BETY-BIOPSYCHOSOCIAL QUESTIONNAIRE IN PARTİCİPANTS RECEIVING RADIOTHERAPY

February 26, 2024 updated by: Umut Bahçacı, Hacettepe University

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Ankara, Turkey, 34349
        • Recruiting
        • Hacettepe University
        • Contact:
        • Contact:
          • Songül Atasavun Uysal, Prof. Dr.
        • Sub-Investigator:
          • Nilay Şahan
        • Sub-Investigator:
          • Mustafa Cengiz
        • Sub-Investigator:
          • Edibe Ünal
        • Principal Investigator:
          • Songül Atasavun Uysal
      • Istanbul, Turkey, 34349
        • Recruiting
        • Florence Nightingale Hospital
        • Contact:
        • Sub-Investigator:
          • Şefik İğdem, Prof. Dr.
        • Principal Investigator:
          • Umut Bahçacı

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients receiving radiotherapy

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 week
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
1 week
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.
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Investigators

  • Study Director: Songül Atasavun Uysal, Prof., Hacettepe University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2020

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

January 19, 2022

First Submitted That Met QC Criteria

January 19, 2022

First Posted (Actual)

January 28, 2022

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 26, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • BETY-BQ

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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