Late effects and Patient Reported Outcomes

Patients treated with radiotherapy (RT) must be ensured the best possible life during and after RT. Interactive use of Patient-reported outcome (PRO) data about patients´ symptoms, functional capacity, and QoL can help reach this goal and increase focus on late effects. More research on PRO will identify frequencies, severity and the development over time of late effects from RT and provide important knowledge for better information of patients and for future interventional strategies to alleviate the late effects. Through the development of different tools for PRO and late effects in selected patient populations, we will aim at improving cancer patients´ lives.

The following focus areas have been selected:

  • National workshop to reach consensus on PRO for each DMCG
  • The potential of PRO during RT in a Head and Neck Cancer study
  • The potential of a PRO-model in breast cancer RT

The models from H&N cancer and breast cancer can be the basis for generic models within the integration of PRO in RT and detection/handling of late effects from RT.


1. National workshop

In autumn 2018 a national workshop on RT related PRO will be held. The focus is to reach a consensus on PRO data to be used by each DMCG and potentially reach consensus on selected PRO data to be used by all DMCGs. The consensus PRO items are to be used in trials in each DMCG, and by year 3 and 5 early and more mature data will be available. DCCC will be applied for support.

At the initial DCCC radiotherapy-workshop March 2018 this approach has been discussed with IP/WP-leaders, and there exists support and interest from the specific IPs to join the national workshop on PRO. It has been suggested to develop core-PRO questions (generic for all patients receiving radiotherapy), anatomic-region PRO questions (for disease-groups) and disease-specific PRO questions. This and other approaches will be discussed in the workshop. Additionally, knowledge of technical PRO-solutions will be shared at the workshop and international, scientific input will be delivered to assure that our future implementation of PRO in radiotherapy reaches international standards.

2. Improving management of side effects in head and neck cancer by systematic use of PRO during treatment

Aim: Generate and validate a generic core PRO-tool for patients receiving RT for head and neck cancer (HNC).

Background: Accelerated RT and concomitant chemotherapy improve disease control in HNC. These intense regimens can result in severe acute and late side effects. In DK, the DAHANCA toxicity score has been used to assess objective RT toxicity. Research in other cancer treatments indicates that systematic patient assessment of side effects may improve treatment outcomes. PROs can be used for symptom monitoring. The main aim of the project is to improve the management of side effects in HNC by a systematic use of PRO during RT. 

Methods: A HNC PRO tool for HNC patients during RT will be developed including a correlation between three existing HNC specific tools and a generic PRO tool. The focus will be on limiting the number of questions and feasibility for the entire patient group including those with lower socioeconomic status. A prospective nation-wide, single-armed sequential cohort study will investigate the effects of active use of PROs in clinical counseling and decision making during RT. Thirdly, a study will investigate the incorporation of PRO-tools in toxicity assessment of randomized studies investigating modified RT.

Expected results:  Inclusion of PROs in HNC RT provides information that may enhance clinical management and improve data quality. The experience gained may help creating a generic model for PROs during RT and knowledge on technical PRO-solutions can be shared national.

3. Improving management of late effects in early breast cancer patients treated with RT by systematic use of PRO during follow up until death

Aim: Generate and validate a PRO-tool for breast cancer patients (BC pts) treated with RT

Background: The majority of BC pts in follow up have received adjuvant RT as part of multimodal therapy, and since RT related late morbidities develop slowly over decades it is likely that some of these morbidities remain undetected and therefore not treated adequately.

Methods: A breast PRO tool for BC pts treated with RT will be developed. At AUH >2600 breast cancer patients in follow up have answered PRO for almost 2 years, and these data will be used to further develop the PRO tool to be used. The tool must include a focus on surgical type, and different types of systemic therapy in addition to the RT related issues.  The PRO tool must be harmony with the PRO data collected in earlier DBCG RT trials to ensure as much comparability with previous DBCG studies as possible. A nation-wide single-arm cohort study will investigate the effects of use of the PRO tool. Pts will be contacted and asked to respond online yearly 1-10 and then every 5 years until death.

Expected results: Using PRO information will improve clinical management of late effects following RT. The results will help identify pts who are candidates for therapy of side effects or enrollment into studies testing new therapies.

Impact/Relevance/Ethics (project B+C)

PRO as a tool in cancer therapy impacts on quality of life (QoL) and survival within metastatic cancer patients undergoing chemotherapy. Recent research tends to show a positive impact of PRO in cancer patients undergoing RT as well. An international standard PRO-tool in RT of not only HNC & BC but in all diagnoses is needed. This project has high clinical relevance and will apply with all ethical standards, while gaining knowledge and developing methods which can be of use for all patients receiving radiotherapy independent of diagnosis.

  • Jan Alsner

    Chefkonsulent, PhD

    Aarhus University Hospital
  • Cecilie Holländer-Mieritz

    1. reservelæge, ph.d.-studerende

    Rigshospitalet, Copenhagen
  • Claus Andrup Kristensen

    Overlæge, Ph.D.

    Rigshospitalet, Copenhagen
  • Ivan R. Vogelius

    Head of Medical Physics, Professor

    Rigshospitalet, Copenhagen
  • Helle Pappot

    Chief Physician

    Rigshospitalet, Copenhagen
  • Birgitte Vrou Offersen

    Professor, MD

    Aarhus University Hospital