Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001192178
Ethics application status
Approved
Date submitted
8/08/2019
Date registered
26/08/2019
Date last updated
26/08/2019
Date data sharing statement initially provided
26/08/2019
Date results information initially provided
26/08/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
A feasibility study: Improving management of comorbidity in patients with colorectal cancer
Scientific title
A feasibility study: Improving management of comorbidity in patients with colorectal cancer utilising Comprehensive Medical Assessment
Secondary ID [1] 298979 0
Nil known
Universal Trial Number (UTN)
U1111-1238-3963
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal Cancer 313969 0
Comorbidity 313970 0
Condition category
Condition code
Cancer 312371 312371 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a non-randomised sequential cohort study with a control phase followed by an intervention phase and finally a qualitative phase to fully assess study feasibility. Patient diagnosis date will determine whether they are invited to participate within the control or intervention phase of the study. All patients who consent will be screened for comorbidity by completing a health questionnaire (taking up to 30 minutes) and medical note review by a research nurse. The nurse will assess the patient’s eligibility to be referred to the intervention using defined decision-making criteria. Patients within the intervention arm who are identified as being eligible will be invited to attend a Comprehensive Medical Assessment (CMA) completed by a study specific Geriatrician within Older Persons’ Health outpatient clinics single session. Each CMA will take 30-60 minutes to complete. The CMA will be tailored to each patient, will cover a) assessment and management of comorbidity; b) assessment and management of polypharmacy; c) evaluation of mental health with a particular focus on depression; and d) review of functional and psychosocial issues, and will result in patient specific care plans. On-going geriatrician management will be determined on a case by case basis. Geriatrician clinical notes and letters will be reviewed to obtain study data pertaining to each patients specific care plan, and to assess intervention fidelity.
Intervention code [1] 315244 0
Treatment: Other
Comparator / control treatment
Patients in the control arm of the study will complete the patient health questionnaire, the research nurse will complete the medical note review and will assess potential eligibility for CMA but patients will receive current standard best-practice care, as determined by the clinical team (the surgeon and/or oncologist). This arm of the study is being done to assess the types and amounts of interventions (e.g. referals or medication changes) that occur within the normal treatment pathway for comorbid cancer patients.
Control group
Active

Outcomes
Primary outcome [1] 320999 0
Whether the study forms, processes and procedures are acceptable and feasibile to enact. This will be assessed by tracking recruitment numbers overall, assessing the proportion of patients who fulfil eligiblity criteria to proceed to CMA and the proportion CMA eligibile intervention arm patients who consent to CMA, and through qualitative feedback from participants (including patients, research nurses and clinicians)
.
Timepoint [1] 320999 0
1 year post enrollment in the study
Primary outcome [2] 321000 0
Chemotherapy uptake rates. This will be assessed and collected by study-specific research coordinators on standardised proforma through manual review of patient’s medical notes.
Timepoint [2] 321000 0
1 year post enrollment in the study
Primary outcome [3] 321001 0
Chemotherapy completion - as planned - rates. This will be assessed and collected by study-specific research coordinators on standardised proforma through manual review of patient’s medical notes.
Timepoint [3] 321001 0
1 year post enrollment in the study
Secondary outcome [1] 373659 0
Common Terminology Criteria for Adverse Events v4.0 (CTCAE) Grade 3-5 toxicity
Timepoint [1] 373659 0
1 year post enrollment in the study
Secondary outcome [2] 373660 0
Unplanned hospitaliastion or Accident and Emergency visit. This will be collected by study-specific research coordinators on standardised proforma through manual review of patient’s medical notes.
Timepoint [2] 373660 0
1 year post enrollment in the study
Secondary outcome [3] 373661 0
Number and type of interventions recommended in care plan as a result of the CMA including medication changes, investigations ordered, referral to other specialists, referral to occupational therapy, physiotherapy, social work, mental health services, dietician or other services, new treatments started, management of pain, and amendment of long-term condition management plans. This will be collected by study-specific research coordinators on standardised proforma through manual review of patient’s medical notes.
Timepoint [3] 373661 0
1 year post enrollment in the study
Secondary outcome [4] 373662 0
Number and type of interventions recommended to patients in the usual cancer pathway in absence of CMA (as per secondary outcome 3, these will be medication changes, investigations ordered, referral to other specialists or services and new treatments started). This will be collected by study-specific research coordinators on standardised proforma through manual review of patient’s medical notes.
Timepoint [4] 373662 0
1 year post enrollment in the study

