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.
PRIMARY OBJECTIVE: To evaluate the feasibility and acceptability of the Conquer Fear Carer Brief intervention among caregivers of patients with metastatic 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 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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
14
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.
Department of Psychology and Behavioural Sciences, Aarhus University
Aarhus, Denmark
RECRUITINGIntervention 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)
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)
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)
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)
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.
Time frame: Post-treatment approximately 7 weeks after baseline (Time 2)
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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.
Time frame: 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.
Time frame: Post-treatment approximately 7 weeks after baseline (Time 2)
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)
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)
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)
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)
Sleep health
Participant-reported sleep health will be assessed using the 6-item RU SATED. RU-SATED stands for: Satisfaction: Are you satisfied with your sleep? Alertness: Do you stay awake all day without dozing? Timing: Are you asleep (or trying to sleep) between 2 am and 4 am? Efficiency: Do you spend less than 30 minutes awake at night (including time to fall asleep and awakenings)? Duration: Do you sleep between 6 and 8 hours per day? Items are rated on a scale from 0 to 4, with total scores ranging from 0 to 24. Higher scores represent greater sleep health.
Time frame: Follow-up approximately 22 weeks after baseline (Time 3)
Decentering from thoughts
Participant-reported decentering from thoughts will be assessed using the 11-item decentering subscale of the Experience Questionnaire (EQ). Items are rated on a scale from 1 to 5, with total scores ranging from 11 to 55. Higher scores indicate greater levels of decentering.
Time frame: Follow-up approximately 22 weeks after baseline (Time 3)
Valued living
Participant-reported valued living will be assessed using the 10-item Valuing Questionnaire (VQ). Items are rated on a scale from 0 to 6. The measure yields two subscales, Progress and Obstruction, each with total scores ranging from 0 to 30. For the Progress subscale, higher scores indicate closer alignment between one's values and actions (positive outcome). For the Obstruction subscale, higher scores indicate greater interference with living consistently with one's values (negative outcome).
Time frame: Follow-up approximately 22 weeks after baseline (Time 3)
Worry
Participant-reported worry will be assessed using the 16-item Penn State Worry Questionnaire (PSWQ). Items are rated on a scale from 1 to 5, with total scores ranging from 16 to 80. Higher scores indicate greater worry.
Time frame: Follow-up approximately 22 weeks after baseline (Time 3)
Metacognitions
Participant-reported metacognitions will be assessed using the 30-item Metacognitions Questionnaire (MCQ-30). Items are rated on a scale from 1 to 5, with total scores ranging from 30 to 120. Higher scores indicate greater levels of unhelpful metacognitions.
Time frame: Follow-up approximately 22 weeks after baseline (Time 3)
Treatment expectancy
Participant-reported treatment expectancy will be assessed using the 6-item Credibility/Expectancy Questionnaire (CEQ). Items are rated on a scale from 1 to 9. The measure yields two subscales, Credibility and Outcome Expectation, with total scores for each subscale ranging from 3 to 27. Higher scores indicate greater perceived credibility and outcome expectancy.
Time frame: Session 1 at approximately day 28
Fear of cancer progression
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.
Time frame: Post-treatment approximately 7 weeks after baseline (Time 2)
Metacognitions
Participant-reported metacognitions will be assessed in the beginning of each session using the 30-item Metacognitions Questionnaire (MCQ-30). Items are rated on a scale from 1 to 5, with total scores ranging from 30 to 120. Higher scores indicate greater levels of unhelpful metacognitions.
Time frame: Post-treatment approximately 7 weeks after baseline (Time 2)
Distance from thoughts
Participant-reported distance from thoughts will be assessed in the beginning of each session using the 11-item decentering subscale of the Experience Questionnaire (EQ). Items are rated on a scale from 1 to 5, with total scores ranging from 11 to 55. Higher scores indicate greater levels of decentering.
Time frame: Post-treatment approximately 7 weeks after baseline (Time 2)
Treatment understanding and everyday application
Participant-reported treatment understanding and everyday application will be assessed using six custom items. Four items are rated on a scale ranging from 1 (not at all) to 5 (to a high degree) and assess the extent to which participants (1) understood Detached Mindfulness (DM), (2) felt self-efficacious in applying DM in everyday life, (3) found DM helpful, and (4) applied DM in everyday life. The remaining two items are open-ended questions asking participants (1) to describe how they would explain DM to a friend and (2) to describe how and when they apply DM in everyday life.
Time frame: Post-treatment approximately 7 weeks after baseline (Time 2)