Health-related problems in adult cancer survivors: development and validation of the Cancer Survivor Core Set.

PURPOSE: Improved survival rates from cancer have increased the need to understand the health-related problems of cancer treatment. We aimed to develop and validate the "Cancer Survivor Core Set" representing the most relevant health-related problems in adult cancer survivors using the International Classification of Functioning, Disability, and Health (ICF). METHODS: First, a Delphi study was conducted to select ICF categories representing the most relevant health-related problems. There were three Dutch expert panels, one each for lung, colorectal, and breast cancer. Each panel comprised lay experts and professionals. The experts reached within- and between-panel consensus in two rounds (≥70 % agreement). Second, a validation study was performed. Generic cancer survivorship questionnaires assessing health-related problems or quality of life among cancer survivors were selected. Items of selected questionnaires were linked to the best-fitting ICF category and to the selected ICF categories from the Delphi study, respectively. RESULTS: In total, 101 experts were included, of which 76 participated in both rounds, reaching consensus on 18 ICF categories. The Distress Thermometer and Problem List, the Impact of Cancer (v2), and the Quality of Life in Adult Cancer Survivors questionnaires were selected for the validation study, which led to the inclusion of one additional ICF category. CONCLUSIONS: The developed Cancer Survivor Core Set consisted of 19 ICF categories representing the most relevant health-related problems in adult cancer survivors: five from the "body functions and structures" component, eight from the "activities and participation" component, and six from the "environmental factors" component. HIGHLIGHTS: • Many adult cancer survivors have persistent health-related problems. • The Cancer Survivor Core Set was developed using the Delphi method. • The patients' perspectives were prioritized in this Delphi study • Content validity was confirmed by validated cancer survivorship questionnaires. • The Cancer Survivor Core Set may help optimize care for cancer survivors.

The distress thermometer as a prognostic tool for one-year survival among patients with lung cancer.

INTRODUCTION: The use of patient-reported outcome measures is increasingly advocated to support high-quality cancer care. We therefore investigated the added value of the Distress Thermometer (DT) when combined with known predictors to assess one-year survival in patients with lung cancer. METHODS: All patients had newly diagnosed or recurrent lung cancer, started systemic treatment, and participated in the intervention arm of a previously published randomised controlled trial. A Cox proportional hazards model was fitted based on five selected known predictors for survival. The DT-score was added to this model and contrasted to models including the EORTC-QLQ-C30 global QoL score (quality of life) or the HADS total score (symptoms of anxiety and depression). Model performance was evaluated through improvement in the -2 log likelihood, Harrell's C-statistic, and a risk classification. RESULTS: In total, 110 patients were included in the analysis of whom 97 patients accurately completed the DT. Patients with a DT score ≥5 (N = 51) had a lower QoL, more symptoms of anxiety and depression, and a shorter median survival time (7.6 months vs 10.0 months; P = 0.02) than patients with a DT score <5 (N = 46). Addition of the DT resulted in a significant improvement in the accuracy of the model to predict one-year survival (P < 0.001) and the discriminatory value (C-statistic) marginally improved from 0.69 to 0.71. The proportion of patients correctly classified as high risk (≥85% risk of dying within one year) increased from 8% to 28%. Similar model performance was observed when combining the selected predictors with QoL and symptoms of anxiety or depression. CONCLUSIONS: Use of the DT allows clinicians to better identify patients with lung cancer at risk for poor outcomes, to further explore sources of distress, and subsequently personalize care accordingly.

Structural distress screening and supportive care for patients with lung cancer on systemic therapy: A randomised controlled trial.

INTRODUCTION: Gaining regular insight into the nature and severity of distress by a psychosocial nurse coupled with referral to psychosocial and/or paramedical healthcare provider(s) is an experimental supportive care approach. We sought to examine the effects of this approach on quality of life (QoL), patient's mood and satisfaction, end-of-life care and survival in patients with lung cancer. METHODS: Patients with newly diagnosed or recurrent lung cancer starting systemic therapy were randomly assigned to receive usual care or the experimental approach. Patients were followed up at 1, 7, 13 and 25 weeks after randomisation with the EORTC-QLQ-C30, the European Quality of Life-5D, the Hospital Anxiety and Depression Scale and the Patient Satisfaction Questionnaire-III. Primary outcome was the mean change in the EORTC-QLQ-C30 global QoL-score between 1 and 25 weeks. RESULTS: A total of 223 patients were randomised of whom 111 (50%) completed all four assessments (44% in the usual care group versus 55% in the experimental group). No significant difference was found in the mean change global QoL-score (-2.4, 95% CI: 12.1-7.2; P = 0.61), nor in the other patient-reported outcomes. Fewer patients in the experimental group received chemotherapy shortly before the end-of-life, and median survival was comparable (10.3 versus 10.1 months, P = 0.62). Of the 112 dropouts, 33 died and 79 discontinued participation for other reasons. CONCLUSIONS: This supportive care approach neither improved QoL nor other patient-reported outcomes in patients with lung cancer. However, it reduced the use of chemotherapy shortly before the end of life. Possibly, (late) side effects of systemic therapy may have obscured effects of our intervention on QoL. CLINICAL TRIAL REGISTRATION: NTR3540.