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| ID | Type | Description | Link |
|---|---|---|---|
| 2023/3717 | Other Identifier | CSET number (Gustave Roussy ID) |
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| Name | Class |
|---|---|
| University Hospital, Bordeaux | OTHER |
| Institut Bergonié | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Educational material aid tool | Sham Comparator | 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. |
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| Educational material plus self-management program - self-administered version | Experimental | Mobile app (Resilience ©) with its educational content plus a self-guided fatigue self-management program based on a cognitive behavioral therapy approach. |
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| Educational material plus self-management program - guided version with mental health professional | Experimental | Mobile app (Resilience ©) with its educational content and the self-management program of arm 2 plus weekly calls with a certified mental health professional certified in cognitive behavioural therapy for guided coaching across the self-management program. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational content | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the effectiveness of standard of care plus three different types of digital aid modalities for the patient. | Compare the effectiveness of standard of care (provided by the patient's cancer center and their treating oncologist) plus three different types of digital aid modalities for the patient (1: educational material; 2: educational material plus self-management program based on a cognitive behavioural therapy strategy - self-administered; 3: educational material plus self-management program based on a cognitive behavioural therapy strategy - guided by a psychologist) in reducing the perceived burden of CRF (cancer-related fatigue), measured as a clinically meaningful change (≥ 6 points) in fatigue scores in the fatigue subscale of the EORTC QLQ C30 questionnaire from baseline to short-term assessments. | 3 months and 6 months after the end of the program. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ines VAZ-LUIS, MD | Contact | +33 (0)1 42 11 48 27 | ines-maria.vaz-duarte-luis@gustaveroussy.fr | |
| Maria Alice FRAZOI, MD | Contact | +33 (0)1 42 11 48 27 | mariaalice.borinelli-franzoi@gustaveroussy.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gustave Roussy | Recruiting | Villejuif | 94805 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40581251 | Derived | Franzoi MA, Pages A, Charles C, Debiasi M, Gillanders E, Ferreira A, Jacques F, Everhard S, GaryBobo G, Sambou C, Alla F, Quivy A, Morin S, Vaz-Luis I. The effectiveness and implementation of a STEpwise Program to Promote INGeniouS ONline supportive solutions for self-management of cancer-related fatigue: The STEPPING-STONe digitally enabled randomized trial. Contemp Clin Trials. 2025 Aug;155:107993. doi: 10.1016/j.cct.2025.107993. Epub 2025 Jun 26. |
| Label | URL |
|---|---|
| Related Info | View source |
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| Educational material plus self-management program - self-administered version | Device | 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. |
|
| Educational material plus self-management program - guided version with mental health professional | Device | 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. |
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| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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