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Trial registered on ANZCTR


Registration number
ACTRN12618000794202
Ethics application status
Approved
Date submitted
26/04/2018
Date registered
10/05/2018
Date last updated
10/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Comprehensive geriatric assessment and interventions in older lung cancer patients
Scientific title
The impact of comprehensive geriatric assessment with personalised multi-disciplinary interventions for identified impairments and vulnerabilities in patients aged 65 years and over with non-small cell lung cancer on quality of life and function.
Secondary ID [1] 291229 0
Nil known
Universal Trial Number (UTN)
U1111-1193-2897
Trial acronym
Linked study record
NA

Health condition
Health condition(s) or problem(s) studied:
Lung Cancer 302150 0
Elderly 302151 0
Condition category
Condition code
Cancer 301761 301761 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Current standard care in the lung oncology clinic at the Royal Melbourne Hospital is for all patients over the age of 65 years to be offered screening for functional impairment(s) and geriatric syndromes by a trained nurse. This consists of a questionnaire completed by patients and/or carers containing information on basic demographic data (marital status, nationality, primary language spoken at home, smoking status, alcohol use and living arrangements), activities of daily living (ADL) and instrumental activities of daily living (IADL), mood (geriatric depression scale GDS), quality of life (EuroQol) and the Functional Assessment of Cancer Therapy – Lung version. The nurse then measures blood pressure, height, weight and body/muscle mass using a bioelectrical impedance analyser (BIA) and completes a mini-mental state examination, a geriatric depression scale (if not self completed), a mini nutritional assessment, tests of physical function (hand grip strength, timed up and go, 10 meter walk and short physical performance battery) and basic tests of hearing and vision. Routine blood tests including a full blood count, renal and liver function tests, corrected calcium, vitamin D, B12 and folate are taken. Repeat (standardised) assessments are offered at 3,6 and 12 months.

In this study, consenting patients will be randomised in a 1:1 ratio to receive either standard care (described above), or comprehensive geriatric assessment (CGA). Participants in the CGA arm, in addition to standard care, will receive review by a geriatrician for medical assessment and management of co-morbidities, impairments/vulnerabilities identified on screening and identified geriatric syndromes (including a medication review). An individualised management plan will then be formulated for each patient and referrals made for interventions for any identified, modifiable conditions such as dietician review for those at risk of malnutrition. This assessment will take 45 min to 1 hour and will occur at baseline (diagnosis), 3,6 and 12 months with the possibility of additional geriatrician reviews at the request of the treating oncologist if the patients clinical condition changes significantly. Consenting patients will also provide a blood sample to a bio-bank established at the University of Melbourne for the purposes of future research. Follow up phone calls will be made at 1,2,4 and 5 months to record health service utilistaion and compliance/participation with suggested interventions. Outpatient review will occur at 3, 6 and 12 months to repeat a standardised nursing and geriatrician assessment and data relating to survival, unplanned hospital admissions, unplanned alterations to anti-cancer treatment, health service utilisation and compliance with suggested interventions will be collected. Modifications to the treatment plan will be made if required and consenting patients will donate a further 40ml sample of blood to the Biobank at the time of routine blood testing. Results of all assessments on this cohort will be provided to both the treating oncology team and the patients General Practitioner. Additional medical (geriatrician) reviews may occur at the request of the treating oncologist if the patients clinical condition changes significantly and phone calls from the nurse to patient for additional support or monitoring of geriatric issues may occur if required.
Intervention code [1] 297276 0
Lifestyle
Intervention code [2] 301005 0
Behaviour
Intervention code [3] 301006 0
Other interventions
Comparator / control treatment
Current standard care in the lung oncology clinic at the Royal Melbourne Hospital is for all patients over the age of 65 years to be offered screening for functional impairment(s) and geriatric syndromes by a trained nurse. This consists of a questionnaire completed by patients and/or carers containing information on basic demographic data (marital status, nationality, primary language spoken at home, smoking status, alcohol use and living arrangements), activities of daily living (ADL) and instrumental activities of daily living (IADL), mood (geriatric depression scale GDS), quality of life (EuroQol) and the Functional Assessment of Cancer Therapy – Lung version. The nurse then measures blood pressure, height, weight and body/muscle mass using a bioelectrical impedance analyser (BIA) and completes a mini-mental state examination, a geriatric depression scale (if not self completed), a mini nutritional assessment, tests of physical function (hand grip strength, timed up and go, 10 meter walk and short physical performance battery) and basic tests of hearing and vision. Routine blood tests including a full blood count, renal and liver function tests, corrected calcium, vitamin D, B12 and folate are taken. Repeat (standardised) assessments are offered at 3,6 and 12 months.
Control group
Active

Outcomes
Primary outcome [1] 305649 0
The primary outcome will be change in health related quality of life (HRQoL) at 3 months as measured by the Trial Outcome Index (TOI).

