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Spots Global Cancer Trial Database for ConquerFear-Group: A Psychological Intervention for Fear of Cancer Recurrence

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Trial Identification

Brief Title: 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 ID: NCT04137575

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Aarhus University Hospital, Aarhus, , Denmark

Contact Details

Name: Robert Zachariae, DMSc

Affiliation: Department of Oncology, Aarhus University Hospital & Aarhus University

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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