None listed
Conditions
Brief summary
The purpose of this study is to examine a new clinician administered care model addressing fear of cancer recurrence in breast cancer survivors. Who is it for? You may be eligible for this study if you are aged 18 or above and have undergone curative treatment for stage I to III breast cancer. Study details All participants in this study will partake in a 10 minute educational intervention which provides patients with advice regarding their fear of cancer recurrence. The program is delivered by their usual breast oncologist at a routine follow-up clinic. All participants will be asked to complete three questionnaires, one prior to the follow-up appointment, and again at 1 week and 3 months after the follow-up appointment. Additionally participants will be invited to participate in an interview about their experiences in participating in this program. It is hoped that this research provide some preliminary evidence that the intervention is effective in preventing the development of high fear-of-cancer-recurrence in breast cancer survivors.
Interventions
This is a phase 1 feasibility study of a novel education and communication intervention delivered by medical oncologists to breast cancer survivors 6 months to 5 years after completion of their hospital-based treatments. A 5-component education/counselling intervention to address fear of cancer recurrence in breast cancer survivors will be used during a routine follow-up clinic appointment at hospital, and is expected to take around ten minutes to deliver. The intervention entails: 1) Fear of ca
This is a phase 1 feasibility study of a novel education and communication intervention delivered by medical oncologists to breast cancer survivors 6 months to 5 years after completion of their hospital-based treatments. A 5-component education/counselling intervention to address fear of cancer recurrence in breast cancer survivors will be used during a routine follow-up clinic appointment at hospital, and is expected to take around ten minutes to deliver. The intervention entails: 1) Fear of cancer recurrence (FCR) normalisation and reassurance delivered by the clinician during the consultation 2) Provision of concrete prognostic information (if desired by the patient) 3) Take-home education sheet on red-flag recurrence symptoms 4) Brief advice on strategies to manage worry 5) Referral to psychologist if FCR is severe or the patient would like additional help. The intervention entails: - 10 minute discussion with the breast oncologist about level of FCR, impact on the patients life, and provision of reassurance and prognostic information about recurrence risk. - Take home pamphlet which has been custom designed specifically for the study, providing advice on symptoms/signs that may suggest cancer recurrence and what to do about these, and advice on how to manage worry - Mode of administration will be one-on-one between the breast oncologist and the patient - Only the usual breast oncologist will administer the intervention - The follow-up appointment where the interventionis being delivered will be audio recorded (with the patient's permission) to assess for intervention adherence as a secondary endpoint. The 5-component intervention to be piloted in this study was developed by the investigators from our systematic review of existing interventions1 and results of cross-sectional surveys on FCR, FCR theoretical models and expert input (including psycho-oncologists, clinicians and consumers at the 2018 Psycho-Oncology Co-Operative Group Concept Development Workshop). 1. Liu J, Butow P, Beith J: Systematic review of clinician interventions for managing fear of cancer recurrence in adult cancer survivors. Presented at the Medical Oncology Group of Australia Annual Scientific Meeting, 2018, Adelaide, Australia, 2018. Manuscript in preparation
Sponsors
Psycho-Oncology Cooperative Group
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Educational / counselling / training
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1) Women aged 18 years and above with histologically confirmed early stage (I-III inclusive) breast cancer who have undergone treatment with curative intent 2) Completed surgery and adjuvant chemotherapy/radiotherapy (where appropriate) greater than or equal to 6 months from time of registration (but may be on adjuvant hormone therapy) 3) Willing and able to complete study requirements including patient-rated outcome (PRO) surveys without assistance or translation 4) Completed signed written informed consent
Exclusion criteria
1) Current severe major depression (as defined by >15 on DASS-21) and anxiety (>21 on DASS-21) 2) Current psychotic illness or other psychiatric/cognitive condition that would impair the ability to participate in the intervention (as judged by the treating clinician) 3) Patients who are unable to understand written or spoken English 4) Objective evidence of recurrence or metastatic cancer of any type, as determined by the treating oncologist.
Outcome results
None listed