Supporting older adults with cancer and their support person through geriatric assessment and remote exercise and education: The SOAR study protocol

IF 3 3区医学 Q3 GERIATRICS & GERONTOLOGY

Journal of geriatric oncology Pub Date : 2025-02-05 DOI:10.1016/j.jgo.2025.102194

Nirusha Jebanesan , Shabbir M.H. Alibhai , Daniel Santa Mina , Jennifer Jones , Nicholas Legacy , Laura Freeman , Ainslee Smith , Saul Cobbing , Neera Vadali , Shiuhang Lo , Kian Godhwani , Ferozah Nasiri , Maryjo Antonio , Douglas Stephens , Eric Pitters , Fay Bennie , Anne Stephens , Janet Papadakos , Linda Cerullo , Margaret Zjadewicz , Martine Puts

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引用次数: 0

Abstract

Introduction

Frail older adults receiving cancer treatment are at heightened risk of adverse outcomes. Despite the known benefits of exercise during cancer treatment to improve well-being, few exercise studies focus on frail older adults receiving cancer treatment and their support person. Geriatric assessment (GA) is often recommended prior to the start of treatment for frail adults with cancer, but combining the GA with a planned exercise regimen remains unexplored. This study aims to determine the feasibility and acceptability of implementing geriatric assessment and management (GAM) in combination with virtual chair-based exercise (CBE) and health education for frail older adults with cancer and their support persons.

Materials and Methods

This phase 2 randomized controlled trial will include patients aged 70 years and above with a lung, gastrointestinal, or genitourinary cancer referred for first- or second-line chemotherapy, immunotherapy, or targeted therapy. Patients must be frail (≥3 on the Vulnerable Elders Survey), sedentary on the Godin Leisure Time Activity Questionnaire (<90 min of moderate/intense activity per week), have English proficiency with ability to consent, a physician-estimated life expectancy of at least six months, and deemed safe to exercise. Each older adult will be invited to bring a support person to participate in the study. Patients will be randomized 1:1 to GAM combined with online CBE and health education for 12 weeks or waitlist control. Participating support persons will follow the same intervention group. Primary endpoints for feasibility and acceptability will be recruitment rate, retention, adherence, and data collection. Outcome measures include physical activity, function, fatigability, quality of life, treatment toxicity, and unplanned hospital visits. Outcome measures will be used to obtain estimates of the effect size and feasibility analysis needed for designing a phase 3 study. The study will take place at two hospitals in Toronto, Canada.

Discussion

This study will investigate the feasibility, acceptability, and obtain preliminary estimates of the outcomes of GAM plus CBE and health education in preventing functional decline and improving quality of life in frail older adults receiving cancer treatment and their support persons. The results will help to design a definitive phase 3 randomized controlled trial.

Trial registration

The trial is registered at ClinicalTrials.gov (Registration Number: NCT05509751).

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来源期刊

Journal of geriatric oncology ONCOLOGY-GERIATRICS & GERONTOLOGY

CiteScore

5.30

自引率

10.00%

发文量

379

审稿时长

80 days

期刊介绍： The Journal of Geriatric Oncology is an international, multidisciplinary journal which is focused on advancing research in the treatment and survivorship issues of older adults with cancer, as well as literature relevant to education and policy development in geriatric oncology. The journal welcomes the submission of manuscripts in the following categories: • Original research articles • Review articles • Clinical trials • Education and training articles • Short communications • Perspectives • Meeting reports • Letters to the Editor.