EORTC radiation proctitis-specific quality of life module – Pretesting in four European countries

doi:10.1016/j.radonc.2010.04.001

Radiotherapy and Oncology

Volume 97, Issue 2, November 2010, Pages 294-300

https://doi.org/10.1016/j.radonc.2010.04.001 Get rights and content

Abstract

Background and purpose

Radiation proctitis is a side effect which can occur after pelvic radiation therapy. Currently available questionnaires do not comprehensively assess the range of problems, nor impact on quality of life associated with proctitis. This article reports on the cultural testing phase of an EORTC module (QLQ-PRT21) developed to assess radiation proctitis specific issues and designed to be used in conjunction with the EORTC core quality of life questionnaire (QLQ-C30).

Methods

The previously developed 21-item module, pre-tested in Australia, was translated into Norwegian, German, French and Italian. Patients completed the EORTC QLQ-C30 and module questionnaires towards the end of their radical pelvic radiation treatment to target acute side effects. Patients experiencing chronic proctitis were also surveyed. Patients also participated in structured interviews to determine issues of comprehensibility, coverage and relevance. Results were compared with Australian data.

Results

Questionnaires were completed by 64 European patients. The module was found to be relevant and culturally acceptable to participants. Feedback has led to minor translation modifications and the inclusion of two additional questions.

Conclusion

This module is ready for Phase IV testing which will consist of large scale field testing with the aim to perform psychometric analysis and finalise a module that will be suitable in the assessment of radiation induced proctitis.

Section snippets

Methods and materials

The four stages for the development of EORTC modules include:

Phase I: Generation of quality of life issues.
Phase II: Construction of issues into a provisional questionnaire.
Phase III: Testing of the questionnaire for acceptability and relevance.
Phase IV Field testing in an international group of patients [19].

We have already reported the development of the module up to the point of International pretesting [18]. However, the module was developed only in English and tested in the Australian

Quantitative analysis

Individual items for the proctitis module responses were scored from 1 = not at all to 4 = very much. Data were entered into SPSS version 17 and analysed using descriptive statistics. Demographic data and mean scores for each item of the proctitis module were compared numerically with the Australian data previously collected. Participants’ responses to the interview questions were compiled into a table to determine what changes needed to be made to the translated questionnaires and whether all

Sample

Questionnaires and interviews were completed by 64 European patients. Their characteristics are recorded in Table 1. Nearly eighty percent (n = 50) of participants were male and 70% (n = 44) of the patients had prostate cancer. Patients recruited in Europe were significantly younger (mean age 67 years vs. 72 years, independent t-test p = 0.017), and more commonly undergoing treatment (64% vs. 46%, Chi Square test p > 0.05) than the assessed Australian cohort. Patients over the age of 80 were recruited in

Discussion

The international Phase III pretesting of the provisional proctitis module (EORTC QLQ-PRT21) has been successfully completed according to EORTC guidelines [19]. Minor modifications to the translated items were not considered sufficient to require further pretesting. The module is now identified as EORTC QLQ-PRT23 because two additional items have been identified for inclusion. The questionnaire will now proceed to phase IV testing.

In total, 92 patients participated in five counties (including

Conclusion

We have developed and pre-tested a proctitis module (EORTC QLQ-PRT23) that can be used in conjunction with the EORTC quality of life questionnaire. Following large scale field testing of this module, it is planned that this module will be suitable to be employed for the assessment of the endpoint of radiation induced proctitis.

Acknowledgements

This project was supported by an Edith Cowan University Industry Collaborative Grant. The authors wish to thank the EORTC QoL Group for their ongoing support and advice. The authors would also like to thank the staff who assisted with data collection in each of the countries involved and the patients who participated.

References (22)

K. Leiper et al.
Treatment of radiation proctitis
Clin Oncol
(2007)
K. Jones et al.
Treatment of radiation proctitis with hyperbaric oxygen
Radiother Oncol
(2006)
A. Capp et al.
Is there more than one proctitis syndrome? A revisitation using data from the TROG 96.01 trial
Radiother Oncol
(2009)
S. Aaltomaa et al.
Eight years experience of local prostate cancer treatment with permanent I125 seed brachytherapy – morbidity and outcome results
Radiother Oncol
(2009)
J. Giralt et al.
Pre-operative chemoradiotherapy with UFT and Leucovorin in patients with advanced rectal cancer: a phase II study
Radiother Oncol
(2008)
J. Colwell et al.
A review of radiation proctitis in the treatment of prostate cancer
J Wound Ostomy Continence Nurs
(2000)
J. Cox et al.
Toxicity criteria of the radiation therapy oncology group (RTOG) and the European Organization for Research and Treatment of Cancer (EORTC)
Int J Radiat Oncol Biol Phys
(1995)
V. Fonteyne et al.
Late radiotherapy-induced lower intestinal toxicity (RILIT) of intensity-modulated radiotherapy for prostate cancer: The need for adapting toxicity scales and the appearance of the sigmoid colon as co-responsible organ for lower intestinal toxicity
Radiother Oncol
(2007)
H. Geinitz et al.
Late rectal symptoms and quality of life after conformal radiation therapy for prostate cancer
Radiother Oncol
(2006)
N. Spry et al.
Development of an EORTC module to assess the quality of life of patients with proctitis following pelvic radiotherapy for malignancy
International Journal of Radiation Oncology, Biology and Physics
(2008)

