The ELDERS Study - Immunotherapy in Elderly Cancer Patients
Research type
Research Study
Full title
Immunotherapy in ELDerly cancer patients: A Prospective Observational pilot study on Efficacy, Health Related Quality of Life and Safety in Melanoma and Lung Cancer Patients.
IRAS ID
205734
Contact name
Fiona Blackhall
Contact email
Sponsor organisation
The University of Manchester
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
This is a prospective, non-interventional study to assess the efficacy, safety profile and impact on quality of life of immunotherapy when given to elderly patients in comparison to non-elderly patients. Patients are eligible if they are due to receive immunotherapy for their advanced/metastatic lung cancer or malignant melanoma. Patients may have received prior treatments for their cancer.
Arm A
Patients who are 70+years of age will be enrolled in to Arm A. Prior to starting immunotherapy, the investigator will apply a co-morbidity scale (CIRS-G) and conduct a geriatric screening assessment (G8). If the G8 tool highlights a patient has an impairment a comprehensive geriatric assessment (CGA) will be carried out using validated tools. The patients GP will be informed of any findings. We will categorise elderly patients as fit or impaired according to the results of these assessments. Patients will complete a quality of life questionnaire (EORTC QLQ-C30) and it's elderly module (QLQ - ELD14) prior to receiving treatment. Patients will start their immunotherapy treatment as scheduled and every 3 months the geriatric assessments (either G8 or the CGA based on previous findings) and quality of life questionnaires will be repeated.Arm B
Patients who are <70 years of age will be enrolled in to Arm B. Prior to starting treatment the investigator will apply a comorbidity scale (CIRS) and patients will complete a quality of life questionnaire (EORTC QLQ-C30). Patients will start their immunotherapy treatment as scheduled and every 3 months will repeat the EORTC QLQ-C30.For patients on both arms, at each outpatient appointment, researchers will collect data relating to treatment response and any adverse events the patient experiences.
Patients will be asked if they are willing to take part in a face to face interview with the researchers to discuss their experiences while receiving immunotherapy. Taking part in an interview is optional.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
16/NW/0459
Date of REC Opinion
27 Jul 2016
REC opinion
Further Information Favourable Opinion