e-Motion : Promoting Emotion Regulation in Chronic Cancer

NCT ID: NCT07236021

Last Updated: 2025-11-21

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-20

Study Completion Date

2026-12-31

Brief Summary

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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

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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

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Metastatic Cancers Myeloma Multiple

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

A pilot feasibility, acceptability and tolerability project. Two steps: The first included 15 patients will be assigned to a Guided Self-Help intervention. The second starts only after the first has ended. For this one, 15 other patients are recruited and assigned to a Group and Guided Self-Help intervention.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Guided Self-Help intervention arm

Guided self-help emotion regulation intervention for patient with chronic and incurable cancer.

Group Type ACTIVE_COMPARATOR

Guided Self-Help intervention

Intervention Type BEHAVIORAL

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.

Group and Guided Self-Help intervention arm

Group and guided self-help emotion regulation intervention for patient with chronic and incurable cancer.

Group Type EXPERIMENTAL

Group and Guided Self-Help intervention

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Having received a diagnosis of chronic cancer (metastatic breast cancer, metastatic melanoma, metastatic colorectal, metastatic ovarian, metastatic uterine, metastatic endometrial, metastatic prostate, metastatic bladder, metastatic kidney or metastatic testicular cancer, symptomatic multiple myeloma, metastatic non-small cell lung, metastatic mesothelioma or metastatic thymoma) in the past 12 months,
* Having completed at least one active treatment session (e.g., chemotherapy, surgery, radiotherapy, immunotherapy, target therapy).

Exclusion Criteria

* Having less than one year of life expectancy
* Having more than one treatment line (for triple negative breast cancer, melanoma, gynecological cancer, colorectal cancer, bladder cancer, kidney cancer, non-small cell lung, mesothelioma and thymoma) or two treatment lines (for other breast cancers and testicular cancer) or three treatment lines (for prostate cancer and multiple myeloma),
* Having a diagnosis of oligometastatic cancer,
* Age \< 18 years,
* Non-fluency in French,
* Inability to follow the online intervention,
* Severe cognitive impairment, and severe and/or acute psychiatric disorder.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre de Psycho-Oncologie (CPO)

OTHER

Sponsor Role collaborator

Jules Bordet Institute

OTHER

Sponsor Role collaborator

Hôpital Universitaire de Bruxelles

UNKNOWN

Sponsor Role collaborator

Université Libre de Bruxelles

OTHER

Sponsor Role lead

Responsible Party

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Prof. Isabelle Merckaert

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Florence Lewis, PhD

Role: PRINCIPAL_INVESTIGATOR

Université Libre de Bruxelles

Isabelle Merckaert, Professor

Role: STUDY_DIRECTOR

Université Libre de Bruxelles

Locations

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Institut Jules Bordet, Hôpital universitaire de Bruxelles

Brussels, Anderlecht, Belgium

Site Status NOT_YET_RECRUITING

H.U.B Institut Jules Bordet

Brussels, Brussels Capital, Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Florence Lewis, PhD

Role: CONTACT

+32 2 541 73 36

Isabelle Merckaert, Professor

Role: CONTACT

+32 2 650 48 80

Facility Contacts

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Florence Lewis, PHD

Role: primary

+32 2 541 73 36

Isabelle Merckaert, Professor

Role: backup

+32 2 650 48 80

Florence Lewis, PhD

Role: primary

+325417336

Other Identifiers

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PO20250132

Identifier Type: -

Identifier Source: org_study_id

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