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Trial registered on ANZCTR


Registration number
ACTRN12619000527167
Ethics application status
Approved
Date submitted
26/02/2019
Date registered
2/04/2019
Date last updated
2/04/2019
Date data sharing statement initially provided
2/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Implementing routine screening assessment for older people with
cancer
Scientific title
Phase II (pilot) step wedge cluster randomised controlled trial of
a nurse-led triage and assessment system to optimize outcomes
for older people with cancer
Secondary ID [1] 297536 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 308543 0
Condition category
Condition code
Cancer 307510 307510 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The assessment is conducted with a trained nurse and the different components can be assessed sequentially over a period of time up to 4 weeks after index clinic visit. The assessment comprises of:
1: Routine introduction of nurse - administered screening tools (TRIAGE) which are completed in 10 minutes or less in the clinic or over the phone
(G8 geriatric screening tool, Vulnerable Elders Survey -13, CRASH (Chemotherapy Risk
Assessment Scale for High-Age patients), and CARG chemotherapy toxicity calculator);
2: Comprehensive Geriatric Assessment (CGA) when further assessment is indicated by
screening using interRAI system) which is conducted in 60 minutes or less in the clinic;
and;
3: Communication of Screening and/or CGA to treating medical and/or radiation Oncologist (assessment entered into medical record and email or verbal communication)
Intervention code [1] 301662 0
Early detection / Screening
Comparator / control treatment
Usual care will consist of determination of clinical assessments for older cancer patients who attend the index clinic by the treating multidisciplinary cancer team, and intervention at a later date (waitlisted control). The duration of the control phase will be the period needed to undertake training, and to collect baseline data for 3 months of clinic data by retrospective medical record audit.
Control group
Active

Outcomes
Primary outcome [1] 306487 0
Completion rate – rate that the screening (G8 geriatric screening tool and Vulnerable Elders Survey - 13) and comprehensive geriatric assessment (interRAI assessment) if indicated is completed for all consecutive eligible new patients (65 years or older (new diagnosis or new recurrent/progressive disease) seen in the index clinic from medical record
Timepoint [1] 306487 0
index clinic visit
Secondary outcome [1] 348657 0
Reasons for non-completion of (G8 geriatric screening tool and Vulnerable Elders Survey - 13) and comprehensive geriatric assessment (interRAI assessment) (study specific questionnaire, composite outcome)
Timepoint [1] 348657 0
index clinic visit
Secondary outcome [2] 367437 0
Timing of screening and/or CGA including when communication to treating Oncologist (including proportion which occurred before and after index clinical
assessment, and reason (study specific questionnaire)
Timepoint [2] 367437 0
within 30 days after index clinic visit
Secondary outcome [3] 367438 0
Proportion of screening/CGA communicated to the treating oncologist (study specific questionnaire)
Timepoint [3] 367438 0
index clinic visit
Secondary outcome [4] 367439 0
Reasons why screening and/or CGA was not completed (non-completion) (study specific questionnaire)
Timepoint [4] 367439 0
index clinic visit
Secondary outcome [5] 367440 0
Feasibility and acceptability of screening and geriatric assessment approaches
(including timing, tool, nurse-led approach), measured via semi-structured interviews
with patients and treating oncologists/oncology registrars
Timepoint [5] 367440 0
at study close
Secondary outcome [6] 367441 0
Sustainability of the intervention: adherence measured for all new clinic patients compared for each month intervention is in place (study specific questionnaire)
Timepoint [6] 367441 0
monthly for the duration of the trial
Secondary outcome [7] 367442 0
Unscheduled hospitalisation (number, length, DRG) from medical record
Timepoint [7] 367442 0
ongoing from entry into the study until study close
Secondary outcome [8] 367444 0
Cancer treatment recommendation (study specific questionnaire to document chemotherapy, targeted therapies, hormone therapy, radiation, and/or surgical treatment recommended)
Timepoint [8] 367444 0
ongoing from entry into the study until study close
Secondary outcome [9] 367985 0
emergency department admissions without admission (number and reason) from medical record
Timepoint [9] 367985 0
ongoing from entry into the study until study close
Secondary outcome [10] 367986 0
Residential aged care placement (from medical record)
Timepoint [10] 367986 0
ongoing from entry into the study until study close
Secondary outcome [11] 367987 0
Therapy toxicity (NCI CTCAE grading scale)
Timepoint [11] 367987 0
ongoing from entry into the study until study close
Secondary outcome [12] 367988 0
Chemotherapy treatment modification for participants on chemotherapy (study specific questionnaire including dose delay, dose modification, agent modification)
Timepoint [12] 367988 0
ongoing from entry into the study until study close
Secondary outcome [13] 367989 0
Body weight (from medical record)
Timepoint [13] 367989 0
ongoing from entry into the study until study close
Secondary outcome [14] 367990 0
performance status (ECOG from medical record)
Timepoint [14] 367990 0
ongoing from entry into the study until study close
Secondary outcome [15] 367991 0
health professional assessments (number and reason using study specific questionnaire)
Timepoint [15] 367991 0
ongoing from entry into the study until study close

Eligibility
Key inclusion criteria
-Cluster (oncology clinic in integrated cancer centre) level:
Inclusion criteria:
• Ambulatory Clinics in integrated cancer centres who provide assessment for adult
cancer patients.
• Written informed consent of the oncologist providing clinical care in the index clinic

-New clinic patients contributing de-identified data
Inclusion criteria:
• Aged 65 years or older
•Diagnosis of cancer
• First clinic assessment at index clinic with new cancer diagnosis OR first clinical
assessment for new occurrence of recurrent or progressive disease

-Individual participants of sub-studies
Two groups of participants will be involved in the sub-studies: i) patients, ii) treating
oncologists and registrars, as per the inclusion and exclusion criteria listed below.

