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Trial Title:
STEpwise Research Program to Promote INGeniouS ONline Supportive Solutions in the Relief of Cancer-related Fatigue (STEPPING-STONe)
NCT ID:
NCT06505590
Condition:
Cancer Diagnosis
Moderate or Severe Score of Cancer-related Fatigue (CRF)
Conditions: Official terms:
Fatigue
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Educational content
Description:
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).
Arm group label:
Educational material aid tool
Intervention type:
Device
Intervention name:
Educational material plus self-management program - self-administered version
Description:
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.
Arm group label:
Educational material plus self-management program - self-administered version
Intervention type:
Device
Intervention name:
Educational material plus self-management program - guided version with mental health professional
Description:
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.
Arm group label:
Educational material plus self-management program - guided version with mental health professional
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age 18 years and older.
- Having a clinical diagnosis of cancer including patients on active treatment or
cancer survivors.
- Self-reporting moderate to severe CRF for at least one week (worst level of fatigue
≥ 4 on a 10-point numerical rating scale, retained in international guidelines as an
optimal cutoff for identifying clinically significant CRF).
- Being able to read and understand French.
- Having access to a smartphone.
- Patients must be affiliated to a social security system or beneficiary of the same.
Exclusion Criteria:
- Suffering from current psychiatric disorder or cognitive disorder that would
interfere with the ability to consent or participate.
- Currently engaging in cognitive-behavioral therapy.
- Currently engaging in another non-drug (behavioral) clinical trial.
- Suffering from physical related reversible and treatable causes of fatigue (anemia,
electrolytes unbalance, infections, renal dysfunction, active metastases causing
fatigue, hormonal unbalances (hypothyroidism, adrenal insufficiency, etc.) -
according to physician's judgement at the moment of inclusion.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Gustave Roussy
Address:
City:
Villejuif
Zip:
94805
Country:
France
Contact:
Last name:
Ines VAZ-LUIS, MD
Phone:
+33 (0)142114827
Email:
ines-maria.vaz-duarte-luis@gustaveroussy.fr
Contact backup:
Last name:
Maria Alice FRAZOI, MD
Phone:
+33 (0)142114827
Email:
mariaalice.borinelli-franzoi@gustaveroussy.fr
Start date:
September 2024
Completion date:
September 2026
Lead sponsor:
Agency:
Gustave Roussy, Cancer Campus, Grand Paris
Agency class:
Other
Collaborator:
Agency:
University Hospital, Bordeaux
Agency class:
Other
Collaborator:
Agency:
Institut Bergonié
Agency class:
Other
Source:
Gustave Roussy, Cancer Campus, Grand Paris
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06505590
https://www.resilience.care/
