clinical outcomes.
The aim of the study is to investigate the association of mindfulness and other psychological predictors with functional and quality of life outcomes in patients undergoing colorectal surgery for oncological condition.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Colorectal cancer patients scheduled for elective curative colorectal surgery.
Key inclusion criteria (3 listed)
- Patients > 18 years old (both males and females).
- Patients diagnosed with colorectal cancer.
- Patients scheduled for elective open or laparoscopic surgery for curative intent.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaires administrationPsychological and quality of life questionnaires | Other | – |
| Five Facet Mindfulness Questionnaire (FFMQ)FFMQ is a 39-item measure consisting of five subscales (observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience). | Other | – |
| Langer Mindfulness Scale (LMS)The LMS Tis a 21-item questionnaire, assessing four domains associated with mindful thinking: novelty-seeking, engagement, novelty producing, and flexibility. | Other | – |
| Cognitive Flexibility Scale (CFS)The CFS is 12-item self-report test assessing awareness. | Other | – |
| Life Orientation Test (LOT)The LOT is a 10-item, self-administered scale assessing generalized expectancies for positive versus negative outcomes. | Other | – |
| Mini Locus of Control test (MLS)The MLS is a 6-item questionnaire that includes 3 factors : chance, powerful others, and internality. | Other | – |
| Hospital Anxiety and Depression Scale (HADS)The HADS is a 14-items rated on a four-point Likert scale. The questionnaire was designed to screen for the presence and severity of depression (HADS-D) and anxiety (HADS-A) in people with a physical symptomatology | Other | – |
| Perceived Stress Scale (PSS)The PSS is 14-item self-report tool commonly used to provide a global measure of perceived stress in daily life. | Other | – |
| Toronto Alexithymia Scale (TAS)The TSA is a 20-item scale that evaluates the three components of alexithymia: difficulty to identify feelings and distinguish between feelings and bodily sensations of emotional arousal difficulty, describing feelings to others, and a cognitive style that is literal, utilitarian, and externally oriented. | Other | – |
Primary outcome
Correlation between psychological predictors questionnaires outcome and length of hospital stay
Time frame: Post-operative day 7
Length of stay calculated in days from the day of surgery until the day of discharge
Correlation between psychological predictors questionnaires outcome and quality of life
Time frame: Post-operative day 90
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)
Correlation between psychological predictors questionnaires outcome and quality of life
Time frame: Post-operative month 6
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)
Correlation between psychological predictors questionnaires outcome and quality of life
Time frame: Post-operative month 12
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonino Spinelli, MD, PhD principal investigator
Istituto Clinico Humanitas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Istituto Clinico Humanitas at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Annalisa Maroli, PhD (+.39 02 8224 7776, annalisa.maroli@humanitas.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between psychological predictors questionnaires outcome and length of hospital stay (time frame: Post-operative day 7). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2018.