The Ottawa clinical fear of recurrence instruments: A screener, self-report, and clinical interview.

OBJECTIVE: Clinical fear of cancer recurrence (FCR) was recently defined by a group of experts during a Delphi study. Five criteria were agreed upon, namely: (a) high levels of preoccupation, (b) high levels of worry, (c) that are persistent, (d) hypervigilance and hypersensitivity to physical sensations that e) may result in functional impairment. No existing instruments comprehensively capture all these criteria for clinical FCR. METHODS: To remedy this gap, a set of three patient-reported outcome instruments including a one-item screener, self-report questionnaire, and semi-structured clinical interview, named the Ottawa Clinical Fear of Recurrence instruments, were developed. To do so, the research team first conducted a literature review of potential items. Additional FCR experts discussed the content of the screener and interview. The self-report's items were assessed for content validity by the same expert panel using Likert ratings and the Content Validity Index to narrow down the number of items. The three instruments were piloted with a group of cancer survivors to assess face validity following the European Organization for Research and Treatment of Cancer recommendations. RESULTS: The literature review and content validity assessment led to a final draft pre-pilot of 23 potential items for the self-report questionnaire. The instruments were piloted. Pilot study participants suggested changing wording and response options (particularly for the self-report) for greater clarity. CONCLUSIONS: Based on the feedback received, minor modifications were made, mostly for the self-report. In general, content and face validity for the three instruments were good for both experts and cancer survivors.

Fear of cancer recurrence therapy (FORT): A randomized controlled trial.

OBJECTIVE: Most fear of cancer recurrence (FCR) interventions have small effects, and few target FCR. This randomized controlled trial (RCT) with breast and gynecological cancer survivors evaluated the efficacy of a cognitive-existential fear of recurrence therapy (FORT) compared to an attention placebo control group (living well with cancer [LWWC]) on FCR. METHOD: One hundred and sixty-four women with clinical levels of FCR and cancer distress were randomly assigned to 6-weekly, 120 min FORT (n = 80) or LWWC (n = 84) group sessions. They completed questionnaires at baseline (T1), posttreatment (T2; primary endpoint), 3 (T3), and 6 months (T4) posttreatment. Generalized linear models were used to compare group differences in the fear of cancer recurrence inventory (FCRI) total score and secondary outcomes. RESULTS: FORT participants experienced greater reductions from T1 to T2 on FCRI total with a between-group difference of -9.48 points (p = .0393), resulting in a medium effect of -0.530, with a maintained effect at T3 (p = .0330) but not at T4. For the secondary outcomes, improvements were in favor of FORT, including FCRI triggers (p = .0208), FCRI coping (p = .0351), cognitive avoidance (p = .0155), need for reassurance from physicians (p = .0117), and quality of life (mental health; p = .0147). CONCLUSIONS: This RCT demonstrated that FORT, compared to an attention placebo control group, resulted in a greater reduction in FCR posttreatment and at 3 months posttreatment in women with breast and gynecological cancer, indicating its potential as a new treatment strategy. We recommend a booster session to sustain gains. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

The Association between Survivorship Care Plans and Patient-Reported Satisfaction and Confidence with Follow-Up Cancer Care Provided by Primary Care Providers.

Survivorship care plans aim to facilitate a smooth transition from tertiary to primary care settings after primary cancer treatment is completed. This study sought to identify the sociodemographic factors associated with receiving a survivorship care plan and examine the relationship between receiving a plan and confidence in follow-up care delivered by primary care providers. A cross-sectional analysis of the Canadian Partnership Against Cancer's Experiences of Cancer Patients in Transition Study was conducted (n = 9970). Separate adjusted multinomial logistic regression models assessed the relationship between survivorship care plans and follow-up care outcomes. Proportion of survivors more likely to receive a survivorship care plan varied by numerous sociodemographic and medical factors, such as cancer type (colorectal and prostate), gender (male), and education (high school or less). In unadjusted and adjusted models, individuals who received a Survivorship Care Plan had significantly higher odds of: having felt their primary care providers were involved; agreeing that their primary care providers understood their needs, knew where to find supports and services, and were able to refer them directly to services; and were confident that their primary care provider could meet their follow-up care needs.

