International validation of the EORTC QLQ-PRT20 module for assessment of quality of life symptoms relating to radiation proctitis: a phase IV study

Halkett, Georgia; Wigley, Charles A.; Aoun, Samar; Portaluri, Maurizio; Tramacere, Francesco; Livi, Lorenzo; Detti, Beatrice; Arcangeli, Stefano; Lund, Jo‐Åsmund; Kristensen, Are Korsnes; McFadden, Nathalie; Grün, Arne; Bydder, Sean; Sackerer, Irina; Greimel, Elfriede; Spry, Nigel

doi:10.1186/s13014-018-1107-x

Cited by 9 publications

(9 citation statements)

References 26 publications

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“…All patients were seen weekly after Week four, and patient toxicity was recorded on a weekly basis. Each patient completed the International Prostate Symptom Score (IPSS) questionnaire, 17 EORTC Quality of Life Questionnaire Prostate Cancer Module (EORTC QLQ PR25) and EORTC QLQ C30 Quality of Life Questionnaire 18,19 at the time of the planning CT and then weekly after the fourth week until completion of treatment.…”

Section: Methodsmentioning

confidence: 99%

Randomised controlled trial on the effect of simethicone bowel preparation on rectal variability during image‐guided radiation therapy for prostate cancer (SPoRT study)

et al. 2022

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Introduction:The purpose of this study was to assess whether simethicone reduces the rectal volume (RV) and gas volume (GV), to increase treatment accuracy and to decrease toxicity of prostate radiation therapy.Methods: 30 patients were randomised to simethicone or no intervention. Cone-beam computed tomography (CBCT) scans were performed on Days 1-3 and weekly until completion of radiation. RV and GV were measured using volume delineation. Toxicity data were collected. Results: 264 CBCTs were analysed. RV and GV were not significantly different in the simethicone group compared with the control group at each time point (P >0.05) after adjusting for Week 0 values as a covariate. The simethicone group showed an average reduction in RV and GV of 10% and 21%, respectively, compared with the control group (P >0.05). Standard deviations were calculated over 10 time points, which were grouped to represent the first 2-3 weeks of radiation therapy versus subsequent weeks. These were not significantly different between the simethicone and control group. However, there was a statistically significant decrease in the variability of RV at time points 6-10 compared with time points 1-5 within the simethicone group (P = 0.012), but no significant difference was found between these grouped time points in the control group (P = 0.581). The toxicity questionnaires showed no significant difference between the groups. Conclusions: Simethicone did not decrease the RV or GV overall. However, simethicone appeared to significantly decrease the RV variability from Week three onwards. This suggests that taking simethicone two to three weeks before starting radiation therapy may reduce RV variability, although a larger study is needed to confirm this.

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Section: Methodsmentioning

confidence: 99%

Randomised controlled trial on the effect of simethicone bowel preparation on rectal variability during image‐guided radiation therapy for prostate cancer (SPoRT study)

et al. 2022

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“…A review by Atkinson et al investigating the association between CTCAE and PRO found poor agreement between well-validated PRO measures and clinician rating (CTCAE) for proctitis among patients with rectal or anal cancer [ 52 ]. A few years later, EORTC validated the first radiation proctitis-specific quality-of-life module (QLQ-PRT20) [ 53 ]. It comprises 21 items, some of which (i.e., rectal pain, diarrhea and rectal bleeding) were already included in the pelvic item set.…”

Section: Discussionmentioning

confidence: 99%

Development of patient-reported outcomes item set to evaluate acute treatment toxicity to pelvic online magnetic resonance-guided radiotherapy

