BETY-BIOPSYCHOSOCIAL QUESTIONNAIRE IN PARTİCİPANTS RECEIVING RADIOTHERAPY

Radiotherapy Clinical Trial

Official title:

VALIDITY AND RELIABILITY OF THE BETY-BIOPSYCHOSOCIAL QUESTIONNAIRE (BETY-BQ) IN PARTİCİPANTS RECEIVING RADIOTHERAPY

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05213416
• Other study ID #: BETY-BQ
• Status: Recruiting
• Start date: February 1, 2020
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Hacettepe University
• Contact: Umut Bahcaci, MSc
• Phone: +905368607324
• Email: umutbahcaci[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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:

• 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

Related Conditions & MeSH terms

• Questionnaire
• Radiotherapy

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara
Turkey	Florence Nightingale Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (16)

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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. — View Citation

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

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. — View Citation

Edibe, Ü., et al., Romatizmali hastalar için bir yasam kalitesi ölçeginin gelistirilmesi: madde havuzunun olusturulmasi. Journal of Exercise Therapy and Rehabilitation 2017. 4(2): p. 67-75.

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. — View Citation

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. — View Citation

Koçyigit, H., Ö. Aydemir, and G.J.R.h.o.b.g.h.i.ç.I.v.T.D. Fisek, Kisa Form-36'nin (KF-36) Türkçe için güvenilirligi ve geçerliligi. 1999. 12: p. 102-106.

Küçüktepe, I., et al., Multiple sklerozlu bireylerde Bilissel Egzersiz Terapi Yaklasimi'nin yorgunluk ve denge u¨zerine etkileri. 2018. 5(2): p. 74-81.

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. — View Citation

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. — View Citation

Oflaz, F.B., Bilissel Egzersiz Terapi Yaklasimi Ölçegi'nin Romatoid Artrit Tanisi Alan Bireylerde Geçerligi, Güvenirligi Ve Duyarliliginin Belirlenmesi. 2018, Saglik Bilimleri Enstitüsü.

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. — View Citation

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. — View Citation

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. — View Citation

ZAHID, M., Bilissel Egzersiz Terapi Yaklasimi Ölçegi'nin Fibromiyalji Tanisi Alan Bireylerde Geçerligi, Güvenirligi ve Duyarliliginin Belirlenmesi. 2018, Saglik Bilimleri Enstitüsü

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	1 week
Secondary	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	1 week
Secondary	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.	1 week