Study protocol for the evaluation of Fear-Less: a stepped-care program for fear of cancer recurrence in survivors with early-stage disease

Abstract

Background Fear of cancer recurrence (FCR) is a significant unmet need amongst cancer survivors and is consistently associated with psychological distress and impaired quality of life. Psychological interventions for FCR, such as ConquerFear, have demonstrated efficacy in reducing FCR and improving emotional wellbeing. Unfortunately, there are barriers to the uptake of evidence-based FCR treatments in clinical practice. A stepped-care FCR treatment model may overcome these barriers and has demonstrated potential in people with advanced melanoma. This study aims to evaluate the acceptability, feasibility, and impact of a stepped-care FCR treatment model (Fear-Less) in people with other cancer types, who have completed treatment with curative intent. Methods Sixty people with early-stage cancer (defined as individuals who have received treatment with curative intent and with no metastatic disease) will be screened for FCR using the Fear of Cancer Recurrence Inventory—Short Form (FCRI-SF). Individuals reporting moderate FCR (FCRI-SF between 13 and 21) will be offered a clinician-guided self-management resource; those reporting high FCR (FCRI-SF ≥ 22) will be offered individual therapy according to the ConquerFear protocol. Participants will complete purpose-built evaluation surveys assessing their FCR screening and intervention experiences. Clinicians will also complete a survey regarding their experiences of the treatment model. Fear-Less will be evaluated in terms of (1) acceptability (i.e., patient and clinician experience), (2) feasibility (i.e., referral uptake, treatment adherence, and time taken to screen and deliver interventions), and (3) impact (i.e., pre- to post-intervention FCR changes). Discussion The Fear-Less stepped-care model is a novel framework for screening FCR and stratifying survivors to the appropriate level of treatment. Our study will provide an indication of whether Fear-Less is a feasible and acceptable FCR model of care amongst survivors with early-stage disease and inform further investigations of this model. Trial registration Australian New Zealand Clinical Trials Registry (ANZCTR); ACTRN12622000818730.

Evaluation of the validity and screening performance of a revised single‐item fear of cancer recurrence screening measure (FCR‐1r)

“…The second screening step would also enable tentative allocation to FCR intervention matched to the level of FCR reported, which would ideally be confirmed in a triage conversation with clinical staff. 21,42 Choosing an appropriate screening tool and cut-off score is dependent on context. 22 The FCR-1r cut-off ≥5/10 and the ESAS-R anxiety item cut-off ≥4/10 have similar sensitivity and specificity, but for services already implementing the ESAS-r, using the ESAS-r anxiety item as the initial step of FCR screening may be most practical if future research supports the comparable screening performance of the FCR-1r and ESAS-r anxiety item.…”

“…While no formal sample size calculation was conducted for this exploratory study, the resultant sample ( n = 54) fell short of including as many participants as the validation of the original FCR‐1 ( n = 69) 20 . We decided to combine data from a second study using the FCR‐1r and FCRI‐SF (as below) 21 …”

“…Participants were recruited from cancer services at Peter MacCallum Cancer Centre, Royal Melbourne Hospital, and Royal Women's Hospital in Melbourne, Australia between November 2021 and May 2022. Data for this analysis was collected using electronic and paper‐and‐pencil screening measures (i.e., the FCR‐1r and FCRI‐SF) completed as part of routine care (e.g., during oncology follow‐up appointments), with eligible participants subsequently invited to participate in the FCR stepped care study (see published protocol 21 for details). The Peter MacCallum Cancer Centre HREC approved the study (HREC/74975/PMCC).…”

“…20 We decided to combine data from a second study using the FCR-1r and FCRI-SF (as below). 21 Study 2 was a single-arm feasibility study of FCR stepped care in cancer survivors with early-stage disease. 21…”

“…21 Study 2 was a single-arm feasibility study of FCR stepped care in cancer survivors with early-stage disease. 21…”