-Patient participants - qualitative sub-study
Inclusion criteria:
•Aged 65 years or older
• Diagnosis of cancer
• Attended the index oncology clinic
• Received the screening and/or CGA assessment
• English speaking or availability of a health care interpreter
• Able to give fully informed written consent
• Able to participate in a brief semi-structured interview

-Oncologist or Oncology Registrar – qualitative sub-study
Inclusion criteria:
• Medical or Radiation Oncologist(s) or Registrar who is involved in the clinical care
and/or clinical decision making for patients seen in index oncology clinic
• Written informed consent
Minimum age
65 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
nil

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
allocation of clusters was conducted at central administration site
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Step wedge design in which consenting participating sites (index oncology clinics) will implement the intervention into routine practice at staggered time points. The study will have a minimum of 4 clusters (index oncology clinics)
Phase
Phase 2
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Data on all outcomes will be summarized with descriptive statistics including their distribution. Frequency and percentage will be used for summarizing categorical variables, and mean, standard deviation, median, and interquartile range for continuous variables.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 11249 0
Prince of Wales Hospital - Randwick
Recruitment hospital [2] 13262 0
Blacktown Hospital - Blacktown
Recruitment hospital [3] 13263 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 23126 0
2031 - Randwick
Recruitment postcode(s) [2] 25827 0
2148 - Blacktown
Recruitment postcode(s) [3] 25828 0
2170 - Liverpool

Funding & Sponsors
Funding source category [1] 299930 0
Other Collaborative groups
Name [1] 299930 0
The Sydney Partnership for Health, Education, Research and Enterprise (SPHERE) Cancer Clinical Academic Group Grant
Address [1] 299930 0
Level 4, Ingham Institute for Applied Medical Research, 1 Campbell Street Liverpool NSW 2170
Country [1] 299930 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Palliative Care Clinical Studies Collaborative
Address
University of Technology Sydney, 235 Jones Street, Ultimo, New South Wales 2007
Country
Australia
Secondary sponsor category [1] 299305 0
None
Name [1] 299305 0
Address [1] 299305 0
Country [1] 299305 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300797 0
South Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 300797 0
Research and Ethics Office
Locked Bag 7103
LIVERPOOL BC NSW 1871
Ethics committee country [1] 300797 0
Australia
Date submitted for ethics approval [1] 300797 0
02/05/2018
Approval date [1] 300797 0
26/06/2018
Ethics approval number [1] 300797 0

Summary
Brief summary
This study will evaluate the feasibility and acceptability of implementing a nurse-led screening assessment for older adults with cancer

Who is it for?
You may be eligible to join this study if you are aged 65 years or older, have been diagnosed with cancer and attend one of the cancer clinics who are implementing the screening assessments into routine practice.

Study details
All cancer clinics will start in the control arm and transition to intervention arm, but the order in which they transition will be allocated randomly (i.e. by chance). During the control arm period older people with cancer attending the clinic will have clinical assessments as decided by the multidisciplinary cancer treatment team. The intervention arm will receive a screening assessment administered by the cancer nurse to assess for mobility, self-rated health, appetite or weight changes and psychological concerns, Further comprehensive geriatric assessment may also be administered if needed to assess physical function, weight, nutritional status, cognition, other medical conditions, medication, and psychosocial wellbeing.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 84842 0
Prof Meera Agar
Address 84842 0
University of Technology Sydney
Level 3, Building 10, 235 Jones St, Broadway NSW 2007
Country 84842 0
Australia
Phone 84842 0
+61 2 9514 4243
Fax 84842 0
Email 84842 0
meera.agar@uts.edu.au
Contact person for public queries
Name 84843 0
Prof Meera Agar
Address 84843 0
University of Technology Sydney
Level 3, Building 10, 235 Jones St, Broadway NSW 2007
Country 84843 0
Australia
Phone 84843 0
+61 2 9514 4243
Fax 84843 0
Email 84843 0
meera.agar@uts.edu.au
Contact person for scientific queries
Name 84844 0
Prof Meera Agar
Address 84844 0
University of Technology Sydney
Level 3, Building 10, 235 Jones St, Broadway NSW 2007
Country 84844 0
Australia
Phone 84844 0
+61 2 9514 4243
Fax 84844 0
Email 84844 0
meera.agar@uts.edu.au

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 the data is not suited for data sharing
What supporting documents are/will be available?
Study protocol
Informed consent form
Summary results
No Results