A Brief Psychological Intervention for Carer Fear of Cancer Progression
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Conquer Fear Carer Brief.
- Who it may be relevant to
- Registry conditions: Fear of Cancer Progression. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Conquer Fear Carer Brief: A Brief Psychological Intervention for Fear of Cancer Progression in Caregivers of Patients With Metastatic Prostate Cancer: A Feasibility Study
Overview
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.
Detailed description
PRIMARY OBJECTIVE:
To evaluate the feasibility and acceptability of the Conquer Fear Carer Brief intervention among caregivers of patients with metastatic prostate cancer.
Feasibility will be assessed based on the following criteria:
1. A treatment dropout rate of \< 20%, 2. A consent rate of \> 50% among eligible caregivers screened for participation, 3. Recruitment of 14 caregivers within the defined study period, 4. Decrease or stability of caregivers' self-reported fear of cancer progression, as assessed on the Fear of Cancer Recurrence Inventory (FCRI), adapted for caregivers of patients with cancer, from pre-intervention (T1) to post-intervention (T2) and follow-up (T3), 5. Intervention delivery fidelity, defined as therapist adherence to key intervention principles, rated on a 0-2 scale. A random sample of 20% of sessions will be independently rated based on video recordings.
Acceptability will be assessed based on the following criteria:
1. A mean sum score of ≥20 on the Client Satisfaction Questionnaire (CSQ), 2. Absence of serious intervention-related negative effects, as assessed using, the Negative Effects Questionnaire (NEQ).
SECONDARY OBJECTIVES:
1. To evaluate the direction of change on specified secondary outcomes among caregivers of patients with metastatic prostate cancer 2. To explore participants' understanding of the intervention content and ability to apply this in everyday life, assessed using a custom-designed questionnaire with open-ended responses.
DESCRIPTION:
The Conquer Fear Carer Brief intervention is based on the Australian metacognitive intervention Conquer Fear, which has demonstrated efficacy in reducing fear of cancer progression and recurrence among cancer survivors in Australia and Denmark (Butow et al., 2017; Tauber et al., 2022; 2024).
The Conquer Fear Carer Brief is a shortened, three-session, online-delivered adaptation targeting fear of cancer progression in caregivers of cancer patients.
STUDY DESIGN:
The study employs a within-subject design with a pre-intervention waiting period (T0-T1). Changes during the waiting period will be compared with changes during the intervention (T1-T2) and follow-up (T1-T3).
ASSESSMENT TIME POINTS:
Participants will complete self-report questionnaires at enrollment (baseline; T0), after a three-week waiting period (pre-treatment; T1), one week after the intervention (post-treatment: T2) and 12 weeks after the intervention (follow-up; T3). Brief session questionnaires will also be completed before each session (S1-S3) and after Session 1 (S1 post).
Interventions
- Behavioral Conquer Fear Carer Brief
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)
Primary outcome measures
- Intervention feasibility: Treatment dropout rate [Time frame: Post-treatment approximately 7 weeks after baseline (Time 2)]
- Intervention feasibility: Consent rate [Time frame: Baseline (Time 0)]
- Intervention feasibility: Successfull recruitment [Time frame: 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) [Time frame: Follow-up approximately 22 weeks after baseline (Time 3)]
- Intervention Feasibility: Intervention delivery fidelity [Time frame: Post-treatment approximately 7 weeks after baseline (Time 2)]
- Intervention acceptability: Retrospective satisfaction [Time frame: Post-treatment approximately 7 weeks after baseline (Time 2)]
- Intervention acceptability: Negative effects [Time frame: Post-treatment approximately 7 weeks after baseline (Time 2)]
Secondary outcome measures (12)
- Anxiety [Time frame: Follow-up approximately 22 weeks after baseline (Time 3)]
- Cancer-specific distress [Time frame: Follow-up approximately 22 weeks after baseline (Time 3)]
- Well-being [Time frame: Follow-up approximately 22 weeks after baseline (Time 3)]
- Caregiver reaction [Time frame: Follow-up approximately 22 weeks after baseline (Time 3)]
- Sleep health [Time frame: Follow-up approximately 22 weeks after baseline (Time 3)]
- Decentering from thoughts [Time frame: Follow-up approximately 22 weeks after baseline (Time 3)]
- Valued living [Time frame: Follow-up approximately 22 weeks after baseline (Time 3)]
- Worry [Time frame: Follow-up approximately 22 weeks after baseline (Time 3)]
- Metacognitions [Time frame: Follow-up approximately 22 weeks after baseline (Time 3)]
- Treatment expectancy [Time frame: Session 1 at approximately day 28]
- Fear of cancer progression [Time frame: Post-treatment approximately 7 weeks after baseline (Time 2)]
- Metacognitions [Time frame: Post-treatment approximately 7 weeks after baseline (Time 2)]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
Denmark · 1 center
- Department of Psychology and Behavioural Sciences, Aarhus University — Aarhus
Identifiers
NCT: NCT07752992 · BSS-2025-041-S1