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

NCT04137575 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2024-06-21

No results posted yet for this study

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.

Conditions

  • Fear of Cancer Recurrence
  • Breast Cancer Female

Interventions

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.

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.

Sponsors & Collaborators

  • University of Aarhus

    collaborator OTHER

  • Aarhus University Hospital

    lead OTHER

Principal Investigators

  • Robert Zachariae, DMSc · Department of Oncology, Aarhus University Hospital & Aarhus University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-21
Primary Completion
2022-06-22
Completion
2022-06-22

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04137575 on ClinicalTrials.gov