The TOI is the sum of scores from the lung cancer (symptom) subscale and the physical and functional well-being subscales of the Functional Assessment of Cancer Therapy – Lung version (FACT-L) questionnaire.
Timepoint [1] 305649 0
3 months following initial geriatric screening or CGA consult appointment
Secondary outcome [1] 346036 0
Change in TOI. The TOI is the sum of scores from the lung cancer (symptom) subscale and the physical and functional well-being subscales of the Functional Assessment of Cancer Therapy – Lung version (FACT-L) questionnaire.
Timepoint [1] 346036 0
6 and 12 months following initial geriatric screening or CGA consult appointment
Secondary outcome [2] 346037 0
Overall survival (OS) at 6 and 12 months
Timepoint [2] 346037 0
6 and 12 months following initial geriatric screening or CGA consult appointment
Secondary outcome [3] 346038 0
Unplanned hospital admission rates.

This will be assessed for all patients using data collected on a standardised case report form at their 3,6 and 12 month follow-up appointments. For patients unable to attend these appointments, the same information/case report form will be completed over the telephone. Information regarding admission dates and hospital will be sought from both the participant, their carer (if relevant) and their General Practitioner. Admission dates and discharge summaries will then be requested from the admitting hospital for verification. This will include admissions for all health problems, not just cancer related and exclude planned admissions for routine anti-cancer treatment (e.g. chemotherapy).
Timepoint [3] 346038 0
6 and 12 months following initial geriatric screening or CGA consult appointment
Secondary outcome [4] 346039 0
Rate of completion of anti-cancer therapy as planned.

This will be assessed for all patients using data collected on a standardised case report form at their 3,6 and 12 month follow-up appointments. For patients unable to attend these appointments, the same information/case report form will be completed over the telephone. Information will be sought from the patient and caregiver and treating oncologist regarding any changes to therapy plan, including dose modifications and cessation of systemic therapies prior to the planned number of cycles. The reasons for cessation will also be collected.
Timepoint [4] 346039 0
3, 6 and 12 months following initial geriatric screening or CGA consult appointment
Secondary outcome [5] 346040 0
Change in level of independence with instrumental ADLS as measured by the Lawton-Brody scale
Timepoint [5] 346040 0
3, 6 and 12 months following initial geriatric screening or CGA consult appointment
Secondary outcome [6] 346041 0
Health care related cost as assessed by calculating difference between resource use and costs from hospital medical records, and data collected on standardised case report forms completed at 3,6 and 12 months . Information collected for all patients will include: type and number of outpatient appointments (medical and allied health), drugs prescribed and associated administration costs (systemic therapy and for symptom management), inpatient admissions, emergency department presentations, significant investigations performed.
Timepoint [6] 346041 0
6 and 12 months following initial geriatric screening or CGA consult appointment

Eligibility
Key inclusion criteria
• > 65 years of age
• New (within 8 weeks) diagnosis of non-small cell lung cancer (NSCLC), any stage. Diagnosis may be on the basis of histology or a consensus clinical diagnosis from the lung oncology MDM group
• Eastern Cooperative Oncology Group (ECOG) score 0-3
• Estimated prognosis > 12 weeks (by treating oncologist
Minimum age
65 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• < 65 years of age
• Brain metastases at time of diagnosis
• ECOG 4
• Estimated prognosis < 12 weeks
• Severe cognitive impairment resulting in inability to consent to or participate in assessment and intervention

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 concealment will occur.

All patients over the age of 65 with a new diagnosis of NSCLC will be offered participation.

Consenting patients will then be randomised using block allocation of groups of 4 and sealed opaque envelops.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be randomised in a 1:1 ratio using block randomisation with block sizes of 4 (to control clinic workflow).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Patients will be recruited from those referred to the lung oncology outpatient clinic at the Royal Melbourne Hospital with a new diagnosis of NSCLC. Approximately 150 patients are expected to be enrolled over the 12 month recruitment period. Based on prior research in a similar setting (NEJM 363; 8 Aug 19 2010 p733-742) and the statistical efficiency of a randomized trial design, the sample size will be sufficient to assess differences in the outcomes between the intervention and control arm.

