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RecruitingNCT05213416Updated Feb 28, 2024

BETY-BIOPSYCHOSOCIAL QUESTIONNAIRE IN PARTİCİPANTS RECEIVING RADIOTHERAPY

An observational study in Questionnaire and Radiotherapy, sponsored by Hacettepe University. Recruiting at 2 sites in Turkey. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-02-28.

Sponsored by Hacettepe University · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as recruiting.
  • Started Feb 2020; still recruiting 6 years 8 months later.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
150
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the detailed description

It is known that psycho-physiological processes affect the results of medical treatment in chronic diseases [1]. In oncological rehabilitation, the psychological, social and functional problems of individuals with cancer are considered together, and goals of the treatment are determined based on this [2]. Biopsychosocial being of human is the main reason for this approach. BETY-Biopsychosocial Questionnaire (BETY-BQ) originates from the Cognitive Exercise Therapy Approach (CETA) which is an innovative exercise approach that targets a holistic treatment techniques in accordance with the biopsychosocial model [3]. This approach contains concepts including function-oriented trunk stabilization exercises, pain management, mood management (dance therapy-authentic movement), sexual knowledge management which are combined with each other. It was first used in patients with ankylosing spondylitis and was observed that besides its positive effects on disease activity, and also provided positive changes in anti-inflammatory parameters [4]. CETA has taken its place in the literature as a biopsychosocial exercise model that can be applied safely in individuals with Multiple Sclerosis [5]. Patients with rheumatism, who have participated in CETA training since 2004, described their recovery characteristics in 2013. The questionary was finalized in 2017 by applying these feedbacks to repetitive statistics and rheumatic patients who did not participate in the group [6]. Validity and reliability studies of the developed scale were conducted in individuals diagnosed with Fibromyalgia, Rheumatoid Arthritis, Osteoarthritis, and individuals with chronic neck and chronic low back pain [3, 7].

Radiotherapy reduces the recurrence rate and provides disease control in patients with cancer [8, 9] However, studies have shown that individuals receiving radiotherapy may experience treatment-related problems such as pain, limitation of movement, and even fractures [10-12]. Cognitive changes such as learning and memory, attention to the painful area, which develop with the influenced limbic system, increase the avoidance of movements. Herewith, the developing muscle spasm, pain and negative mood which results in vicious circle, can be experienced that leads to limitation of movement. Therefore, physical and psychosocial factors are also associated with musculoskeletal disorders [13]. Determining the biopsychosocial status of individuals receiving radiotherapy should be considered when evaluating the effectiveness of treatment. However, when the literature in this field is examined, it is clear that there is a need for biopsychosocial assessment tools.

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

02

Conditions studied

  • Questionnaire
  • Radiotherapy

Keywords

  • Reliability and Validity
  • Biopsychosocial Models
  • Questionnaire
  • Radiotherapy
  • Quality of Life
  • Conservative Treatment
03

In context

Lead sponsor

Hacettepe University is the lead sponsor of 983 studies on the registry; 212 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients receiving radiotherapy

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
150 participants (estimated)
Patient registry
No
06

What researchers measure

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

    Time frame: 1 week

Secondary outcomes

  1. Quality of Life Scale Short Form-36 (SF-36)

    It is one of the frequently used scales to measure quality of life. It evaluates 8 different categories such as general health perception, physical function, social function, pain, mental health, role difficulty due to physical reasons, role difficulty due to emotional reasons, and vitality with a total of 36 sub-items. Items are scored as '0 = worst health condition 100 = best health state'. Each subcategory is scored between 0 and 100 points, with a high score indicating good health.

    Time frame: 1 week

  2. Functional Assessment of Cancer Therapy-General (FACT-G)

    It is used to evaluate the multifaceted quality of life in cancer patients; It is a general 27-item scale in which patients evaluate their own condition. There are 4 sub-scales in the questionnaire that evaluate physical, social, emotional and functional status. Participants will be asked how appropriate a particular statement was to them in the past 7 days on a 5-point scale as '0: never; 1: a little, 2: a little; 3: quite; 4: too much'. High scores indicate a high quality of life, and low scores indicate a decreased quality of life

    Time frame: 1 week

  3. Hospital Anxiety and Depression Scale (HADS)

    It is a scale consisting of 14 questions which 7 of these questions assess anxiety and 7 assess depression. Likert type measurement is used to evaluate this scale. The cut-off score for the anxiety subscale is 10/11 and for the depression subscale is 7/8. Accordingly, those who score above these scores are considered at risk.

    Time frame: 1 week

07

Study locations

2 of 2 sites recruiting
  • Hacettepe University
    Ankara, 34349, Turkey
    • Umut Bahcacı · Contact · umutbahcaci@gmail.com · +905368607324
    • Songül Atasavun Uysal, Prof. Dr. · Contact
    • Nilay Şahan · Sub investigator
    • Mustafa Cengiz · Sub investigator
    • Edibe Ünal · Sub investigator
    • Songül Atasavun Uysal · Principal investigator
    Recruiting
  • Florence Nightingale Hospital
    Istanbul, 34349, Turkey
    • Umut Bahcacı, MSc · Contact · umutbahcaci@gmail.com · 05368607324
    • Şefik İğdem, Prof. Dr. · Sub investigator
    • Umut Bahçacı · Principal investigator
    Recruiting
08

References and documents

Publications

  • 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. PubMed 2341695 ↗
  • 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. PubMed 29183040 ↗
  • Oflaz, F.B., Bilişsel Egzersiz Terapi Yaklaşımı Ölçeği'nin Romatoid Artrit Tanısı Alan Bireylerde Geçerliği, Güvenirliği Ve Duyarlılığının Belirlenmesi. 2018, Sağlık Bilimleri Enstitüsü.
  • 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. PubMed 26850804 ↗
  • Küçüktepe, İ., et al., Multiple sklerozlu bireylerde Bilişsel Egzersiz Terapi Yaklaşımı'nın yorgunluk ve denge üzerine etkileri. 2018. 5(2): p. 74-81.
  • 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.
  • ZAHİD, M., Bilişsel Egzersiz Terapi Yaklaşımı Ölçeği'nin Fibromiyalji Tanısı Alan Bireylerde Geçerliği, Güvenirliği ve Duyarlılığının Belirlenmesi. 2018, Sağlık Bilimleri Enstitüsü
  • 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. PubMed 22019144 ↗
  • Citrin DE. Recent Developments in Radiotherapy. N Engl J Med. 2017 Sep 14;377(11):1065-1075. doi: 10.1056/NEJMra1608986. No abstract available. PubMed 28902591 ↗
  • 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. PubMed 31320114 ↗
  • 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. PubMed 21083535 ↗
  • 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. PubMed 9135487 ↗
  • 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. PubMed 8673184 ↗
  • 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.
  • 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. PubMed 8445433 ↗
  • Aydemir, O.J.T.P.D., Hastane anksiyete ve depresyon olcegi Turkce formunun gecerlilik ve guvenilirligi. 1997. 8: p. 187-280.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05213416
Lead sponsor
Hacettepe University
Responsible party
Umut Bahçacı (Principal investigator, Hacettepe University) — Principal investigator
First posted
Jan 28, 2022
Start date
Feb 1, 2020
Primary completion
Dec 2024 (estimated)
Completion
Dec 2024 (estimated)
Last update
Feb 28, 2024

Study contacts

Umut Bahcacı, MSc
Contact
umutbahcaci@gmail.com
+905368607324
Songül Atasavun Uysal, Prof.
study director · Hacettepe University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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