ConquerFear-Group: A Psychological Intervention for Fear of Cancer Recurrence

Study Overview
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Brief Summary
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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
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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: Evaluate the efficacy of CF-G on FCR, 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. Explore emotion regulation, metacognitions, working alliance, patient adherence, and group cohesion will be explored as possible mediators. 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.

Official Title
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A Randomized Controlled Trial of ConquerFear: A Group-Based Psychological Intervention for Fear of Cancer Recurrence in Cancer Survivors

Conditions
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Fear of Cancer Recurrence, Breast Cancer Female

Intervention / Treatment
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* Behavioral: ConquerFear-Group
* Behavioral: Relaxation Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants are randomized in blocks of 16. Participants in each block will be randomly assigned in a 1:1 ratio to either CF-G or CC, resulting 2 x 8 groups of approx. 8 participants (min 5 and max 10 participants in each group). A computer-generated randomization list will be created by a person not directly involved in the intervention. Allocation to condition will take place after completion of the baseline questionnaire package
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ConquerFear-Group<br>ConquerFear-Group is a psychological intervention developed specifically for fear of cancer recurrence | Behavioral: ConquerFear-Group<br>* The intervention consist of one 1½-hour individual session in which a psychologist will conduct an oral psychological assessment, and five 2-hour group sessions. The key goals of the intervention are to: a) teach strategies for controlling worry and excessive threat monitoring; b) modify underlying unhelpful beliefs about worry; c) develop appropriate monitoring and screening behaviors; d) educate about follow-up care and empirically-supported behavioral change (e.g., weight loss, exercise, etc.) to improve overall survival; e) address existential changes brought about by a cancer diagnosis; f) promote goal-setting. Each session is accompanied by home-based practice of skills learned in session and home reading to consolidate skill acquisition. Four trained psychologists (MSc) will perform the therapy. The intervention will be delivered on Zoom, a secure online platform.<br>|
| Placebo Comparator: Relaxation Training<br>The Relaxation Training serves as a placebo comparator and is not developed specifically to target fear of cancer recurrence. | Behavioral: Relaxation Training<br>* The control group will receive one 1½-hour individual session and participate in five 2-hour group sessions. Patients will receive guided progressive muscle relaxation training. The intervention will be delivered on Zoom, a secure online platform.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Metacognitions | Changes in metacognitions will be measured with the Metacognitions Questionnaire-30 | Baseline, one week post intervention, 3- and 6-months follow-up | 
| Mindfulness | Changes in mindfulness will be measured with the Five Facet Mindfulness Questionnaire | Baseline, one week post intervention, 3- and 6-months follow-up | 
| Sleep | Changes in sleep will be measured with the Insomnia Severity Index | Baseline, one week post intervention, 3- and 6-months follow-up | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fear of Cancer Recurrence, Cancer Survivorship, Breast Cancer, Distress, Emotion Regulation