ConquerFear-Group: A Psychological Intervention for Fear of Cancer Recurrence
- Conditions
- Fear of Cancer RecurrenceBreast Cancer Female
- Interventions
- Behavioral: ConquerFear-GroupBehavioral: Relaxation Training
- Registration Number
- NCT04137575
- Lead Sponsor
- Aarhus University Hospital
- Brief Summary
The primary aim of this randomized controlled trial is to evaluate the effect of ConquerFear-Group (CF-G), compared with a control condition (CC), on Fear of Cancer Recurrence (FCR). Secondary aims are to explore the effect of CF-G on emotion regulation and additional psychological outcomes, and to explore mediating effects of emotion regulation, metacognitions, working alliance, patient adherence, and group cohesion. In addition, treatment expectancy, participation in other treatments after completion of the intervention of the study and demographic and clinical variables will be explored as moderators.
- Detailed Description
A randomized controlled trial testing the efficacy of ConquerFear-Group (CF-G) on breast cancer survivors with clinical levels of Fear of Cancer Recurrence (FCR), compared with a control condition (CC), will be conducted.
The aims are to:
1. Evaluate the efficacy of CF-G on FCR,
2. Explore the effects on the secondary outcomes of emotion regulation, general distress, health-related QoL, survivors' unmet needs, mindfulness, metacognitions, intervention satisfaction, negative effects of intervention, and sleep.
3. Explore emotion regulation, metacognitions, working alliance, patient adherence, and group cohesion will be explored as possible mediators.\*
4. Explore treatment expectancy, participation in other treatments after completion of the CF-G or the CC and demographic and clinical variables as possible moderators.
Primary hypothesis:
CF-G will yield larger reductions in FCR than CC at post treatment, and the effect will be maintained through the follow-up period.
Secondary hypotheses:
CF-G will demonstrate a larger improvement in measures of emotion regulation than CC following the intervention period.
Changes in emotion regulation during treatment will mediate the effect of CF-G on FCR.\* Changes in metacognitions during treatment will mediate the effect of CF-G on FCR.\* CF-G will yield larger reductions in general distress, health-related QoL, survivors' unmet needs than CC, and CF-G will yield larger improvements in metacognitions, mindfulness, and sleep than CC following the intervention period.
\*The prerequesties for conducting for mediation analysis were not fulfilled. Consequently, these analyses were abandoned. Data can be obtained upon request.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 85
- Eligible patients have a confirmed past diagnosis of stage 1-3 breast cancer,
- have been treated with curative intent,
- have completed all hospital-based adjuvant treatments 3 months to 5 years prior to study entry,
- are disease free,
- scores in the clinical range (≥22) on the Short Form of the Fear of Cancer Recurrence Inventory (FCRI-SF),
- are able to read and write Danish,
- are over the age of 18 years, and
- are able to give informed consent.
- self-reported current major depression,
- currently receiving psychological treatment from a therapist not involved in the study,
- self-reported active psychotic illness or other severe psychiatric conditions.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ConquerFear-Group ConquerFear-Group ConquerFear-Group is a psychological intervention developed specifically for fear of cancer recurrence Relaxation Training Relaxation Training The Relaxation Training serves as a placebo comparator and is not developed specifically to target fear of cancer recurrence.
- Primary Outcome Measures
Name Time Method Fear of cancer recurrence Baseline, 1, 2, 3, 4, 5, and 6 weeks after baseline, 1 week post intervention, 3- and 6-months follow-up 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
- Secondary Outcome Measures
Name Time Method Negative effects of intervention One week post intervention, 3- and 6-months follow-up Negative effects of the intervention will be measured with the Negative effects Questionnaire - hopelessness and failure subscales
General distress 1 Baseline, one week post intervention, 3- and 6-months follow-up Changes in general distress will be measured with the Impact of Event Scale-Revised Questionnaire
General distress Baseline, one week post intervention, 3- and 6-months follow-up Changes in general distress will be measured with the Depression, Anxiety, Stress Scale-21 Questionnaire
Health-related quality-of-life Baseline, one week post intervention, 3- and 6-months follow-up Changes in health-related quality-of-life will be measured with EuroQol-5 Domain Questionnaire
Survivors' unmet needs Baseline, one week post intervention, 3- and 6-months follow-up Changes in survivors' unmet needs will be measured with the Survivors' Unmet Need Survey - 8 item Information Sub-Scale Questionnaire
Sleep Baseline, one week post intervention, 3- and 6-months follow-up Changes in sleep will be measured with the Insomnia Severity Index
Emotion regulation Baseline, one week post intervention, 3- and 6-months follow-up Changes in emotion regulation will be assessed with the Difficulties in Emotion Regulation Questionnaire
Fear of cancer recurrence Baseline, one week post intervention, 3- and 6-months follow-up Changes in fear of cancer recurrence will be measured with the Concerns About Recurrence Questionnaire
Metacognitions Baseline, one week post intervention, 3- and 6-months follow-up Changes in metacognitions will be measured with the Metacognitions Questionnaire-30
Mindfulness Baseline, one week post intervention, 3- and 6-months follow-up Changes in mindfulness will be measured with the Five Facet Mindfulness Questionnaire
Intervention satisfaction One week post intervention, 3- and 6-months follow-up Intervention satisfaction will be measured with three questions regarding satisfaction with the treatment
Trial Locations
- Locations (1)
Aarhus University Hospital
🇩🇰Aarhus, Denmark