Health anxiety and illness-related fears across diverse chronic illnesses: A systematic review on conceptualization, measurement, prevalence, course, and correlates.

BACKGROUND: Patients with chronic diseases commonly report fears of illness or symptoms recurring or worsening. These fears have been addressed from an illness-specific perspective (e.g., fear of cancer recurrence), a generic illness perspective (e.g., fear of progression), and a psychiatric perspective (DSM-5 illness anxiety disorder and somatic symptom disorder). The broader concept of health anxiety (HA) can also be applied to patients with a chronic disease. This review was conducted to investigate the conceptual, theoretical, measurement-overlap, and differences between these distinct perspectives. We also aimed to summarize prevalence, course, and correlates of these fears in different chronic illnesses. METHODS: We used PsycINFO, PubMED, CINAHL, Web of Science, SCOPUS, and PSYNDEX to conduct a systematic review of studies pertaining to these fears in chronic illness published from January 1996 to October 2017. A total of 401 articles were retained. RESULTS: There were commonalities across different conceptualizations and diseases: a high prevalence of clinical levels of fears (>20%), a stable course over time, and a deleterious impact on quality of life. Reviewed studies used definitions, models, and measures that were illness-specific, with only a minority employing a psychiatric perspective, limiting cross-disease generalizability. There appears to be some applicability of DSM-5 disorders to the experience of fear of illness/symptoms in patients with a chronic illness. While conceptualizing HA on a continuum ranging from mild and transient to severe may be appropriate, there is a lack of agreement about when the level of fear becomes 'excessive.' The definitions, models, and measures of HA across chronic illnesses involve affective, cognitive, behavioral, and perceptual features. CONCLUSIONS: The concept of HA may offer a unifying conceptual perspective on the fears of illness/symptoms worsening or returning commonly experienced by those with chronic disease.

Identifying the key characteristics of clinical fear of cancer recurrence: An international Delphi study.

OBJECTIVE: Without an agreed-upon set of characteristics that differentiate clinical from nonclinical levels of fear of cancer recurrence (FCR), it is difficult to ensure that FCR severity is appropriately measured, and that those in need of intervention are identified. The objective of this study was to establish expert consensus on the defining features of clinical FCR. METHOD: A three-round Delphi was used to reach consensus on the defining features of clinical FCR. Sixty-five experts in FCR (researchers, psychologists, physicians, nurses, and allied health professionals) were recruited to suggest and rate potential features of clinical FCR. Participants who indicated they could communicate diagnoses within their clinical role were also asked to consider the application of established DSM-5 and proposed ICD-11 diagnostic criteria (Health Anxiety, Illness Anxiety Disorder, Somatic Symptom Disorder) to clinical FCR. RESULTS: Participants' ratings suggested that the following four features are key characteristics of clinical FCR: (a) high levels of preoccupation; (b) high levels of worry; (c) that are persistent; and (d) hypervigilance to bodily symptoms. Of participants whose professional role allowed them to diagnose mental disorders, 84% indicated it would be helpful to diagnose clinical FCR, but the use of established diagnostic criteria related to health anxiety or somatic-related disorders to clinical FCR was not supported. This suggests that participants consider clinical FCR as a presentation that is specific to cancer survivors. CONCLUSION: Clinical FCR was conceptualized as a multidimensional construct. Further research is needed to empirically validate the proposed defining features.

A Systematic Review of Interventions for Health Anxiety Presentations Across Diverse Chronic Illnesses.