D. Hayne et al.

Anorectal injury following Pelvic radiotherapy

Br J Surg

(2001)

Cited by (13)

Analysis of Radiation Dose/Volume Effect Relationship for Anorectal Morbidity in Children Treated for Pelvic Malignancies
2021, International Journal of Radiation Oncology Biology Physics
Citation Excerpt :
Anorectal morbidity endpoints examined followed morbidity analysis data from adults treated with image guided brachytherapy and included rectal bleeding, proctitis, stenosis, and fistula.21 Based on radiation proctitis-specific quality of life analyses from the European Organization for Research and Treatment of Cancer, the following endpoints were also included: encopresis, transit disorders (diarrhea and/or constipation) and, if associated with other anorectal symptoms, abdominopelvic pain.27 Anorectal events were analyzed independently and together as overall anorectal morbidity.
To examine dose-volume effect relationships for anorectal morbidity in children treated with image-guided brachytherapy for pelvic tumors.
Medical records of all consecutive children with pelvic tumors treated in our center and receiving image-guided pulsed-dose-rate brachytherapy with or without external beam radiation therapy (EBRT) between 2005 and 2019 were reviewed. The effect of the minimal doses to the most exposed 0.5 cm³, 1 cm³, and 2 cm³ of the anorectum (respectively: D_0.5cm³, D_1cm³, and D_2cm³), total reference air kerma (TRAK), and volume of 100% isodose was examined for anorectal toxicities.
Seventy-eight consecutive children were included. Median age was 2.9 years (range, 0.8-14.9 years). Most of the tumors were bladder or prostate (67%) or vaginal (22%) rhabdomyosarcoma. Six patients received EBRT in addition to brachytherapy. Median follow-up was 21.3 months. At last follow-up, 30 children (38%) had experienced Common Terminology Criteria for Adverse Events version 5 grade ≥1 acute or late anorectal events: 24% had grade 1 events, 7.7% had grade 2 events, and 6.4% had grade 3 events. No toxicity greater than grade 3 was observed (eg, fistula or stricture). In univariate analysis, the D_0.5cm³ and D_1cm³ were significant for probability of grade 1 to 3 (P = .009 and P = .017, respectively) and grade 2 to 3 anorectal morbidity (P = .007 and P = .049, respectively). There was no significant correlation for D_2cm³ (P = .057 for grade 1-3; P = .407 for grade 2-3). A 10% probability (95% confidence interval, 4%-20%) for anorectal toxicity of grade 2 or greater was reached for a D_0.5cm³ = 52 Gy. The age, EBRT use, TRAK, and treated volume values were not significant.
To our knowledge, this study is the first to show a significant dose–volume effect relationships for anorectal morbidity in children undergoing treatment with brachytherapy. Integrating these data into brachytherapy treatment planning could help to optimize the therapeutic index in these young patients.
Efficacy of synbiotics to reduce acute radiation proctitis symptoms and improve quality of life: A randomized, double-blind, placebo-controlled pilot trial
2014, International Journal of Radiation Oncology Biology Physics
Citation Excerpt :
Patient compliance with the intake of the sachets in both groups was ensured during the follow-up in every week. Each participant answered the questions of the EORTC QLQ-PRT23 (European Organization for Research and Treatment of Cancer Quality of Life Module for Proctitis–23 items) questionnaire (21, 22) before the beginning of radiation therapy and immediately after the first, second, third, and fourth weeks of treatment. The questions were always asked by an examiner blinded to the study design and type of treatment used.
To evaluate whether the daily intake of synbiotics interferes in radiation-induced acute proctitis symptoms and in quality of life in patients with prostate cancer.
Twenty patients who underwent 3-dimensional conformal radiation therapy for prostate cancer were randomized to intake either a synbiotic powder containing Lactobacillus reuteri 10⁸ colony-forming units and 4.3 g of soluble fiber (Nestlé) or placebo. The questionnaire EORTC QLQ-PRT23 was applied before the beginning of radiation therapy and in every week for the first 4 weeks of treatment. The sum of both the complete (proctitis symptoms plus quality of life) and partial (proctitis symptoms) scores of the EORTC QLQ-PRT23 (European Organization for Research and Treatment of Cancer Quality of Life Module for Proctitis–23 items) questionnaire were the main endpoints.
This pilot study showed that the complete questionnaire score (median [range]) was higher in the second (23 [21-30] vs 26.5 [22-34], P<.05) and third (23 [21-32] vs 27.5 [24-33], P<.01) weeks in the placebo group. Proctitis symptoms were highest scored in the placebo group in both the second (19.5 [16-25]) and third (19 [17-24]) weeks than in the synbiotic group (week 2: 16.5 [15-20], P<.05; week 3: 17 [15-23], P<.01). In both scores the placebo group had a significantly higher result (P<.01) than the synbiotic group (repeated-measures analysis of variance).
