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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04137575
Other study ID # NINTAU
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 21, 2019
Est. completion date June 22, 2022

Study information

Verified date June 2024
Source Aarhus University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Completed
Enrollment 85
Est. completion date June 22, 2022
Est. primary completion date June 22, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Eligible patients have a confirmed past diagnosis of stage 1-3 breast cancer, 2. have been treated with curative intent, 3. have completed all hospital-based adjuvant treatments 3 months to 5 years prior to study entry, 4. are disease free, 5. scores in the clinical range (=22) on the Short Form of the Fear of Cancer Recurrence Inventory (FCRI-SF), 6. are able to read and write Danish, 7. are over the age of 18 years, and 8. are able to give informed consent. Exclusion Criteria: 1. self-reported current major depression, 2. currently receiving psychological treatment from a therapist not involved in the study, 3. self-reported active psychotic illness or other severe psychiatric conditions.

Study Design


Intervention

Behavioral:
ConquerFear-Group
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.
Relaxation Training
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.

Locations

Country Name City State
Denmark Aarhus University Hospital Aarhus

Sponsors (2)

Lead Sponsor Collaborator
Aarhus University Hospital University of Aarhus

Country where clinical trial is conducted

Denmark, 

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
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