Fear of Cancer Recurrence (FoR) Trajectory During Radiation Treatment

Breast Cancer Clinical Trial

— FORECAST  

Official title:

Fear of Cancer Recurrence (FoR) Trajectory During Radiation Treatment and Follow-up Into Survivorship of 100 Breast Cancer patients-a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02599506
• Other study ID #: 20l5MaySP529
• Status: Completed
• Start date: December 1, 2015
• Est. completion date: October 31, 2016

Study information

• Verified date: September 2018
• Source: University of St Andrews
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This pilot study concentrates on studying the trajectory of breast cancer patient's fear of recurrence (FoR) over the course of radiation therapy. The aim is to collect repeated ratings of 100 breast cancer patient's FoR over the course of their treatment. It is hypothesized that cancer patient's FoR level will rise on nearing the termination of the in radiotherapy treatment, and radiotherapist-patient interaction modifies the development of patient's FoR.

Description:

The aim of this pilot study is to examine the collection of FoR levels in a longitudinal design with 100 breast cancer patients receiving radiotherapy for their disease. In this study, an intensive longitudinal design will be employed (Bolger & Laurenceau, 2013). There will be two data collection types. First, will be self-reported questionnaires. Patients will complete questions including three sections: 1) demographic information (i.e. age, education, employment, marital/family status), 2) a 7-item FoR scale (ACCRE FCR) and 3) a 20-item Affect Schedule (PANAS) before first radiation treatment (T1). Throughout the period of treatment, a 3-item FoR questionnaire (ACCRE FCR 3 Items) will be designed as a daily diary to monitor patient's FoR level. Then, at the end of the radiotherapy treatment (T2), PANAS will be measured again. Finally, six-eight weeks after the end of the treatment (T3), all participants will be asked to complete the 7-items FCR questionnaire once again as well as a 5-item EuroQoL EQ-5D-3L scale by telephone.

The second data collection media is audiotape. The conversations between radiotherapist and patient in the weekly review appointment will be recorded and a behavioural coding system (VR-CoDES) will be used to analyse the interactions between patient and radiotherapist.

Data analysis will involve statistical analysis and qualitative methods. Statistical analyses will be conducted using Statistical Package for the Social Sciences (SPSS) Analytics software v.22, Analysis of MOment Structures (AMOS) v.22 and MPlus™ (SEM: Structural Equation Modelling). Initial analysis will plot individual and group average curves over the days that patients are treated. The analysis will develop a statistical model based upon SEM principles of growth curves. Each patient is expected to disclose increased fears of recurrence over the course of treatment. Latent curve modelling will be developed to test the relationship of FoR over the time course of the treatment.

As part of this pilot study the investigators wish to investigate the appropriateness of these models and to test the extent of growth of FoR to the outcome at 6-8 weeks follow up, using the FoR 7 item measure. Covariates will be introduced for control purposes and indicate initial level of negative affectivity (The Positive and Negative Affect Schedule - PANAS), age and initial level of disease severity. Alternative strategies of analysis are considered appropriate and may enable a parallel strategy. This would involve a simpler approach concentrating on the raw data. Linear modelling (multi-level) which will include estimation of linear slopes being used to predict FoR outcome.

Audio recordings of the consultation will be transcribed verbatim in order to investigate how the radiotherapist-patient communication affects the development of FoR.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: October 31, 2016
• Est. primary completion date: June 1, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Female patient who are diagnosed with breast cancer, age 18+

Exclusion Criteria:

• Under 18 years old

• Male

• Known psychiatric illness

• Receiving palliative radiotherapy (non-curative)

• Unable to communicate in English

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Recurrence

Locations

Country	Name	City	State
United Kingdom	NHS Lothian Edinburgh Cancer Centre	Edinburgh

Sponsors (2)

Lead Sponsor	Collaborator
University of St Andrews	NHS Lothian

Country where clinical trial is conducted

United Kingdom, 

References & Publications (3)

Crawford JR, Henry JD. The positive and negative affect schedule (PANAS): construct validity, measurement properties and normative data in a large non-clinical sample. Br J Clin Psychol. 2004 Sep;43(Pt 3):245-65. — View Citation

Schrag A, Selai C, Jahanshahi M, Quinn NP. The EQ-5D--a generic quality of life measure-is a useful instrument to measure quality of life in patients with Parkinson's disease. J Neurol Neurosurg Psychiatry. 2000 Jul;69(1):67-73. — View Citation

Walters SJ, Brazier JE. Comparison of the minimally important difference for two health state utility measures: EQ-5D and SF-6D. Qual Life Res. 2005 Aug;14(6):1523-32. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fear of Recurrence Level-ACCRE FCR	The ACCRE FCR scale has been employed in a national study, it ranges from 4-20. A score of 10 is a significant level (60th percentile) considered appropriate for the patient to receive a brief intervention.	6-8 weeks after treatment
Secondary	The Positive and Negative Affect Schedule (PANAS)	The Positive and Negative Affect Schedule (PANAS) is a 20-item self-report measure of positive and negative affect. The PANAS has been shown to possess adequate psychometric properties in a large sample drawn from the general adult population, and the construct validity of the PANAS scales and the reliabilities of both scales were adequate, Cronbach's a were 0.89 for Positive Affectivity and 0.85 for Negative Affectivity (Crawford & Henry, 2004).	4 weeks following baseline visit
Secondary	5 EQ-5D-3L	The EQ-5D-3L is a standardised instrument for use as a measure of health outcome and was developed by the EuroQol Research foundation. It consists of five questions relating to five dimensions of health; mobility, self-care, usual activities, pain and discomfort and anxiety and depression. The EQ-5D has well-established validity and reliability and has been used in many studies of patients with a variety of chronic conditions in many different countries (Schrag et al., 2000; Walters & Brazier, 2005).	6-8 weeks after treatment