Renal Cell Carcinoma MetastaticCAPABLE-ITNCT06161233
Pilot Study of the eHealth Application "Cancer Patients Better Life Experience" (CAPABLE) - Italy
A study testing CAPABLE cohort in people with Renal Cell Carcinoma Metastatic and Breast Cancer, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
Trial summary
The purpose of the CAPABLE study is to compare health-related quality of life in renal cell carcinoma patients who use or do not use a mobile-based application to monitor adverse events for cancer treatment at home. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma Metastatic, Breast Cancer, Head and Neck Cancer
- What is being tested?
- CAPABLE cohort
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteItaly
- Study dates
- 16 May 2023to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (age >=18 years)
- Sufficient understanding of the Italian language
- Patients or their caregiver (upon patient's consent) can use a smartphone
- Histologically or cytologically confirmed diagnosis of RCC, lung, breast, thyroid o head and neck cancer
- Candidate to systemic treatment (targeted agents, immune checkpoint inhibitors, or a combination of the two)
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at the start of the treatment.
Who cannot join
- Recruitment and consent denial
- Not able of understanding and complying with the protocol requirements (including basic technological abilities)
- Given the fact that each subject involved in the clinical study must be able to understand and sign the informed consent presented by the researcher, lack of this capability represents a specific exclusion criterion in the study protocol.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the CAPABLE study is to compare health-related quality of life in renal cell carcinoma patients who use or do not use a mobile-based application to monitor adverse events for cancer treatment at home. As secondary objectives, the study investigates the usability of the system and its generalizability to other cancer types
Read the detailed description
The study is designed as a prospectively enrolling, quasi-experimental cohort study in cancer patients, eligible for systemic treatment.
The CAPABLE cohort will receive the smartphone application and a multi-sensorial smartwatch (ASUS VivoWatch 5 HC-B05). Patients will be asked to use the system for at least 6 months after enrollment. If, after 6 months, a patient wants to keep using the system, he will be allowed to do so, until the end of the study. Questionnaires on health-related quality of life will be administered to the patients on baseline (T0) and every three months (T1 and T2). Lost to follow-up data will be included in intention-to-treat analysis. Qualitative and quantitative user experience studies will be done at enrollment, after 3 months and at the end of the follow-up period with the CAPABLE system. Results of this interventional study will be compared with a control cohort consisting of renal cell carcinoma patients, recruited in 2021 with the same inclusion criteria as this study population, but receiving standard care (ICSM CE number 2546, dated 13/04/2021 and amended on 09/02/2022).
- Conditions
- Renal Cell Carcinoma Metastatic, Breast Cancer, Head and Neck Cancer, Thyroid Cancer, Ovary Cancer, Lung Cancer
- Being tested
- CAPABLE cohort
- Medical subject headings
- Breast Neoplasms, Head and Neck Neoplasms, Thyroid Neoplasms, Ovarian Neoplasms, Lung Neoplasms, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAPABLE cohortDevice
The CAPABLE cohort receives the mobileapplication and a multi-sensorial smartwatch (ASUS VivoWatch 5 HC-B05). Patients will be asked to use the system for at least 6 months. The CAPABLE app serves three main functionalities for the patient: symptom monitoring, information needs fulfilment and interventions to improve mental- and physical wellbeing
| Study group | Role | What they receive |
|---|---|---|
| CAPABLE cohort | Experimental | Group that receives the CAPABLE mobile application and a smartwatch during treatment Receives: Device: CAPABLE cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in health-related QoL outcomes in RCC patients
The primary objective of this study is to investigate whether HRQoL of RCC patients eligible for systemic treatment can be improved by a patient-centred mobile coaching- and monitoring system
Measured: 6 months after the enrollment
Secondary outcomes (2)
User experience of the CAPABLE system in RCC patients
This study will gather qualitative and quantitative information to quantify usefulness, easiness, acceptability and feasibility of the end users' solutions. The patient app will be assessed also in terms of perceived impact and support derived from the digital technologies. The health professional web application will be evaluated to understand to what extent this can be integrated and adopted in the clinical practice
Measured: 6 months after the enrollment
User experience of the CAPABLE system in other cancer types patients
To evaluate the generalizability of the system on other cancer types, the user experience study is performed also on patients with cancer types different from RCC (e.g Breast, Ovary, Head\&Neck cancer). The patient app will be assessed also in terms of perceived impact and support derived from the digital technologies. The health professional web application will be evaluated to understand to what extent this can be integrated and adopted in the clinical practice
Measured: 6 months after the enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start16 May 2023
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell Carcinoma MetastaticStudies of the same condition, open and under way.
