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Fear of Cancer Recurrence (FoR) Trajectory During Radiation Treatment (FORECAST)

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ClinicalTrials.gov Identifier: NCT02599506
Recruitment Status : Completed
First Posted : November 6, 2015
Last Update Posted : October 1, 2018
Sponsor:
Collaborator:
NHS Lothian
Information provided by (Responsible Party):
Prof G Humphris, University of St Andrews

Brief 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.

Condition or disease
Breast Cancer

Detailed 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.


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Study Type : Observational
Actual Enrollment : 97 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Fear of Cancer Recurrence (FoR) Trajectory During Radiation Treatment and Follow-up Into Survivorship of 100 Breast Cancer patients-a Pilot Study
Actual Study Start Date : December 1, 2015
Actual Primary Completion Date : June 1, 2016
Actual Study Completion Date : October 31, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort
breast cancer radiation therapy
Observation over a period of all treatment sessions for radiotherapy



Primary Outcome Measures :
  1. Fear of Recurrence Level-ACCRE FCR [ Time Frame: 6-8 weeks after treatment ]
    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.


Secondary Outcome Measures :
  1. The Positive and Negative Affect Schedule (PANAS) [ Time Frame: 4 weeks following baseline visit ]
    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 α were 0.89 for Positive Affectivity and 0.85 for Negative Affectivity (Crawford & Henry, 2004).

  2. 5 EQ-5D-3L [ Time Frame: 6-8 weeks after treatment ]
    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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
In this study, 100 breast cancer patients receiving radiotherapy at the Edinburgh Cancer Centre will be recruited.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02599506


Locations
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United Kingdom
NHS Lothian Edinburgh Cancer Centre
Edinburgh, United Kingdom, EH4 2XU
Sponsors and Collaborators
University of St Andrews
NHS Lothian
Investigators
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Principal Investigator: Gerald M Humphris, PhD University of St Andrews

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Prof G Humphris, Professor of Health Psychology, University of St Andrews
ClinicalTrials.gov Identifier: NCT02599506     History of Changes
Other Study ID Numbers: 20l5MaySP529
First Posted: November 6, 2015    Key Record Dates
Last Update Posted: October 1, 2018
Last Verified: September 2018
Keywords provided by Prof G Humphris, University of St Andrews:
breast cancer
fear of recurrence
longitudinal study
radiation therapy
emotional concerns
trajectory
psychological constructs
diary keeping
Additional relevant MeSH terms:
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Breast Neoplasms
Recurrence
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Disease Attributes
Pathologic Processes