ConfortNCT07671586
Enhancing Patient Experience in Geriatric Oncology
A study testing Comfort menu and cart implemented in people with Confort and Older Adults With Cancer, run by Hospital Sirio-Libanes at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Confort, Older Adults With Cancer
- What is being tested?
- Comfort menu and cart implemented
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Aug 2026to 20 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
Hospital Sírio Libanês
São Paulo, São Paulo, 01308050
Theodora Karnakis, MD, PhD, +55 11 942025633, theokarnakis@gmail.com
About this study
Official title: 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
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.
- Conditions
- Confort, Older Adults With Cancer
- Being tested
- Comfort menu and cart implemented
- Keywords
- Older adults with cancer, Patient experience, Comprehensive Geriatric assessment, Non Pharmacological Intervention, Caregiver Burden, Geriatric Oncology
- Medical subject headings
- Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comfort menu and cart implementedOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Pré - Intervention | No intervention | Usual Oncologic Care |
| Post - Intervention | Experimental | Comfort menu and cart implemented Receives: Other: Comfort menu and cart implemented |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline assessment during oncologic center stay
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline assessement using oncologic center stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start20 Aug 2026 (estimated)
- Primary completion20 Sep 2027 (estimated)
- Study completion20 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConfortStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This study will utilize a quasi-experimental, before-and-after design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Sirio-Libanes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Theodora Karnakis, Hospital Sirio-Libanes
- Investigators
- Theodora Karnakis, MD, PhD, Principal investigator, Hospital Sirio-Libanes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07671586
- Sponsor's protocol ID
- AVAP-NG 3776-B
- Status last verified
- Jun 2026
- First submitted
- 10 Jun 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient Confidentialy
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07671586
- Acronym / sponsor ID
- AVAP-NG 3776-B
- Conditions
- Confort, Older Adults With Cancer
- Keywords
- Older adults with cancer, Patient experience, Comprehensive Geriatric assessment, Non Pharmacological Intervention, Caregiver Burden, Geriatric Oncology
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- Hospital Sirio-LibanesUniversity, hospital or other
- Study start
- 20 Aug 2026 (estimated)
- Primary completion
- 20 Sep 2027 (estimated)
- Study completion
- 20 Oct 2027 (estimated)
- First posted
- 26 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study will utilize a quasi-experimental, before-and-after design
| Arm | Type | Receives |
|---|---|---|
| Pré - Intervention | No intervention | –Usual Oncologic Care |
| Post - Intervention | Experimental | Other: Comfort menu and cart implementedComfort menu and cart implemented |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comfort menu and cart implementedThe 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. | Other | Post - Intervention |
Primary outcome
Experience of older patients treated in the tertiary oncology center
Time frame: 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
5 secondary outcomes
Experience of medical and multidisciplinary staff involved in caring for older patients treated in the oncologic Center
Time frame: 6 months pre and post intervention, cuncurrent with patients inclusion
Transactional Net Promoter Score
Time frame: 30 days
Number of Ombudsman Manifestations Classified by Type
Time frame: 30 days
Caregiver anxiety and depression symptoms
Time frame: Baselina assessment during Oncologic Center stay
Caregiver burden
Time frame: Baseline assessement using oncologic center stay
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Individual participant dataSharing planned: No. Patient Confidentialy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Theodora Karnakis, MD, PhD principal investigator
Hospital Sirio-Libanes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comfort menu and cart implemented in people with Confort and Older Adults With Cancer, run by Hospital Sirio-Libanes at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Theodora Karnakis, MD, PhD (055 11 984957475, theokarnakis@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Experience of older patients treated in the tertiary oncology center (time frame: Baseline assessment during oncologic center stay). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.