| 1. |
- Fransson, Per, et al.
(författare)
-
Ultra-hypofractionated versus conventionally fractionated radiotherapy for prostate cancer (HYPO-RT-PC) : patient-reported quality-of-life outcomes of a randomised, controlled, non-inferiority, phase 3 trial
- 2021
-
Ingår i: The Lancet Oncology. - : Elsevier. - 1470-2045 .- 1474-5488. ; 22:2, s. 235-245
-
Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: The HYPO-RT-PC trial compared conventionally fractionated radiotherapy with ultra-hypofractionated radiotherapy in patients with localised prostate cancer. Ultra-hypofractionation was non-inferior to conventional fractionation regarding 5-year failure-free survival and toxicity. We aimed to assess whether patient-reported quality of life (QOL) differs between conventional fractionation and ultra-hypofractionation up to 6 years after treatment in the HYPO-RT-PC trial.METHODS: HYPO-RT-PC is a multicentre, open-label, randomised, controlled, non-inferiority, phase 3 trial done in 12 centres (seven university hospitals and five county hospitals) in Sweden and Denmark. Inclusion criteria were histologically verified intermediate-to-high-risk prostate cancer (defined as T1c-T3a with one or two of the following risk factors: stage T3a; Gleason score ≥7; and prostate-specific antigen 10-20 ng/mL with no evidence of lymph node involvement or distant metastases), age up to 75 years, and WHO performance status 0-2. Participants were randomly assigned (1:1) to conventional fractionation (78·0 Gy in 39 fractions, 5 days per week for 8 weeks) or ultra-hypofractionation (42·7 Gy in seven fractions, 3 days per week for 2·5 weeks) via a minimisation algorithm with stratification by trial centre, T-stage, Gleason score, and prostate-specific antigen. QOL was measured using the validated Prostate Cancer Symptom Scale (PCSS) and European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire (EORTC QLQ-C30) at baseline, the end of radiotherapy, months 3, 6, 12, and 24 after radiotherapy, every other year thereafter up to 10 years, and at 15 years. The primary endpoint (failure-free survival) has been reported elsewhere. Here we report QOL, a secondary endpoint analysed in the per-protocol population, up to 6 years after radiotherapy. The HYPO-RT-PC trial is registered with the ISRCTN registry, ISRCTN45905321.FINDINGS: Between July 1, 2005, and Nov 4, 2015, 1200 patients were enrolled and 1180 were randomly assigned (conventional fractionation n=591, ultra-hypofractionation n=589); 1165 patients (conventional fractionation n=582, ultra-hypofractionation n=583) were included in this QOL analysis. 158 (71%) of 223 patients in the conventional fractionation group and 146 (66%) of 220 in the ultra-hypofractionation group completed questionnaires at 6 years. The median follow-up was 48 months (IQR 25-72). In seven of ten bowel symptoms or problems the proportion of patients with clinically relevant deteriorations at the end of radiotherapy was significantly higher in the ultra-hypofractionation group than in the conventional fractionation group (stool frequency [p<0·0001], rush to toilet [p=0·0013], flatulence [p=0·0013], bowel cramp [p<0·0001], mucus [p=0·0014], blood in stool [p<0·0001], and limitation in daily activity [p=0·0014]). There were no statistically significant differences in the proportions of patients with clinically relevant acute urinary symptoms or problems (total 14 items) and sexual functioning between the two treatment groups at end of radiotherapy. Thereafter, there were no clinically relevant differences in urinary, bowel, or sexual functioning between the groups. At the 6-year follow-up there was no difference in the incidence of clinically relevant deterioration between the groups for overall urinary bother (43 [33%] of 132 for conventional fractionation vs 33 [28%] of 120 for ultra-hypofractionation; mean difference 5·1% [95% CI -4·4 to 14·6]; p=0·38), overall bowel bother (43 [33%] of 129 vs 34 [28%] of 123; 5·7% [-3·8 to 15·2]; p=0·33), overall sexual bother (75 [60%] of 126 vs 59 [50%] of 117; 9·1% [-1·4 to 19·6]; p=0·15), or global health/QOL (56 [42%] of 134 vs 46 [37%] of 125; 5·0% [-5·0 to 15·0]; p=0·41).INTERPRETATION: Although acute toxicity was higher for ultra-hypofractionation than conventional fractionation, this long-term patient-reported QOL analysis shows that ultra-hypofractionation was as well tolerated as conventional fractionation up to 6 years after completion of treatment. These findings support the use of ultra-hypofractionation radiotherapy for intermediate-to-high-risk prostate cancer.
|
|
| 2. |
- Petersson, Jöran, et al.