Møller

Pappot

Bernchou

et al. 2021

J Patient Rep Outcomes

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Background A new technology in cancer treatment, the MR-linac, provides online magnetic resonance-guided radiotherapy (MRgRT) that combines real-time visualization of the tumor and surrounding tissue with radiation therapy to deliver treatment more accurately. Online MRgRT makes it possible to minimize treatment volume, potentially reducing acute treatment toxicity. Patient-reported outcomes (PRO) add the patient perspective to evaluating treatment toxicity related to new technology. The objective of this mixed-methods study was to develop and explore the content validity of a set of PRO items to evaluate acute pelvic toxicity to radiotherapy including online MRgRT. Methods A literature review and chart audit were conducted to identify symptomatic adverse events (AEs) to be selected from the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) library and European Organisation for Research and Treatment of Cancer (EORTC) item library. To validate the content, the item set was applied in a prospective pilot cohort of patients referred for primary pelvic RT with curative intent. Patients reported symptoms weekly during RT (4–8 weeks) and the subsequent 4 weeks. Follow-up reports were collected at 8, 12, and 24 weeks after RT. To ensure symptom coverage clinician-reported toxicity and individual patient interviews were conducted. The symptomatic AEs were included in the final item set if ≥20% of patients reported them. Results Eighteen acute symptomatic AEs were selected for the initial item set. Forty patients (32 prostate cancer, 8 cervical cancer) were included in the pilot study. Patients with prostate cancer and those with cervical cancer both reported all 18 acute AEs. However, vomiting was not reported by > 20% of patients thus excluded from the item set. Adding a few diagnosis-specific AEs to the final item set was required for both prostate and cervical cancer patients. Conclusions A PRO item set for patients with pelvic cancer treated with radiotherapy with a curative intent was developed and content validity explored. In the pilot study, the item set captured the most common acute symptomatic AEs for patients with prostate and cervical cancer related to pelvic RT including online MRgRT. Further validation of the content in broader disease sites would be needed in future studies.

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“…EORTC QLQ-PRT20 questionnaire, unlike the speci c pathology modules of the EORTC, is focused on QoL related to side effects and is effective in detecting intestinal symptoms related to radiotherapy. In addition, it is able to identify changes in the symptoms of patients, proving to be adequate in the evaluation of acute changes after pelvic radiotherapy (9). This study was able to detect worsening of symptoms of fecal urgency and leakage, data that are usually underestimated in the assessment of quality of life.…”

Section: (15)mentioning

confidence: 88%

“…The relevence of patient reported outcomes (PROs) has increased in decision-making and, therefore, efforts have been made to standardize these data (7). The European Organisation of Research and Treatment of Cancer (EORTC) Quality of Life Group (QLG) developed the EORTC QLQ-PRT20, a module for RP that could be applied with the core QoL questionnaire EORTC QLQ-C30 (5,(8)(9)(10). The questionnaire's validation was published in 2018 by Halkett et al and it focuses on QoL related to RP, evaluating bowel symptoms that patients may experience during or after pelvic radiotherapy (9).…”

Section: Introductionmentioning

confidence: 99%

Assessment of Quality of Life Related to Radiation Proctitis in Patients Who Received Pelvic Radiotherapy

Seabra¹,

Jesus²,

Leão³

et al. 2020

Preprint

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Background: Radiotherapy is widely used in the treatment of several pelvic neoplasms, Radiation-related adverse events may result in intestinal, urinary, sexual, bone and dermatological disorders, impacting quality of life. The prevalence of radiation proctitis is probably underestimated. The aim of this study is to assess the quality of life associated with radiation proctitis in patients undergoing pelvic radiotherapy.Methods: A cohort of 40 consecutive patients from an academic institution in Brazil who received pelvic radiotherapy was analyzed. Patients completed questionnaires EORTC QLQ-C30 and EORTC QLQ-PRT20 at the beginning and at the end of treatment. Clinico-pathological features were also collected using standard templates. Results: Thirty-seven patients were included in the analysis. Thirty-two patients (80%) were male and had prostate cancer. Pelvic radiotherapy was associated with worsening bowel control (p=0.0171) leakage (p=0.0542) and pain (p=0.0074) in EORTC QLQ-PRT20. Patients had increased number of bowel movements per day after treatment (p=0.0036). Fatigue (p=0.0176) and diarrhea (p=0.0103) increased after radiation therapy. There was no statistical difference in global quality of life in patients who received radiotherapy. Conclusion: EORTC QLQ-PRT20 questionnaire is suitable for assessing the quality of life related to radiation proctitis in patients undergoing pelvic radiotherapy. This tool may help clinicians in the management and monitoring of treatment-related adverse events of this treatment modality.

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International validation of the EORTC QLQ-PRT20 module for assessment of quality of life symptoms relating to radiation proctitis: a phase IV study

Cited by 9 publications

References 26 publications

Randomised controlled trial on the effect of simethicone bowel preparation on rectal variability during image‐guided radiation therapy for prostate cancer (SPoRT study)

Randomised controlled trial on the effect of simethicone bowel preparation on rectal variability during image‐guided radiation therapy for prostate cancer (SPoRT study)

Development of patient-reported outcomes item set to evaluate acute treatment toxicity to pelvic online magnetic resonance-guided radiotherapy

Assessment of Quality of Life Related to Radiation Proctitis in Patients Who Received Pelvic Radiotherapy

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