A Brief Psychological Intervention for Carer Fear of Cancer Progression
ConditionFear of Cancer Progression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Aarhus
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Self-identified caregiver of a patient with metastatic, non-curable 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)
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Conquer Fear Carer Brief
BehavioralThe 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.
Treatment groups
14 Participants
are divided into 1 treatment groupGroup A: Conquer Fear Carer BriefExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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%.
Time frame
Post-treatment approximately 7 weeks after baseline (Time 2)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%.
Time frame
Baseline (Time 0)3
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.
Time frame
Baseline (Time 0)4
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.
Time frame
Follow-up approximately 22 weeks after baseline (Time 3)Secondary outcomes
1
Anxiety
Participant-reported anxiety will be assessed using the 7-item anxiety subscale of the Hospital Anxiety and Depression Scale (HADS). Items are rated on a scale from 0 to 3, with total scores ranging from 0 to 28. Higher scores indicate greater anxiety.
Time frame
Follow-up approximately 22 weeks after baseline (Time 3)2
Cancer-specific distress
Participant-reported cancer-specific distress will be assessed using the 22-item Impact of Events Scale Revised (IES-R). Items are rated on a scale from 0 to 4, with total scores ranging from 0 to 88. Higher scores indicate greater distress.
Time frame
Follow-up approximately 22 weeks after baseline (Time 3)3
Well-being
Participant-reported well-being will be assessed using the 5-item World Health Organization-Five Well-Being Index (WHO-5). Items are rated on a scale from 0 to 5, with total scores ranging from 0 to 100. Higher scores indicate greater well-being.
Time frame
Follow-up approximately 22 weeks after baseline (Time 3)4
Caregiver reaction
Participant-reported caregiver reaction will be assessed using the 24-item Caregiver Reaction Assessment (CRA). Items are rated on a scale from 1 to 5. The CRA comprises five subscales: Self Esteem, Lack of Family Support, Impact on Finances, Impact on Schedule, Impact on Health. For the Self Esteem subscale, higher scores indicate greater esteem (positive outcome). For the remaining four subscales, higher scores indicate greater caregiver burden (negative outcome). Subscale scores are calculated as mean item scores ranging from 1.0 to 5.0.
Time frame
Follow-up approximately 22 weeks after baseline (Time 3)Sponsors and contacts
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Source ClinicalTrials.gov