e-Motion : Promoting Emotion Regulation in Chronic Cancer

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Recruitment rate — Baseline (T0)
  At least 25% of eligible patients agree to participate.
• 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.
• 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."
• 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.
• 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).
• 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.
• 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.
• 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.
• 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.

Trial sites (2)

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