- More trials run by Istituti Clinici Scientifici Maugeri SpAThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pavia, Policlinico di Bari Ospedale Giovanni Paolo XXIII, Biomeris srl, The Netherlands Cancer Institute, University of Haifa, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), IBM Research, Bitsens JSC, Poznań University of Technology, Deontics LTD, Associazione Italiana Malati di Cancro AIMAC, Universidad Politecnica de Madrid
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06161233
- Sponsor's protocol ID
- CAPABLE-IT
- Acronym
- CAPABLE-IT
- Status last verified
- Mar 2024
- First submitted
- 30 Nov 2023
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the eHealth Application "Cancer Patients Better Life Experience" (CAPABLE) - Italy
- ClinicalTrials.gov ID
- NCT06161233
- Acronym / sponsor ID
- CAPABLE-IT / CAPABLE-IT
- Conditions
- Renal Cell Carcinoma Metastatic, Breast Cancer, Head and Neck Cancer, Thyroid Cancer, Ovary Cancer, Lung Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpAUniversity, hospital or other
- Collaborators
- University of Pavia, Policlinico di Bari Ospedale Giovanni Paolo XXIII, Biomeris srl, The Netherlands Cancer Institute, University of Haifa, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), IBM Research, Bitsens JSC, Poznań University of Technology, Deontics LTD, Associazione Italiana Malati di Cancro AIMAC, Universidad Politecnica de Madrid
- Study start
- 16 May 2023 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 7 Dec 2023 (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.
The purpose of the CAPABLE study is to compare health-related quality of life in renal cell carcinoma patients who use or do not use a mobile-based application to monitor adverse events for cancer treatment at home. As secondary objectives, the study investigates the usability of the system and its generalizability to other cancer types
Detailed description
The study is designed as a prospectively enrolling, quasi-experimental cohort study in cancer patients, eligible for systemic treatment.
The CAPABLE cohort will receive the smartphone application and a multi-sensorial smartwatch (ASUS VivoWatch 5 HC-B05). Patients will be asked to use the system for at least 6 months after enrollment. If, after 6 months, a patient wants to keep using the system, he will be allowed to do so, until the end of the study. Questionnaires on health-related quality of life will be administered to the patients on baseline (T0) and every three months (T1 and T2). Lost to follow-up data will be included in intention-to-treat analysis. Qualitative and quantitative user experience studies will be done at enrollment, after 3 months and at the end of the follow-up period with the CAPABLE system. Results of this interventional study will be compared with a control cohort consisting of renal cell carcinoma patients, recruited in 2021 with the same inclusion criteria as this study population, but receiving standard care (ICSM CE number 2546, dated 13/04/2021 and amended on 09/02/2022).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAPABLE cohort | Experimental | Device: CAPABLE cohortGroup that receives the CAPABLE mobile application and a smartwatch during treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults (age >=18 years)
- Sufficient understanding of the Italian language
- Patients or their caregiver (upon patient's consent) can use a smartphone
- Histologically or cytologically confirmed diagnosis of RCC, lung, breast, thyroid o head and neck cancer
- Candidate to systemic treatment (targeted agents, immune checkpoint inhibitors, or a combination of the two)
Key exclusion criteria (3 listed)
- Recruitment and consent denial
- Not able of understanding and complying with the protocol requirements (including basic technological abilities)
- Given the fact that each subject involved in the clinical study must be able to understand and sign the informed consent presented by the researcher, lack of this capability represents a specific exclusion criterion in the study protocol.
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 |
|---|---|---|
| CAPABLE cohortThe CAPABLE cohort receives the mobileapplication and a multi-sensorial smartwatch (ASUS VivoWatch 5 HC-B05). Patients will be asked to use the system for at least 6 months. The CAPABLE app serves three main functionalities for the patient: symptom monitoring, information needs fulfilment and interventions to improve mental- and physical wellbeing | Device | CAPABLE cohort |
Primary outcome
Change in health-related QoL outcomes in RCC patients
Time frame: 6 months after the enrollment
The primary objective of this study is to investigate whether HRQoL of RCC patients eligible for systemic treatment can be improved by a patient-centred mobile coaching- and monitoring system
2 secondary outcomes
User experience of the CAPABLE system in RCC patients
Time frame: 6 months after the enrollment
User experience of the CAPABLE system in other cancer types patients
Time frame: 6 months after the enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAPABLE cohort in people with Renal Cell Carcinoma Metastatic and Breast Cancer, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
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 6 inclusion and 3 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: finished, as of the sponsor's last update on 8 Mar 2024. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in health-related QoL outcomes in RCC patients (time frame: 6 months after the enrollment). 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 8 Mar 2024.