NCT05213416

Brief Summary

The aim of this study is to investigate the validity and reliability of BETY-BQ as a biopsychosocial assessment tool in individuals receiving radiotherapy.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2020

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Study Start

First participant enrolled

February 1, 2020

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

January 19, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 28, 2022

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

4.8 years

First QC Date

January 19, 2022

Last Update Submit

February 26, 2024

Conditions

QuestionnaireRadiotherapy

Keywords

Reliability and ValidityBiopsychosocial ModelsQuestionnaireRadiotherapyQuality of LifeConservative Treatment

Outcome Measures

Primary Outcomes (1)

  • BETY-Biopsychosocial Questionnaire (BETY-BQ

    It is used to evaluate the biopsychosocial process associated with the disease. A 5-point Likert system is used to score this scale. Each question is scored as "0= never, 1=yes rarely, 2=yes sometimes, 3=yes often 4=yes always" and gives a total score over 30 items. A high score means a low biopsychosocial level

    1 week

Secondary Outcomes (3)

  • Quality of Life Scale Short Form-36 (SF-36)

    1 week

  • Functional Assessment of Cancer Therapy-General (FACT-G)

    1 week

  • Hospital Anxiety and Depression Scale (HADS)

    1 week

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients receiving radiotherapy

You may qualify if:

  • Having been diagnosed with cancer
  • Receiving radiotherapy from cancer treatments
  • Cancer stage between 1-3
  • Being between the ages of 18-70
  • Having a Mini Mental Test Score of 24 and above

You may not qualify if:

  • Not being able to read and/or understand the questionaries
  • Not being willing to participate in the study
  • Having a neurological disease which affects the cognition
  • History of orthopaedic surgery in the last three years
  • Presence of psychiatric diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hacettepe University

Ankara, 34349, Turkey (Türkiye)

RECRUITING

Florence Nightingale Hospital

Istanbul, 34349, Turkey (Türkiye)

RECRUITING

Related Publications (16)

  • Kline Leidy N, Ozbolt JG, Swain MA. Psychophysiological processes of stress in chronic physical illness: a theoretical perspective. J Adv Nurs. 1990 Apr;15(4):478-86. doi: 10.1111/j.1365-2648.1990.tb01843.x.

    PMID: 2341695BACKGROUND

  • Rick O, Dauelsberg T, Kalusche-Bontemps EM. Oncological Rehabilitation. Oncol Res Treat. 2017;40(12):772-777. doi: 10.1159/000481709. Epub 2017 Nov 29.

    PMID: 29183040BACKGROUND

  • Oflaz, F.B., Bilişsel Egzersiz Terapi Yaklaşımı Ölçeği'nin Romatoid Artrit Tanısı Alan Bireylerde Geçerliği, Güvenirliği Ve Duyarlılığının Belirlenmesi. 2018, Sağlık Bilimleri Enstitüsü.

    BACKGROUND

  • Kisacik P, Unal E, Akman U, Yapali G, Karabulut E, Akdogan A. Investigating the effects of a multidimensional exercise program on symptoms and antiinflammatory status in female patients with ankylosing spondylitis. Complement Ther Clin Pract. 2016 Feb;22:38-43. doi: 10.1016/j.ctcp.2015.11.002. Epub 2015 Dec 2.

    PMID: 26850804BACKGROUND

  • Küçüktepe, İ., et al., Multiple sklerozlu bireylerde Bilişsel Egzersiz Terapi Yaklaşımı'nın yorgunluk ve denge üzerine etkileri. 2018. 5(2): p. 74-81.

    BACKGROUND

  • Edibe, Ü., et al., Romatizmalı hastalar için bir yaşam kalitesi ölçeğinin geliştirilmesi: madde havuzunun oluşturulması. Journal of Exercise Therapy and Rehabilitation 2017. 4(2): p. 67-75.