For the primary and secondary outcomes, intention-to-treat analysis will be performed for each regression model, where intervention/control status will be included as the primary predictor. Linear regression will be used to assess the association between intervention/control status and continuous outcomes (Trial Outcome Index at 3, 6, and 12 months, unplanned hospital admission rates,). If any of these continuous outcomes show a strong positive skew, negative binomial regression will be used instead as a more appropriate statistical model. Gamma regression will be used to analyse cost data since it is expected to be a skewed variable with a large range. For dichotomous outcomes (overall survival at 6 and 12 months, rate of completion of anti-cancer therapy as planned), logistic regression will be used. For the change in level of independence with instrumental ADLs, ordinal logistic regression will be used, with three categories chosen based on the distribution of change observed in the data. Statistical significance will be defined using a cutoff of p = 0.05. All statistical analyses will be performed using IBM SPSS Statistics 24.0 (Armonk, NY: IBM Corp.).
A secondary analysis using inverse probability weighting to account for missing data will be conducted, and the results compared to the intention to treat analysis. Inverse probability weighting will provide a more flexible algorithm to account for missing data compared to traditional methods.


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)
VIC
Recruitment hospital [1] 10784 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 22522 0
3050 - Royal Melbourne Hospital
Recruitment postcode(s) [2] 22523 0
3050 - Parkville

Funding & Sponsors
Funding source category [1] 295679 0
Hospital
Name [1] 295679 0
The Royal Melbourne Hospital
Address [1] 295679 0
300 Grattan Street
Parkville
Victoria
3050
Country [1] 295679 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
University of Melbourne
Grattan Street
Parkville
3010
Country
Australia
Secondary sponsor category [1] 298587 0
None
Name [1] 298587 0
Address [1] 298587 0
Country [1] 298587 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296993 0
Melbourne Health HREC
Ethics committee address [1] 296993 0
The Royal Melbourne Hospital Office for Research
Level 2
South West
300 Grattan Street
Parkville, Victoria, 3050
Ethics committee country [1] 296993 0
Australia
Date submitted for ethics approval [1] 296993 0
22/02/2017
Approval date [1] 296993 0
22/02/2018
Ethics approval number [1] 296993 0

Summary
Brief summary
This study is assessing the effects of a comprehensive geriatric assessment on health-related quality of life

Who is it for?
You may be eligible for this study if you are aged over 65 and have a new diagnosis of non-small cell lung cancer (NSCLC)

Study details
Participants will be randomised (by chance) into two groups. One group will receive the standard oncology care, including blood tests and questionnaire. The other group will recieve standard care as well as a Comprehensive Geriatric Assesment (CGA). CGA refers to the multi-disciplinary assessment of an older patients’ physical function, cognition, mood, other health problems, medication use and social situation, followed by the implementation of an individualised management plan aimed at improving any identified impairments or vulnerabilities. The assessments used and interventions prescribed are all frequently used in common medical, geriatric, practice and as such, are not expected to pose any significant risks or safety concerns.

It is hoped this study will demonstrate the utility of the CGA model which may contribute to its implementation in standard practice.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72646 0
Prof Andrea B. Maier
Address 72646 0
The Royal Melbourne Hospital
Department of Medicine and Community Care
Level 6 North
300 Grattan Street
Parkville, VICTORIA
AUSTRALIA 3052
Country 72646 0
Australia
Phone 72646 0
+61 3 93422635
Fax 72646 0
+61 3 9342 7866
Email 72646 0
andrea.maier@mh.org.au
Contact person for public queries
Name 72647 0
Dr Claire Maddison
Address 72647 0
Royal Melbourne Hospital
Department of Aged Care
300 Grattan Street
Parkville, VICTORIA
AUSTRALIA 3052
Country 72647 0
Australia
Phone 72647 0
+61 3 9342 7000
Fax 72647 0
Email 72647 0
claire.maddison@mh.org.au
Contact person for scientific queries
Name 72648 0
Dr Claire Maddison
Address 72648 0
Royal Melbourne Hospital
Department of Aged Care
300 Grattan Street
Parkville, VICTORIA
AUSTRALIA 3052
Country 72648 0
Australia
Phone 72648 0
+61 3 9342 7000
Fax 72648 0
Email 72648 0
claire.maddison@mh.org.au

No information has been provided regarding IPD availability
Summary results
No Results