NCT05827289

Brief 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). 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

April 15, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 25, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

July 6, 2023

Status Verified

July 1, 2023

Enrollment Period

9 months

First QC Date

January 11, 2023

Last Update Submit

July 3, 2023

Conditions

Melanoma

Outcome Measures

Primary Outcomes (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

    Baseline, month 3, month 6

Secondary Outcomes (11)

  • 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).

    Baseline, month 3, month 6

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

    Baseline, month 3, month 6

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

    Baseline, month 3, month 6

  • 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

    Baseline, month 3, month 6

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

    Baseline, month 6

  • +6 more secondary outcomes

Study Arms (1)

CAPABLE cohort

EXPERIMENTAL

Group that receives the CAPABLE application during treatment

Device: Cancer Patients Better Life Experience (CAPABLE)

Interventions

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.

CAPABLE cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Netherlands Cancer Institute

Amsterdam, North Holland, 1066CX, Netherlands

RECRUITING

Related Publications (1)

  • 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.

    PMID: 37819691DERIVED

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Itske Fraterman, MSc

CONTACT

+31205122036i.fraterman@nki.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2023

First Posted

April 25, 2023

Study Start

April 15, 2023

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

July 6, 2023

Record last verified: 2023-07

Locations

NL(1)