OC-0070 Patient-reported symptoms of late radiation toxicity in breast cancer patients

2021 ◽  
Vol 161 ◽  
pp. S43-S44
Author(s):  
D. Mink van der Molen ◽  
M. Batenburg ◽  
A. Doeksen ◽  
T. van Dalen ◽  
E. Schoenmaeckers ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Patients ◽  
Radiation Toxicity ◽  
Breast Cancer Patients ◽  
Patient Reported

scholarly journals Comparison of the clinical effectiveness of treatments for aromatase inhibitor-induced arthralgia in breast cancer patients: a protocol for a systematic review and network meta-analysis

BMJ Open ◽  
2020 ◽  
Vol 10 (5) ◽  
pp. e033461
Author(s):  
Kyeore Bae ◽  
Si Yeon Song
Keyword(s):  
Breast Cancer ◽  
Systematic Review ◽  
Pain Intensity ◽  
Aromatase Inhibitor ◽  
Cancer Patients ◽  
Meta Analysis ◽  
Indirect Evidence ◽  
Secondary Outcome ◽  
Breast Cancer Patients ◽  
Patient Reported

IntroductionAromatase inhibitor-induced arthralgia (AIA) is a major adverse event of aromatase inhibitors (AIs) and leads to premature discontinuation of AI therapy in breast cancer patients. The objective of this protocol for a systematic review and network meta-analysis (NMA) is to provide the methodology to compare the change in pain intensity between different AIA treatments and demonstrate the rank probabilities for different treatments by combining all available direct and indirect evidence.Methods and analysisPubMed, the Cochrane Controlled Register of Trials (CENTRAL), EMBASE, Web of Science and ClinicalTrials.gov will be searched to identify publications in English from inception to November 2019. We will include randomised controlled trials (RCTs) assessing the effects of different treatments for AIA in postmenopausal women with stage 0–III hormone receptor-positive breast cancer. The primary endpoints will be the change in patient-reported pain intensity from baseline to post-treatment. The number of adverse events will be presented as a secondary outcome.Both pairwise meta-analysis and NMA with the Frequentist approach will be conducted. We will demonstrate summary estimates with forest plots in meta-analysis and direct and mixed evidence with a ranking of the treatments as the P-score in NMA. The revised Cochrane risk-of-bias tool for randomised trials will be used to assess the methodological quality within individual RCTs. The quality of evidence will be assessed.Ethics and disseminationAs this review does not involve individual patients, ethical approval is not required. The results of this systematic review and NMA will be published in a peer-reviewed journal. This review will provide valuable information on AIA therapeutic options for clinicians, health practitioners and breast cancer survivors.PROSPERO registration numberCRD42019136967.

scholarly journals The impact of hyperbaric oxygen therapy on late radiation toxicity and quality of life in breast cancer patients

2021 ◽  
Author(s):  
Marilot C. T. Batenburg ◽  
Wies Maarse ◽  
Femke van der Leij ◽  
Inge O. Baas ◽  
Onno Boonstra ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Side Effects ◽  
Cancer Patients ◽  
Oxygen Therapy ◽  
Radiation Toxicity ◽  
Breast Pain ◽  
Breast Cancer Patients

Abstract Purpose To evaluate symptoms of late radiation toxicity, side effects, and quality of life in breast cancer patients treated with hyperbaric oxygen therapy (HBOT). Methods For this cohort study breast cancer patients treated with HBOT in 5 Dutch facilities were eligible for inclusion. Breast cancer patients with late radiation toxicity treated with ≥ 20 HBOT sessions from 2015 to 2019 were included. Breast and arm symptoms, pain, and quality of life were assessed by means of the EORTC QLQ-C30 and -BR23 before, immediately after, and 3 months after HBOT on a scale of 0–100. Determinants associated with persistent breast pain after HBOT were assessed. Results 1005/1280 patients were included for analysis. Pain scores decreased significantly from 43.4 before HBOT to 29.7 after 3 months (p < 0.001). Breast symptoms decreased significantly from 44.6 at baseline to 28.9 at 3 months follow-up (p < 0.001) and arm symptoms decreased significantly from 38.2 at baseline to 27.4 at 3 months follow-up (p < 0.001). All quality of life domains improved at the end of HBOT and after 3 months follow-up in comparison to baseline scores. Most prevalent side effects of HBOT were myopia (any grade, n = 576, 57.3%) and mild barotrauma (n = 179, 17.8%). Moderate/severe side effects were reported in 3.2% (n = 32) of the patients. Active smoking during HBOT and shorter time (i.e., median 17.5 vs. 22.0 months) since radiotherapy were associated with persistent breast pain after HBOT. Conclusion Breast cancer patients with late radiation toxicity reported reduced pain, breast and arm symptoms, and improved quality of life following treatment with HBOT.

