Clinical trial NCT04137575: ConquerFear-Group: A Psychological Intervention for Fear of Cancer Recurrence
Official title: A Randomized Controlled Trial of ConquerFear: A Group-Based Psychological Intervention for Fear of Cancer Recurrence in Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fear of Cancer Recurrence
Breast Cancer Female
Keywords: Fear of Cancer Recurrence
Cancer Survivorship
Breast Cancer
Distress
Emotion Regulation
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: University of Aarhus
First posted: 2019-10-24
Enrollment: 85
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fear of cancer recurrence
timeFrame: Baseline, 1, 2, 3, 4, 5, and 6 weeks after baseline, 1 week post intervention, 3- and 6-months follow-up
Secondary outcomes:
measure: Emotion regulation
timeFrame: Baseline, one week post intervention, 3- and 6-months follow-up
measure: General distress 1
timeFrame: Baseline, one week post intervention, 3- and 6-months follow-up
measure: General distress
timeFrame: Baseline, one week post intervention, 3- and 6-months follow-up
measure: Health-related quality-of-life
timeFrame: Baseline, one week post intervention, 3- and 6-months follow-up
measure: Health-related quality-of-life
timeFrame: Baseline, one week post intervention, 3- and 6-months follow-up
measure: Survivors' unmet needs
timeFrame: Baseline, one week post intervention, 3- and 6-months follow-up
measure: Fear of cancer recurrence
timeFrame: Baseline, one week post intervention, 3- and 6-months follow-up
measure: Metacognitions
timeFrame: Baseline, one week post intervention, 3- and 6-months follow-up
measure: Mindfulness
timeFrame: Baseline, one week post intervention, 3- and 6-months follow-up
measure: Sleep
timeFrame: Baseline, one week post intervention, 3- and 6-months follow-up
measure: Negative effects of intervention
timeFrame: One week post intervention, 3- and 6-months follow-up
measure: Negative effects of intervention
timeFrame: One week post intervention, 3- and 6-months follow-up
measure: Intervention satisfaction
timeFrame: One week post intervention, 3- and 6-months follow-up
Other outcomes:
measure: Moderator: Background information about the participants
timeFrame: Assessed at baseline only
measure: Moderator: Clinical data
timeFrame: Collected from patients records
measure: Moderator: Treatment expectancy
timeFrame: Assessed at baseline only
measure: Participation in other psychological, medical or complementary and alternative treatments for FCR after completion of the interventions of the present study
timeFrame: Assessed at 3- and 6-months follow-up
measure: Mediator: Emotion regulation
timeFrame: Assessed 1, 2, 3, 4, 5, and 6 weeks after baseline.
measure: Mediator: Emotion regulation
timeFrame: Assessed 1, 2, 3, 4, 5, and 6 weeks after baseline.
measure: Mediator: Emotion regulation
timeFrame: Assessed 1, 2, 3, 4, 5, and 6 weeks after baseline.
measure: Mediator: Metacognitions
timeFrame: Assessed 1, 2, 3, 4, 5, and 6 weeks after baseline.
measure: Mediator: Working alliance
timeFrame: Assessed 1, 2, 3, 4, 5, and 6 weeks after baseline.
measure: Mediator: Patient adherence
timeFrame: Assessed 3, 4, 5, and 6 weeks after baseline.
measure: Mediator: Group cohesion
timeFrame: Assessed 2, 3, 4, 5, and 6 weeks after baseline.
measure: Mediator: Level of physical relaxation/calmness
timeFrame: Assessed 1, 2, 3, 4, 5, and 6 weeks after baseline.
measure: Mediator: Level of mental calmness
timeFrame: Assessed 1, 2, 3, 4, 5, and 6 weeks after baseline.
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
affiliation: Department of Oncology, Aarhus University Hospital & Aarhus University
name: Robert Zachariae, DMSc
role: STUDY_DIRECTOR
References: