e-Motion : Promoting Emotion Regulation in Chronic Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversité Libre de Bruxelles
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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,
Trial design
Design model
Parallel
Treatments tested in this trial
Guided Self-Help intervention
BehavioralThis 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
BehavioralIt 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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Guided Self-Help intervention armActive comparator 1 intervention
Group B: Group and Guided Self-Help intervention armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Recruitment rate
At least 25% of eligible patients agree to participate.
Time frame
Baseline (T0)2
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.
Time frame
Baseline (T0), Weekly 15 (T2)3
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."
Time frame
Weeks 1 to 12 (intervention with weekly call)4
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.
Time frame
Weeks 1 to 12 (intervention with weekly call)Secondary outcomes
1
The Generalized Anxiety Disorders 7 items (GAD-7)
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.
Time frame
Baseline (T1), Week 15 (T2)2
The Patient Health Questionnaire 9 items (PHQ-9)
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.
Time frame
Baseline (T1), Week 15 (T2)3
The Penn State Worry Questionnaire (PSWQ)
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.
Time frame
Baseline (T1), Week 15 (T2)4
Fear of Cancer Recurrence Inventory (FCRI)
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.
Time frame
Baseline (T1), Week 15 (T2)Sponsors and contacts
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Université Libre de Bruxelles
Lead sponsor
Centre de Psycho-Oncologie (CPO)
Collaborator
Jules Bordet Institute
Collaborator
Erasme University Hospital
Collaborator
Source ClinicalTrials.gov