Esophageal CancerNCT01738620
Quality of Life After Esophagectomy for Cancer - Step 1
A study testing psychological counseling and prevention of sleep disorders in ICU in people with Esophageal Cancer and Sleep Disturbance, run by University of Padova at 1 site in Italy.
Trial summary
Background: A recent systematic review showed that patients undergoing esophagectomy for cancer had scores of physical function, vitality and performance of health in general significantly lower than those obtained from the reference population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer, Sleep Disturbance, Quality of Life
- What is being tested?
- psychological counseling and prevention of sleep disorders in ICU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2013to Feb 2016
- Phase
- Interventional
- 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
Who may be able to join
- age above 18 years old
- scheduled for esophagectomy for cancer
Who cannot join
- age below 18 years old
- incapability to autonomously fill in questionnaires
- primary language not italian
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quality of Life After Esophagectomy for Cancer - QOLEC1
Background: A recent systematic review showed that patients undergoing esophagectomy for cancer had scores of physical function, vitality and performance of health in general significantly lower than those obtained from the reference population. The analysis of the quality of life at six months follow-up showed that the total score and physical function were better before surgery and symptoms-based scales indicated that the fatigue, dyspnoea and diarrhea were worse six months after esophagectomy. The objective of this study is therefore to assess the impact of esophageal resections for cancer on the quality of life of patients and to improve it through simple interventions of post operative care.
The study is divided into two steps.
Read more
This is step 1.
Patients will be randomized into four groups receiving respectively: psychological counseling for support plus appropriate measures to reduce sleep-wake rhythm disorders during ICU stay; psychological counseling alone; appropriate measures to reduce sleep-wake rhythm disorders during ICU stay alone; or standard care. The primary end point are the items SL (sleep disorder) and QL2 of the QLQ C30, and the secondary end point is the score of the PSQI.
- Conditions
- Esophageal Cancer, Sleep Disturbance, Quality of Life
- Being tested
- psychological counseling, prevention of sleep disorders in ICU
- Keywords
- esophageal cancer, sleep disturbance, quality of life
- Medical subject headings
- Esophageal Neoplasms, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psychological counselingBehavioural
prevention of sleep disorders in ICUBehavioural
| Study group | Role | What they receive |
|---|---|---|
| psychological counseling+prevention of sleep disorders in ICU | Experimental | patients will receive both psychological counseling and interventions to prevent sleep disorders during their ICU stay Receives: Behavioral: psychological counseling; Behavioral: prevention of sleep disorders in ICU |
| psychological counseling | Experimental | patients will receive psychological counseling Receives: Behavioral: psychological counseling |
| prevention of sleep disorders in ICU | Experimental | interventions to prevent sleep disorders during their ICU stay Receives: Behavioral: prevention of sleep disorders in ICU |
| standard care | No intervention | patients will receive standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
items SL (sleep disorder) and QL2 of the QLQ C30
Measured: 14 days (average time to hospital discharge)
Secondary outcomes (1)
PSQI score
Measured: 14 days (average time to hospital discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2012 (estimated)
- Study startJan 2013
- Primary completionDec 2015
- Study completionFeb 2016
Why it stopped: In October 2015 ICU's setting completely changed from an open concept 8-beds unit to a single bed isolated room.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione Guido Berlucchi, Istituto Oncologico Veneto IRCCS
- Responsible party
- Sponsor
- Investigators
- Carlo Castoro, MD, Principal investigator, Istituto Oncologico Veneto (IOV-IRCCS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01738620
- Sponsor's protocol ID
- QOLEC1 - step 1
- Status last verified
- Apr 2017
- First submitted
- 20 Oct 2012
- Last updated
- 12 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Geense WW, van den Boogaard M, van der Hoeven JG, Vermeulen H, Hannink G, Zegers M. Nonpharmacologic Interventions to Prevent or Mitigate Adverse Long-Term Outcomes Among ICU Survivors: A Systematic Review and Meta-Analysis. Crit Care Med. 2019 Nov;47(11):1607-1618. doi: 10.1097/CCM.0000000000003974.
PubMed 31464769Scarpa M, Pinto E, Saraceni E, Cavallin F, Parotto M, Alfieri R, Nardi MT, Marchi MR, Cagol M, Castoro C; QOLEC Group. Randomized clinical trial of psychological support and sleep adjuvant measures for postoperative sleep disturbance in patients undergoing oesophagectomy. Br J Surg. 2017 Sep;104(10):1307-1314. doi: 10.1002/bjs.10609. Epub 2017 Jul 14.
