Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001231932
Ethics application status
Approved
Date submitted
26/08/2020
Date registered
17/11/2020
Date last updated
17/11/2020
Date data sharing statement initially provided
17/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Increasing Attainment of Patient-Identified Goals through Comprehensive Geriatric Assessment: A Controlled Trial for Frail Older People with Lung Cancer
Scientific title
Increasing Attainment of Patient-Identified Goals through Comprehensive Geriatric Assessment: A Controlled Trial for Frail Older People with Lung Cancer
Secondary ID [1] 302130 0
None
Universal Trial Number (UTN)
Trial acronym
GOAL: Lung Cancer
Linked study record

Health condition
Health condition(s) or problem(s) studied:
advanced non small cell lung cancer 318760 0
frailty 318761 0
Condition category
Condition code
Cancer 316774 316774 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention in this trial is a Comprehensive Geriatric Assessment. This assessment is conducted by a Geriatrician on a 1-to-1 basis and typically takes one hour to complete. It is a one off assessment, where the Geriatrician will identify particular problem areas across multiple health domains, and subsequently begin a process of managing these problem areas. This often occurs by referring the patient to the relevant specialist, including but not limited to: a physiotherapist (to improve physical function), nutritionist (to improve nutrition), pharmacist (to review medications), etc. A Comprehensive Geriatric Assessment and subsequent referrals are highly patient-centred and will be unique to each individual, however, they will each examine domains related to physical health, psychological health, functioning, and social circumstances. The Geriatrician will write a report detailing their findings and recommendations, and make the necessary referrals.

The Geriatrician will not typically be involved in follow-up or measuring adherence to the recommendations. However, research and medical staff involved in this study will measure adherence using patient self-report, and discussions with relevant professionals, if required.
Intervention code [1] 318429 0
Treatment: Other
Comparator / control treatment
The comparator group in this study is patients provided standard care. Standard care involves all patients being assessed for frailty, followed by their usual appointment with the oncologist and subsequent management by a multi-disciplinary team. In very rare cases (<2%), patients are referred to a Geriatrician for a Comprehensive Geriatric Assessment, or other supportive care, if the oncologist feels this is necessary. Standard care will continue to follow this process.
Control group
Active

Outcomes
Primary outcome [1] 324894 0
Goal attainment, assessed using the Goal Attainment Scale - an individualised outcome measure involving goal selection and scaling that is standardised in order to calculate the extent to which a patient's goals are met.
Timepoint [1] 324894 0
3 months post-commencement of intervention
Secondary outcome [1] 386131 0
Change in frailty index
Timepoint [1] 386131 0
At 3 and 6 months post-intervention commencement
Secondary outcome [2] 387406 0
Change in quality of life, assessed using the EQ5D-5L
Timepoint [2] 387406 0
At 3 and 6 months post-intervention commencement

Eligibility
Key inclusion criteria
• Newly diagnosed with metastatic non-small cell lung cancer,
• Aged 65 years or older,
• Frail patients (those scoring > 0.25 on the frailty index-short form)
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Have a life expectancy < 6 months
• Are unable to provide informed consent and/or participate in the Goal Attainment Scaling process due to cognitive impairment or another reason

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
Patients recruited in the first 6 months will receive usual care (treatment/best supportive care or oncological/palliative care management). Patients recruited in the second 6 months will receive a Comprehensive Geriatric Assessment (CGA).
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculation:
The primary outcome will be based on change in the Goal Attainment Scale (GAS) measured at 3 months post-intervention commencement. From data on frail older adults, we estimate that the CGA intervention will improve GAS by at least 10 points from an average score of 50 at baseline (which presents a change in one standard deviation, equivalent to a medium effect size). A controlled trial with a minimum of 20 patients per group would have 90% power to detect a mean difference in GAS scores of 10 units between control and intervention groups. This power calculation, giving a minimum sample size of 40 in the final analysis, assumes a common standard deviation of 10 units. Allowing for a 20% loss to follow-up over the 12 months of the trial would require recruitment of 50 participants (25 per group). Our target referral rate of 130 patients over 12 months has been assessed to be achievable with approximately 11 new patients each month aged 65 years or older. Pilot data with 22 patients to date (median age (range): 74 (70-84) years; 64% male) demonstrated a median (range) FI of 0.27 (0.09-0.60). Approximately 55% of patients (12 of 22) were frail (FI > 0.25). From the average number of people attending the clinic at Princess Alexandra Hospital, we expect to have a minimum of 65 patients who meet the eligibility criteria (aged 65 years or more; FI>0.25). Of these it is estimated that approximately 10% will not consent to participate, leaving a minimum 50 consenting trial participants.

