e-Motion : Promoting Emotion Regulation in Chronic Cancer

NCT07236021 | Recruiting

• 1 other identifier: PO20250132
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Metastatic Cancers; Myeloma Multiple

Keywords

Advanced cancer; Cognitive Behavioral Therapy (CBT); Emotional regulation; Ecological Momentary Assessment (EMA); Hypnosis; Psychotherapy Group

Outcome Measures

Primary Outcomes (10)

• Recruitment rate

  At least 25% of eligible patients agree to participate.

  Baseline (T0)

• Retention rate

  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.

  Baseline (T0), Weekly 15 (T2)

• Adherence to intervention

  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."

  Weeks 1 to 12 (intervention with weekly call)

• Adherence to between-session practice

  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.

  Weeks 1 to 12 (intervention with weekly call)

• Data completeness self-report questionnaire

  At least 90% of patients complete all data of questionnaires at both time points (T1 and T2).

  Baseline (T1) and Weekly 15 (T2)

• Data completeness EMA

  At least 70% of data are collected for the ecological momentary assessments.

  Baseline (T1), Weeks 1 to 12 (Ecological weekly assessment), Weekly 15 (T2)

• Satisfaction of the intervention

  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.

  Week 15 (T2)

• Willingness to recommend

  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.

  Week 15 (T2)

• Dropout rate due to intervention-related burden

  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.

  Baseline (T1), Weeks 1 to 12 (Intervention), Weekly 15 (T2)

• Self-reported emotional impact

  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.

  Week 15 (T2)

Secondary Outcomes (5)

• The Generalized Anxiety Disorders 7 items (GAD-7)

  Baseline (T1), Week 15 (T2)

• The Patient Health Questionnaire 9 items (PHQ-9)

  Baseline (T1), Week 15 (T2)

• The Penn State Worry Questionnaire (PSWQ)

  Baseline (T1), Week 15 (T2)

• Fear of Cancer Recurrence Inventory (FCRI)

  Baseline (T1), Week 15 (T2)

• Self-efficacy

  Baseline (T1), Week 15 (T2)

Study Arms (2)

Guided Self-Help intervention arm

ACTIVE COMPARATOR

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

Behavioral: Guided Self-Help intervention

Group and Guided Self-Help intervention arm

EXPERIMENTAL

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

Behavioral: Group and Guided Self-Help intervention

Interventions

Guided Self-Help intervention 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.

Guided Self-Help intervention arm

Group and Guided Self-Help intervention 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.

Group and Guided Self-Help intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Université Libre de Bruxelles: lead
• Centre de Psycho-Oncologie (CPO): collaborator
• Jules Bordet Institute: collaborator
• Erasme University Hospital: collaborator

Study Sites (2)

Institut Jules Bordet, Hôpital universitaire de Bruxelles

Brussels, Anderlecht, 1070, Belgium

NOT YET RECRUITING

H.U.B Institut Jules Bordet

Brussels, Brussels Capital, 1070, Belgium

RECRUITING

MeSH Terms

Conditions

Neoplasms; Multiple Myeloma; Emotional Regulation

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Self-Control; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Florence Lewis, PhD

  Université Libre de Bruxelles

  PRINCIPAL INVESTIGATOR

• Isabelle Merckaert, Professor

  Université Libre de Bruxelles

  STUDY DIRECTOR

Central Study Contacts

Florence Lewis, PhD

CONTACT

+32 2 541 73 36; florence.lewis@hubruxelles.be

Isabelle Merckaert, Professor

CONTACT

+32 2 650 48 80; isabelle.merckaert@ulb.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: November 19, 2025
• Study Start: November 20, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)