PubMed 28707741
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life After Esophagectomy for Cancer - QOLEC1
- ClinicalTrials.gov ID
- NCT01738620
- Acronym / sponsor ID
- QOLEC1 - step 1
- Conditions
- Esophageal Cancer, Sleep Disturbance, Quality of Life
- Keywords
- esophageal cancer, sleep disturbance, quality of life
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: In October 2015 ICU's setting completely changed from an open concept 8-beds unit to a single bed isolated room.
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Collaborators
- Fondazione Guido Berlucchi, Istituto Oncologico Veneto IRCCS
- Study start
- Jan 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 30 Nov 2012 (estimated)
- 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.
Background: A recent systematic review showed that patients undergoing esophagectomy for cancer had scores of physical function, vitality and performance of health in general significantly lower than those obtained from the reference population. The analysis of the quality of life at six months follow-up showed that the total score and physical function were better before surgery and symptoms-based scales indicated that the fatigue, dyspnoea and diarrhea were worse six months after esophagectomy. The objective of this study is therefore to assess the impact of esophageal resections for cancer on the quality of life of patients and to improve it through simple interventions of post operative care.
The study is divided into two steps.
This is step 1.
Patients will be randomized into four groups receiving respectively: psychological counseling for support plus appropriate measures to reduce sleep-wake rhythm disorders during ICU stay; psychological counseling alone; appropriate measures to reduce sleep-wake rhythm disorders during ICU stay alone; or standard care. The primary end point are the items SL (sleep disorder) and QL2 of the QLQ C30, and the secondary end point is the score of the PSQI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| psychological counseling+prevention of sleep disorders in ICU | Experimental | Behavioral: psychological counseling, Behavioral: prevention of sleep disorders in ICUpatients will receive both psychological counseling and interventions to prevent sleep disorders during their ICU stay |
| psychological counseling | Experimental | Behavioral: psychological counselingpatients will receive psychological counseling |
| prevention of sleep disorders in ICU | Experimental | Behavioral: prevention of sleep disorders in ICUinterventions to prevent sleep disorders during their ICU stay |
| standard care | No intervention | –patients will receive standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age above 18 years old
- scheduled for esophagectomy for cancer
Key exclusion criteria (3 listed)
- age below 18 years old
- incapability to autonomously fill in questionnaires
- primary language not italian
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 |
|---|---|---|
| psychological counseling | Behavioural | psychological counseling, psychological counseling+prevention of sleep disorders in ICU |
| prevention of sleep disorders in ICU | Behavioural | prevention of sleep disorders in ICU, psychological counseling+prevention of sleep disorders in ICU |
Primary outcome
items SL (sleep disorder) and QL2 of the QLQ C30
Time frame: 14 days (average time to hospital discharge)
1 secondary outcome
PSQI score
Time frame: 14 days (average time to hospital discharge)
Results and safety
The study was stopped early (reason given: In October 2015 ICU's setting completely changed from an open concept 8-beds unit to a single bed isolated room.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2017.
- Derived from this study: PubMed 31464769Geense WW, van den Boogaard M, van der Hoeven JG, Vermeulen H, Hannink G, Zegers M. Nonpharmacologic Interventions to Prevent or Mitigate Adverse Long-Term Outcomes Among ICU Survivors: A Systematic Review and Meta-Analysis. Crit Care Med. 2019 Nov;47(11):1607-1618. doi: 10.1097/CCM.0000000000003974.
- Derived from this study: PubMed 28707741Scarpa M, Pinto E, Saraceni E, Cavallin F, Parotto M, Alfieri R, Nardi MT, Marchi MR, Cagol M, Castoro C; QOLEC Group. Randomized clinical trial of psychological support and sleep adjuvant measures for postoperative sleep disturbance in patients undergoing oesophagectomy. Br J Surg. 2017 Sep;104(10):1307-1314. doi: 10.1002/bjs.10609. Epub 2017 Jul 14.
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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.
Carlo Castoro, MD principal investigator
Istituto Oncologico Veneto (IOV-IRCCS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing psychological counseling and prevention of sleep disorders in ICU in people with Esophageal Cancer and Sleep Disturbance, run by University of Padova 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 2 inclusion and 3 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: stopped early, as of the sponsor's last update on 12 Apr 2017. 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?
The study was stopped early (reason given: In October 2015 ICU's setting completely changed from an open concept 8-beds unit to a single bed isolated room.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
items SL (sleep disorder) and QL2 of the QLQ C30 (time frame: 14 days (average time to hospital discharge)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01738620, which also lists 2 linked publications.
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 12 Apr 2017.