Trial reportJournal of the National Cancer Institute2016
Symptoms and QOL as Predictors of Chemoprevention Adherence in NRG Oncology/NSABP Trial P-1.
Trial report in Journal of the National Cancer Institute, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
14 citing papers in PubMed, 36 citations in OpenAlex.
- Visualizing adverse events in clinical trials using correspondence analysis with R-package visae.BMC medical research methodology · 2021Trial
- Low-Dose Tamoxifen for Mammographic Density Reduction: A Randomized Controlled Trial.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2021Trial
- Impact of extended release naltrexone on health-related quality of life in individuals with legal involvement and opioid use disorders.Substance abuse · 2021Trial
- Randomized Placebo Controlled Trial of Low-Dose Tamoxifen to Prevent Local and Contralateral Recurrence in Breast Intraepithelial Neoplasia.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2019Trial
- Early participant-reported symptoms as predictors of adherence to anastrozole in the International Breast Cancer Intervention Studies II.Annals of oncology : official journal of the European Society for Medical Oncology · 2018Trial
- Participant-Reported Symptoms and Their Effect on Long-Term Adherence in the International Breast Cancer Intervention Study I (IBIS I).Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2017Trial
- Factors Associated with Low-Dose Tamoxifen Use among Women with Atypical Hyperplasia or Lobular or Ductal Carcinoma In Situ.Cancer prevention research (Philadelphia, Pa.) · 2026Article
- Treatment interruption and discontinuation of hormonal therapy in hormone receptor-positive breast cancer patients.Breast cancer research and treatment · 2020Review
- Tamoxifen-related endocrine symptoms in Chinese patients with breast cancer: Study protocol clinical trial (SPIRIT Compliant).Medicine · 2020Article
- The quality of life index: a pilot study integrating treatment efficacy and quality of life in oncology.NPJ breast cancer · 2020Article
- Quality of life in patients with midgut NET following peptide receptor radionuclide therapy.European journal of nuclear medicine and molecular imaging · 2019Article
- Beliefs About Medication and Uptake of Preventive Therapy in Women at Increased Risk of Breast Cancer: Results From a Multicenter Prospective Study.Clinical breast cancer · 2019Article
- Impact of preexisting mental illness on breast cancer endocrine therapy adherence.Breast cancer research and treatment · 2019Article
- Improving quality of life in patients with pancreatic neuroendocrine tumor following peptide receptor radionuclide therapy assessed by EORTC QLQ-C30.European journal of nuclear medicine and molecular imaging · 2018Article
Corrections and comments
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Authors and funding
6 authors at 3 institutions in 1 country.
Funding
Abstract
backgroundTamoxifen provides a 50% reduction in the incidence of breast cancer (BC) among high-risk women, yet many do not adhere to the five-year course of therapy. Using the prospective double-blind National Surgical Adjuvant Breast and Bowel Project P-1 study, we evaluated whether participant-reported outcomes were associated with drug adherence and whether baseline behavioral risk factors modified those associations.
methodsP-1 participants were randomly assigned to placebo vs tamoxifen (20mg/day). Mixed effects logistic regression was used to evaluate whether baseline or three-month SF-36 quality of life (QOL) mental and physical component summaries (MCS, PCS), and participant-reported symptoms (gynecologic, vasomotor, sexual, and other) predicted 12-month drug adherence (76-100% of assigned medication). The evaluation accounted for age, treatment, estimated breast cancer risk, education, baseline smoking, alcohol consumption, and obesity. All statistical tests were two-sided.
resultsParticipants enrolled at least three years before trial unblinding and without medically indicated discontinuation before 12 months were eligible for the present analyses (n = 10 576). At 12 months, 84.3% were adherent. Statistically significant predictors of adherence were: three-month MCS (odds ratio [OR] = 1.15 per 10 points, 95% confidence interval [CI] = 1.06 to 1.25); three-month gynecologic symptoms among moderate alcohol drinkers (OR = .79, 95% CI = 0.72 to 0.88); baseline vasomotor symptoms among participants assigned tamoxifen (OR = .88, 95% CI = 0.80 to 0.97); and three-month sexual symptoms among younger participants (OR = .89 at age 41 years, 95% CI = 0.80 to 0.99). The strongest association was with three-month other symptoms (OR = .77, 95% CI = 0.63 to 0.93). PCS was not associated with adherence. Symptom and QOL associations were not modified by smoking or obesity.
conclusionsPromoting QOL and managing symptoms early in therapy may be important strategies to improve adherence.
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