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  • Wettergren, Lena, et al. (författare)
  • Comparison of two instruments for measurement of quality of life in clinical practice - a qualitative study
  • 2014
  • Ingår i: BMC Medical Research Methodology. - 1471-2288 .- 1471-2288. ; 14, s. 115
  • Tidskriftsartikel (refereegranskat)abstract
    • Background: The study aimed to investigate the meaning patients assign to two measures of quality of life: the Schedule for Evaluation of Individual Quality of Life Direct Weighting (SEIQoL-DW) and the SEIQoL-DW Disease Related (DR) version, in a clinical oncology setting. Even though the use of quality of life assessments has increased during the past decades, uncertainty regarding how to choose the most suitable measure remains. SEIQoL-DW versions assesses the individual's perception of his or her present quality of life by allowing the individual to nominate the domains to be evaluated followed by a weighting procedure resulting in qualitative (domains) as well as quantitative outcomes (index score). Methods: The study applied a cross-sectional design with a qualitative approach and collected data from a purposeful sample of 40 patients with gastrointestinal cancer. Patients were asked to complete two measures, SEIQoL-DW and the SEIQoL-DR, to assess quality of life. This included nomination of the areas in life considered most important and rating of these areas; after completion patients participated in cognitive interviews around their selections of areas. Interviews were audiotaped and transcribed verbatim which was followed by analysis using a phenomenographic approach. Results: The analyses of nominated areas of the two measures resulted in 11 domains reflecting what patients perceived had greatest impact on their quality of life. Analysis of the cognitive interviews resulted in 16 thematic categories explaining the nominated domains. How patients reflected around their quality of life appeared to differ by version (DW vs. DR). The DW version more often related to positive aspects in life while the DR version more often related to negative changes in life due to having cancer. Conclusions: The two SEIQoL versions tap into different concepts; health-related quality of life, addressing losses and problems related to having cancer and, quality of life, more associated with aspects perceived as positive in life. The SEIQoL-DR and the SEIQoL-DW are recommended in clinical practice to take both negative and positive aspects into account and acting on the problems of greatest importance to the patient.
  • Whither, Stine Braendegaard, et al. (författare)
  • Reduced-dose combination chemotherapy (S-1 plus oxaliplatin) versus full- dose monotherapy (S-1) in older vulnerable patients with metastatic colorectal cancer (NORDIC9) : a randomised, open-label phase 2 trial
  • 2019
  • Ingår i: The Lancet Gastroenterology & Hepatology. - ELSEVIER INC. - 2468-1253. ; 4:5, s. 376-388
  • Tidskriftsartikel (refereegranskat)abstract
    • Background: Older or vulnerable patients with metastatic colorectal cancer are seldom included in randomised trials.The multicentre NORDIC9 trial evaluated reduced-dose combination chemotherapy compared with full-dose monotherapy in older, vulnerable patients.Methods: This randomised, open-label phase 2 trial was done in 23 Nordic oncology clinics and included patients aged 70 years or older with previously untreated metastatic colorectal cancer who were not candidates for full-dose combination chemotherapy. Patients were block randomised (1: 1) using a web-based tool to full-dose S-1 (30 mg/m(2) orally twice daily on days 1-14 every 3 weeks) followed by second-line treatment at progression with irinotecan (250 mg/m(2) intravenously on day 1 every 3 weeks or 180 mg/m(2) intravenously on day 1 every 2 weeks) or reduceddose combination chemotherapy with S-1 (20 mg/m(2) orally twice daily on days 1-14) and oxaliplatin (100 mg/m(2) intravenously on day 1 every 3 weeks) followed by second-line treatment at progression with S-1 (20 mg/m(2) orally twice daily on days 1-14) and irinotecan (180 mg/m(2) intravenously on day 1 every 3 weeks). Use of bevacizumab (7.5 mg/kg intravenously on day 1 of each cycle) was optional. Treatment allocation was not masked and randomisation was stratified for institution and bevacizumab. The primary outcome was progression-free survival. Survival analyses were by intention to treat and safety analyses were done on the treated population. This trial is registered with EudraCT, number 2014-000394-39, and is closed to new participants.Findings: From March 9, 2015, to Oct 11, 2017, 160 patients with a median age of 78 years (IQR 76-81) were randomly assigned to full-dose monotherapy (n=83) or reduced-dose combination chemotherapy (n=77). At data cutoff (Sept 1, 2018; median follow-up 23.8 months [IQR 18.8-30.9]), 81 (98%) patients in the full-dose monotherapy group and 71 (92%) patients in the reduced-dose combination group had progressed or died. Median progression-free survival was significantly longer with reduced-dose combination chemotherapy (6.2 months [95% CI 5.3-8.3]) than with full-dose monotherapy (5.3 months [4.1-6.8]; hazard ratio [HR] 0.72 [95% CI 0.52-0.99]; p=0.047). Toxicity was evaluated in 157 patients who received treatment. Significantly more patients in the full-dose monotherapy group (51 [62%] of 82 patients) experienced at least one grade 3-4 adverse event than in the reduced-dose combination group (32 [43%] of 75 patients; p=0.014). Grade 3-4 diarrhoea (12 [15%] vs two [3%]; p=0.018), fatigue (ten [12%] vs three [4%]; p=0.083), and dehydration (five [6%] vs none; p=0.060) were more frequent in the full-dose monotherapy group than in the reduced-dose combination group. Treatment-related deaths occurred in three patients during firstline treatment and three patients during second-line treatment (two in the full-dose monotherapy group vs one in the reduced-dose combination group in both cases).Interpretation: Reduced-dose combination chemotherapy with S-1 and oxaliplatin for older, vulnerable patients with metastatic colorectal cancer was more effective and resulted in less toxicity than full-dose monotherapy with S-1. Reduced-dose combination chemotherapy could be a preferred treatment for this population.
