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

Gustave Roussy

Status: Not yet enrolling

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

Treatments: Device: Educational content; Device: Educational material plus self-management program - guided version with mental health professional; Device: Educational material plus self-management program - self-administered version

Study type: Interventional

Funder types: Other

Identifiers

NCT06505590

2023-A02082-43

2023/3717 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 372 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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372 participants in 3 patient groups

Educational material aid tool

Sham Comparator group

Description:

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.

Treatment:

Device: Educational content

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

Experimental group

Description:

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

Treatment:

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

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

Experimental group

Description:

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.

Treatment:

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