Publications by authors named "Darke A"

Article Synopsis
  • Premenopausal women with early-stage, high-risk hormone receptor-positive breast cancer often stop their adjuvant endocrine therapy (ET) due to side effects, which can lead to higher chances of recurrence and mortality.
  • The study will enroll 540 participants to test if Active Symptom Monitoring (ASM) combined with patient education can help reduce early discontinuation of ET by tracking symptoms through weekly check-ins.
  • The main goal is to see if better management of ET-related side effects increases adherence to treatment, improving overall cancer outcomes and quality of life over the course of 72 weeks.
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Background: Cancer-related financial hardship is a side effect of cancer diagnosis and treatment, and affects both patients and caregivers. Although many oncology clinics have increased financial navigation services, few have resources to proactively provide financial counseling and assistance to families affected by cancer before financial hardship occurs. As part of an ongoing randomized study testing a proactive financial navigation intervention, S1912CD, among sites of the National Cancer Institute Community Oncology Research Program (NCORP), we conducted a baseline survey to learn more about existing financial resources available to patients and caregivers.

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Importance: A key issue for the adjuvant treatment of patients with melanoma is the assessment of the effect of treatment on relapse, survival, and quality of life (QOL).

Objective: To compare QOL in patients with resected melanoma at high risk for relapse who were treated with adjuvant pembrolizumab vs standard of care with either ipilimumab or high-dose interferon α 2b (HDI).

Design, Setting, And Participants: The S1404 phase 3 randomized clinical trial was conducted by the SWOG Cancer Research Network at 211 community/academic sites in the US, Canada, and Ireland.

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Importance: Aromatase inhibitors (AIs) have proven efficacy for the treatment of hormone-sensitive breast cancer; however, arthralgias (pain and stiffness) contribute to nonadherence with therapy for more than 50% of patients.

Objective: To examine the effect of acupuncture in reducing AI-related joint pain through 52 weeks.

Design, Setting, And Participants: A randomized clinical trial was conducted at 11 sites in the US from May 1, 2012, to February 29, 2016, with a scheduled final date of follow-up of September 5, 2017, to compare true acupuncture (TA) with sham acupuncture (SA) or waiting list control (WC).

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Background: Financial toxicity is a growing problem in oncology, but no prior studies have prospectively measured the financial impact of cancer treatment in a diverse national cohort of newly diagnosed cancer patients. S1417CD was the first cooperative group-led multicenter prospective cohort study to evaluate financial hardship in metastatic colorectal cancer (mCRC) patients.

Methods: Patients aged 18 years or older within 120 days of mCRC diagnosis completed quarterly questionnaires for 12 months.

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Purpose: Health-related quality of life (HRQOL) is an established prognostic factor for mortality; however, it is unclear if HRQOL is predictive of time to disease progression, a particularly meaningful outcome for patients. We examined the association between HRQOL and progression-free survival (PFS) in SWOG Cancer Research Network clinical trials.

Methods: For this secondary analysis, we reviewed all completed SWOG clinical trials to identify those for patients with advanced cancer that incorporated Functional Assessment of Cancer Therapy (FACT) questionnaires at baseline.

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Purpose: Patient-reported outcomes may be associated with cancer outcomes. We evaluated clinically significant fatigue (CSF), overall survival, adverse events (AEs), and quality of life (QOL) during cancer treatment.

Methods: We compared outcomes in four phase II or III chemotherapy trials, two advanced non-small-cell lung cancer and two advanced hormone-refractory prostate cancer, with or without baseline CSF.

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Importance: Osteonecrosis of the jaw (ONJ) affects patients with cancer and metastatic bone disease (MBD) treated with bone-modifying agents (BMAs), yet the true incidence is unknown.

Objective: To define the cumulative incidence of ONJ at 3 years in patients receiving zoledronic acid for MBD from any malignant neoplasm.

Design, Setting, And Participants: This multicenter, prospective observational cohort study (SWOG Cancer Research Network S0702) included patients with MBD with either limited or no prior exposure to BMAs and a clinical care plan that included use of zoledronic acid within 30 days of registration.

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Objective: Recent literature has highlighted a link between hearing loss as a result of otitis media in the early years of life and impacted binaural processing skills in later childhood. Such findings are of particular relevance to Indigenous Australian children, who tend to experience otitis media earlier in life and for longer periods than their non-Indigenous counterparts. There is also growing interest in the effects of reduced auditory processing ability on a child's early learning of language and, specifically, on phonological awareness that contributes to word reading skills.