(författare)
-
Teaching dimensional analysis in secondary school mathematics
- 2021
-
Ingår i: Abstract book nofa8. - : Western Norway University of Applied Sciences.
-
Konferensbidrag (övrigt vetenskapligt/konstnärligt)abstract
- AbstractIn its elementary form, the idea of dimensional analysis is to look at the unit of a magnitude, for example speed, and conclude that speed measured in m/s is a quotient having meters in the numerator and seconds in the denominator. However, despite dimensional analysis being a not un-common theme for research in mathematics education at tertiary level teaching, it seems in practice absent below that level. This is surprising since dimensional analysis is useful in mathematical problem solving involving proportionality. Even more so since, from halves and doubles in preschool to scalar multiplication in upper secondary school, proportionality permeates school mathematics and is well-researched (Lamon, 2007). Hence, the authors initiated a research project on how to teach dimensional analysis in school years 6-12. The novelty of this area made us choose didactical engineering (Artigue, 2015) as a theoretical framework suitable for developing the teaching of dimensional analysis. Accordingly, in a cycle of a priori and a posteriori analyses, the authors are developing an empirically based teaching model for dimensional analysis including the topic of constructing exercises for students. We present results from this on-going development project. ReferencesArtigue, M. (2015). Perspectives on Design Research: The Case of Didactical Engineering. In A. Bikner-Ahsbahs, C. Knipping, N. Presmeg. (Eds.). Approaches to Qualitative Research in Mathematics Education. Dordrecht: Springer.Lamon, S. J. (2007). Rational numbers and proportional reasoning: Towards a theoretical framework. In F.K. Lester (red) Second handbook of research on mathematics teaching and learning, vol 2 (pp. 629–668). Charlotte, NC: NCTM.
|
|
| 3. |
- Björeland, Ulrika, et al.
(författare)
-
Hyaluronic acid spacer in prostate cancer radiotherapy : dosimetric effects, spacer stability and long-term toxicity and PRO in a phase II study
- 2023
-
Ingår i: Radiation Oncology. - : BioMed Central (BMC). - 1748-717X. ; 18:1
-
Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: Perirectal spacers may be beneficial to reduce rectal side effects from radiotherapy (RT). Here, we present the impact of a hyaluronic acid (HA) perirectal spacer on rectal dose as well as spacer stability, long-term gastrointestinal (GI) and genitourinary (GU) toxicity and patient-reported outcome (PRO).METHODS: In this phase II study 81 patients with low- and intermediate-risk prostate cancer received transrectal injections with HA before external beam RT (78 Gy in 39 fractions). The HA spacer was evaluated with MRI four times; before (MR0) and after HA-injection (MR1), at the middle (MR2) and at the end (MR3) of RT. GI and GU toxicity was assessed by physician for up to five years according to the RTOG scale. PROs were collected using the Swedish National Prostate Cancer Registry and Prostate cancer symptom scale questionnaires.RESULTS: There was a significant reduction in rectal V70% (54.6 Gy) and V90% (70.2 Gy) between MR0 and MR1, as well as between MR0 to MR2 and MR3. From MR1 to MR2/MR3, HA thickness decreased with 28%/32% and CTV-rectum space with 19%/17% in the middle level. The cumulative late grade ≥ 2 GI toxicity at 5 years was 5% and the proportion of PRO moderate or severe overall bowel problems at 5 years follow-up was 12%. Cumulative late grade ≥ 2 GU toxicity at 5 years was 12% and moderate or severe overall urinary problems at 5 years were 10%.CONCLUSION: We show that the HA spacer reduced rectal dose and long-term toxicity.
|
|
| 4. |
|
|
| 5. |
- Rendek, Zlatica, et al.
