NCT02599506

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 3, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 6, 2015

Completed
25 days until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2016

Completed
Last Updated

October 1, 2018

Status Verified

September 1, 2018

Enrollment Period

6 months

First QC Date

November 3, 2015

Last Update Submit

September 27, 2018

Conditions

Breast Cancer

Keywords

breast cancerfear of recurrencelongitudinal studyradiation therapyemotional concernstrajectorypsychological constructsdiary keeping

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • The Positive and Negative Affect Schedule (PANAS)

    4 weeks following baseline visit

  • 5 EQ-5D-3L

    6-8 weeks after treatment

Study Arms (1)

breast cancer radiation therapy

Observation over a period of all treatment sessions for radiotherapy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

In this study, 100 breast cancer patients receiving radiotherapy at the Edinburgh Cancer Centre will be recruited.

You may qualify if:

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

You may not qualify if:

  • Under 18 years old
  • Male
  • Known psychiatric illness
  • Receiving palliative radiotherapy (non-curative)
  • Unable to communicate in English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NHS Lothian Edinburgh Cancer Centre

Edinburgh, EH4 2XU, United Kingdom

Location

Related Publications (6)

  • 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. doi: 10.1348/0144665031752934.

    PMID: 15333231RESULT

  • 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. doi: 10.1136/jnnp.69.1.67.

    PMID: 10864606RESULT

  • 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. doi: 10.1007/s11136-004-7713-0.

    PMID: 16110932RESULT

  • Popov V, Ellis-Robinson A, Humphris G. Modelling reassurances of clinicians with hidden Markov models. BMC Med Res Methodol. 2019 Jan 9;19(1):11. doi: 10.1186/s12874-018-0629-0.

    PMID: 30626327DERIVED

  • Yang Y, Cameron J, Bedi C, Humphris G. Fear of cancer recurrence trajectory during radiation treatment and follow-up into survivorship of patients with breast cancer. BMC Cancer. 2018 Oct 20;18(1):1002. doi: 10.1186/s12885-018-4908-2.

    PMID: 30342495DERIVED

  • Humphris G, Yang Y, Barracliffe L, Cameron J, Bedi C. Emotional talk of patients with breast cancer during review appointments with therapeutic radiographers: effects on fears of cancer recurrence. Support Care Cancer. 2019 Jun;27(6):2143-2151. doi: 10.1007/s00520-018-4484-7. Epub 2018 Oct 1.

    PMID: 30276473DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Gerald M Humphris, PhD

    University of St Andrews

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Health Psychology

Study Record Dates

First Submitted

November 3, 2015

First Posted

November 6, 2015

Study Start

December 1, 2015

Primary Completion

June 1, 2016

Study Completion

October 31, 2016

Last Updated

October 1, 2018

Record last verified: 2018-09

Locations

GB(1)