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BackgroundRandomized controlled trials (RCTs) often provide accurate estimates of the internal validity of an intervention but lack information on external validity (generalizability). We conducted an RCT on the effectiveness of a self-management intervention among patients with lymphoma in a population-based setting. ObjectiveThe objectives of the current study were to describe the proportion of RCT participants compared to all patients invited to participate, and compare sociodemographic and clinical characteristics of RCT participants with all respondents, all patients invited to participate, and all patients selected from the Netherlands Cancer Registry (NCR) to determine the reach of the intervention. An additional objective was to assess differences on RCT outcome variables between RCT and paper respondents. MethodsPatients with lymphoma or chronic lymphocytic leukemia ≥18 years old at diagnosis from 13 hospitals in the Netherlands were selected from the population-based NCR, which routinely collects data on sociodemographic and clinical characteristics. Eligible patients were invited to participate in an RCT and complete a questionnaire. Web-based completion determined RCT enrollment, whereas paper respondents were followed observationally. ResultsA total of 1193 patients were selected from the NCR, 892 (74.77%) of whom were invited to participate in the trial by their hematologist after verifying eligibility. Among those invited, 25.4% (227/892) completed the web-based questionnaire and were enrolled in the RCT. The RCT participants were younger and there was a higher proportion of men than nonparticipants (P

Background: Health‐related quality of life (HRQOL) is a critical aspect to consider when making treatment decisions for patients with non‐Hodgkin‐lymphoma (NHL). This international study by the European Organisation for Research and Treatment of Cancer (EORTC) tested the psychometric properties of two newly developed measures for patients with high‐grade (HG)‐ and low‐grade (LG)‐NHL: the EORTC QLQ‐NHL‐HG29 and the EORTC QLQ‐NHL‐LG20 to supplement the core questionnaire (EORTC QLQ‐C30). Methods: Overall, 768 patients with HG‐NHL (N = 423) and LG‐NHL (N = 345) from 12 countries completed the QLQ‐C30, QLQ‐NHL‐HG29/QLQ‐NHL‐LG20 and a debriefing questionnaire at baseline, and a subset at follow‐up for either retest (N = 125/124) or responsiveness to change (RCA; N = 98/49). Results: Confirmatory factor analysis showed an acceptable to good fit of the 29 items of the QLQ‐NHL‐HG29 on its five scales (symptom burden [SB], neuropathy, physical condition/fatigue [PF], emotional impact [EI], and worries about health/functioning [WH]), and of the 20 items of the QLQ‐NHL‐LG20 on its four scales (SB, PF, EI, and WH). Completion took on average 10 minutes. Test–retest reliability, convergent validity, known‐group comparisons, and RCA find satisfactory results of both measures. A total of 31%–78% of patients with HG‐NHL and 22%–73% of patients with LG‐NHL reported symptoms and/or worries (e.g., tingling in hands/feet, lack of energy, and worries about recurrence). Patients reporting symptoms/worries had substantially lower HRQOL compared to those without. Discussion: The use of the EORTC QLQ‐NHL‐HG29 and QLQ‐NHL‐LG20 questionnaires in clinical research and practice will provide clinically relevant data to better inform treatment decision‐making. Plain language summary: The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group developed two questionnaires.These questionnaires measure health‐related quality of life.The questionnaires are for patients with high‐grade or low‐grade non‐Hodgkin lymphoma.They are called the EORTC QLQ‐NHL‐HG29 and QLQ‐NHL‐LG20.The questionnaires are now internationally validated.This study demonstrates that the questionnaires are reliably and valid, which are important aspects of a questionnaire.The questionnaires can now be used in clinical trials and practice.With the information gathered from the questionnaires, patients and clinicians can better evaluate treatments and discuss the best choice for a patient. This study provides two internationally validated questionnaires for health‐related quality of life assessment in non‐Hodgkin lymphoma: the European Organisation for Research and Treatment of Cancer (EORTC) QLQ‐NHL‐HG29 and EORTC QLQ‐NHL‐LG20. The use of these EORTC questionnaires in research and practice will provide clinically relevant data to better inform treatment decision‐making. [ABSTRACT FROM AUTHOR]

To take cancer survivorship research to the next level, it's important to gain insight in trajectories of changing patient-reported outcomes and impaired recovery after cancer. This is needed as the number of survivors is increasing and a large proportion is confronted with changing health after treatment. Mechanistic research can facilitate the development of personalized risk-stratified follow-up care and tailored interventions to promote healthy cancer survivorship. We describe how these trajectories can be studied by taking the recently extended Dutch population-based Patient Reported Outcomes Following Initial treatment and Long term Evaluation of Survivorship (PROFILES) registry as an example. PROFILES combines longitudinal assessment of patient-reported outcomes with novel, ambulatory and objective measures (eg, activity trackers, blood draws, hair samples, online food diaries, online cognitive tests, weighing scales, online symptoms assessment), and cancer registry and pharmacy databases. Furthermore, we discuss methods to optimize the use of a multidomain data collection-like return of individual results to participants, which may improve not only patient empowerment but also long-term cohort retention. Also, advanced statistical methods are needed to handle high-dimensional longitudinal data (with missing values) and provide insight into trajectories of changing patient-reported outcomes after cancer. Our coded data can be used by academic researchers around the world. Registries like PROFILES, which go beyond boundaries of disciplines and institutions, will contribute to better predictions of who will experience changes and why. This is needed to prevent and mitigate long-term and late effects of cancer treatment and to identify new interventions to promote health. [ABSTRACT FROM AUTHOR]

Summary: Selecting the most appropriate chronic lymphocytic leukaemia (CLL) treatment is challenging. Patient‐reported health‐related quality of life (HRQoL) is therefore a critical aspect to consider. This international study by the European Organization for Research and Treatment of Cancer (EORTC) tested the psychometric properties of a newly developed measure for CLL patients: the EORTC QLQ‐CLL17 to supplement the core questionnaire (EORTC QLQ‐C30). Patients with CLL (n = 341) from 12 countries completed the QLQ‐C30, QLQ‐CLL17 and a debriefing questionnaire. Sociodemographic and clinical data were recorded from medical records. A high percentage (30%–66%) reported symptoms and/or worries (e.g. aches/pains in muscles, lack of energy and worry/fears about health). Confirmatory factor analysis showed an acceptable to good fit of the 17 items on the three scales (i.e. symptom burden, physical condition/fatigue and worries/fears about health and functioning). Completion took on average 8 min. Test–retest and convergent validity was demonstrated. The QLQ‐CLL17 differentiated between patients with an Eastern Cooperative Oncology group (ECOG) performance of 0 versus 1–3 (p's < 0.01 and clinically relevant). The newly developed EORTC QLQ‐CLL17 will increase sensitivity of HRQoL assessment in patients with CLL. Implementation of this questionnaire both in clinical research and practice will help to generate unique clinically relevant data to better inform CLL treatment decision‐making. [ABSTRACT FROM AUTHOR]