Short summary

Part I: A prospective, descriptive study of all outpatients with newly diagnosed solid tumors, age 70 years or more.

Part 2: A Randomized Controlled Trial, where potentially frail (G8) patients will be randomized 1:1 to CGA or usual standard care, to assess the prognostic value of CGA with intervention and to determine whether older cancer patients, whose health is initially too poor for antineoplastic treatment, can be optimized through CGA so that they become eligible for treatment.

Rationale

Older patients with cancer constitute a heterogeneous group with varying degrees of comorbidities; therefore, both the American Society for Clinical Oncology (ASCO) and the International Society of Geriatric Oncology (SIOG) recommend geriatric assessment (GA) in oncologic care. However, a comprehensive geriatric assessment (CGA) is time-consuming and may not be necessary for all older patients with cancer. Therefore, SIOG recommends a two-step approach, starting with a screening tool, of which the Geriatric 8 (G8) is among the most promising. Currently, there are no guidelines for CGA in older patients with cancer in Denmark.

We hypothesize that by screening persons age 70 years or more with newly diagnosed cancer, with the G8, and subsequently randomizing potentially frail patients to CGA or usual standard treatment, we can assess the prognostic value and identify a subgroup of patients who will benefit from a CGA.

This study will generate new knowledge on how to identify older cancer patients who can receive the recommended standard treatment and those who are too frail and may need additional support or treatment modification, as well as establish the importance of CGA in Oncology. While we presently do not have any guidelines for geriatric screening and CGA in oncology, it is our hope that through our collaboration with the DCCC Age network, this knowledge will be constructive in establishing national guidelines in Denmark. Through this, we can help to ensure that older persons with cancer will be offered cancer treatment that takes into account the needs of the individual.

Description of the cohort

This is a descriptive study and randomized controlled trial, including all outpatients age 70 years or more with newly diagnosed solid malignancies, referred to the Department of Oncology at OUH for antineoplastic treatment.

Data and biological material

Part 1:G8, mG8, and QoL questionnaire data, functional strength tests data, medical record data, including patient identification information, age, diagnosis, survival data, treatment plan and adherence, and treatment-related toxicity data.

Part 2: G8-, and QoL questionnaire data, medical record data including patient identification information, age, diagnosis, survival data, treatment plan and adherence, and treatment-related toxicity, drug use, social conditions and resource data, cognition and functional tests data, blood test and diagnostic imaging data.

Collaborating researchers and departments

Department of Oncology, Odense University Hospital

• Helena Møgelbjerg Ditzel, MD
• Consultant Trine Lembrecht Jørgensen, PhD
• Consultant Stefan Starup Jeppesen, Associate Professor, PhD
• Stine Brændegaard Winther, MD, PhD

Department of Geriatric Medicine, Odense University Hospital

• Ann-Kirstine Weber Giger, MD
• Consultant Jesper Ryg, PhD

Faculty of Health Sciences, University of Southern Denmark

• Professor Marianne Ewertz, MD, PhD

Department of Clinical Medicine, Herlev and Gentofte Hospital

• Consultant Cecilia Margareta Lund, PhD