Effectiveness of a guided online primary care intervention for fear of cancer recurrence: A randomised controlled trial.

OBJECTIVE: Fear of Cancer Recurrence (FCR) is highly prevalent among cancer survivors and leads to decreased quality of life and increased healthcare costs. We assessed the effectiveness of a guided online primary care intervention for FCR, compared to waiting list. METHODS: In this RCT, participants were recruited online and randomised 1:1. All adults who finished successful curative cancer treatment between 3 months and 10 years ago, wanted support for FCR, and had sufficient Dutch skills were eligible. The intervention consisted of a 10-week online programme and three to five video calling sessions with a trained mental health worker. After 6 months, the control group received the same intervention. The primary outcome was the difference between the groups in the change in FCR severity from baseline (T0) to 6 months (T2), measured online with the short form of the Fear of Cancer Recurrence Inventory. RESULTS: One hundred and seventy-three participants were enroled and randomised to the intervention (n = 86) or control group (n = 87). FCR severity dropped 2.1 points more in the intervention group than in the control group (2.7 points (SD = 3.9) versus 0.6 points (SD = 3.6), t(154) = 3.4, p = 0.0007). General mental well-being also improved significantly in the intervention group and remained stable in the control group. These improvements remained at 10 months follow up. CONCLUSIONS: This easily accessible and relatively inexpensive intervention effectively reduces FCR and has potential to replace or precede existing more intensive psychological treatments, improving patients' access to care. TRIAL REGISTRATION: The trial was prospectively registered in the Netherlands Trial Register on 25-02-2019 with number NL7573.

Patient-reported needs for coping with worry or fear about cancer recurrence and the extent to which they are being met: a survey study.

PURPOSE: Many cancer patients and survivors experience fear or worry about cancer recurrence (FCR). Evidence suggests support for FCR is their largest unmet need. We aimed to assess which types of support are needed, which providers are preferred and to what extent patients' needs are being met. METHODS: Together with the Dutch Federation of Cancer Patient Organisations (NFK), a purpose-designed questionnaire was distributed online via e-mail, newsletters and social media. All questions were multiple choice or Likert scales, except for an open-ended question about the preferred provider of care. RESULTS: Out of 5323 respondents, 4511 had experienced FCR and were included. Among them, 94% indicated a need for support. The required types of support that were reported the most were talking about FCR (69%), enjoyable activities for distraction (56%) and psychological help or coaching (40%). On average, younger respondents and women wanted more support than older respondents and men. Eighty-five percent of respondents received at least one type of support they wanted. Practical tips about FCR and additional medical check-ups were most often missed. Social contacts provided an important part of support, especially with talking and distracting activities. For other types of support, respondents usually preferred professionals. CONCLUSIONS: Almost all patients who experience FCR have a need for support. Even though most receive some support, several gaps remain. IMPLICATIONS FOR CANCER SURVIVORS: Many report an unmet need for psychological help or practical tips about FCR. We recommend for healthcare providers to discuss FCR with patients and inform them about the support available.

What is the prevalence of fear of cancer recurrence in cancer survivors and patients? A systematic review and individual participant data meta-analysis.

OBJECTIVE: Care for fear of cancer recurrence (FCR) is considered the most common unmet need among cancer survivors. Yet the prevalence of FCR and predisposing factors remain inconclusive. To support targeted care, we provide a comprehensive overview of the prevalence and severity of FCR among cancer survivors and patients, as measured using the short form of the validated Fear of Cancer Recurrence Inventory (FCRI-SF). We also report on associations between FCR and clinical and demographic characteristics. METHODS: This is a systematic review and individual participant data (IPD) meta-analysis on the prevalence of FCR. In the review, we included all studies that used the FCRI-SF with adult (≥18 years) cancer survivors and patients. Date of search: 7 February 2020. Risk of bias was assessed using the Joanna Briggs Institute critical appraisal tool. RESULTS: IPD were requested from 87 unique studies and provided for 46 studies comprising 11,226 participants from 13 countries. 9311 respondents were included for the main analyses. On the FCRI-SF (range 0-36), 58.8% of respondents scored ≥13, 45.1% scored ≥16 and 19.2% scored ≥22. FCR decreased with age and women reported more FCR than men. FCR was found across cancer types and continents and for all time periods since cancer diagnosis. CONCLUSIONS: FCR affects a considerable number of cancer survivors and patients. It is therefore important that healthcare providers discuss this issue with their patients and provide treatment when needed. Further research is needed to investigate how best to prevent and treat FCR and to identify other factors associated with FCR. The protocol was prospectively registered (PROSPERO CRD42020142185).

Study protocol of the BLANKET trial: a cluster randomised controlled trial on the (cost-) effectiveness of a primary care intervention for fear of cancer recurrence in cancer survivors.

INTRODUCTION: Many successfully treated patients with cancer suffer from fear of cancer recurrence (FCR), affecting their quality of life and their physical, emotional, cognitive and social functioning. Effective psychological interventions for FCR exist but are not widely available, as they are typically offered by specialised psycho-oncology professionals and institutes. Concurrently, the role of primary care in cancer and survivorship care is increasing. Therefore, there could be a role for general practitioners (GPs) and mental health workers (MHWs) working in primary care in supporting patients with FCR. In the current study, the effectiveness of a primary care delivered FCR intervention will be evaluated. METHODS AND ANALYSIS: A two-armed cluster randomised trial will be conducted. The primary outcome will be FCR severity; secondary outcomes will be FCR-related distress, healthcare uptake and healthcare costs. Primary care practices in the Netherlands will be invited to participate in the study. Participating practices will be stratified by size and socioeconomic status and randomised. In the control arm, practices will provide care as usual. In the intervention arm, practices will offer the cognitive-behavioural FCR intervention that is being studied, which consists of an intake with the GP and five sessions with the MHW. Patients who have finished successful curative treatment for cancer between 3 months and 10 years ago will be invited to participate in the study by invitation letter from their GPs. Participating patients will fill out questionnaires at baseline, after 3 months and after 12 months. Data on healthcare use will be collected from their electronic health records. Qualitative interviews are held at T1 with patients and practitioners in the intervention group. ETHICS AND DISSEMINATION: The Medical Research Ethics Committee (METC) Utrecht has reviewed the study in accordance with the Dutch Medical Research Involving Human Subjects Act (WMO) and other applicable Dutch and European regulations. Based on the requirements of the WMO, the METC Utrecht has issued an approval of the above-mentioned study. Any protocol amendments will be communicated to all relevant parties. Written consent is obtained from study participants. Results will be dispersed through peer-reviewed publications and scientific presentations. TRIAL REGISTRATION NUMBER: NL7573 in the Netherlands Trial Register on 25-02-2019.