    BACKGROUND

  • ZAHİD, M., Bilişsel Egzersiz Terapi Yaklaşımı Ölçeği'nin Fibromiyalji Tanısı Alan Bireylerde Geçerliği, Güvenirliği ve Duyarlılığının Belirlenmesi. 2018, Sağlık Bilimleri Enstitüsü

    BACKGROUND

  • Early Breast Cancer Trialists' Collaborative Group (EBCTCG); Darby S, McGale P, Correa C, Taylor C, Arriagada R, Clarke M, Cutter D, Davies C, Ewertz M, Godwin J, Gray R, Pierce L, Whelan T, Wang Y, Peto R. Effect of radiotherapy after breast-conserving surgery on 10-year recurrence and 15-year breast cancer death: meta-analysis of individual patient data for 10,801 women in 17 randomised trials. Lancet. 2011 Nov 12;378(9804):1707-16. doi: 10.1016/S0140-6736(11)61629-2. Epub 2011 Oct 19.

    PMID: 22019144BACKGROUND

  • Citrin DE. Recent Developments in Radiotherapy. N Engl J Med. 2017 Sep 14;377(11):1065-1075. doi: 10.1056/NEJMra1608986. No abstract available.

    PMID: 28902591BACKGROUND

  • Vallejo Bernad C, Casamayor Franco MDC, Perez-Tierra Ruiz JV, Martinez Lahoz Y, Carrasquer Puyal A, Pallares Segura JL, Sanchez Marin JP, Barra Pardos MV. Breast-conserving surgery in breast cancer and intraoperative radiotherapy. Can we predict the fibrosis? Cir Esp (Engl Ed). 2019 Nov;97(9):517-522. doi: 10.1016/j.ciresp.2019.05.012. Epub 2019 Jul 15. English, Spanish.

    PMID: 31320114BACKGROUND

  • Mavrogenis AF, Papagelopoulos PJ, Romantini M, Guerra G, Ruggieri P. Side effects of radiation in musculoskeletal oncology. J Long Term Eff Med Implants. 2009;19(4):287-304. doi: 10.1615/jlongtermeffmedimplants.v19.i4.60.

    PMID: 21083535BACKGROUND

  • Liljegren G, Holmberg L. Arm morbidity after sector resection and axillary dissection with or without postoperative radiotherapy in breast cancer stage I. Results from a randomised trial. Uppsala-Orebro Breast Cancer Study Group. Eur J Cancer. 1997 Feb;33(2):193-9. doi: 10.1016/s0959-8049(96)00375-9.

    PMID: 9135487BACKGROUND

  • Skov T, Borg V, Orhede E. Psychosocial and physical risk factors for musculoskeletal disorders of the neck, shoulders, and lower back in salespeople. Occup Environ Med. 1996 May;53(5):351-6. doi: 10.1136/oem.53.5.351.

    PMID: 8673184BACKGROUND

  • Koçyiğit, H., Ö. Aydemir, and G.J.R.h.o.b.g.h.i.ç.İ.v.T.D. Fişek, Kısa Form-36'nın (KF-36) Türkçe için güvenilirliği ve geçerliliği. 1999. 12: p. 102-106.

    BACKGROUND

  • Cella DF, Tulsky DS, Gray G, Sarafian B, Linn E, Bonomi A, Silberman M, Yellen SB, Winicour P, Brannon J, et al. The Functional Assessment of Cancer Therapy scale: development and validation of the general measure. J Clin Oncol. 1993 Mar;11(3):570-9. doi: 10.1200/JCO.1993.11.3.570.

    PMID: 8445433BACKGROUND

  • Aydemir, O.J.T.P.D., Hastane anksiyete ve depresyon olcegi Turkce formunun gecerlilik ve guvenilirligi. 1997. 8: p. 187-280.

    BACKGROUND

Study Officials

  • Songül Atasavun Uysal, Prof.

    Hacettepe University

    STUDY DIRECTOR

Central Study Contacts

Umut Bahcacı, MSc

CONTACT

+905368607324umutbahcaci@gmail.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 19, 2022

First Posted

January 28, 2022

Study Start

February 1, 2020

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

February 28, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(2)