(författare)
-
Early Tensile Loading in Nonsurgically Treated Achilles Tendon Ruptures Leads to a Larger Tendon Callus and a Lower Elastic Modulus : A Randomized Controlled Trial
- 2022
-
Ingår i: American Journal of Sports Medicine. - : Sage Publications Inc. - 0363-5465 .- 1552-3365. ; 50:12, s. 3286-3298
-
Tidskriftsartikel (refereegranskat)abstract
- Background: Early tensile loading improves material properties of healing Achilles tendon ruptures in animal models and in surgically treated human ruptures. However, the effect of such rehabilitation in patients who are nonsurgically treated remains unknown. Hypothesis: In nonsurgically treated Achilles tendon ruptures, early tensile loading would lead to higher elastic modulus 19 weeks after the injury compared with controls. Study Design: Randomized controlled trial; Level of evidence, 2. Methods: Between October 2015 and November 2018, a total of 40 nonsurgically treated patients with acute Achilles tendon rupture were randomized to an early tensile loading (loaded group) or control group. Tantalum bead markers were inserted percutaneously into the tendon stumps 2 weeks after the injury to allow high-precision measurements of callus deformation under mechanical testing. The loaded group used a training pedal twice daily to produce a gradual increase in tensile load during the following 5 weeks. Both groups were allowed full weightbearing in an ankle orthosis and unloaded range of motion exercises. Patients were followed clinically and via roentgen stereophotogrammetric analysis and computed tomography at 7, 19, and 52 weeks after the injury. Results: The mean +/- standard deviation elastic modulus at 19 weeks was 95.6 +/- 38.2 MPa in the loaded group and 108 +/- 45.2 MPa in controls (P = .37). The elastic modulus increased in both groups, although it was lower in the loaded group at all time points. Tendon cross-sectional area increased from 7 weeks to 19 weeks, from 231 +/- 99.5 to 388 +/- 142 mm(2) in the loaded group and from 188 +/- 65.4 to 335 +/- 87.2 mm(2) in controls (P < .001 for the effect of time). Cross-sectional area for the loaded group versus controls at 52 weeks was 302 +/- 62.4 mm(2) versus 252 +/- 49.2 mm(2), respectively (P = .03). Gap elongation was 7.35 +/- 13.9 mm in the loaded group versus 2.86 +/- 5.52 mm in controls (P = .27). Conclusion: Early tensile loading in nonsurgically treated Achilles tendon ruptures did not lead to higher elastic modulus in the healing tendon but altered the structural properties of the tendon via an increased tendon thickness. Registration: NCT0280575 (ClinicalTrials.gov identifier).
|
|
| 6. |
- Rönningås, Ulrika, et al.
(författare)
-
Signs and symptoms in relation to progression, experiences of an uncertain illness situation in men with metastatic castration-resistant prostate cancer : A qualitative study
- 2022
-
Ingår i: European Journal of Cancer Care. - : Wiley-Blackwell. - 0961-5423 .- 1365-2354. ; 31:4
-
Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVE: Signs and symptoms are important in monitoring prostate cancer, but there is a lack of understanding about the men's interpretation of signs and symptoms in relation to disease progression in advanced phases of the disease. The aim was to illuminate the experience of signs and symptoms in relation to disease progression in men with metastatic castration-resistant prostate cancer (mCRPC).METHOD: Thirty longitudinal interviews were conducted with 11 men undergoing life-prolonging treatment for mCRPC. Conventional content analysis was used.RESULTS: The results illuminate an uncertainty that the men experience when interpreting signs and symptoms. The overarching theme was The experience of an uncertain illness situation within the framework of progression, with four subthemes: Symptoms triggering thoughts about disease progression; Making sense of signs, also in the absence of symptoms; Making sense of symptoms during treatment; Progression triggering thoughts about the remainder of life.CONCLUSION: In the uncertain illness situation, the men strive to make sense of signs and symptoms based on previous experiences and in relation to disease progression. Understanding the men's perspectives on signs and symptoms in this late phase may help health care professionals communicate about disease progression considering the balance between treatment outcome and quality of life.
|
|
| 7. |
- Rönningås, Ulrika, et al.