scholarly journals The Trajectory and Influence Factors of Breast Cancer Patients’ Main Chemotherapy-Related Symptoms: A Longitudinal Study

2021 ◽  
Author(s):  
Yishu Qi ◽  
Ning Zhang ◽  
Ye Ma ◽  
Ewen Xu ◽  
Qingmei Huang ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Patients ◽  
Influencing Factors ◽  
Family Income ◽  
Influence Factors ◽  
Severe Depression ◽  
Stage Ii ◽  
Breast Cancer Patients ◽  
Growth Mixture Model ◽  
Patient Reported

Abstract Introduction: Identifying the pattern of change in symptoms is critical to effective symptom management. This study aimed to determine the trajectory of Main Chemotherapy-related Symptoms (MCRS) in breast cancer patients, explore the influencing factors of potential categories of MCRS trajectory.Methods: Patient-reported Outcomes Measurement System- breast-chemotherapy was used to measure the four highest incidence MCRS (pain, fatigue, anxiety, and depression) weekly in Breast cancer patients. The Growth Mixture Model (GMM) was used to fit the potential categories of the MCRS trajectory. Logistic regression was used to explore the influencing factors of potential categories of MCRS change trajectory.Results: 239 breast cancer patients completed the study. Fatigue and depression showed an overall upward trend during the chemotherapy cycle, while pain and anxiety showed a downward trend. There are two potential categories of anxiety trajectory, three potential categories of fatigue and pain trajectory, and four potential categories of depression trajectory. Compared with the mild-fatigue group, Patients in the moderate and high fatigue groups were more likely to be less educated, have lower household income, and be treated with anthracyclines. Compared with the mild-pain group, patients in the pain-declining and fluctuating-pain groups were young, live-alone, and treated with paclitaxel. Patients in the anxiety-rising group were younger, had premenopausal menstruation with regular monthly menstruation, and had stage II disease. Patients in the depression-rising and severe depression groups were more likely to be solitary and younger.Conclusion: The potential classes of major chemotherapy-related symptom trajectories vary in breast cancer patients. As for fatigue management, great attention should be paid to patients with low education, low family income, and anthracycline chemotherapy. For pain management, close attention should be paid to younger, solitary, and paclitaxel chemotherapy patients; For anxiety management, attention should be paid to younger patients with premenopausal menstruation and regular monthly menstruation patients, and those with stage II disease. In managing depression, attention should be paid to younger and solitary patients.

Patient-reported acute fatigue in elderly breast cancer patients treated with and without regional nodal radiation

2020 ◽  
Vol 183 (2) ◽  
pp. 391-401
Author(s):  
Shagun Misra ◽  
Grace Lee ◽  
Yasmin Korzets ◽  
Lisa Wang ◽  
Anthea Lau ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Patients ◽  
Breast Cancer Patients ◽  
Patient Reported

scholarly journals Assessing the effect of hyperbaric oxygen therapy in breast cancer patients with late radiation toxicity (HONEY trial): a trial protocol using a trial within a cohort design

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
M. C. T. Batenburg ◽  
H. J. G. D. van den Bongard ◽  
C. E. Kleynen ◽  
W. Maarse ◽  
A. Witkamp ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Patients ◽  
Hyperbaric Oxygen ◽  
Hyperbaric Oxygen Therapy ◽  
Oxygen Therapy ◽  
Intervention Studies ◽  
Control Group ◽  
Radiation Toxicity ◽  
Breast Cancer Patients ◽  
Randomized Controlled

