AzTrials
AzTrials

MelanomaCAPABLENCT05827289

'Cancer Patients Better Life Experience'

A study testing Cancer Patients Better Life Experience (CAPABLE) in people with Melanoma, run by The Netherlands Cancer Institute at 1 site in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to compare health-related quality of life, specifically fatigue, in melanoma patients treated with immunotherapy who use or do not use a patient-centered mobile coaching and monitoring system (CAPABLE). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma
What is being tested?
Cancer Patients Better Life Experience (CAPABLE)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteNetherlands
Study dates
15 Apr 2023to 31 Dec 2023
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

  • >18 years of age
  • Sufficient understanding of the Dutch language
  • Participants or their caregiver can use a smartphone (upon patient's consent)
  • Histologically confirmed stage III or IV melanoma who receive treatment with immune checkpoint-inhibitors, according to the clinical guidelines.

Who cannot join

  • Included in a clinical trial
  • >12 months on active treatment

Trial locations and contacts

1 site in 1 country.

Itske Fraterman, MSc contact

+31205122036

i.fraterman@nki.nl

Netherlands1 site, 1 recruiting

  • Netherlands Cancer Institute

    Amsterdam, North Holland, 1066CX

    Itske Fraterman, +31205122036, i.fraterman@nki.nl

    Recruiting

Other trials in Netherlands

About this study

Official title: Pilot Study of the eHealth Application 'Cancer Patients Better Life Experience'

The purpose of this study is to compare health-related quality of life, specifically fatigue, in melanoma patients treated with immunotherapy who use or do not use a patient-centered mobile coaching and monitoring system (CAPABLE). It is expected that by using the CAPABLE eHealth tool, patients' fatigue worsens less significantly (10 points) in the first 3 months follow-up than observed in usual care.

Read the detailed description

This is a prospectively enrolling, explorative cohort study in melanoma patients, eligible for or on treatment with ICI therapy. The explorative cohort receives the CAPABLE smartphone application and a multi-sensorial smartwatch. Patients will be asked to use the system for minimum of three to maximum of six months after enrolment. Questionnaires on health-related quality of life (such as fatigue) and user experience will be administered to the patients on baseline/before start treatment (T0), three months (T1) and six months (T2). Results of this interventional study will be compared with a historical cohort consisting of melanoma patients (P20MEL; NL75996.031.20) with the same inclusion criteria as this study population, but receiving standard care (e.g. without the CAPABLE app).

Conditions
Melanoma
Being tested
Cancer Patients Better Life Experience (CAPABLE)
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cancer Patients Better Life Experience (CAPABLE)Device

    The CAPABLE system serves three main goals for the patient: symptom monitoring, information needs fulfilment and interventions to improve mental- and physical wellbeing. These are available to the patient as a smartphone application that is connected to a smartwatch to monitor activity, blood pressure, sleep and heart rate. Patients are able to report symptoms experienced from the treatment and are eligible to do interventions such as mindfulness or yoga. Patients will receive the CAPABLE application and smartwatch for a minimum 3 to a maximum of 6 months after start treatment.

Study groups in NCT05827289
Study groupRoleWhat they receive
CAPABLE cohortExperimentalGroup that receives the CAPABLE application during treatment
Receives: Device: Cancer Patients Better Life Experience (CAPABLE)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in fatigue between baseline and 3 and 6 months, as measured by fatigue symptom scale of The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-core 30 (EORTC QLQ-C30)

    Fatigue is measured on a score from 0-100, the lower the score the less fatigue a patient has

    Measured: Baseline, month 3, month 6

Secondary outcomes (11)

  1. Change in health-related quality of life and QALY's between baseline and 3 and 6 months, as measured by The EuroQoL-5D (EQ-5D-5L).

    The EQ-5D is a standardised 5-level, 5-dimensional multi-attribute utility questionnaire that measures mobility, self-care, usual activities, pain/discomfort and anxiety/depression. It contains a visual analogue scale, with a score from 0 to 100, the higher the score, the better the outcome. Furthermore, it measures utility scores that can be linked to a country index and be further used in cost-effectiveness analysis.

    Measured: Baseline, month 3, month 6

  2. Change in health-related quality of life and physical symptoms between baseline and 3 and 6 months, as measured by the EORTC QLQ-C30

    Funtional domains: scale from 0 to 100, the higher the score, the better the functioning.