  • Winterling, Jeanette, et al. (författare)
  • Expectations for the recovery period after cancer treatment – a qualitative study
  • 2009
  • Ingår i: European Journal of Cancer Care. - 0961-5423 .- 1365-2354. ; 18:6, s. 585-593
  • Tidskriftsartikel (refereegranskat)abstract
    • The aim was to explore what expectations patients have concerning the   recovery period after completed curative cancer treatment and the   degree to which these expectations were realized slightly more than 1   year later. A purposeful sample of 16 patients was selected from a   larger study and those patients were interviewed 16 months after   treatment completion. The interviews were analysed using the   phenomenographic method. Patients' expectation for their recovery   period was generally to become well, but they often lacked plans for   how to recover. If the recovery period was perceived as 'smooth'   expectations were always met. However, if the period was perceived as   'tough' expectations were often unfulfilled, but most of these patients   were satisfied with their current life anyway owing to positive changes   and it was only a small proportion of the patients that still felt   unwell. Even though most of the patients had managed to adjust well to   the situation slightly more than 1 year after completed treatment,   several patients had not been aware of how tough recovery could be and   requested further support from the healthcare system.
  • Winterling, Jeanette, et al. (författare)
  • Factors associated with psychological distress and grief resolution in surviving spouses of patients with advanced gastrointestinal cancer
  • 2010
  • Ingår i: Supportive Care in Cancer. - 0941-4355 .- 1433-7339. ; 18:11, s. 1377-1384
  • Tidskriftsartikel (refereegranskat)abstract
    • GOALS OF WORK:Patients with advanced gastrointestinal cancer often have a short survival time. This means that spouses only have a short time to adjust to the approaching death. The aim was to explore whether psychological distress at diagnosis, the course of the illness (anti-tumour treatment, respite period and survival time), the spouses' experience of the care and of losing a loved one were related to distress and grief resolution after the patient had deceased.MATERIALS AND METHODS:Twenty-one spouses were followed prospectively from the patient's diagnosis of advanced gastrointestinal cancer to 6 months after the patient death. Spouses' experiences were measured with an interview, psychological distress with the Hospital Anxiety and Depression Scale and grief resolution with the Grief Resolution Index. MAINRESULTS:The spouses' anxiety at the time of diagnosis was related to their anxiety and grief resolution at follow-up. Two additional factors were associated with higher levels of anxiety at follow-up; the patient having received anti-tumour treatment and the spouse having experienced stress as a caregiver.CONCLUSIONS: The study indicates that anti-tumour treatment, though it has the potential to prolong life, does not positively influence spouses' psychological distress and bereavement after the death of the patient.
  • Winterling, Jeanette, et al. (författare)
  • Relevance of philosophy of life and optimism for psychological distress among individuals in a stage where death is approaching.
