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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

372 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-01

Study Completion Date

2027-11-30

Brief Summary

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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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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Educational material aid tool

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.

Group Type SHAM_COMPARATOR

Educational content

Intervention Type 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).

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

Mobile app (Resilience ©) with its educational content plus a self-guided fatigue self-management program based on a cognitive behavioral therapy approach.

Group Type EXPERIMENTAL

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

Intervention Type 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

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.

Group Type EXPERIMENTAL

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

Intervention Type 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.

Interventions

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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).

Intervention Type 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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No