Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
Moderator: Background information about the participants |
Background information about the participants will be assessed with a questionnaire regarding demongraphic information as possible moderators |
Assessed at baseline only |
|
Other |
Moderator: Clinical data |
Clinical data will be explored as possible moderators |
Collected from patients records |
|
Other |
Moderator: Treatment expectancy |
Treatment expectancy will be measured with the Credibility/Expectancy questionnaire as a possible moderator |
Assessed at baseline only |
|
Other |
Participation in other psychological, medical or complementary and alternative treatments for FCR after completion of the interventions of the present study |
Two questions regarding participation in other psychological, medical or complementary and alternative treatments for FCR after completion of the interventions of the present study will be assessed as a possible moderator |
Assessed at 3- and 6-months follow-up |
|
Other |
Mediator: Emotion regulation |
Changes in emotion regulation will be measured with the Brooding - Rumination and Reflection Scale |
Assessed 1, 2, 3, 4, 5, and 6 weeks after baseline. |
|
Other |
Mediator: Emotion regulation |
Changes in emotion regulation will be measured with the Penn State Worry Questionnaire |
Assessed 1, 2, 3, 4, 5, and 6 weeks after baseline. |
|
Other |
Mediator: Emotion regulation |
Changes in emotion regulation will be measured with the Experience Questionnaire |
Assessed 1, 2, 3, 4, 5, and 6 weeks after baseline. |
|
Other |
Mediator: Metacognitions |
Changes in metacognitions will be measured with the Metacognitions Questionnaire-30 |
Assessed 1, 2, 3, 4, 5, and 6 weeks after baseline. |
|
Other |
Mediator: Working alliance |
Changes in working alliance will be measured with the Working Alliance Inventory Revised Short Form |
Assessed 1, 2, 3, 4, 5, and 6 weeks after baseline. |
|
Other |
Mediator: Patient adherence |
Changes in patient adherence will be assessed with a diary of home exercise completion |
Assessed 3, 4, 5, and 6 weeks after baseline. |
|
Other |
Mediator: Group cohesion |
Changes in group cohesion will be assessed with the Therapeutic Factors Inventory Cohesiveness Scale |
Assessed 2, 3, 4, 5, and 6 weeks after baseline. |
|
Other |
Mediator: Level of physical relaxation/calmness |
Single question to asses level of physical relaxation before and after each session |
Assessed 1, 2, 3, 4, 5, and 6 weeks after baseline. |
|
Other |
Mediator: Level of mental calmness |
Single question to asses level of mental calmness before and after each session |
Assessed 1, 2, 3, 4, 5, and 6 weeks after baseline. |
|
Primary |
Fear of cancer recurrence |
Changes in fear of cancer recurrence will be measured with the 42-item Fear of Cancer Recurrence Inventory at baseline, 1 week post intervention, 3- and 6-months follow-up, and session-by-session with the 9-item Fear of Cancer Recurrence Inventory-Short Form |
Baseline, 1, 2, 3, 4, 5, and 6 weeks after baseline, 1 week post intervention, 3- and 6-months follow-up |
|
Secondary |
Emotion regulation |
Changes in emotion regulation will be assessed with the Difficulties in Emotion Regulation Questionnaire |
Baseline, one week post intervention, 3- and 6-months follow-up |
|
Secondary |
General distress 1 |
Changes in general distress will be measured with the Impact of Event Scale-Revised Questionnaire |
Baseline, one week post intervention, 3- and 6-months follow-up |
|
Secondary |
General distress |
Changes in general distress will be measured with the Depression, Anxiety, Stress Scale-21 Questionnaire |
Baseline, one week post intervention, 3- and 6-months follow-up |
|
Secondary |
Health-related quality-of-life |
Changes in health-related quality-of-life will be measured with the European Organization for Research and Treatment of Cancer QLQ-C30 Questionnaire |
Baseline, one week post intervention, 3- and 6-months follow-up |
|
Secondary |
Health-related quality-of-life |
Changes in health-related quality-of-life will be measured with EuroQol-5 Domain Questionnaire |
Baseline, one week post intervention, 3- and 6-months follow-up |
|
Secondary |
Survivors' unmet needs |
Changes in survivors' unmet needs will be measured with the Survivors' Unmet Need Survey - 8 item Information Sub-Scale Questionnaire |
Baseline, one week post intervention, 3- and 6-months follow-up |
|
Secondary |
Fear of cancer recurrence |
Changes in fear of cancer recurrence will be measured with the Concerns About Recurrence Questionnaire |
Baseline, one week post intervention, 3- and 6-months follow-up |
|
Secondary |
Metacognitions |
Changes in metacognitions will be measured with the Metacognitions Questionnaire-30 |
Baseline, one week post intervention, 3- and 6-months follow-up |
|
Secondary |
Mindfulness |
Changes in mindfulness will be measured with the Five Facet Mindfulness Questionnaire |
Baseline, one week post intervention, 3- and 6-months follow-up |
|
Secondary |
Sleep |
Changes in sleep will be measured with the Insomnia Severity Index |
Baseline, one week post intervention, 3- and 6-months follow-up |
|
Secondary |
Negative effects of intervention |
Negative effects of the intervention will be assessed with one question about negative effects of the intervention experienced by the participants (narrative response) |
One week post intervention, 3- and 6-months follow-up |
|
Secondary |
Negative effects of intervention |
Negative effects of the intervention will be measured with the Negative effects Questionnaire - hopelessness and failure subscales |
One week post intervention, 3- and 6-months follow-up |
|
Secondary |
Intervention satisfaction |
Intervention satisfaction will be measured with three questions regarding satisfaction with the treatment |
One week post intervention, 3- and 6-months follow-up |
|