NCT03073031

Brief Summary

This study evaluates if melanoma patients who report their side effects to immunotherapy weekly by the use of ePRO-CTCAE will experience an overall reduction of grade 3 and 4 events with 50% compared to routine monitoring carried out every 3 weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
146

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

October 31, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

January 10, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 8, 2017

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

January 26, 2023

Status Verified

January 1, 2023

Enrollment Period

2.8 years

First QC Date

October 31, 2016

Last Update Submit

January 24, 2023

Conditions

Adverse Effects

Outcome Measures

Primary Outcomes (1)

  • The number of patients who experience drug-related grade 3 or 4 adverse events assessed by CTCAE 4.0 will be reduced by 50% in the intervention arm compared to patients in the control arm

    The first 6 months of treatment with immunotherapy

Secondary Outcomes (9)

  • The time patients experience grade 2 or higher toxicity assessed by CTCAE, differs in the intervention arm and the control arm respectively

    The first 6 months of treatment with immunotherapy

  • The number of drug-related adverse events assessed by CTCAE 4.0 reported in the intervention will be higher compared to the adverse events reported in the control arm

    The first 6 months of treatment with immunotherapy

  • The number of contacts to the hospital will be higher in the intervention arm compared to patients in the control arm

    The first 6 months of treatment with immunotherapy

  • The number of hospitalizations are fewer in the intervention arm compared to the control arm.

    The first 6 months of treatment with immunotherapy

  • Patients in the intervention arm receive a lower accumulated prednisone dose compared to patients in the control arm

    The first 6 months of treatment with immunotherapy

  • +4 more secondary outcomes

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Patients report their adverse events on a tablet once a week (intervention) as a supplement to having them monitored every 3 weeks by a physician

Device: Tablet: Samsung Galaxy Tab A

Control

NO INTERVENTION

Patients have their side effects monitored by a physician every 3 weeks (control)

Interventions

Tablet: Samsung Galaxy Tab ADEVICE
Intervention

Eligibility Criteria

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

You may qualify if:

  • Men and women ≥18 years of age
  • who read and understand Danish,
  • who have been diagnosed with malignant melanoma,
  • who are about to be treated with immunotherapy for their disease (1st and 2nd line, mono-therapy and combination therapy).
  • Moreover, patients must have signed and dated a written informed consent form in accordance with regulatory and institutional guidelines and 6) be willing and able to comply with the completion of PRO-CTCAE and other required questionnaires.

You may not qualify if:

  • \- None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Odense University Hospital

Odense, 5000, Denmark

Location

Related Publications (3)

  • Tolstrup LK, Pappot H, Bastholt L, Moller S, Dieperink KB. Impact of patient-reported outcomes on symptom monitoring during treatment with checkpoint inhibitors: health-related quality of life among melanoma patients in a randomized controlled trial. J Patient Rep Outcomes. 2022 Jan 21;6(1):8. doi: 10.1186/s41687-022-00414-5.

    PMID: 35061112DERIVED

  • Tolstrup LK, Bastholt L, Dieperink KB, Moller S, Zwisler AD, Pappot H. The use of patient-reported outcomes to detect adverse events in metastatic melanoma patients receiving immunotherapy: a randomized controlled pilot trial. J Patient Rep Outcomes. 2020 Oct 30;4(1):88. doi: 10.1186/s41687-020-00255-0.

    PMID: 33125537DERIVED

  • Tolstrup LK, Pappot H, Bastholt L, Zwisler AD, Dieperink KB. Patient-Reported Outcomes During Immunotherapy for Metastatic Melanoma: Mixed Methods Study of Patients' and Clinicians' Experiences. J Med Internet Res. 2020 Apr 9;22(4):e14896. doi: 10.2196/14896.

    PMID: 32271150DERIVED

Study Officials

  • Laerke K. Tolstrup, MD

    Odense University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

October 31, 2016

First Posted

March 8, 2017

Study Start

January 10, 2017

Primary Completion

November 1, 2019

Study Completion

November 1, 2019

Last Updated

January 26, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)