    Symptoms: on a scale from 0 to 100, the higher the score, the worse the symptom

    Measured: Baseline, month 3, month 6

  3. Change in melanoma specific quality of life between baseline and 3 and 6 months, as measured by the FACT-M

    Of the FACT-M, we use the Melanoma Subscale (scale 0 to 64) and the Melanoma Surgery Subscale (scale 0 to 32), items specific to quality of life in melanoma patients. High scores show a high quality of life. The higher the score the better the quality of life is.

    Measured: Baseline, month 3, month 6

  4. Change in patient reported immunotherapy-related toxicity between baseline and 3 and 6 months, as measured by a self-developed questionnaire using EORTC item bank items

    We identified, based on literature and expert opinion, 19 symptoms and created a symptom list based on items of the EORTC item Library. Scale from 0 to 100, the higher the score, the worse the symptom.

    Measured: Baseline, month 3, month 6

  5. Change in psychological distress between baseline and 6 months, as measured by the Hospital Anxiety and Depression Scale (HADS).

    The HADS is a 14-itemquestionnaire, assesses symptoms of mood disturbance, yielding separate scale scores for anxiety and depression, as well as a total score. The higher the score, the worse the depression and/or anxiety is.

    Measured: Baseline, month 6

  6. Change in information satisfaction/needs between baseline and 6 months, as measured by the EORTC QLQ-INFO25

    Measures different domains of satisfaction with delivered information. Scale of 0 to 100, the higher the score the higher the satisfaction/delivered information.

    Measured: Baseline, month 6

  7. Recruitment rate

    The ratio of patients that are included in the study out of the patients eligible for study participation

    Measured: Through study completion, an average of 6 months

  8. Patient compliance

    The ratio of patients completing the questionnaire and using the CAPABLE app, out of the included patients

    Measured: Through study completion, an average of 6 months

  9. Usability/user experience as measured by The System Usability Scale (SUS)

    The System Usability Scale (SUS) consists of a 10 item questionnaire with five response options for respondents. The participant's scores are converted to original scores of 0-40 to 0-100. Scores should be considered only in terms of their percentile ranking.

    Measured: Baseline

  10. Usability/user experience as measured by PAtient Trust Assessment Tool (PATAT)

    Measured on a Likert-scale from 1 to 5. A score higher than 3 is considered trust in telemedicine. Reported as the percentage that has a score higher than 3 and the percentage that scored equal or below 3.

    Measured: Month 3

  11. Usability/user experience as measured by the User Version of the Mobile Application Rating Scale (uMARS)

    The uMARS is a20-item measure that includes 4 objective quality subscales-engagement, functionality, aesthetics, and information quality-and 1 subjective quality subscale. The higher the score the better the outcomes.

    Measured: Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2023
  2. Study start15 Apr 2023
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion31 Dec 2023 (estimated)

Resources

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
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05827289
Sponsor's protocol ID
P22BLE
Other IDs
NL81970.000.22
Acronym
CAPABLE
Status last verified
Jul 2023
First submitted
11 Jan 2023
Last updated
6 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Fraterman I, Wollersheim BM, Tibollo V, Glaser SLC, Medlock S, Cornet R, Gabetta M, Gisko V, Barkan E, di Flora N, Glasspool D, Kogan A, Lanzola G, Leizer R, Mallo H, Ottaviano M, Peleg M, van de Poll-Franse LV, Veggiotti N, Sniatala K, Wilk S, Parimbelli E, Quaglini S, Rizzo M, Locati LD, Boekhout A, Sacchi L, Wilgenhof S. An eHealth App (CAPABLE) Providing Symptom Monitoring, Well-Being Interventions, and Educational Material for Patients With Melanoma Treated With Immune Checkpoint Inhibitors: Protocol for an Exploratory Intervention Trial. JMIR Res Protoc. 2023 Oct 11;12:e49252. doi: 10.2196/49252.

    PubMed 37819691

Questions about this trial

What is this clinical trial studying?

A study testing Cancer Patients Better Life Experience (CAPABLE) in people with Melanoma, run by The Netherlands Cancer Institute at 1 site in Netherlands.

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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 6 Jul 2023. 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 Netherlands. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Itske Fraterman, MSc (+31205122036, i.fraterman@nki.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in fatigue between baseline and 3 and 6 months, as measured by fatigue symptom scale of The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-core 30 (EORTC QLQ-C30) (time frame: Baseline, month 3, month 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05827289, which also lists 1 linked publication.

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 6 Jul 2023.

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