Survivorship

With continuing improvement in early detection and treatment and the ageing of the worldwide population, the number of cancer survivors is growing steadily. This has resulted in a growing interest in evaluating the health-related quality of life (HRQOL) of cancer survivors. Increasingly, clinical trials and comparative effectiveness studies are being designed to include long-term follow-up to assess, in addition to survival, late effects of treatment and HRQOL. To integrate HRQOL in such studies, it is essential to develop measures that capture the full range of issues relevant to disease-free cancer survivors.

Even in the case of cure, cancer survivors may be at risk for a range of short-, and long-term adverse physical and psychosocial effects. For example, persistent fatigue, pain, musculoskeletal problems, peripheral neurological symptoms (e.g. polyneuropathy), body image issues, sexual dysfunction, relationship problems, cognitive dysfunctions, anxiety and depression, and fear of recurrence. Further issues may encompass socioeconomic challenges such as return to work, loss of income, and difficulties in obtaining insurance, financial loans, mortgages, etc. There is also evidence that surviving cancer can have positive psychological effects. All these effects, both positive and negative, might impact on the individual’s quality of life, and so this project aims to produce a patient-reported outcome measure that can address the survivorship context.

The development of this questionnaire module, the EORTC QLQ-SURV100, has completed all four phases. Throughout these phases the questionnaire module has been developed, pre-tested, and validated, including a large scale international psychometric and cross-cultural validation study. The QLQ-SURV100 is hence validated and available for use in multiple languages.

Furthermore, three cancer site-specific add-on modules for breast cancer (BR-SURV40), colorectal cancer (CR-SURV33), and prostate cancer (PR-SURV19) have been developed, with final validation still pending.

In phase I of this questionnaire development project we interviewed 575 disease-free cancer survivors (breast, colorectal, prostate, bladder, gynecological, head and neck, lung, or testicular cancer, lymphoma, melanoma, or glioma) recruited from 14 countries to generate one generic and 11 site-specific issue lists. The resulting consolidated generic issue list consisted of 122 issues. Based on the results, we have developed a provisional survivorship core questionnaire (QLQ-SURV111) and three provisional site-specific survivorship modules for breast (BR-SURV45), colorectal (CR-SURV34) and prostate (PR-SURV30) cancer (Phase II). These questionnaires have been translated into 14 languages and have been pilot-tested in a sample of 400 survivors from a range of European countries and Australia, Brazil and India (phase IIIa), resulting in the QLQ-SURV100, BR-SURV40, CR-SURV33, and the PR-SURV19.

To meet the needs for a shorter version of the QLQ-SURV100 that is suitable for evaluating long-term health-related quality of life (HRQOL) outcomes in clinical trials, we have made a distinction between essential and optional scales of the QLQ-SURV100, based on the correspondence with the QLQ-C30 scales and their underlying construct. After, we have consulted patient experts, health care professionals, and HRQOL researchers, to judge whether the remaining scales indeed were non-essential. Based on the prioritizing of the scales we have moved the essential scales to the beginning of the questionnaire. Consecutively, we have pretested the updated QLQ-SURV100 (changed order and items updated in phase IIIa) in a group of 78 survivors.

We have now completed a large-scale international validation study involving more than 46 research sites across 21 countries. The data we have collected have been psychometrically analysed for structural validity, item stability, cross-cultural consistency, and construct validity, amongst other things. These analyses have shown the QLQ-SURV100 to perform well, and we hope to publish the results of this analysis imminently.

This project aimed to develop a questionnaire that can be used to measure health-related quality of life in individuals who are known as being in the ‘survivorship’ phase of their disease trajectory. In other words, they have been previously treated with a curative intent and now have no active or recurrent disease.

We have now completed phase IV of the project, which is the final phase and consisted of a large-scale international study, to ‘validate’ the questionnaire. In this phase, many people from different countries completed the questionnaire, and psychometric analyses on these data have shown that the module is fit for purpose and is valid across different cultures.