Enhancing the Experience of Older Adults With Cancer Through a Comfort Menu and Cart for: Protocol of a Quasi-experimental, Before-and-after Study in a Tertiary Oncology Center
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 264
- 试验地点
- 1
- 主要终点
- Experience of older patients treated in the tertiary oncology center
研究概览
简要总结
Approximately 60% of new cancer diagnoses and 70% of cancer-related deaths occur in adults aged 65 years and older, a population frequently affected by multimorbidity, frailty, sensory impairment, and treatment-related symptom burden. Outpatient oncology centers, although designed for efficient antineoplastic therapy delivery, are rarely adapted to the specific needs of older adults, and pragmatic, low-cost interventions to enhance patient experience and the clinical care journey remain scarce. The "comfort menu and cart," a non-pharmacological strategy initially developed for the emergency department, has shown promising effects on patient and staff experience, but has not been evaluated in the geriatric oncology setting.
Methods: This protocol describes a quasi-experimental, before-and-after, single-center study evaluating the implementation of a comfort menu and cart at the Oncology Center of Hospital Sírio-Libanês, a tertiary philanthropic hospital in São Paulo, Brazil. Patients aged 65 years and older receiving intravenous chemotherapy, supportive therapy, or evaluation of intercurrent symptoms during oncological treatment will be recruited over 12 months: six months pre-intervention and six months post-intervention, with 132 participants per phase and a total sample of 264 participants. All participants will undergo a comprehensive geriatric assessment, including G8, Charlson Comorbidity Index, Clinical Frailty Scale, Geriatric Depression Scale - 15-item version, Katz Index of Independence in Activities of Daily Living, Barthel Index of Activities of Daily Living, Lawton-Brody Instrumental Activities of Daily Living Scale, 10-point Cognitive Screener, and EuroQol 5-Dimension questionnaire. This assessment will be complemented by oncology-specific patient-reported outcomes, including the Edmonton Symptom Assessment System, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Information 25, and a structured adherence questionnaire. Caregiver anxiety, depression, and burden will be assessed using the Hospital Anxiety and Depression Scale and the Zarit Burden Interview short version. The primary outcome will be patient experience, measured using Likert-scale instruments adapted from previously published comfort care and emergency department experience instruments. Secondary outcomes include staff experience, length of stay, satisfaction indicators, oncological treatment adherence, symptom control, patient understanding of disease-related information, functionality, need for re-evaluation, hospital admissions, and caregiver outcomes at 30 days.
Expected Results: The study is expected to demonstrate that a low-cost, non-pharmacological intervention can enhance the experience of older adults with cancer and multidisciplinary teams, with favorable effects on symptom control, information comprehension, treatment adherence, and 30-day clinical outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
A research assistant, blinded to the initial assessment and ED care details, will conduct a phone interview 30 days (± 2 days) post-initial assessment.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 60 years or older.
- •Receiving care at the Oncology Center in the context of active cancer treatment: intravenous chemotherapy, supportive therapy, or clinical evaluation.
- •Capacity to provide informed consent and respond to the interview, or presence of a legal representative or companion able to do so.
排除标准
- •Refusal to participate in the study or to use the comfort menu and cart items.
- •Decreased level of consciousness or acute clinical instability (hemodynamic instability, acute respiratory failure).
- •Absence of a companion able to consent and provide information when the patient presents cognitive impairment.
- •Inability to be contacted by telephone for the follow-up interview.
结局指标
主要结局
Experience of older patients treated in the tertiary oncology center
时间窗: Baseline assessment during oncologic center stay
Patient experience will be assessed using the Older Adult Oncology Patient Experience Scale, composed by Likert scale items. measured by Likert-scale items, assess perceived comfort, age-specific care, communication, and respect during the index oncology center visit. Each item is scored on a 5-point LIKERT SCALE ranging 1 to 5, whwrw 1 indicates the least fevorable experience and 5 indicates the most favorable experience. Higher scores indicate a better patient experience. In the post - intervention phase, assitional items will assess use of, and perceived value atributed, the comfort card and comfort menu. These items will also be scored on the same 5-point Likert scale randging 1 to 5, with higher scores indicating greater perceived values or satisfaction
次要结局
- Experience of medical and multidisciplinary staff involved in caring for older patients treated in the oncologic Center(6 months pre and post intervention, cuncurrent with patients inclusion)
- Transactional Net Promoter Score(30 days)
- Number of Ombudsman Manifestations Classified by Type(30 days)
- Caregiver anxiety and depression symptoms(Baselina assessment during Oncologic Center stay)
- Caregiver burden(Baseline assessement using oncologic center stay)
研究者
Theodora Karnakis
Principal Investigator
Hospital Sirio-Libanes