An interventional study of Comfort menu and cart implemented in Confort and Older Adults With Cancer, sponsored by Hospital Sirio-Libanes. Not yet recruiting at 1 site in Brazil. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-06-26.
Sponsored by Hospital Sirio-Libanes · Not applicable, Interventional, and Health services research
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.
500 studies on the registry are indexed under Caregiver Burden; 164 are open to participants now.
This study's planned enrollment of 264 is above the median of 71 across 402 interventional studies indexed under Caregiver Burden.
Browse Caregiver Burden studies →Hospital Sirio-Libanes is the lead sponsor of 44 studies on the registry; 12 are open to participants now.
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Exclusion criteria.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Usual Oncologic Care
Comfort menu and cart implemented
Other: Comfort 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.
Experience of older patients treated in the tertiary oncology center
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
Time frame: Baseline assessment during oncologic center stay
Experience of medical and multidisciplinary staff involved in caring for older patients treated in the oncologic Center
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.
Time frame: 6 months pre and post intervention, cuncurrent with patients inclusion
Transactional Net Promoter Score
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.
Time frame: 30 days
Number of Ombudsman Manifestations Classified by Type
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.
Time frame: 30 days
Caregiver anxiety and depression symptoms
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.
Time frame: Baselina assessment during Oncologic Center stay
Caregiver burden
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.
Time frame: Baseline assessement using oncologic center stay
Length of Stay Beyond Programmed Duration in the Infusion Oncology Center
Length of stay beyond the programmed duration will be assessed during the index visit to the Infusion Oncology Center. This outcome will be calculated as the difference between the actual time spent in the Infusion Oncology Center and the programmed duration of the visit, reported in minutes.
Time frame: At discharge from the index Oncology Center visit
Symptom burden
Symptom burden will be assessed using the Edmonton Symptom Assessment System (ESAS). Each symptom is scored from 0 to 10, where 0 indicates absence of the symptom and 10 indicates the worst possible symptom severity. The total ESAS symptom burden score will be calculated as the sum of the assessed symptom items, ranging from 0 to 90, with higher scores indicating greater symptom burden and therefore a worse outcome.
Time frame: At 30 days after the index Oncology Center visit
Understanding of the information received
Understanding of the information received will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Information 25 (EORTC QLQ-INFO25). Scores will be transformed to a scale ranging from 0 to 100, with higher scores indicating better understanding of the information received and therefore a better outcome.
Time frame: At 30 days after the index Oncology Center visit
Completion of Oncological Treatment as Planned
Oncological treatment completion will be assessed as the proportion of patients who complete the planned oncological treatment without unplanned discontinuation during the 30-day assessment period. The outcome will be reported as the number and percentage of patients who completed treatment as planned.
Time frame: 30 days after the index Oncology Center visit
Functionality- Basic Activities of Daily Living Assessed by the Katz Index
Basic activities of daily living will be assessed using the Katz Index of Independence in Activities of Daily Living. The total score ranges from 0 to 6, with higher scores indicating greater functional independence and therefore a better outcome.
Time frame: At 30 days after the index Oncology Center visit
Functionality- Basic Activities of Daily Living Assessed by the Barthel Index
Basic activities of daily living will be assessed using the Barthel Index of Activities of Daily Living. The total score ranges from 0 to 100, with higher scores indicating greater functional independence and therefore a better outcome.
Time frame: At 30 days after the index Oncology Center visit
Functionality - Instrumenctal activities of daily living
Instrumental activities of daily living will be assessed using the Lawton-Brody Instrumental Activities of Daily Living Scale. In the version used in this study, total scores range from 9 to 27, with higher scores indicating better functionality and less dependence, from total dependence to mild dependence.
Time frame: At 30 days after the index Oncology Center visit
Cognitive performance
Adressed using the 10 point cognitive screener. With a score ranging from 0 to 10, it classifies cognitive performance as normal ( \> = 8) , possible cognitive impeirement (6-7), or probaple cognitive imeirement (0-5), with adjustments for education level.
Time frame: At 30 days after the index Oncology Center visit
Mood symptom
Mood symptoms will be assessed using the Geriatric Depression Scale - 15-item version (GDS-15). The total score ranges from 0 to 15, with higher scores indicating more depressive symptoms and therefore a worse outcome.
Time frame: At 30 days after the index Oncology Center visit
Clinical re-evaluations and unplanned hospital admissions
Number of clinical re-evaluations and unplanned hospital admissions in the 30 days following the index visit.
Time frame: At 30 days after the index Oncology Center visit
Falls
number of falls at 30 days.
Time frame: At 30 days after the index Oncology Center visit
Mortality
Mortality at 30 days.
Time frame: At 30 days after the index Oncology Center visit
Dose Reduction Due to Toxicity
Dose reduction due to toxicity will be assessed as the proportion of patients who require any reduction in the planned oncological treatment dose because of treatment-related toxicity during the 30-day assessment period. The outcome will be reported as the number and percentage of patients with dose reduction due to toxicity.
Time frame: 30 days after the index Oncology Center visit
Treatment Delay or Interruption Due to Toxicity
Treatment delay or interruption due to toxicity will be assessed as the proportion of patients who experience any delay or interruption of oncological treatment because of treatment-related toxicity during the 30-day assessment period. The outcome will be reported as the number and percentage of patients with treatment delay or interruption due to toxicity.
Time frame: 30 days after the index Oncology Center visit
Plan to share: No — Patient Confidentialy
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Sep 2027, 13 months later.
Of 282 non-industry interventional studies with no phase under Caregiver Burden, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 31. This study's planned 13 months is below that.
Counting every sponsor, half of 291 studies reached it within 16 months; a quarter within 7 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
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Hospital Sirio-Libanes