Statistical analyses:
GAS scores at 3 months post-intervention commencement will be analysed using separate linear regression models with group membership (intervention vs control) as the exposure variable, in both unadjusted models and model adjusting for baseline GAS scores, age and sex. Secondary research questions regarding repeatedly measured continuous outcomes (FI, GAS, and EQ-5D scores at baseline, 3 and 6 months) will be examined using linear mixed models with fixed effects for intervention group, timepoint (0, 3, 6 months), the intervention-by-time interaction, and baseline measurements of the outcome. The association of frailty status at baseline with goal attainment will be assessed using appropriate regression analyses.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2020
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 17326 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 31052 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 306555 0
Hospital
Name [1] 306555 0
Princess Alexandra Hospital
Country [1] 306555 0
Australia
Primary sponsor type
Hospital
Name
Princess Alexandra Hospital
Address
199 Ipswich Rd, Woolloongabba QLD 4102
Country
Australia
Secondary sponsor category [1] 307081 0
None
Name [1] 307081 0
Address [1] 307081 0
Country [1] 307081 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306745 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 306745 0
Metro South Research
Level 7, Translational Research Institute
37 Kent Street
Woolloongabba QLD 4102
Ethics committee country [1] 306745 0
Australia
Date submitted for ethics approval [1] 306745 0
25/08/2020
Approval date [1] 306745 0
16/09/2020
Ethics approval number [1] 306745 0
HREC/2020/QMS/66814

Summary
Brief summary
This study will determine whether conducting a comprehensive health assessment in older people with non-small cell lung cancer can assist in setting health-related goals and personalised treatment plans to achieve these goals.

Who is it for?
You may be eligible for this study if you are aged 65 years and older, you have been diagnosed with metastatic (spread to other body systems) non-small cell lung cancer, and you meet certain objective 'frailty' criteria.

Study details
Participants who are enrolled in the first 6 months of this study will receive standard care from their Oncologist. Participants who are enrolled in the second 6 months of this study will undergo a Comprehensive Geriatric Assessment, which involves seeing a Geriatrician for a 1-hour face-to-face assessment. The Geriatrician will ask participants a number of questions relating to their physical, mental and social health, identify any issues, and subsequently write a report with their recommendations and refer the patient to specialists who can help them further. All participants will be asked to complete a goal setting exercise after they have agreed to participate in the study, and will be asked to complete two questionnaires about their health as well. Participants in both phases of the study will be asked to attend two follow-up visits at 3 and 6 months after study enrolment.

It is hoped this research may be used to improve health outcomes for older patients with non-small cell lung cancer by identifying health outcomes that are important to them and designing their treatment in a personalised manner to achieve these outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104878 0
Prof Ruth Hubbard
Address 104878 0
Geriatric and Rehabilitation Unit
Princess Alexandra Hospital
199 Ipswich Rd, Woolloongabba QLD 4102
Country 104878 0
Australia
Phone 104878 0
+617 3443 8043
Fax 104878 0
Email 104878 0
[email protected]
Contact person for public queries
Name 104879 0
Dr Natasha Reid
Address 104879 0
Centre for Health Services Research
Faculty of Medicine
The University of Queensland
Level 6, Oral Health Building
The University of Queensland
Herston Rd, Herston Qld 4006
Country 104879 0
Australia
Phone 104879 0
+617 3346 5350
Fax 104879 0
Email 104879 0
[email protected]
Contact person for scientific queries
Name 104880 0
Dr Natasha Reid
Address 104880 0
Centre for Health Services Research
Faculty of Medicine
The University of Queensland
Level 6, Oral Health Building
The University of Queensland
Herston Rd, Herston Qld 4006
Country 104880 0
Australia
Phone 104880 0
+617 3346 5350
Fax 104880 0
Email 104880 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification.
When will data be available (start and end dates)?
Beginning with publication of main outcomes in peer reviewed journal and ending 5 years following this publication.
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor.
Available for what types of analyses?
To achieve the aims in the approved proposal.
For IPD meta-analyses
How or where can data be obtained?
Access is subject to approval by the Principle Investigator and can be requested by emailing [email protected] or [email protected].


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.