Abstract Background Breast cancer treatment with radiotherapy can induce late radiation toxicity, characterized by pain, fibrosis, edema, impaired arm mobility, and poor cosmetic outcome. Hyperbaric oxygen therapy (HBOT) has been proposed as treatment for late radiation toxicity; however, high-level evidence of effectiveness is lacking. As HBOT is standard treatment and reimbursed by insurers, performing classic randomized controlled trials is difficult. The “Hyperbaric OxygeN therapy on brEast cancer patients with late radiation toxicity” (HONEY) trial aims to evaluate the effectiveness of HBOT on late radiation toxicity in breast cancer patients using the trial within cohorts (TwiCs) design. Methods The HONEY trial will be conducted within the Utrecht cohort for Multiple BREast cancer intervention studies and Long-term evaluation (UMBRELLA). Within UMBRELLA, breast cancer patients referred for radiotherapy to the University Medical Centre Utrecht are eligible for inclusion. Patients consent to collection of clinical data and patient-reported outcomes and provide broad consent for randomization into future intervention studies. Patients who meet the HONEY in- and exclusion criteria (participation ≥ 12 months in UMBRELLA, moderate/severe breast or chest wall pain, completed primary breast cancer treatment except hormonal treatment, no prior treatment with HBOT, no contraindications for HBOT, no clinical signs of metastatic or recurrent disease) will be randomized to HBOT or control group on a 2:1 ratio (n = 120). Patients in the control group will not be informed about participation in the trial. Patients in the intervention arm will undergo 30–40 HBOT treatment sessions in a high pressure chamber (2.4 atmospheres absolute) where they inhale 100% oxygen through a mask. Cohort outcome measures (i.e., physical outcomes, quality of life, fatigue, and cosmetic satisfaction) of the HBOT group will be compared to the control group at 3 months follow-up. Discussion This pragmatic trial within the UMBELLA cohort was designed to evaluate the effectiveness of HBOT on late radiation toxicity in breast cancer patients using the TwiCs design. Use of the TwiCs design is expected to address issues encountered in classic randomized controlled trials, such as contamination (i.e., HBOT in the control group) and disappointment bias, and generate information about acceptability of HBOT. Trial registration ClinicalTrials.gov. NCT04193722. Registered on 10 December 2019.

Minimal clinically important difference (MCID) for the functional assessment of cancer therapy: Cognitive function (FACT-Cog) in breast cancer patients.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 6589-6589
Author(s):  
Alexandre Chan ◽  
Yu Lee Foo ◽  
Maung Shwe Ham Guo ◽  
Yuan Chuan Kee ◽  
Yee Pin Tan ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Patients ◽  
Minimal Clinically Important Difference ◽  
Cognitive Deterioration ◽  
Size Estimation ◽  
Breast Cancer Patients ◽  
Clinically Important Difference ◽  
Patient Reported ◽  
Eortc Qlq C30 ◽  
Eortc Qlq

6589 Background: Establishing the Minimal Clinically Important Difference (MCID) is essential for interpreting the clinical relevance of patient reported outcomes. This is the first study to date to determine the MCID of FACT-Cog, a 37-item validated subjective neuropsychological instrument designed to evaluate cancer patients’ perceived cognitive deterioration on their quality of life. Methods: This prospective, observational study involved 220 breast cancer patients who have completed FACT-Cog and EORTC-QLQ-C30 at two time points: baseline and at least 3 months following chemotherapy. The MCID was computed using 3 approaches: 1) an anchor-based approach utilized the validated EORTC-QLQ-C30-Cognitive Functioning scale (CF) as the anchor for patients who showed a minimal deterioration on the CF (defined as a one-step deterioration on the CF scale); 2) a Receiver Operating Characteristic (ROC) curve was used to identify an optimal MCID cut-off point for deterioration; 3) a distribution-based approach utilized the 0.33 SD, 0.5 SD and one standard error of measurement (SEM) of the total FACT-Cog score (148 points) to estimate the MCID. Results: There was moderate correlation between the mean change scores of FACT-Cog and CF (rp= 0.43, p<0.001). The CF-anchored MCID was 9.6 points (95% CI 4.4 - 14.8). MCID derived from the ROC method was 7.5 points (AUC: 0.75; sensitivity: 75.6%; specificity: 68.8%). Using the distribution-based approach, MCID corresponding to effect sizes of 0.33SD to 0.5SD of the total FACT-Cog score ranged from 6.9 – 10.3 points and one-SEM criterion resulted in a MCID estimate of 10.6 points. Combining results from all approaches, the MCID identified for FACT-Cog ranged from 6.9 – 10.6 points (4.7% to 7.2% of total score). Conclusions: A 6.9 to 10.6 points reduction of the FACT-Cog score corresponds to the smallest clinically-relevant perceived cognitive deterioration. These estimates are important as they can facilitate the interpretation of patient-reported cognitive changes and sample size estimation in future studies.

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