Clinician Intervention to Reduce Fear of Recurrence in Cancer Survivors (CIFeR Study)

Not Applicable

Completed

• Conditions: breast cancer; fear of cancer recurrence; Cancer - Breast; Mental Health - Other mental health disorders

• Registration Number: ACTRN12618001615279
• Lead Sponsor: Psycho-Oncology Cooperative Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-02
• Study Completion: 2020-04-28
• Last Update Posted: 16 February 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 61

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility of the intervention as determined by patient acceptability. The outcome measure for feasibility is the proportion of eligible, consenting patients who rate the intervention as satisfactory (a score of 3 or higher on a 4-point Likert scale from 1 (unacceptable) to 4 (very acceptable)). The CIFeR intervention will be defined as feasible if greater than or equal to 65% of patients receive the intervention and rate it as acceptable, whereas the intervention will be unfeasible if <40% of patients receive the intervention or rate it as acceptable. [1 week after intervention delivery as rated by participants]