Eligibility
Key inclusion criteria
All patients with newly diagnosed colorectal adenocarcinoma who have undergone or who are planned to undergo major resection,
Metastatic relapse of colorectal adenocarcinoma, as judged by histological confirmation of relapse or as confirmed by a specialist multi-disciplinary team meeting (MDTM),
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 or colon or rectum with polypectomy or local excision as only treatment,
Unable to give informed consent,
Not able to comply with study procedures and/or 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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
This study will be conducted in three phases: an observation only phase where patients are screened for comorbidity but recieve usual care followed by an intervention phase where patients are screened for comorbidity and wre eligible are invited for the CMA intervention. A third qualitative phase will help to further answer questions of study feasibility.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Because this is a feasibility study, analyses will be largely descriptive. Whilst no formal hypothesis testing is planned, we will compare outcomes between patients who undergo the intervention with those who do not.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
2/05/2016
Date of last participant enrolment
Anticipated
Actual
31/05/2017
Date of last data collection
Anticipated
Actual
22/12/2017
Sample size
Target
124
Accrual to date
Final
72
Recruitment outside Australia
Country [1] 21753 0
New Zealand
State/province [1] 21753 0

Funding & Sponsors
Funding source category [1] 303518 0
Hospital
Name [1] 303518 0
Health Research South Grant for Health Service Delivery Research, Dunedin Hospital
Country [1] 303518 0
New Zealand
Funding source category [2] 303520 0
University
Name [2] 303520 0
Otago Medical School Collaborative Research Grant
Country [2] 303520 0
New Zealand
Funding source category [3] 303521 0
University
Name [3] 303521 0
Otago University, Wellington Deans Research Grant
Country [3] 303521 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Otago Medical School
PO Box 56
Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 303578 0
None
Name [1] 303578 0
Address [1] 303578 0
Country [1] 303578 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304042 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 304042 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 304042 0
New Zealand
Date submitted for ethics approval [1] 304042 0
22/10/2015
Approval date [1] 304042 0
09/11/2015
Ethics approval number [1] 304042 0
15/STH/193

Summary
Brief summary
Patients who are diagnosed with colorectal cancer often have other health problems as well as their cancer. These concurrent medical conditions (comorbidity) can impact on the treatment that is recommended for them, and on their recovery from their cancer. In addition, people with a lot of additional health problems may find cancer treatment more difficult to tolerate. International research has examined the impact of Comprehensive Geriatric Assessment on patients who are receiving chemotherapy. Studies have shown that people undergoing this assessment have fewer serious side effects from the chemotherapy. We are proposing a large, multi-centre study looking at the impact of a slightly broader intervention aimed at managing comorbidity in patients with colorectal cancer who are undergoing surgery, chemotherapy, or both. Prior to embarking on such a large study we need to test the appropriateness and acceptability of our screening tools and “road test” our comprehensive medical (geriatric) assessment, and so we are conducting pilot study where we aim to test these tools and determine feasibility of the study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95634 0
Prof Diana Sarfati
Address 95634 0
University of Otago, Dept of Public Health, PO Box, 7343, 23a Mein Street, Newtown, Wellington, 6242
Country 95634 0
New Zealand
Phone 95634 0
+64 049186042
Fax 95634 0
Email 95634 0
diana.sarfati@otago.ac.nz
Contact person for public queries
Name 95635 0
Dr Virginia Signal
Address 95635 0
University of Otago, Dept of Public Health, PO Box, 7343, 23a Mein Street, Newtown, Wellington, 6242
Country 95635 0
New Zealand
Phone 95635 0
+64 049186188
Fax 95635 0
Email 95635 0
virginia.signal@otago.ac.nz
Contact person for scientific queries
Name 95636 0
Prof Diana Sarfati
Address 95636 0
University of Otago, Dept of Public Health, PO Box, 7343, 23a Mein Street, Newtown, Wellington, 6242
Country 95636 0
New Zealand
Phone 95636 0
+64 049186042
Fax 95636 0
Email 95636 0
diana.sarfati@otago.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
As a feasibility study, these data are not available. We have not received ethical nor patient consent to share data.


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Study protocol  virginia.signal@otago.ac.nz


Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo Participants: 72 patients of all ages (36 observat... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseImproving management of comorbidity in patients with colorectal cancer using comprehensive medical assessment: A pilot study.2020https://dx.doi.org/10.1186/s12885-020-6526-z
N.B. These documents automatically identified may not have been verified by the study sponsor.