Confort, Older Adults With Cancer
Conditions
Keywords
Older adults with cancer, Patient experience, Comprehensive Geriatric assessment, Non Pharmacological Intervention, Caregiver Burden, Geriatric Oncology
Brief summary
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.
Interventions
OTHERComfort menu and cart implemented
The comfort menu and cart will be implemented after the pre-intervention data collection phase.The cart will be positioned in an easily accessible area of the infusion floor, and the menu will be presented to eligible patients in printed or digital format (tablet). A one-month rollout period will precede post-intervention enrolment, dedicated to staff training and resolution of logistic challenges, in order to optimize fidelity. Comfort cart contents: Hot and cold packs; Extra blankets and pillows; face towels; gloves and hats; Personal hygiene kit (toothbrush, toothpaste, cotton swabs, sleep mask, comb, deodorant, hand lotion); Distraction items (magazines, word-search puzzles, playing cards, coloring pages); Communication and orientation aids (reading glasses, magnifying glass, penlight, mobile phone charger, notepad, sound amplification device). Comfort menu options (oncology-specific): Physiotherapy assessment;Conversation with chaplain, concierge, or social worker.
Sponsors
Hospital Sirio-Libanes
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Masking description
A research assistant, blinded to the initial assessment and ED care details, will conduct a phone interview 30 days (± 2 days) post-initial assessment.
Intervention model description
This study will utilize a quasi-experimental, before-and-after design
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Experience of older patients treated in the tertiary oncology center | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | The interview will fololow the standartization of the original comfort cart validation study, 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. |
| Transactional Net Promoter Score | 30 days | Institutional satisfaction will be assessed using the Transactional Net Promoter Score, calculated from the standard 0-to-10 recommendation question. Respondents scoring 9-10 will be classified as promoters, 7-8 as passives, and 0-6 as detractors. The final Transactional Net Promoter Score ranges from -100 to +100, with higher scores indicating greater institutional satisfaction. |
| Number of Ombudsman Manifestations Classified by Type | 30 days | Ombudsman manifestations related to the intervention period will be classified as complaints, suggestions, or compliments. The outcome will be reported as the number of manifestations in each category during the 30-day assessment period. |
| Caregiver anxiety and depression symptoms | Baselina assessment during Oncologic Center stay | Caregiver anxiety and depression symptoms will be assessed using the Hospital Anxiety and Depression Scale (HADS). The HADS includes two subscales: anxiety and depression. Each subscale ranges from 0 to 21, with higher scores indicating greater symptom severity and therefore a worse outcome. |
| Caregiver burden | Baseline assessement using oncologic center stay | Caregiver burden will be assessed using the 12-item Zarit Burden Interview Short Form (ZBI-12). Each item is scored from 0 to 4, and the total score ranges from 0 to 48, with higher scores indicating greater caregiver burden and therefore a worse outcome. |
Countries
Brazil
Contacts
CONTACTTheodora Karnakis, MD, PhD
CONTACTTheodora Karnakis, Md, PhD
PRINCIPAL_INVESTIGATORTheodora Karnakis, MD, PhD
Hospital Sirio-Libanes
Outcome results
None listed