A Brief Psychological Intervention for Carer Fear of Cancer Progression

Condition(s) studied

Investigational drug(s) / intervention(s)

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) 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.

Study 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.

Eligibility

Primary outcome measure(s)

• Intervention feasibility: Treatment dropout rate — Post-treatment approximately 7 weeks after baseline (Time 2)
  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%.
• Intervention feasibility: Consent rate — Baseline (Time 0)
  Consent rate among eligible caregivers screened for participation will be evaluated. Feasibility will be indicated by a consent rate \> 50%.
• Intervention feasibility: Successfull recruitment — Baseline (Time 0)
  The number of included participants will be recorded. Feasibility will be indicated by the recruitment of 14 caregivers within the defined study period.
• Intervention feasibility: Change in fear of cancer progression from pre-intervention (Time 1) to post-intervention (Time 2) and follow-up (Time 3) — Follow-up approximately 22 weeks after baseline (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.
• Intervention Feasibility: Intervention delivery fidelity — Post-treatment approximately 7 weeks after baseline (Time 2)
  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.
• Intervention acceptability: Retrospective satisfaction — Post-treatment approximately 7 weeks after baseline (Time 2)
  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.
• Intervention acceptability: Negative effects — Post-treatment approximately 7 weeks after baseline (Time 2)
  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.

Trial sites (1)

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