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QuestionnaireNCT05213416

BETY-BIOPSYCHOSOCIAL QUESTIONNAIRE IN PARTİCİPANTS RECEIVING RADIOTHERAPY

An observational study of Questionnaire and Radiotherapy, run by Hacettepe University at 2 sites in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Questionnaire, Radiotherapy
How many people
150 participants
Where
2 sitesTurkey (Türkiye)
Study dates
1 Feb 2020to Dec 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients receiving radiotherapy

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Umut Bahcacı, MSc contact

+905368607324

umutbahcaci@gmail.com

Turkey (Türkiye)2 sites, 2 recruiting

  • Hacettepe University

    Ankara, 34349

    Umut Bahcacı, +905368607324, umutbahcaci@gmail.com

    Songül Atasavun Uysal, Prof. Dr.

    Recruiting

  • Florence Nightingale Hospital

    Istanbul, 34349

    Umut Bahcacı, MSc, 05368607324, umutbahcaci@gmail.com

    Şefik İğdem, Prof. Dr.

    Recruiting

Other trials in Turkey (Türkiye)

About this study

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

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.

Keywords
Reliability and Validity, Biopsychosocial Models, Questionnaire, Radiotherapy, Quality of Life, Conservative Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 1 week

Secondary outcomes (3)

  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.

    Measured: 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

    Measured: 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.

    Measured: 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2022
  2. Study start1 Feb 2020
  3. Primary completionDec 2024 (estimated)
  4. Study completionDec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05213416
Sponsor's protocol ID
BETY-BQ
Status last verified
Feb 2024
First submitted
19 Jan 2022
Last updated
28 Feb 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

An observational study of Questionnaire and Radiotherapy, run by Hacettepe University at 2 sites in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Umut Bahcacı, MSc (+905368607324, umutbahcaci@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

BETY-Biopsychosocial Questionnaire (BETY-BQ (time frame: 1 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05213416, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.

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