Background
Objectives
Methods and design
Design
Eligibility
Recruitment
Procedures
Screening (T0)
Measurement points (T1, T2 and T3)
T0 Screening | T1, T2 and T3 Measurement points | T4 Measurement point |
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Questionnaires:
| Session 1 |
Questionnaires:
|
- ESAS (only 6 items) |
Questionnaires
- General information - VAS (psychological state) - ESAS (complete version) - HADS - PSWQ - FCRI - MAC - WBSI - MFI-20 - CERQ - ICQ - ISI | - MFI-20 - HADS - ESAS (complete version) - FCRI - Long-term benefits of the intervention |
Tasks
| ||
- Self-relaxation task + Questionnaire about relaxation strategies - Guided relaxation task + Questionnaire about relaxation habits | ||
Between session 1 and session 2 (during 9 days) - Smartphone application (RealLifeExp) to collect information about daily emotional regulation. - Actigraph to measure sleep, activity and heart rate. | ||
Session 2 | ||
Questionnaires
| ||
- VAS (motivation and implication) - Attentional bias task - FACT-Cog - FFMQ - MCQ-30 - PTGI - Rosenberg’s self-esteem scale - CICS - DCI - Expected/perceived benefits from the intervention |
One-year follow-up (T4)
Intervention
Assessments
Questionnaires
Tasks
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Two relaxation exercises: Anxiety regulation is measured during two relaxation exercises. Before each exercise, anxiety is triggered by the completion of the MAC (before exercise 1) and the ICQ (before exercise 2) questionnaires. During the first exercise, participants have to use their own strategies to relax by themselves for about 13 mins, and during the second, they are guided by an audio recording for approximately the same time. Heart rate (beats per minute) is measured during the exercises by the Lifecard CF holter monitor as an indicator of anxiety regulation [85]. Heart rate variability has been shown to be correlated with emotion regulation [86] and influenced by emotional distress (depression and anxiety) [87, 88].
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An attentional task: A computerized task is used to assess the attentional bias toward threat. This computerized task, designed by the Université Libre de Bruxelles (ULB, Belgium), aims to evaluate the intensity of the attentional bias toward emotional information. Several pairs of words (each word being positive, negative, or neutral; and related or not related to cancer) are presented to the participants, followed by a point, located at the same place as one of the two words. The participants have to click on the up or down button of the keyboard depending of the location of the point. An increased response time for points following cancer-related words could suggest the presence of an attentional bias towards threat. Response time and accuracy will be measured in order to calculate different attentional bias indexes [18], which will evaluate the severity of the bias before and after the intervention.
Ecological momentary assessments
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Emotional regulation: At each measurement point, participants have to use an application on a smartphone for 9 days. This application was designed by ULB and aims to evaluate the emotional state of the participant at six different times of the day (intensity and perceived controllability of emotions, and energy level).
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Activity and sleep measurements: At each measurement point, participants wear an actigraph (Garmin Vivoactive® HR), which measures their physical activity (number of steps per day) and their sleep (number of hours of deep and light sleep per night and waking time after initial sleep onset) for 9 days. Wrist actigraphs provide an accurate 24-h sleep assessment and activity patterns in a natural environment [89, 90] and have been used in several studies with cancer patients [90‐92].