PURPOSE: Health anxiety (HA) is associated with reduced quality of life among individuals with chronic illnesses. However, little is known about effective interventions for reducing HA in this context. This study aimed to comprehensively review the literature on interventions for the treatment of HA in chronic illness. METHODS: This study was conducted as part of a larger systematic review on HA among individuals diagnosed with a chronic illness, using literature published between January 1996 and October 2017. A total of 51 articles were selected as they reported on interventions with pre-post measures and described the impact of the intervention on HA. RESULTS: The data on psychotherapy (CBT, third-wave CBT, and mindfulness), patient education, and rehabilitation programs demonstrated effectiveness in cancer and cardiac patients. Exercise interventions demonstrated effectiveness in patients with Parkinson's disease, and medical interventions showed limited effectiveness in reducing HA in diabetes and epilepsy. Most interventions yielding significant outcomes were at least 6 to 8 weeks long. CONCLUSIONS: The literature supports that a variety of interventions may be effective in reducing HA in individuals with chronic illness. Future research should test single interventions across several illnesses, as well as several interventions within a single illness to better understand how HA can be managed across chronic illnesses.

Barriers and facilitators to healthcare professional behaviour change in clinical trials using the Theoretical Domains Framework: a case study of a trial of individualized temperature-reduced haemodialysis.

BACKGROUND: Implementing the treatment arm of a clinical trial often requires changes to healthcare practices. Barriers to such changes may undermine the delivery of the treatment making it more likely that the trial will demonstrate no treatment effect. The 'Major outcomes with personalized dialysate temperature' (MyTEMP) is a cluster-randomised trial to be conducted in 84 haemodialysis centres across Ontario, Canada to investigate whether there is a difference in major outcomes with an individualized dialysis temperature (IDT) of 0.5 °C below a patient's body temperature measured at the beginning of each haemodialysis session, compared to a standard dialysis temperature of 36.5 °C. To inform how to deploy the IDT across many haemodialysis centres, we assessed haemodialysis physicians' and nurses' perceived barriers and enablers to IDT use. METHODS: We developed two topic guides using the Theoretical Domains Framework (TDF) to assess perceived barriers and enablers to IDT ordering and IDT setting (physician and nurse behaviours, respectively). We recruited a purposive sample of haemodialysis physicians and nurses from across Ontario and conducted in-person or telephone interviews. We used directed content analysis to double-code transcribed utterances into TDF domains, and inductive thematic analysis to develop themes. RESULTS: We interviewed nine physicians and nine nurses from 11 Ontario haemodialysis centres. We identified seven themes of potential barriers and facilitators to implementing IDTs: (1) awareness of clinical guidelines and how IDT fits with local policies (knowledge; goals), (2) benefits and motivation to use IDT (beliefs about consequences; optimism; reinforcement; intention; goals), (3) alignment of IDTs with usual practice and roles (social/professional role and identity; nature of the behaviour; beliefs about capabilities), (4) thermometer availability/accuracy and dialysis machine characteristics (environmental context and resources), (5) impact on workload (beliefs about consequences; beliefs about capabilities), (6) patient comfort (behavioural regulation; beliefs about consequences; emotion), and (7) forgetting to prescribe or set IDT (memory, attention, decision making processes; emotion). CONCLUSIONS: There are anticipatable barriers to changing healthcare professionals' behaviours to effectively deliver an intervention within a randomised clinical trial. A behaviour change framework can help to systematically identify such barriers to inform better delivery and evaluation of the treatment, therefore potentially increasing the fidelity of the intervention to increase the internal validity of the trial. These findings will be used to optimise the delivery of IDT in the MyTEMP trial and demonstrate how this approach can be used to plan intervention delivery in other clinical trials. TRIAL REGISTRATION: ClinicalTrials.gov NCT02628366 . Registered November 16 2015.

When fear of cancer recurrence becomes a clinical issue: a qualitative analysis of features associated with clinical fear of cancer recurrence.

