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NCT Number: NCT06505590

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

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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Key information

Conditions

Cancer Diagnosis Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Moderate or Severe Score of Cancer-related Fatigue (CRF) Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

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.

Primary outcomes

  1. Compare the effectiveness of standard of care plus three different types of digital aid modalities for the patient.

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ines VAZ-LUIS, MD

CONTACT

[email protected]

+33 (0)1 42 11 48 27

Maria Alice FRAZOI, MD

CONTACT

[email protected]

+33 (0)1 42 11 48 27

Sponsors and collaborators

Lead sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Other

Collaborators

  • Institut Bergonié
  • University Hospital, Bordeaux

Registry information

Official study title

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

Acronym: STEPPING-STONe

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 17, 2024
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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