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ClinicalTrials.gov Identifier: NCT05213416
Recruitment Status : Recruiting
First Posted : January 28, 2022
Last Update Posted : January 31, 2023
Information provided by (Responsible Party):
Umut Bahçacı, Hacettepe University

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.

Condition or disease
Questionnaire Radiotherapy

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.

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Actual Study Start Date : February 1, 2020
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : January 2024

Primary Outcome Measures :
  1. BETY-Biopsychosocial Questionnaire (BETY-BQ [ Time Frame: 1 week ]
    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

Secondary Outcome Measures :
  1. Quality of Life Scale Short Form-36 (SF-36) [ Time Frame: 1 week ]
    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.

  2. Functional Assessment of Cancer Therapy-General (FACT-G) [ Time Frame: 1 week ]
    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

  3. Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 1 week ]
    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.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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:

  • 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

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): NCT05213416

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Contact: Umut Bahcacı, MSc +905368607324 umutbahcaci@gmail.com

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Hacettepe University Recruiting
Ankara, Turkey, 34349
Contact: Umut Bahcacı    +905368607324    umutbahcaci@gmail.com   
Contact: Songül Atasavun Uysal, Prof. Dr.         
Sub-Investigator: Nilay Şahan         
Sub-Investigator: Mustafa Cengiz         
Sub-Investigator: Edibe Ünal         
Principal Investigator: Songül Atasavun Uysal         
Florence Nightingale Hospital Recruiting
Istanbul, Turkey, 34349
Contact: Umut Bahcacı, MSc    05368607324    umutbahcaci@gmail.com   
Sub-Investigator: Şefik İğdem, Prof. Dr.         
Principal Investigator: Umut Bahçacı         
Sponsors and Collaborators
Hacettepe University
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Study Director: Songül Atasavun Uysal, Prof. Hacettepe University
Oflaz, F.B., Bilişsel Egzersiz Terapi Yaklaşımı Ölçeği'nin Romatoid Artrit Tanısı Alan Bireylerde Geçerliği, Güvenirliği Ve Duyarlılığının Belirlenmesi. 2018, Sağlık Bilimleri Enstitüsü.
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
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.
Aydemir, O.J.T.P.D., Hastane anksiyete ve depresyon olcegi Turkce formunun gecerlilik ve guvenilirligi. 1997. 8: p. 187-280.

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Responsible Party: Umut Bahçacı, Principal investigator, Hacettepe University
ClinicalTrials.gov Identifier: NCT05213416    
Other Study ID Numbers: BETY-BQ
First Posted: January 28, 2022    Key Record Dates
Last Update Posted: January 31, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Umut Bahçacı, Hacettepe University:
Reliability and Validity
Biopsychosocial Models
Quality of Life
Conservative Treatment