PURPOSE: Fear of cancer recurrence (FCR) is a common experience for cancer survivors. However, it remains unclear what characteristics differentiate non-clinical from clinical levels of FCR. The goal of this study was to investigate the potential hallmarks of clinical FCR. METHODS: A convenience sample of 40 participants (n = 19 female) was drawn from another study (Lebel et al. in Qual Life Res 25:311-321. doi: 10.1007/s11136-015-1088-2 , 2016). The semi-structured interview for fear of cancer recurrence (Simard and Savard in J Cancer Surviv 9:481-491. doi: 10.1007/s11764-015-0424-4 , 2015) was used to identify participants with non-clinical and clinical FCR and qualitative analysis of these interviews was performed. RESULTS: Individuals with clinical FCR reported the following features: death-related thoughts, feeling alone, belief that the cancer would return, experiencing intolerance of uncertainty, having cancer-related thoughts and imagery that were difficult to control, daily and recurrent, lasted 30 minutes or more, increased over time, caused distress and impacted their daily life. Triggers of FCR and coping strategies did not appear to be features of clinical FCR as they were reported by participants with a range of FCR scores. CONCLUSIONS: While features of clinical FCR found in this analysis such as intrusive thoughts, distress and impact on functioning confirmed previous FCR research, other features spontaneously emerged from the interviews including "death-related thoughts," "feeling alone," and "belief that the cancer will return." The participants' descriptions of cancer-specific fear and worry suggest that FCR is a distinct phenomenon related to cancer survivorship, despite similarities with psychological disorders (e.g., Anxiety Disorders). Future research investigating the construct of FCR, and the distinguishing features of clinical FCR across a range of cancer types and gender is required.

From normal response to clinical problem: definition and clinical features of fear of cancer recurrence.

PURPOSE: Research to date on fear of cancer recurrence (FCR) shows that moderate to high FCR affects 22-87 % of cancer survivors and is associated with higher psychological morbidity (Simard et al J Cancer Surviv 7:300-322, 2013). Despite growing research interest in FCR, the lack of consensus on its definition and characteristics when it reaches a clinical level has impeded knowledge transfer into patient services. METHODS: In order to address these gaps, expert researchers, policy makers, trainees, and patient advocates attended a 2-day colloquium at the University of Ottawa in August 2015. A Delphi method was used to identify the most relevant definition of FCR, and the attendees generated possible diagnostic characteristics of clinical FCR. RESULTS: After three rounds of discussion and voting, the attendees reached consensus on a new definition of FCR: "Fear, worry, or concern relating to the possibility that cancer will come back or progress." Regarding clinical FCR, five possible characteristics were proposed: (1) high levels of preoccupation, worry, rumination, or intrusive thoughts; (2) maladaptive coping; (3) functional impairments; (4) excessive distress; and (5) difficulties making plans for the future. CONCLUSIONS: The new proposed definition of FCR reflects the broad spectrum in which patients experience FCR. A consensual definition of FCR and the identification of the essential characteristics of clinical FCR are necessary to accurately and consistently measure FCR severity and to develop effective interventions to treat FCR. We hope this broad definition can encourage further research and the development of inclusive policies for all cancer patients and survivors who are struggling with this issue.

Addressing fear of recurrence: improving psychological care in cancer survivors.

PURPOSE: Fear of cancer recurrence (FCR) is defined as "the fear or worry that the cancer will return or progress in the same area or another part of the body." FCR is associated with impaired functioning and lower quality of life in cancer patients. A cognitive-existential (CE) manualized group intervention for women with FCR showed a moderate effect size in reducing FCR, cancer-specific distress, and maladaptive coping. However, it appears that no individual intervention for FCR exists for both men and women. Therefore, the group intervention was adapted to an individual format. METHODS: This study was conducted to determine the feasibility, acceptability, and satisfaction of the individual intervention. The intervention was pilot-tested on n = 3 cancer survivors. The 6-week sessions included cognitive restructuring, structured exercises, and relaxation techniques. Participants completed questionnaire packages during a 4-week baseline period and throughout the 6-week intervention. Participants completed exit interviews following the intervention. RESULTS: General trends in baseline and intervention stages were compared. Based on the line graphs, the individual intervention appears to help survivors lower their elevated FCR and cancer-specific distress. Qualitative exit interviews conducted with the study participants demonstrated that the intervention was acceptable and satisfactory. CONCLUSIONS: This clinical intervention allows researchers to systematically focus on evidence-based treatments for managing FCR, and displays the availability of treatment options in different therapeutic modalities. However, further research is needed to identify the active therapeutic ingredients and mechanisms of change in the intervention. Overall, intervention studies suggest it is possible to help cancer survivors manage their FCR.