(författare)
-
Symptoms and quality of life among men starting treatment for metastatic castration-resistant prostate cancer : a prospective multicenter study
- 2024
-
Ingår i: BMC Palliative Care. - : BioMed Central (BMC). - 1472-684X. ; 23:1
-
Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: Men with metastatic castration-resistant prostate cancer (mCRPC) have an incurable disease. Along with prolonging life, symptom management is one of the main goals with treatment. This is also important from a palliative care perspective where the life prolonging outcomes should be balanced with quality of life (QoL) in this late phase. It is also essential in symptom management to view different dimensions of symptoms, for example how severe or distressing symptoms are, to support best QoL. Therefore, more knowledge is needed about the symptom experience when these treatments are initiated and thus the aim of this study was to describe different dimensions of symptoms in men with mCRPC starting their first-line of life-prolonging treatment, and to describe the association between symptom burden and QoL.METHODS: Baseline data from a prospective longitudinal study of 143 men with mCRPC starting their first-line life-prolonging treatment were used. Symptoms were measured using the Memorial Symptom Assessment Scale (MSAS) and global QoL was measured by the EORTC QLQ C-30. Data was analyzed using descriptive- and multivariable linear regression analyses.RESULTS: On average, the men had more than 10 symptoms (range 0-31 of 33). 50% or more reported sweats, lack of energy, pain, problems with sexual activity and sexual desire. The symptoms they reported as most severe, or most distressing were not always the ones that were reported as most frequent. There was an association between QoL and physical symptoms, and also between QoL, and analgesic use and prostate-specific antigen (PSA) values.CONCLUSION: Even if some men with mCRPC report many symptoms, the dimensions of severity and distress levels vary, and the most frequent symptoms was not always the most burdensome or distressing. There was an association between high physical symptom burden and QoL, suggesting that it is not the number of symptoms that affects QoL but rather the subjective perceived impact of the physical symptoms experienced. The knowledge of how men with mCRPC experience and perceive their symptoms may help health care professionals in symptom management aiming to improve QoL, which is a cornerstone in integrating early palliative care.
|
|
| 8. |
- Sun, Sun, et al.
(författare)
-
Is ultra-hypo-fractionated radiotherapy more cost-effective relative to conventional fractionation in treatment of prostate cancer? A cost–utility analysis alongside a randomized HYPO-RT-PC trial
- 2023
-
Ingår i: European Journal of Health Economics. - : Springer. - 1618-7598 .- 1618-7601. ; 24, s. 237-246
-
Tidskriftsartikel (refereegranskat)abstract
- Background: Economic evidence for comparing low fraction with ultra-hypo fractionated (UHF) radiation therapy in the treatment of intermediate-to-high-risk prostate cancer (PC) is lacking, especially in Europe. This study presents an economic evaluation performed alongside an ongoing clinical trial.Aim: To investigate up to 6 years’ follow-up whether conventional fractionation (CF, 78.0 Gy in 39 fractions, 5 days per week for 8 weeks) is more cost-effective than UHF (42.7 Gy in 7 fractions, 3 days per week for 2.5 weeks inclusive of 2 weekends) radiotherapy in treatment for patients with intermediate-to-high-risk PC.Method: HYPO-RT-PC trial is an open-label, randomized, multicenter (10 in Sweden; 2 in Denmark) phase-3 trial. Patients from Sweden (CF 434; UHF 445) were included in this study. The trial database was linked to the National Patient Registry (NPR). Costs for inpatient/non-primary outpatient care for each episode were retrieved. For calculating Quality-adjusted life years (QALYs), the EORTC QLQ-C30 questionnaire was mapped to the EQ-5D-3L index. Multivariable regression analyses were used to compare the difference in costs and QALYs, adjusting for age and baseline costs, and health status. The confidence interval for the difference in costs, QALYs and incremental cost-effectiveness ratio effectiveness ratio (ICER) was estimated by the bootstrap percentile method.Results: No significant differences were found in ICER between the two arms after 6 years of follow-up.Conclusion: The current study did not support that the ultra-hypo-fractionated treatment was more cost-effective than the conventional fraction treatment up to the sixth year of the trial.
|
|
