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Assessing patients’ perceived bother from the gastrointestinal side effects of radiotherapy for localized prostate cancer: initial questionnaire development and validation
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Radiology, Oncology and Radiation Science, Oncology. (Vårdforskning inom onkologisk vård)
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Radiology, Oncology and Radiation Science, Oncology.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Radiology, Oncology and Radiation Science, Oncology.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Radiology, Oncology and Radiation Science, Oncology. (Vårdforskning i onkologisk vård)
2014 (English)In: Acta Oncologica, ISSN 0284-186X, E-ISSN 1651-226X, Vol. 53, no 3, 368-377 p.Article in journal (Refereed) Published
Abstract [en]

Background

The present study reports on the development and first steps of validation of the Gastrointestinal Side Effects Questionnaire (GISEQ), a measure of patient-reported gastrointestinal symptoms following local radiotherapy to the prostate. The questionnaire design provides a novel approach of assessment of side effects of prostate radiotherapy, by enabling measurement of patient-perceived change in symptoms.

Material and methods

The eight-item GISEQ was administered to 130 prostate cancer patients referred to radiotherapy. Patients completed the GISEQ at four, eight and 15 weeks after start of radiotherapy. The psychometric properties including validity, reliability, responsiveness and feasibility were evaluated. The EORTC QLQ-C30 and QLQ-PR25 were chosen as comparative measures.

Results

Expert opinion supported content validity. For concurrent validity, correlation between the GISEQ and matching items in the EORTC questionnaires was moderate but significant (r > 0.41, p < 0.001). The responsiveness was adequate, indicated by changes in GISEQ scores over time corresponding to the effects of radiation. Internal consistency was satisfactory (overall Cronbach's α> 0.70). Sensitivity and specificity for items diarrhea, constipation and blood in stools ranged from 50% to 100% and from 68% to 100%, respectively. All items had a floor effect above 15%. The response rates ranged from 85% to 92% and missing items was < 0.8%, indicating good feasibility.

Conclusions

The GISEQ showed satisfactory internal consistency and adequate content validity, concurrent validity and responsiveness. It is brief, easy to use and can be quickly evaluated, making it useful not only for research but possibly also for clinical settings. Modification of response scale and extension of items are potential improvements. Further work is needed to strengthen the psychometric qualities of the GISEQ and to evaluate its clinical use and potential effects of response shift and recall bias.

Place, publisher, year, edition, pages
2014. Vol. 53, no 3, 368-377 p.
National Category
Nursing
Identifiers
URN: urn:nbn:se:uu:diva-188191DOI: 10.3109/0284186X.2013.819994ISI: 000331804200011OAI: oai:DiVA.org:uu-188191DiVA: diva2:576737
Available from: 2012-12-13 Created: 2012-12-13 Last updated: 2017-12-06Bibliographically approved
In thesis
1. Diet and Gastrointestinal Symptoms in Patients with Prostate Cancer Treated with Radiotherapy
Open this publication in new window or tab >>Diet and Gastrointestinal Symptoms in Patients with Prostate Cancer Treated with Radiotherapy
2014 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

Objective The main objective of this thesis was to explore the effects of diet on gastrointestinal symptoms in prostate cancer patients treated with local curative radiotherapy, by evaluating dietary intake prior to treatment (Study I), the psychometric properties of a new questionnaire on patient-reported gastrointestinal side effects (Study II), and the effect of a dietary intervention on acute and long-term gastrointestinal symptoms up to 2 years after radiotherapy completion (Study III-IV).

Methods A total of 130 men with localized prostate cancer referred to dose-escalated radiotherapy (ED2 87-102 Gy, α/β=3 Gy) were recruited to a dietary intervention trial. Patients were randomized to receive either standard care plus the dietary intervention of a fibre- and lactose-restricted diet (intervention group, IG; n=64) or standard care alone (standard care group, SCG; n=66). Data on gastrointestinal symptoms and dietary intake were collected pre-treatment and at seven time points during a follow-up period of 26 months.

Results Prior to treatment, grain products and milk products were major sources of energy. Unbalanced fatty acid intake and low intake of selenium were observed (Study I). Validation of the Gastrointestinal Side Effects Questionnaire (GISEQ) revealed satisfactory internal consistency, moderate concurrent validity and adequate responsiveness (Study II). There were no significant effects of the intervention on acute or long-term gastrointestinal symptoms, but a tendency towards lower prevalence and severity of bloating and diarrhoea in the IG compared to the SCG during radiotherapy. Gastrointestinal symptoms were predominantly mild, and the frequency of clinically relevant symptoms was merely a few percent. Dietary adherence in the IG was initially good, but tended to decline beyond 12 months post-radiotherapy (Study III-IV).

Conclusions A fibre- and lactose-restricted diet was not superior to the habitual diet in reducing gastrointestinal symptoms in patients undergoing high-dose, small-volume radiotherapy for localized prostate cancer. The GISEQ enables assessment of patient-perceived change in symptoms, but further work is needed to strengthen its psychometric qualities. It is suggested that continued research in this area target patient categories referred to irradiation of larger pelvic volumes with a higher risk of gastrointestinal symptoms, and that dietary interventions incorporate established strategies to enhance adherence and effectiveness.

Place, publisher, year, edition, pages
Uppsala: Acta Universitatis Upsaliensis, 2014. 93 p.
Series
Digital Comprehensive Summaries of Uppsala Dissertations from the Faculty of Medicine, ISSN 1651-6206 ; 969
Keyword
Dietary intervention, gastrointestinal symptoms, prostate cancer, radiotherapy, randomized controlled trial, health-related quality of life, questionnaire design, nutritional assessment
National Category
Cancer and Oncology
Research subject
Medical Science
Identifiers
urn:nbn:se:uu:diva-215410 (URN)978-91-554-8861-1 (ISBN)
Public defence
2014-03-07, Enghoffsalen, Ing 50, Akademiska sjukhuset, Uppsala, 09:15 (English)
Opponent
Supervisors
Available from: 2014-02-13 Created: 2014-01-13 Last updated: 2014-04-29

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Pettersson, AnnaTuresson, IngelaPersson, ChristinaJohansson, Birgitta

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