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STEpwise Research Program to Promote INGeniouS ONline Supportive Solutions in the Relief of Cancer-related Fatigue

NCT06505590 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 372

Last updated 2025-09-15

No results posted yet for this study

Summary

Decentralized, randomized hybrid type 2 (effectiveness/implementation) controlled trial comparing the effectiveness of three different digital aid modalities programs in reducing the perceived burden of CRF in cancer patients while also gathering data on the implementation strategy.

Conditions

  • Cancer Diagnosis
  • Moderate or Severe Score of Cancer-related Fatigue (CRF)

Interventions

DEVICE

Educational content

Patients will have access to educational content on the mobile app Resilience © in the format of articles, videos or podcasts on treatment related symptoms and on validated supportive care interventions. This version is currently public available in France and Belgium at www.resilience.care and is considered the control group (education only).

DEVICE

Educational material plus self-management program - self-administered version

Patients will have access to the same mobile app (Resilience ©) with its educational content will be powered with a self-guided fatigue self-management program based on a cognitive behavioral therapy approach.

DEVICE

Educational material plus self-management program - guided version with mental health professional

Patients will have access to the same mobile app (Resilience ©) with its educational content and the self-management program of arm 2 and weekly calls with a certified mental health professional certified in cognitive behavioural therapy for guided coaching across the self-management program.

Sponsors & Collaborators

  • University Hospital, Bordeaux

    collaborator OTHER

  • Institut Bergonié

    collaborator OTHER

  • Gustave Roussy, Cancer Campus, Grand Paris

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2027-11-30
Completion
2027-11-30

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06505590 on ClinicalTrials.gov