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Comprehensive geriatric assessment and interventions in older lung cancer patients

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.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618000794202
Enrollment
150
Registered
2018-05-10
Start date
2018-05-18
Completion date
2019-05-18
Last updated
2018-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 in

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.

Sponsors

University of Melbourne
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
65 Years to No maximum
Healthy volunteers
No

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026