Synbiotics reduce proctitis symptoms and improve quality of life in radiation-induced acute proctitis during radiation therapy for prostate cancer.
The impact of gastrointestinal and genitourinary toxicity on health related quality of life among irradiated prostate cancer patients
2014, Radiotherapy and Oncology
Citation Excerpt :
From this point of view, it remains uncertain if the clinical introduction of new radiation techniques aiming at reducing the dose to specific anatomical structures will also results in a reduction of rectal pain and eventually in better HRQoL. To investigate the uncertainties surrounding the concept of radiation proctitis the new EORTC proctitis module, including items regarding pain and painful cramping [36], offers an opportunity to look at this toxicity more closely. In the present study, no effect of radiation technique (3D-CRT versus IMRT) and hormonal therapy (yes versus no) on HRQoL was observed.
To determine the impact of late radiation-induced toxicity on health-related quality of life (HRQoL) among patients with prostate cancer.
The study sample was composed of 227 patients, treated with external beam radiotherapy. Common Terminology Criteria for Adverse Events version 3.0 were used to grade late genitourinary and gastrointestinal toxicity. The European Organization for Research and Treatment of Cancer Quality of life Questionnaire C30 (EORTC QLQ-C30) was used to assess HRQoL at baseline, and 6, 12 and 24 months after completion of radiotherapy. Statistical analysis was performed using a multivariate analysis of variance (MANOVA).
Urinary incontinence and rectal discomfort significantly affected HRQoL. The impact of urinary incontinence on HRQoL was most pronounced 6 months after radiotherapy and gradually decreased over time. The impact of rectal discomfort on HRQoL was predominant at 6 months after radiotherapy, decreased at 12 months and increased again 2 years after radiotherapy. No significant impact on HRQoL was observed for any of the other toxicity endpoints, or non-toxicity related factors such as hormonal therapy, radiotherapy technique or age.
Urinary incontinence and rectal discomfort have a significant impact on HRQoL. Prevention of these side effects may likely improve quality of life of prostate cancer patients after completion of treatment.
Long-term control of refractory hemorrhagic radiation proctitis with ozone therapy
2013, Journal of Pain and Symptom Management
Citation Excerpt :
There are no specific criteria for the diagnosis and assessment of the different symptoms of radiation proctitis and their impact on patient quality of life. Currently, the European Organization for Research and Treatment of Cancer is in the process of validating a specific questionnaire to address this issue.8 Mild symptoms of radiation proctitis may remit spontaneously without specific therapy within six months in up to a third of affected patients.1
Persistent or severe hemorrhagic radiation proctitis (HRP) has limited therapeutic options.
To describe our experience with ozone therapy (O₃T) in the management of refractory HRP.
Patients (n = 17; median age 69 years [range 42–80 years]) previously irradiated for prostate or uterine cancer and suffering persistent or severe HRP without response to conventional treatment were enrolled to receive an O₃/O₂ gas mixture via rectal insufflations and topical application of ozonized oil. Most of the patients (83%) had Grade 3 or Grade 4 toxicity. Median follow-up post-O₃T was 40 months (range 3–56 months).
Endoscopic treatments required were: 43 (median 1; range 0–10) pre-O₃T; 17 (median 0; range 0–8; P = 0.063) during O₃T; and five (median 0; range 0–2; P = 0.008) during follow-up. Hemoglobin levels were 10.35 g/dL (7–14 g/dL) pre-O₃T and 13 g/dL (9–15 g/dL) (P = 0.001) post-O₃T. Median toxicity grades were 3 (range 2–4) pre-O₃T, 1 (range 0–2; P < 0.001) at the end of O₃T, and 0 (range 0–1; P < 0.001) at the last follow-up.
Persistent advanced HRP was significantly improved with O₃T. The addition of O₃T can be useful as a complementary treatment in the long-term management of HRP and, as such, merits further evaluation.
A Systematic Review of Population-Based Studies of Chronic Bowel Symptoms in Cancer Survivors following Pelvic Radiotherapy
2023, Cancers
Argon plasma: therapeutic response and quality of life in patients with radiation proctitis
2022, Revista Habanera de Ciencias Medicas

View all citing articles on Scopus

View full text

Quality of lifeEORTC radiation proctitis-specific quality of life module – Pretesting in four European countries

Abstract

Background and purpose

Methods

Results

Conclusion

Section snippets

Methods and materials

Quantitative analysis

Sample

Discussion

Conclusion

Acknowledgements

Clin Oncol

Radiother Oncol

Radiother Oncol

Radiother Oncol

Radiother Oncol

J Wound Ostomy Continence Nurs

Int J Radiat Oncol Biol Phys

Radiother Oncol

Radiother Oncol

International Journal of Radiation Oncology, Biology and Physics

Anorectal injury following Pelvic radiotherapy

Br J Surg

Quality of life
EORTC radiation proctitis-specific quality of life module – Pretesting in four European countries