A Brief Psychological Intervention for Carer Fear of Cancer Progression

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).

• Anxiety [Срок оценки: Follow-up approximately 22 weeks after baseline (Time 3)]
• Cancer-specific distress [Срок оценки: Follow-up approximately 22 weeks after baseline (Time 3)]
• Well-being [Срок оценки: Follow-up approximately 22 weeks after baseline (Time 3)]
• Caregiver reaction [Срок оценки: Follow-up approximately 22 weeks after baseline (Time 3)]
• Sleep health [Срок оценки: Follow-up approximately 22 weeks after baseline (Time 3)]
• Decentering from thoughts [Срок оценки: Follow-up approximately 22 weeks after baseline (Time 3)]
• Valued living [Срок оценки: Follow-up approximately 22 weeks after baseline (Time 3)]
• Worry [Срок оценки: Follow-up approximately 22 weeks after baseline (Time 3)]
• Metacognitions [Срок оценки: Follow-up approximately 22 weeks after baseline (Time 3)]
• Treatment expectancy [Срок оценки: Session 1 at approximately day 28]
• Fear of cancer progression [Срок оценки: Post-treatment approximately 7 weeks after baseline (Time 2)]
• Metacognitions [Срок оценки: Post-treatment approximately 7 weeks after baseline (Time 2)]