Trials / Recruiting
RecruitingNCT06505590
STEpwise Research Program to Promote INGeniouS ONline Supportive Solutions in the Relief of Cancer-related Fatigue
STEpwise Research Program to Promote INGeniouS ONline Supportive Solutions in the Relief of Cancer-related Fatigue (STEPPING-STONe)
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 372 (estimated)
- Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2025-09-01
- Primary completion
- 2027-11-01
- Completion
- 2027-11-01
- First posted
- 2024-07-17
- Last updated
- 2025-09-15
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT06505590. Inclusion in this directory is not an endorsement.