A Brief Psychological Intervention for Carer Fear of Cancer Progression

NCT07752992 | Recruiting

• 1 other identifier: BSS-2025-041-S1
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the feasibility and acceptability of the Conquer Fear Carer Brief, a three-session psychological intervention targeting fear of cancer progression among caregivers of patients with metastatic prostate cancer.

Conditions

Fear of Cancer Progression

Keywords

Fear of Cancer Progression; Caregivers; Metacognitive therapy; Feasibility; Online-delivered psychological therapy

Outcome Measures

Primary Outcomes (7)

• Intervention feasibility: Treatment dropout rate

  Treatment dropout is defined as attending fewer than two of the three sessions and not completing the post-intervention (Time 2) questionnaire. Feasibility will be indicated by a dropout rate of \<30%.

  Post-treatment approximately 7 weeks after baseline (Time 2)

• Intervention feasibility: Consent rate

  Consent rate among eligible caregivers screened for participation will be evaluated. Feasibility will be indicated by a consent rate \> 50%.

  Baseline (Time 0)

• Intervention feasibility: Successfull recruitment

  The number of included participants will be recorded. Feasibility will be indicated by the recruitment of 14 caregivers within the defined study period.

  Baseline (Time 0)

• Intervention feasibility: Change in fear of cancer progression from pre-intervention (Time 1) to post-intervention (Time 2) and follow-up (Time 3)

  Participant-reported fear of cancer progression will be assessed in the beginning of each session using the Fear of Cancer Recurrence Inventory Short Form (FCRI-SF), adapted to measure fear of cancer progression in caregivers of patients with cancer. The FCRI-SF is a 9-item measure rated on a scale from 0 to 4, with total scores ranging from 0 to 45. Higher scores indicate greater fear of cancer progression. Feasibility will be indicated by stability or decrease throughout the defined time frame.

  Follow-up approximately 22 weeks after baseline (Time 3)

• Intervention Feasibility: Intervention delivery fidelity

  Therapist adherence to key intervention principles (i.e., delivery of core therapeutic elements as intended) will be rated on a 0-2 scale. A random sample of 20% of sessions will be independently rated based on video recordings.

  Post-treatment approximately 7 weeks after baseline (Time 2)

• Intervention acceptability: Retrospective satisfaction

  Participant-reported treatment satisfaction will be assessed using the 8-item Client Satisfaction Questionnaire (CSQ). Items are rated on a scale from 1 to 4, with total scores ranging from 8 to 32. Higher scores indicate greater treatment satisfaction. Acceptability will be indicated by a mean sum score of ≥20.

  Post-treatment approximately 7 weeks after baseline (Time 2)

• Intervention acceptability: Negative effects

  Participant-reported negative effects will be assessed using the 20-item Negative Effects Questionnaire (NEQ). First, respondents indicate whether each negative effect occurred during treatment using a yes/no format. Second, they rate the severity of each endorsed negative effect on a scale from 0 to 4, with higher scores indicating greater severity. Third, respondents attribute each negative effect either to "the treatment I received" or to "other circumstances". Acceptability will be indicated by an absence of serious adverse events attributed to the intervention.

  Post-treatment approximately 7 weeks after baseline (Time 2)

Secondary Outcomes (14)

• Anxiety

  Follow-up approximately 22 weeks after baseline (Time 3)

• Cancer-specific distress

  Follow-up approximately 22 weeks after baseline (Time 3)

• Well-being

  Follow-up approximately 22 weeks after baseline (Time 3)

• Caregiver reaction

  Follow-up approximately 22 weeks after baseline (Time 3)

• Sleep health

  Follow-up approximately 22 weeks after baseline (Time 3)

Study Arms (1)

Conquer Fear Carer Brief

EXPERIMENTAL

Metacognitive therapy delivered individually over 3 sessions.

Behavioral: Conquer Fear Carer Brief

Interventions

Conquer Fear Carer Brief BEHAVIORAL

The intervention is delivered online by a psychologist or a master's-level student in psychology over three sessions during a 3-4-week period. The three sessions are structured to enhance participants' abilities in Detached Mindfulness (DM), a cognitive technique used in Metacognitive Therapy that involves perceiving thoughts and feelings as passing events without engaging with them. In Session 1, DM is introduced through dialogue, examples, and exercises. In session 2, Attention Training (AT) is introduced to support participants' ability to engage in DM through dialogue, examples, and exercises. In Session 3, DM and AT are reviewed and discussed depending on participants' needs, and their future application are discussed. Participants apply the introduced techniques at home between sessions through assigned homework.

Conquer Fear Carer Brief

Eligibility Criteria

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

You may qualify if:

• Self-identified caregiver of a patient with metastatic, non-curable prostate cancer
• Aged ≥18 years
• Score in the clinical range (≥22) on the Fear of Cancer Recurrence Inventory Short Form (FCRI-SF)
• Score in the clinical range (\>15) on the Brief Penn State Worry Questionnaire (PSWQ)
• Sufficient proficiency in Danish
• Able to provide informed consent
• Stable or no use of antidepressant or anxiolytic medication (i.e., stable dosage for ≥6 weeks)
• Able to participate in online-delivered therapy via a computer with a video camera

You may not qualify if:

• Severe psychiatric conditions (e.g., major depression) that would make participation in the intervention inappropriate
• Currently enrolled in psychotherapy or counseling targeting the same problem
• Substance abuse or dependence judged to require treatment
• Suicide risk requiring immediate psychiatric intervention or hospitalization

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Department of Psychology and Behavioural Sciences, Aarhus University

Aarhus, 8000, Denmark

RECRUITING

Central Study Contacts

Cecilie R Buskbjerg, PhD

CONTACT

+4529842526; cdrc@psy.au.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoc

Model Details: Within-subject repeated-measures design including a pre-intervention waiting period

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: August 7, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: August 7, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)