Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001312538
Ethics application status
Approved
Date submitted
13/11/2015
Date registered
1/12/2015
Date last updated
1/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
A feasibility study: Improving management of comorbidity in patients with colorectal cancer
Scientific title
Feasibility of a comprehensive medical assessment in reducing comorbidity in colorectal cancer patients
Secondary ID [1] 287762 0
Nil Known
Universal Trial Number (UTN)
U1111-1175-7547
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
colorectal cancer 296647 0
comorbidity 296648 0
Condition category
Condition code
Cancer 296875 296875 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Potential patients will complete a screening tool (questionnaire) to identify any comorbidities (administered by the Research Nurse). Patients will also be asked to identify all current medications, patient notes will be reviewed to identify all medications on admission, and patients GP will be contacted to identify accuracy of prescription. medications will be entered into the Lexi-Comp online interaction checker, a printout of potential interactions will be provided to the study clinician.
Patients identified via the screening tool are invited to attend a comprehensive medical assessment "CMA" (approximately one hour, attendance at an outpatient clinic, or, carried out whilst an inpatient if appropriate). This will include:
Geriatrician led medical assessment of comorbidity with medical optimisation, investigations or further referrals where indicated and treatment of medical comorbidity:
- assessment of mental health status with referral as necessary;
- analgesia and pain management review, assessment of impact on BP, cognisiton, balance and mood;
- assessment of ECOG status;
- social circumstances review;
- referral to OT, physio, social work, dietician and palliative care as appropriate;
- follow up appt at three months from assessment or when indicated (if < 3 months)
(Assessment of inpatients is intended to focus on offering advice on comorbidity management, not issues pertaining directly to surgical management.) Strategies to monitor adherence are not applicable to this study.
Intervention code [1] 293160 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 296478 0
Proportion of patients with colorectal adenocarcinoma who are approached who consent to enter.

This outcome will be assessed by use of a screening log, this will capture all those who are approached and whether they consented to proceed.
Timepoint [1] 296478 0
At one year after enrolment of first eligible patient
Primary outcome [2] 296557 0
Proportion of patients who consent to enter whom complete screening criterial and fulfil criteria to proceed to CMA

This outcome will be assessed by use of a screening log, whether or not a subject proceeds to CMA will be captured as part of the screening log.
Timepoint [2] 296557 0
one year from enrolment of first eligible patient
Primary outcome [3] 296558 0
Narrative of comorbid conditions identified at CMA
Timepoint [3] 296558 0
one year from enrolment of first eligible patient
Secondary outcome [1] 318747 0
Discrepancy between medications identified at admission and those held by GP and at pharmacy.

This outcome will be assessed by identifying the medications noted on the study screening form, and by telephone contact with GP.
Timepoint [1] 318747 0
one year from enrolment of first eligible patient
Secondary outcome [2] 318748 0
Completion rate of QOL

Whether a QOL is completed will be captured on the subject screening log, the study coordinator will note the date the QOL was completed, if it was not completed a note explaining why e.g subject refused.
Timepoint [2] 318748 0
one year from enrolment of first eligible patient
Secondary outcome [3] 318749 0
Narrative feedback from participants (including physicians)
Timepoint [3] 318749 0
one year from enrolment of first eligible patient

Eligibility
Key inclusion criteria
patients with newly diagnosed colorectal adenocarcinoma who have undergone or who are planned to undergo major resection
OR
Metastatic relapse of colorectal adenocarcinoma, as judged by histological confirmation of relapse or as confirmed by a specialist multi-disciplinary team meeting (MDTM)
OR
Undifferentiated carcinoma (grade 4) with clinical features consistent with colorectal cancer (and confirmed by a MDTM) will be permitted.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Histological or cytological diagnosis of cancer type other than adenocarcinoma;
Adenocarcinoma of colon or rectum with polypectomy or local excision as only treatment;
Treatment acuity such that intervention not able to be administered without potentially compromising patient outcome (e.g acute or sub-acute bowel obstruction, incipient perforation, major GI haemorrhage);
Unable to give informed consent;
Not able to comply with follow up;
Locally recurrent rectal cancer without metastatic relapse;
Life expectancy less than three months from diagnosis.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
NA
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
This is a feasibility study, no formal hypothesis testing nor statistical analyses are planned.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/01/2016
Actual
Date of last participant enrolment
Anticipated
1/06/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 7301 0
New Zealand
State/province [1] 7301 0
Dunedin

Funding & Sponsors
Funding source category [1] 292351 0
Other
Name [1] 292351 0
Surplus Funds from Commercial Trials
Country [1] 292351 0
New Zealand
Primary sponsor type
Individual
Name
Dr Christopher Jackson
Address
Dunedin Hospital
Southern Blood and Cancer Centre
201 Great King Street
Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 291030 0
None
Name [1] 291030 0
None
Address [1] 291030 0
NA
Country [1] 291030 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293815 0
Health and Disability Ethics Committee
Ethics committee address [1] 293815 0
Ministry of Health
Freyburg Building
20 Aitken Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 293815 0
New Zealand
Date submitted for ethics approval [1] 293815 0
22/10/2015
Approval date [1] 293815 0
09/11/2015
Ethics approval number [1] 293815 0
15/STH/193

Summary
Brief summary
.The primary purpose of this pilot trial is to assess the feasibility of running screening and comprehensive medical assessment (CMA) sessions to reduce the co-existing health conditions of colorectal cancer patients. Who is it for? You may be eligible to participate in this study if you have been diagnosed with colorectal adenocarcinoma or metastatic colorectal adenocarcinoma for which a major resection has been planned or carried out. Study details All participants in this study will be asked to complete a screening questionnaire to identify any co-existing health conditions, and to provide a list of all current medications. Patients with co-existing conditions will then attend a one hour comprehensive medication assessment session with a geriatrician in which these conditions will be discussed and referrals made to specialists as required. This trial is primarily assessing the feasibility of carrying out the screening and CMA sessions and researchers will investigate the response rates of questionnaires and numbers of eligible patients. It is hoped that this study will provide information on whether such a program is feasible, with the aim of reducing co-existing health conditions in colorectal cancer patients and thus increasing quality of life.
Trial website
NA
Trial related presentations / publications
Nil to date.
Public notes
Attachments [1] 624 624 0 0
/AnzctrAttachments/369551-Pilot study protocol v1 1 Final 24 August 2015.docx

Contacts
Principal investigator
Name 61262 0
Dr Christopher Jackson
Address 61262 0
Dunedin Hospital - Southern Blood and Cancer Centre
201 Great King Street
Dunedin
9054
Country 61262 0
New Zealand
Phone 61262 0
+64 3 474 0999
Fax 61262 0
Email 61262 0
[email protected]
Contact person for public queries
Name 61263 0
Christopher Jackson
Address 61263 0
Dunedin Hospital - Southern Blood and Cancer Centre
201 Great King Street
Dunedin
9054
Country 61263 0
New Zealand
Phone 61263 0
+64 3 474 0999
Fax 61263 0
Email 61263 0
[email protected]
Contact person for scientific queries
Name 61264 0
Christopher Jackson
Address 61264 0
Dunedin Hospital - Southern Blood and Cancer Centre
201 Great King Street
Dunedin
9054
Country 61264 0
New Zealand
Phone 61264 0
+64 3 474 0999
Fax 61264 0
Email 61264 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.