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 has already completed phase I, phase II, and phase III. Throughout these phases the questionnaire module has been developed and pre-tested; and furthermore three site-specific add-on modules for breast cancer (BR-SURV45), colorectal cancer (CR-SURV34), and prostate cancer (PR-SURV30) have been developed.

The project is now in phase IV – which is the final phase – and which consists of a large scale international psychometric and cross-cultural validation study of the questionnaire that has been produced (SURV-100).

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.
Currently, we are at the start of the large scale international phase IV validation study involving more than 40 research sites. The study is open for participant enrolment at several sites and data is being collected.

Current status:
• Phase IV
• Currently open for recruitment in Croatia, Cyprus, Denmark, Germany, Greece, Iceland, Israel, Italy, Japan, Jordan, Netherlands, Norway, Portugal, Turkey, and the UK. At the time of writing, recruitment is soon to be open in Belgium and Canada.

The study is aiming to collect all study data by December 2023; and to have analysed all collected data by December 2024.

This project aims 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 are now undertaking phase IV of the project, which is the final phase and consists of a large scale international study, to ‘validate’ the questionnaire. In this phase, many people from different countries will complete the questionnaire, and psychometric analyses on this data will be undertaken to ensure that the module is fit for purpose and is valid across different cultures.