Update of the EORTC QLQ-PAN26 questionnaire for the assessment of health-related quality of life (HRQoL) in patients with pancreatic adenocarcinoma

Study ID: 51710
Short Title: Update of the EORTC QLQ-PAN26
Trust Name: UHS
Recruitment Site: Southampton General Hospital
Disease Area: Upper GI
Phase: N/A
Expected End Date: 31/03/2024
Postcode: SO16 6YD
Contact Name: Amanda Pattie
Contact Email: studysupport1and3.crnwessex@nihr.ac.uk
Active: Yes

Inclusion criteria, exclusion criteria and study summary

Patient participants inclusion criteria a.Adults aged > = 18 years b.Histologically proven as adenocarcinoma of the pancreas (head, body, tail) with disease stages I-IV. c.Patients receiving treatment (either currently or within the last 12 months) including a systemic treatment (chemotherapy, radiotherapy or chemoradiotherapy), biological and immunotherapy), surgical resection, and radiotherapy or receiving supportive or palliative care. d.Patients who are willing and able to give fully informed consent to participate. e.Patients who are currently enrolled in a clinical trial of a therapeutic agent (phase I-II) whose enrolment in this study is permitted under the trial eligibility criteria AND where any concurrent quality of life assessment (e.g., as part of the trial endpoint) will not affect the results of the current study. For example, inclusion would include a trial where the EORTC QLQ-C30 and QLQ-PAN26 are being formally used for the assessment of quality of life. Health Care Professional inclusion criteria a.Adults aged > = 18 years b.Clinician, nurse, or other HCP (e.g., advanced practitioner) with specific senior expertise and experience (> 2 years) in the treatment and care of patients with PDAC (e.g., oncology, surgery, radiotherapy, specialist nurse, palliative care). c.Willingness to undertake an interview or written questionnaire in English.

Patient participants exclusion criteria a.Patients under 18 years of age. b.Patients with a concurrent malignancy. c.Patients enrolled in other quality of life studies which will affect the results of the current study. Health Care Professional exclusion criteria a.HCPs under 18 years of age. b.HCPs with limited experience (< 2 years).

The measure for Health-Related Quality of Life (HRQoL) in pancreatic cancer (EORTC QLQ-PAN26), was developed by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group in 1996. As new treatments are now available for pancreatic cancer new symptoms and side-effects are being reported. A review is needed to see if the EORTC QLQ-PAN26 needs to be updated. We will invite people diagnosed with Pancreatic Duct Adenocarcinoma (PDAC; n= 95), and senior Health Care Professionals (HCP) with PDAC expertise (n= 20) for interviews in an international study. Patients will be purposely recruited by a member of the local research or clinical team while visiting the hospital as an inpatient or outpatient or they will be contacted by their clinician. Interviews will be carried out at the hospital, over the telephone, video conference or at home. In phase I, patients will be asked to talk about how PDAC has affected their HRQoL. Patients will be asked about their experience of PDAC, treatments, symptoms, side effects, their functioning and well-being. HCPs will be asked to share their experience of treating patients with PDAC and HRQoL issues. Both patients and HCPs will be asked to rate the content of the EORTC QLQ PAN26 for importance and relevance, and comment on issues on the more general cancer HRQoL questionnaire EORTC QLQ-C30. In phase II, any new content that has been proposed from phase I will be written in a style and format that fits with the EORTC QLG assessment system. This new content will then be presented in form of a list that will be reviewed by the project team and a patient panel, who decide in agreement what content will be included and how it they will be put together to form an updated questionnaire.

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