A Single Session Intervention For Fear Of Recurrence In Breast Cancer Patients
Condition: Fear
MeSH terms: Recurrence
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a controlled trial of the Mini-AFTERc intervention to reduce fears of recurrence in
      breast cancer patients. The sample will be collected in NHS Fife Breast Cancer Services
      (n=32). The intervention is a short telephone counseling service of 20 minutes delivered by
      the patient's breast cancer specialist nurse. Dependent measures consist of the ACCRE FoR 4
      item measure and the EORTC Intervention overall satisfaction scale.
    

Detailed description: 
      1. Background The majority of breast cancer patients completes successfully their treatment
           and therefore become survivors with some of them experience negative outcomes. One of
           the most prevalent unmet needs of the breast cancer survivors is Fear of Recurrence.
           Fear of Cancer Recurrence is defined as "the fear or worry that cancer will return,
           progress or metastasise". More specifically, 33% to 96% of the patients report FoR of
           cancer, while in 9% to 34% of these patients, the fear of recurrence is so detrimental
           even to their lives. Women of younger age with children have reported to have more
           severe FCR .

           Findings suggest that FoR can remain stable in cancer survivors five years or more after
           the diagnosis . Research has shown that cancer survivors that experience FoR, suffer
           from psychological and affective difficulties because of their initial worries of being
           cancer patients a second time. The most frequent of these negative outcomes are
           distress, stress-response symptoms and lower quality of life. Consequently, there is
           much interest of the researchers to focus on the factors that influence FoR in cancer
           patients, and the effect of FoR in survivors' quality of life . Less research has
           focused on interventions that can reduce fear of recurrence in cancer patients. The
           AFTER intervention is one of them, conducted a systematic intervention. The intervention
           was successful, since the study reported reduction in FoR at 6 month follow-up.

           The aim of the current study is to examine the effect of the Mini-AFTERc intervention,
           which is a shorter version of AFTER intervention, in reduction of fear of recurrence in
           breast cancer survivors with moderate level of FoR in comparison with a control group,
           where as the full AFTER intervention target patients with more severe FoR.

        2. Research Question Whether the single-session intervention Mini AFTERc, delivered by a
           phone call, can reduce fear of recurrence in breast cancer patients with moderate level
           of fear in contrast with a control group.

        3. Hypothesis The mini AFTERc intervention will reduce fear of recurrence in breast cancer
           patients with moderate level of fear, whereas FoR will not be reduced in the control
           group.

        4. Methods and materials 4.1 Study design The study will be a quasi-experiment design
           implementing a single-session intervention which is aimed at reducing fear of recurrence
           in breast cancer patients with moderate level of fear, whereas FoR will not be reduced
           in the comparison group.

           4.2 Location of study The location of the study will be at NHS fife, Breast Cancer Unit
           of Queen Margaret Hospital, Dunfermline, where breast cancer patients can be treated and
           supported. Three experienced nurses of this unit will employ the Mini-AFTERc
           intervention.

           4.3 Participants Patients of NHS fife, Breast Cancer Unit of Queen Margaret Hospital,
           Dunfermline, in order to be included in the study, have to be breast cancer patients who
           have completed primary treatment and are worried about fear of cancer recurrence. An
           estimated number of participants are 34 patients to be able to answer successfully the
           research question. More specifically, the 17 patients of the treated group will receive
           a structured phone, based on the mini AFTERc intervention, whereas call the 17 patients
           of the control group will receive a standard phone call, which will not be a mini-
           After. A power analysis was conducted using NQueryAdvisor. A sample size of 17 in each
           group will have 80% power to detect a difference in means of 4 on the four item Fears of
           Recurrence Scale (the difference between the Control group mean: 25 and a Intervention
           group mean: 21) assuming that the common standard deviation is 4 using a two group
           t-test with a 0.05 two-sided significance level. Values obtained of SD and likely effect
           size from unpublished data held by Ozakinci and Humphris of breast and colorectal cancer
           patients and the original feasibility study conducted by Davidson and Humphris.

           All patients of the unit are welcome to participate. Participants will be invited in the
           study after the primary treatment, during a routine-care follow-up. The information
           sheet, the consent form and a pre-paid envelope will be provided in the patients. After
           they have completed the consent form, they will complete the questionnaire measure of
           FoR severity (ACCRE), in which they have to score above the cut-off to be included in
           the study.

           4.4 Measures and intervention The severity of FoR will be measured by employing the
           4-item severity scale ACCRE at baseline and at 1-month follow-up. The second outcome
           measure will be the EORTC Satisfaction of Intervention measuring the overall
           satisfaction of the patients. The study will employ the Mini-AFTERc intervention, which
           is based on the six-session full AFTER intervention. The AFTER intervention was
           initially developed for head and neck patients to be targeted as patients with high
           level of FoR.

           The Mini-AFTERc intervention is a single-session, cognitive behavioral intervention
           based on the Leventhal's Self-Regulation Model and has been designed to be used with
           patients who report moderate levels of FoR. The aim of the intervention is to normalize
           and reduce FoR to a manageable level but still facilitate patients to be aware of the
           risks. The patients are enabled to be vigilant in symptoms change.

        5. Data analysis The audio recording of the intervention consultation will be transcribed.
           Analysis of pre and post tests will be conducted by SPSS Predictive Analytics software
           v.21. The post-test will be subtracted from the pre-test to derive a change score. An
           analysis of variance will be conducted with a number of covariates (i.e. age and disease
           severity). The dependent variable will be the FoR ACCRE change score

        6. Ethical approval

           The National Research Ethics Service will be contacted to prepare the NRES form and NHS
           Fife R&D Governance forms as the study will be conducted with NHS Fife.

           Furthermore, we need to apply UTREC Ethics for the University of St Andrews, too.

        7. Governance of study and support of participants The research project will be supervised
           by Professor Gerry Humphris. If needed, additional support to the patients will be
           provided by The Psychological Services at Edinburgh Cancer Unit, where Professor
           Humphris is a honorary clinical psychology consultant to the service and can pick up
           these referrals.
    

Intervention name(s): Mini-AFTERc; telephone call
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 20-30 minute structured conversation following guidelines and instruction within the Mini-AFTERc 20 page manual; this consists of a 20-30 minute conversation about the general well-being of the patient with no specific reference to recurrence fears unless raised by the patient explicitly themselves
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: fears of recurrence; cancer; brief intervention; telephone counseling; following primary cancer treatment