Fear of Cancer Progression
Conditions
Keywords
Fear of Cancer Progression, Caregivers, Metacognitive therapy, Feasibility, Online-delivered psychological therapy
Brief 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.
Detailed description
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).
Interventions
BEHAVIORALConquer 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.
Sponsors
University of Aarhus
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Within-subject repeated-measures design including a pre-intervention waiting period
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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) * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety | Follow-up approximately 22 weeks after baseline (Time 3) | 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. |
| Cancer-specific distress | Follow-up approximately 22 weeks after baseline (Time 3) | 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. |
| Well-being | Follow-up approximately 22 weeks after baseline (Time 3) | 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. |
| Caregiver reaction | Follow-up approximately 22 weeks after baseline (Time 3) | 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. |
| Sleep health | Follow-up approximately 22 weeks after baseline (Time 3) | 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. |
| Decentering from thoughts | Follow-up approximately 22 weeks after baseline (Time 3) | 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. |
| Valued living | Follow-up approximately 22 weeks after baseline (Time 3) | 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). |
| Worry | Follow-up approximately 22 weeks after baseline (Time 3) | 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. |
| Metacognitions | Follow-up approximately 22 weeks after baseline (Time 3) | 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. |
| Treatment expectancy | Session 1 at approximately day 28 | 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. |
| Fear of cancer progression | Post-treatment approximately 7 weeks after baseline (Time 2) | 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. |
| Distance from thoughts | Post-treatment approximately 7 weeks after baseline (Time 2) | 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. |
| Treatment understanding and everyday application | Post-treatment approximately 7 weeks after baseline (Time 2) | 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. |
Countries
Denmark
Contacts
CONTACTCecilie R Buskbjerg, PhD
Outcome results
None listed