Fear of Cancer RecurrenceNCT04137575
ConquerFear-Group: A Psychological Intervention for Fear of Cancer Recurrence
A study testing ConquerFear-Group and Relaxation Training in people with Fear of Cancer Recurrence and Breast Cancer Female, run by Aarhus University Hospital at 1 site in Denmark.
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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fear of Cancer Recurrence, Breast Cancer Female
- What is being tested?
- ConquerFear-Group and Relaxation Training
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 85 participants
- Where
- 1 siteDenmark
- Study dates
- 21 Oct 2019to 22 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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:
- 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.
*The prerequesties for conducting for mediation analysis were not fulfilled. Consequently, these analyses were abandoned. Data can be obtained upon request.
- Conditions
- Fear of Cancer Recurrence, Breast Cancer Female
- Being tested
- ConquerFear-Group, Relaxation Training
- Keywords
- Fear of Cancer Recurrence, Cancer Survivorship, Breast Cancer, Distress, Emotion Regulation
- Medical subject headings
- Breast Neoplasms, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ConquerFear-GroupBehavioural
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 TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| ConquerFear-Group | Experimental | ConquerFear-Group is a psychological intervention developed specifically for fear of cancer recurrence Receives: Behavioral: ConquerFear-Group |
| Relaxation Training | Placebo comparator | The Relaxation Training serves as a placebo comparator and is not developed specifically to target fear of cancer recurrence. Receives: Behavioral: Relaxation Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, 1, 2, 3, 4, 5, and 6 weeks after baseline, 1 week post intervention, 3- and 6-months follow-up
Secondary outcomes (13)
Emotion regulation
Changes in emotion regulation will be assessed with the Difficulties in Emotion Regulation Questionnaire
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline, one week post intervention, 3- and 6-months follow-up
Metacognitions
Changes in metacognitions will be measured with the Metacognitions Questionnaire-30
Measured: Baseline, one week post intervention, 3- and 6-months follow-up
Mindfulness
Changes in mindfulness will be measured with the Five Facet Mindfulness Questionnaire
Measured: Baseline, one week post intervention, 3- and 6-months follow-up
Sleep
Changes in sleep will be measured with the Insomnia Severity Index
Measured: 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)
Measured: 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
Measured: 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
Measured: One week post intervention, 3- and 6-months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2019
- Study start21 Oct 2019
- Primary completion22 Jun 2022
- Study completion22 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fear of Cancer RecurrenceStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus
- Responsible party
- Principal investigator, Nina M. Tauber, Aarhus University Hospital
- Investigators
- Robert Zachariae, DMSc, Study director, Department of Oncology, Aarhus University Hospital & Aarhus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04137575
- Sponsor's protocol ID
- NINTAU
- Status last verified
- Jun 2024
- First submitted
- 21 Oct 2019
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data underlying publication will be shared in accordance with current data sharing regulations at host institutions.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of ConquerFear: A Group-Based Psychological Intervention for Fear of Cancer Recurrence in Cancer Survivors
- ClinicalTrials.gov ID
- NCT04137575
- Acronym / sponsor ID
- NINTAU
- Conditions
- Fear of Cancer Recurrence, Breast Cancer Female
- Keywords
- Fear of Cancer Recurrence, Cancer Survivorship, Breast Cancer, Distress, Emotion Regulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- University of Aarhus
- Study start
- 21 Oct 2019 (actual)
- Primary completion
- 22 Jun 2022 (actual)
- Study completion
- 22 Jun 2022 (actual)
- First posted
- 24 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
*The prerequesties for conducting for mediation analysis were not fulfilled. Consequently, these analyses were abandoned. Data can be obtained upon request.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| ConquerFear-Group | Experimental | Behavioral: ConquerFear-GroupConquerFear-Group is a psychological intervention developed specifically for fear of cancer recurrence |
| Relaxation Training | Placebo comparator | Behavioral: Relaxation TrainingThe Relaxation Training serves as a placebo comparator and is not developed specifically to target fear of cancer recurrence. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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),
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ConquerFear-GroupThe 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. | Behavioural | ConquerFear-Group |
| Relaxation TrainingThe 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. | Behavioural | Relaxation Training |
Primary outcome
Fear of cancer recurrence
Time frame: 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
13 secondary outcomes
Emotion regulation
Time frame: Baseline, one week post intervention, 3- and 6-months follow-up
General distress 1
Time frame: Baseline, one week post intervention, 3- and 6-months follow-up
General distress
Time frame: Baseline, one week post intervention, 3- and 6-months follow-up
Health-related quality-of-life
Time frame: Baseline, one week post intervention, 3- and 6-months follow-up
Health-related quality-of-life
Time frame: Baseline, one week post intervention, 3- and 6-months follow-up
Survivors' unmet needs
Time frame: Baseline, one week post intervention, 3- and 6-months follow-up
Fear of cancer recurrence
Time frame: Baseline, one week post intervention, 3- and 6-months follow-up
Metacognitions
Time frame: Baseline, one week post intervention, 3- and 6-months follow-up
Mindfulness
Time frame: Baseline, one week post intervention, 3- and 6-months follow-up
Sleep
Time frame: Baseline, one week post intervention, 3- and 6-months follow-up
Negative effects of intervention
Time frame: One week post intervention, 3- and 6-months follow-up
Negative effects of intervention
Time frame: One week post intervention, 3- and 6-months follow-up
Intervention satisfaction
Time frame: One week post intervention, 3- and 6-months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- Individual participant dataSharing planned: Yes. All data underlying publication will be shared in accordance with current data sharing regulations at host institutions.
Related trials for Fear of Cancer Recurrence
Not yet recruitingPhase 2
Psilocybin FCR Early-Stage Breast Cancer
Early-stage Breast Cancer, Fear of Cancer Recurrence
RecruitingPhase 1
Study of Psilocybin Assisted Psychotherapy to Address Fear of Recurrence
Breast Cancer, Ovarian Cancer
Recruiting
The Effect of a Stepped-care Metacognition-based Intervention on Managing Fear of Cancer Recurrence
Cancer, Fear of Cancer Recurrence
Recruiting
Implementation and Evaluation of a Fear of Cancer Recurrence Screening, Referral and Management Program
Fear of Cancer Recurrence, Cancer
Not yet recruiting
Acceptance and Commitment Therapy (ACT) Versus Cognitive Behavioural Therapy (CBT) for Fear of Cancer Recurrence (FCR) in Cancer Survivors and Their Spouses
Fear of Cancer Recurrence, Cancer Survivorship
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Zachariae, DMSc study director
Department of Oncology, Aarhus University Hospital & Aarhus University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ConquerFear-Group and Relaxation Training in people with Fear of Cancer Recurrence and Breast Cancer Female, run by Aarhus University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fear of cancer recurrence (time frame: Baseline, 1, 2, 3, 4, 5, and 6 weeks after baseline, 1 week post intervention, 3- and 6-months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024.