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Background: Few studies have assessed the financial impact of cancer diagnosis on patients and caregivers in diverse clinical settings. S1417CD, led by the SWOG Cancer Research Network, is the first prospective longitudinal cohort study assessing financial outcomes conducted in the NCI Community Oncology Research Program (NCORP). We report our experience navigating design and implementation barriers.

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Aim: To report the surgical and audiological outcomes of myringoplasty (Type I tympanoplasty) in Indigenous Australian children living in remote and regional communities in northern Australia.

Method: An observational cohort study, with prospective recording of the details of surgery. Audiological outcomes were collected independently, and these data were integrated in the present study.

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Importance: Musculoskeletal symptoms are the most common adverse effects of aromatase inhibitors and often result in therapy discontinuation. Small studies suggest that acupuncture may decrease aromatase inhibitor-related joint symptoms.

Objective: To determine the effect of acupuncture in reducing aromatase inhibitor-related joint pain.

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Background: To what extent steroid hormones contribute to lung cancer in male and female never smokers and smokers is unclear. We examined expression of hormone receptors in lung tumors by sex and smoking.

Methods: Patients with primary non-small cell lung cancer were recruited into an Intergroup study in the United States and Canada, led by SWOG (S0424).

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Importance: Oxidative stress is an established dementia pathway, but it is unknown if the use of antioxidant supplements can prevent dementia.

Objective: To determine if antioxidant supplements (vitamin E or selenium) used alone or in combination can prevent dementia in asymptomatic older men.

Design, Setting, And Participants: The Prevention of Alzheimer's Disease by Vitamin E and Selenium (PREADViSE) trial began as a double-blind randomized clinical trial in May 2002, which transformed into a cohort study from September 2009 to May 2015.

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Purpose: SWOG S0702 was a cohort study of patients with cancer with bone metastases due to any cancer. Using baseline data from S0702, this report characterizes the oral health and oral health-related quality of life (OHRQoL) of patients with advanced cancer.

Methods: S0702 case report forms captured dental assessment and patient-reported outcome (PRO) data.

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Selenium and vitamin E micronutrients have been advocated for the prevention of colorectal cancer. Colorectal adenoma occurrence was used as a surrogate for colorectal cancer in an ancillary study to the Selenium and Vitamin E Cancer Prevention Trial (SELECT) for prostate cancer prevention. The primary objective was to measure the effect of selenium (as selenomethionine) on colorectal adenomas occurrence, with the effect of vitamin E (as α-tocopherol) supplementation on colorectal adenoma occurrence considered as a secondary objective.

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Article Synopsis
  • The Selenium and Vitamin E Cancer Prevention Trial (SELECT) was a large-scale study aimed at assessing the effectiveness of these antioxidants in preventing prostate cancer, involving 35,533 men divided into four treatment groups.
  • Four ancillary studies were implemented to explore other health issues (like Alzheimer's and respiratory function) using the same participant pool, focusing on different endpoints unrelated to prostate cancer.
  • Adding these ancillary studies increased participant adherence to SELECT but introduced complexities such as timing issues and differing levels of engagement from study site investigators.
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Background: Epidemiologic studies and secondary analyses of randomized trials supported the hypothesis that selenium and vitamin E lower prostate cancer risk. However, the Selenium and Vitamin E Cancer Prevention Trial (SELECT) showed no benefit of either supplement. Genetic variants involved in selenium or vitamin E metabolism or transport may underlie the complex associations of selenium and vitamin E.

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Objective: To evaluate the associations of non-steroidal anti-inflammatory drug (NSAID) use with risk of erectile dysfunction (ED), considering the indications for NSAID use.

Patients And Methods: We analysed data from 4 726 men in the placebo arm of the Prostate Cancer Prevention Trial (PCPT) without evidence of ED at baseline. Incident ED was defined as mild/moderate (decrease in normal function) or severe (absence of function).

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Importance: Observational studies suggest a role for dietary nutrients such as vitamin E and selenium in cataract prevention. However, the results of randomized clinical trials of vitamin E supplements and cataract have been disappointing and are not yet available for selenium.

Objective: To test whether long-term supplementation with selenium and vitamin E affects the incidence of cataract in a large cohort of men.

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Article Synopsis
  • * Research on mice showed that administering antioxidants like N-acetylcysteine boosted prostate cell growth, and human studies indicated that vitamin E increased prostate cancer risk, highlighting a potential link.
  • * The study found that certain NKX3.1 gene variations combined with antioxidant use (selenium or vitamin E) were associated with an increased risk of prostate cancer, suggesting that genetic factors might affect the effectiveness of these supplements in cancer prevention.
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