  • 2006
  • Ingår i: Supportive Care in Cancer. - 0941-4355. ; 14:4, s. 310-319
  • Tidskriftsartikel (refereegranskat)abstract
    • The purpose was to investigate the relevance of philosophy of life as well as optimism for the psychological distress among Swedish individuals in a stage where death is approaching. Sixty-nine persons were included; of these were 42 patients newly diagnosed with advanced gastrointestinal cancer and 26 were partners to these patients. The participants' philosophy of life was studied through a semi-structured interview. The interview statements were subjected to content analysis. Optimism was measured by the Life Orientation Test and psychological distress by the Hospitality and Depression Scale. The results showed that optimistic respondents had less psychological distress. Two aspects of philosophy of life had relevance for such distress. These were wondering about why the cancer had occurred and having a feeling of being able to live a good life having or living near a person with advanced cancer. In conclusion, the above-mentioned aspects of philosophy of life as well as optimism have relevance for psychological distress among these individuals, which stress the importance that health-care staff address both patients' and their partners' concerns about their philosophy of life.
  • Winterling, Jeanette, et al. (författare)
  • The importance of expectations on the recovery period after cancer treatment
  • 2008
  • Ingår i: Psycho-Oncology. - 1057-9249 .- 1099-1611. ; 17:2, s. 190-198
  • Tidskriftsartikel (refereegranskat)abstract
    • The purpose was to study expectations concerning recovery-related changes in life, e.g. beliefs regarding future adjustment back to 'normal' life after curative cancer treatment, whether these expectations were met and their importance for both patients' and their spouses' quality of life and psychological distress. Sixty-two patients and 42 spouses took part in the study. Data on recovery-related expectations, measured using a study-specific questionnaire (RRE), on quality of life using EORTC-QLQ C-30 and on psychological distress using HADS, were collected directly after completion of treatment, four and 16 months later. Optimism was measured using LOT at the last follow-up. The results demonstrate that patients generally had higher recovery-related expectations than did their spouses, and their expectations were also fulfilled to a lesser degree at both follow-ups. However, the expectations, or whether these were met, were generally not associated with their quality of life or psychological distress. The few associations that were made indicated that fulfilled expectations meant higher quality of life and/or less distress. The participants' optimism was associated with both their quality of life and psychological distress. It is concluded that optimism influenced the participants' quality of life and psychological distress to a higher degree than did their recovery-related expectations.
  • Winther, Stine Braendegaard, et al. (författare)
  • Randomized study comparing full dose monotherapy (S-1 followed by irinotecan) and reduced dose combination therapy (S-1/oxaliplatin followed by S-1/irinotecan) as initial therapy for older patients with metastatic colorectal cancer NORDIC 9
  • 2017
  • Ingår i: BMC Cancer. - BIOMED CENTRAL LTD. - 1471-2407 .- 1471-2407. ; 17
  • Tidskriftsartikel (refereegranskat)abstract
    • Background: Metastatic colorectal cancer (mCRC) is a disease of older age, but there is a relative lack of knowledge about effects of chemotherapy in older patients as they are under-represented in clinical trials. Little data can guide whether the strategy in older mCRC patients should be a sequential full-dose monotherapy chemotherapy approach or a dose-reduced combination chemotherapy approach. The oral 5FU prodrug S-1 seems to have less side effects than capecitabine and should be an optimal drug for older patients, but few data are available. Improved geriatric assessments are needed to select which older patients should receive therapy.Methods: The NORDIC 9 trial is a Nordic multicenter randomized phase II study comparing full dose monotherapy (S-1 30 mg/m(2) twice daily days 1-14 every 3 weeks, followed by second line irinotecan 250-350 mg/m(2) iv day 1 every 3 weeks or 180-250 mg/m(2) iv day 1 every 2 weeks) with reduced dose combination therapy (S-1 20 mg/m(2) days 1-14 + oxaliplatin 100 mg/m(2) iv day 1 every 3 weeks, followed by second line S-1 20 mg/m(2) days 1-14 + irinotecan 180 mg/m(2) day 1 every 3 week) for older patients (>= 70 years) with mCRC who are not candidates for full-dose standard combination therapy. Additional bevacizumab (7.5 mg/kg) is optional in first-line. Blood samples and tumor tissue will be collected to investigate predictive markers. Geriatric screening tools (G-8, VES-13, Timed-Up-and- Go and Handgrip strength), Charlson Comorbidty Index and quality of life (EORTC QLQ-C30) will be evaluated as predictors of efficacy and toxicity. The target sample size is 150 patients. The primary endpoint is progression-free survival and secondary endpoints are time-to-failure of strategy, overall survival, response rate, toxicity, and correlations between biomarkers, pre-treatment characteristics and geriatric assessments.Discussion: The study will add knowledge on how to treat older mCRC patients who are not candidates for standard combination therapy. Furthermore it may provide understanding of efficacy and tolerability of chemotherapy in older cancer patients and thus offer a better chance for tailored treatment strategies in these patients.
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