e-Motion : Promoting Emotion Regulation in Chronic Cancer

Not Applicable

Recruiting

• Conditions: Metastatic Cancers; Myeloma Multiple

• Registration Number: NCT07236021
• Lead Sponsor: Université Libre de Bruxelles

Brief 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.

Study Timeline

• Study First Submitted: 2025-09-05
• Status Verified: 2025-11
• Study First Submitted QC: 2025-11-17
• Study First Posted: 2025-11-19
• Study Start: 2025-11-20
• Last Update Submitted: 2025-11-20
• Last Update Posted: 2025-11-21
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Data completeness EMA	Baseline (T1), Weeks 1 to 12 (Ecological weekly assessment), Weekly 15 (T2)	At least 70% of data are collected for the ecological momentary assessments.
Willingness to recommend	Week 15 (T2)	At least 80% of patients would recommend the intervention to other patients. This percentage is calculated based on the response to one of the questions in the satisfaction questionnaire, which is 1-item, 6-point self-report questionnaire (0 = Not at all, 6 = Absolutely). The question investigates the extent to which participants would recommend this intervention to other patients in their situation. Mean score is ≥ 4 in the satisfaction questionnaire. The questionnaire was developed for this study.
Dropout rate due to intervention-related burden	Baseline (T1), Weeks 1 to 12 (Intervention), Weekly 15 (T2)	No more than 10% of patients discontinue participation due to emotional distress or perceived burden linked to the intervention, as assessed by one question of the drop-out questionnaire which is: 'The reasons for this decision are related to: A. The intervention B. The questionnaires C. Both.' The percentage is calculated based on the number of patients who answered A or C.
Retention rate	Baseline (T0), Weekly 15 (T2)	At least 80% of patients complete the study to the end. The study completion rate is calculated based on the difference between the number of patients enrolled in T0 and those who completed the study in T2.
Recruitment rate	Baseline (T0)	At least 25% of eligible patients agree to participate.
Adherence to between-session practice	Weeks 1 to 12 (intervention with weekly call)	At least 70% of patients complete all assigned between-session exercises. The weekly call includes a question asking participants if they have done their exercises throughout the week. Answer with yes or no. The exercise completion rate between sessions is defined as the proportion of patients who reported having completed all weekly exercises among those who responded to the follow-up question.
Adherence to intervention	Weeks 1 to 12 (intervention with weekly call)	At least 70% of patients complete all sessions regardless of the intervention arm. The weekly call includes a question asking participants whether they attended the week's session. Answer with Yes or No. If yes: go through all of the following questions. If no: investigate further to see if anything has been done."
Data completeness self-report questionnaire	Baseline (T1) and Weekly 15 (T2)	At least 90% of patients complete all data of questionnaires at both time points (T1 and T2).
Satisfaction of the intervention	Week 15 (T2)	At least 80% of patients rate the intervention as satisfactory. This percentage is calculated based on the response to one of the questions in the satisfaction questionnaire, which is 1-item, 6-point self-report questionnaire (0 = Not at all, 6 = Absolutely). The question investigates whether, overall, participants were satisfied with the intervention. Mean score is ≥ 4 in the satisfaction questionnaire. Satisfaction will also be assessed through a qualitative analysis (thematic analysis) of the transcript of the exit interview. The questionnaires were developed for this study.
Self-reported emotional impact	Week 15 (T2)	At least 80% of patients indicate that the intervention was emotionally manageable and not overly distressing. This percentage is calculated based on the response to one of the questions in the satisfaction questionnaire, which is 1-item, 6-point self-report questionnaire (0 = Not at all, 6 = Absolutely). The question investigates the extent to which participants found this intervention emotionally comfortable or bearable. Mean score is ≥ 4 in the satisfaction questionnaire. Self-reported emotion impact will also be based on responses from the exit interviews (which is a semi-structured interview), assessed through a qualitative analysis (thematic analysis). The questionnaires were developed for this study.

Secondary Outcome Measures

Name	Time	Method
The Generalized Anxiety Disorders 7 items (GAD-7)	Baseline (T1), Week 15 (T2)	The preliminary efficacy and interventions differences will be assessed using self-report questionnaires. The GAD-7, which is a validated 7-item, 4-point self-report questionnaire assessing anxiety symptoms. A higher score indicates higher levels of anxiety.
The Patient Health Questionnaire 9 items (PHQ-9)	Baseline (T1), Week 15 (T2)	The preliminary efficacy and interventions differences will be assessed using self-report questionnaires. The PHQ-9 which is a validated 10-item, 4-point self-report questionnaire assessing depressive symptoms. A higher score indicates higher levels of depression.
The Penn State Worry Questionnaire (PSWQ)	Baseline (T1), Week 15 (T2)	The preliminary efficacy and interventions differences will be assessed using self-report questionnaires. The PSWQ which is a validated 16-item, 5-point self-report questionnaire assessing worry. A higher score indicates higher levels of worry.
Fear of Cancer Recurrence Inventory (FCRI)	Baseline (T1), Week 15 (T2)	The preliminary efficacy and interventions differences will be assessed using self-report questionnaires. The FCRI (Fear of cancer progression modified Fear of Cancer Recurrence Inventory) : which is a validated 42-item, 5-point self-report questionnaire assessing seven dimensions of fear of cancer recurrence (0 = Never, 4 = All the time): triggers, severity, psychological distress, coping strategies, functioning impairments, insight, and reassurance. This scale has been validated in patients with metastatic cancer. However, to simplify the understanding of the items, the investigators have adapted it by substituting "fear of cancer recurrence" by "fear of cancer progression". Higher score indicates higher levels of fear of cancer progression.
Self-efficacy	Baseline (T1), Week 15 (T2)	The preliminary efficacy and interventions differences will be assessed using self-report questionnaires. The self-efficacy questionnaire was designed to assess patients' confidence in their ability to effectively manage and regulate their emotions. Self-efficacy was assessed using a questionnaire developed for this study, which is a 13 items on a 10-point Likert scale (0 = Not at all certain, 10 = Absolutely certain).

Trial Locations

Locations (2)

H.U.B Institut Jules Bordet; 🇧🇪 Brussels, Brussels Capital, Belgium

Institut Jules Bordet, Hôpital universitaire de Bruxelles; 🇧🇪 Brussels, Anderlecht, Belgium