Older adult loneliness is associated with depression, disability and higher mortality rates. As a public health concern, it contributes to increased medical and nursing care costs. Several intervention studies have been conducted to reduce loneliness; however, no universally effective method has been established. We hypothesise that if older adults use their physical abilities to perform petit volunteering, their feelings of loneliness would likely be reduced. This trial aims to investigate the benefits of using petit volunteers for loneliness alleviation (PetitVOLA) application as a sustainable programme to prevent loneliness through the creation of an Ikigai-based volunteer system.
We intend to conduct a randomised controlled trial with a 3-month intervention period to verify the effectiveness of the PetitVOLA programme (sample size, 126 participants; power, 0.8; significance level, 0.05). The primary outcome is loneliness, which we will measure using the UCLA Loneliness Scale (V.3). Secondary outcomes include social isolation (assessed via multicomponent objective criteria), life satisfaction, physical function (gait speed and grip strength), cognitive function, psychological status and lifestyle, each assessed with validated instruments (eg, Mini-Mental State Examination, Geriatric Depression Scale-15 and the Active Mobility Index). The main analysis uses an intention-to-treat approach, while a full analysis set and a per-protocol set are included for sub-analyses.
The trial was approved by the Human Research Ethics Committee of the National Center for Geriatrics and Gerontology, Japan (approval No. 1794). The results of this trial will be disseminated through peer-reviewed journals, conference presentations and reports to the participating community.
UMIN000056649.
To explore patients’ perceptions of managing adverse events (AEs) from anticancer drugs for gynaecological cancer, focusing on AEs they want to avoid, views on dose adjustments and communication with healthcare professionals.
Observational study using a web-based questionnaire.
Women in Japan who had received chemotherapy for endometrial or ovarian/fallopian tube cancer were enrolled. Healthcare professionals, including obstetrics and gynaecology physicians, nurses and pharmacists, who administered chemotherapy to these patients, were also enrolled.
AEs that patients wished to avoid or found distressing; varied perceptions of AEs before and after treatment; discrepancies in the communication of AEs between patients and healthcare professionals; administration time and intervals between hospital visits patients found distressing; patient awareness of dose adjustment (reduction, interruption or discontinuation) to suppress AEs.
Participants comprised 153 physicians, 166 nurses, 154 pharmacists and 154 patients. Nausea/vomiting (28.6%), alopecia (18.2%) and peripheral neuropathy (9.1%) were the most distressing AEs overall. Physicians rated nausea/vomiting lower (15.4%) and alopecia higher (38.2%) than patients, while pharmacists emphasised peripheral neuropathy (25.7%). Many patients found AEs, including peripheral neuropathy (53/99), fatigue (52/105) and alopecia (46/120), to be more severe than expected. Communication patterns revealed that 49.4% of patients reported all symptoms, even uncertain ones, but younger patients tended to communicate fewer symptoms. Physicians (54.2%), nurses (92.2%) and pharmacists (85.7%) preferred full disclosure of symptoms. While 28.6% of patients wished to avoid dose reductions because of fears of disease progression, 18.2% preferred dose reduction or discontinuation when AEs became intolerable. Drug administration times and visit intervals influenced patient distress. Treatment administration of over 3 hours (19.5%) and visits occurring more frequently than once every 3 weeks (27.3%) were the most distressing.
This study highlights discrepancies in AE perceptions and communication between patients and healthcare professionals, emphasising the need for tailored communication strategies and shared decision-making to improve cancer treatment experiences and outcomes.
jRCT1040220088, Japan Registry of Clinical Trials (jRCT).