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

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer Female; Fear of Cancer Recurrence
• Intervention / Treatment: Behavioral: ConquerFear-Group; Behavioral: Relaxation Training

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.

• Study Type: Interventional
• Enrollment (Actual): 85
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark
    • Aarhus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ConquerFear-Group; ConquerFear-Group is a psychological intervention developed specifically for fear of cancer recurrence	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.
Placebo Comparator: Relaxation Training; The Relaxation Training serves as a placebo comparator and is not developed specifically to target fear of cancer recurrence.	Behavioral: 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Moderator: Clinical data	Clinical data will be explored as possible moderators	Collected from patients records
Moderator: Treatment expectancy	Treatment expectancy will be measured with the Credibility/Expectancy questionnaire as a possible moderator	Assessed at baseline only
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
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.
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.
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.
Mediator: Metacognitions	Changes in metacognitions will be measured with the Metacognitions Questionnaire-30	Assessed 1, 2, 3, 4, 5, and 6 weeks after baseline.
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.
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.
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.
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.
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.

Collaborators and Investigators

• Sponsor: Aarhus University Hospital
• Collaborators: University of Aarhus
• Investigators: Study Director: Robert Zachariae, DMSc, Department of Oncology, Aarhus University Hospital & Aarhus University

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2019
• Primary Completion (Actual): June 22, 2022
• Study Completion (Actual): June 22, 2022

Study Registration Dates

• First Submitted: October 21, 2019
• First Submitted That Met QC Criteria: October 22, 2019
• First Posted (Actual): October 24, 2019

Study Record Updates

• Last Update Posted (Actual): June 21, 2024
• Last Update Submitted That Met QC Criteria: June 19, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Breast Cancer; Emotion Regulation; Distress; Cancer Survivorship; Fear of Cancer Recurrence
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Recurrence
• Other Study ID Numbers: NINTAU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All data underlying publication will be shared in accordance with current data sharing regulations at host institutions.
• IPD Sharing Time Frame: 6 months after publication
• IPD Sharing Access Criteria: Researchers aiming to publish IPD meta-analyses. The authors to review requests are the PI and senior supervisors (NT, MSO, RZ, PB).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No