NCT07236021

e-Motion : Promoting Emotion Regulation in Chronic Cancer

Promoting Emotion Regulation in Patients Living With Chronic Cancer : A Pilot Feasibility, Acceptability and Tolerability Study (e-Motion Project)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Université Libre de Bruxelles · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The present study aimed to pilot evaluate two interventions: a Guided Self-Help Intervention alone, and a combined Group and Guided Self-Help Intervention, designed to support individuals living with chronic cancer and recently diagnosed. The primary aim of this pilot study is to assess the feasibility, acceptability and tolerability of the interventions. The secondary aim of the pilot study is to assess the interventions preliminary efficacy and differences on psychological symptoms.

Detailed description

The investigators aim to conduct a pilot study to assess feasibility, acceptability and tolerability of two interventions on 30 chronic cancer patients: a Guided Self-Help Intervention and a combined Group and Guided Self-Help Intervention. Both interventions will rely on emotion regulation component, with CBT, hypnosis, and positive psychology techniques. The first 15 patients that will be recruited will be allocated to the Guided Self-Help Intervention (Arm 1). The recruitment of the 15 other patients will start after the last assessment of the last patient included in the first arm. These 15 other patients will be allocated by group of 5 to the combined Group and Guided Self-Help Intervention (Arm 2). Each participants will be assessed before intervention (T1), during intervention (Ecological weekly assessment, week 1 to week 12) and after the intervention (T2, 15 weeks after T1). T1 and T2 assessments will include self-reported questionnaires about psychological symptoms and a 7-day ecological momentary assessment (EMA) on emotions. In T2, a semi-structured interview will be performed for each participant to collect qualitative information on the tolerability and acceptability of the interventions. Participants will also complete a satisfaction questionnaire.

Conditions

• Metastatic Cancers
• Myeloma Multiple

Interventions

Type	Name	Description
BEHAVIORAL	Guided Self-Help intervention	This intervention will consist of 8 self-administered modules that patients will complete every week. The sessions integrate an emotion regulation component with breathing exercises, relaxation exercises, hypnosis, etc. Once a week (maximum 15-minute), a trained psychologist will call the patient to help and/or encourage them. Each module will consist of podcasts, a reading assignment (with psycho-educational information) and writing assignments. The intervention will include home exercises and patients will be encouraged to practice exercises and skills learned between the sessions.
BEHAVIORAL	Group and Guided Self-Help intervention	It will consist of the same content described above, but given in 8 group sessions (2-hour) held by videoconference (Zoom) that will take place every week. Patients will also have access to the podcasts, home exercises and reading assignment, but will benefit from increased motivation and support from both the therapist and their peers in the group. Each group will be composed of 5 patients.

Timeline

• Start date: 2025-11-20
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2025-11-19
• Last updated: 2025-11-21

Locations

2 sites across 1 country: Belgium