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

NCT04137575 | Completed

• 1 other identifier: NINTAU
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Fear of Cancer Recurrence; Breast Cancer Female

Keywords

Fear of Cancer Recurrence; Cancer Survivorship; Breast Cancer; Distress; Emotion Regulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Emotion regulation

  Baseline, one week post intervention, 3- and 6-months follow-up

• General distress 1

  Baseline, one week post intervention, 3- and 6-months follow-up

• General distress

  Baseline, one week post intervention, 3- and 6-months follow-up

• Health-related quality-of-life

  Baseline, one week post intervention, 3- and 6-months follow-up

• Health-related quality-of-life

  Baseline, one week post intervention, 3- and 6-months follow-up

Other Outcomes (13)

• Moderator: Background information about the participants

  Assessed at baseline only

• Moderator: Clinical data

  Collected from patients records

• Moderator: Treatment expectancy

  Assessed at baseline only

Study Arms (2)

ConquerFear-Group

EXPERIMENTAL

ConquerFear-Group is a psychological intervention developed specifically for fear of cancer recurrence

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.

Behavioral: Relaxation Training

Interventions

ConquerFear-Group BEHAVIORAL

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.

ConquerFear-Group

Relaxation Training BEHAVIORAL

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.

Relaxation Training

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aarhus University Hospital: lead
• University of Aarhus: collaborator

Study Sites (1)

Aarhus University Hospital

Aarhus, Denmark

Location

MeSH Terms

Conditions

Breast Neoplasms; Emotional Regulation

Interventions

Relaxation Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Self-Control; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Robert Zachariae, DMSc

  Department of Oncology, Aarhus University Hospital & Aarhus University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigator and assessor is masked in terms of not knowing to which condition the participants will be randomized until after completion of the baseline assessment. The participants are masked in terms of not knowing that one intervention is hypothesized to yield larger effects than the other.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc

Model Details: 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

Study Record Dates

• First Submitted: October 21, 2019
• First Posted: October 24, 2019
• Study Start: October 21, 2019
• Primary Completion: June 22, 2022
• Study Completion: June 22, 2022
• Last Updated: June 21, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 6 months after publication
• Access Criteria: Researchers aiming to publish IPD meta-analyses. The authors to review requests are the PI and senior supervisors (NT, MSO, RZ, PB).

Locations

DK (1)