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

Gustave Roussy, Cancer Campus, Grand Paris372 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

372

Conditions

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

Interventions

Educational contentDEVICE

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 versionDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Gustave Roussy

Villejuif, France

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 3 months and 6 months after the end of the program.

Central Contacts

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

Data from ClinicalTrials.gov

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