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Background: Cancer-related fatigue is a significant problem and is associated with poor quality of life. Behavioral interventions include exercise and cognitive-behavioral therapy, which survivors may be unwilling or unable to adopt. Pharmacologic interventions (e.g., selective serotonin reuptake inhibitors) have been disappointing. One potential therapy is the antidepressant bupropion, a norepinephrine-dopamine reuptake inhibitor that targets both inflammation and the hypothalamic-pituitary-adrenal axis. The current study is intended to provide a rigorous test of the efficacy and tolerability of bupropion for cancer-related fatigue., Methods: A randomized, double-blind, placebo-controlled trial will examine the effects of bupropion on cancer-related fatigue. The trial will be conducted nationwide through the University of Rochester Medical Center (URMC) National Cancer Institute Community Oncology Research Program (NCORP). Disease-free breast cancer survivors (n = 422) who completed chemotherapy and/or radiotherapy 12-60 months previously and report significant fatigue will be randomized 1:1 to receive bupropion (300 mg/day) or placebo. Outcomes will be assessed at baseline and the 12-week follow-up. The primary outcome, fatigue, will be measured with the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F). Secondary outcomes include quality of life, depression, and drug tolerability. Exploratory outcomes include cognition and symptomatology. Potential biological mechanisms and genetic moderators of cancer-related fatigue will also be explored., Discussion: This study is the first placebo-controlled trial to our knowledge to evaluate bupropion for cancer-related fatigue. Positive results could revolutionize the treatment of cancer-related fatigue, as bupropion is safe, inexpensive, widely-available, and may be more tolerable and acceptable for many patients than current, limited treatment options., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Purpose: There is a dearth of knowledge and limited research on the needs of Hispanic male cancer survivors (HMCSs). There is a clear need for the development of culturally and linguistically adapted needs assessment tools that are valid and reliable for use among the growing HMCS population. Thus, the purpose of this paper is to describe the field testing and psychometric evaluation of the translated and culturally adapted Spanish Cancer Survivor Unmet Needs Measure (S-CaSUN)., Methods: Hispanic male cancer survivors (n = 84) completed the Spanish CaSUN (S-CaSUN), the Hospital Anxiety and Depression Scale (HADS), and the Functional Assessment of Cancer Therapy-General Population (FACT-GP). Construct validity of the S-CaSUN was assessed by correlation analysis among aforesaid measures. A test-retest procedure with 2-week delay was used to examine reproducibility with a participant subsample (n = 50). Cronbach's alpha was computed to assess internal consistency of the S-CaSUN., Results: Construct validity of the S-CaSUN was estimated by moderate correlation with the HADS anxiety (r = 0.55, P < 0.001) and depression scales (r = 0.60, P < 0.001) and the FACT-GP (r = - 0.62, P < 0.001). The test-retest correlation coefficient for the S-CaSUN was 0.78. Cronbach's alpha was 0.96. Field testing yielded a mean S-CaSUN score of 38.3 (SD = 26.2); all needs and positive change items were endorsed., Conclusion: Findings from field testing and preliminary psychometric evaluation of the S-CaSUN provide initial evidence of validity and reliability of the measure and highlight the importance of going beyond translation when adapting measures to take culture, literacy, and language into consideration., Implications for Cancer Survivors: Reliable, culturally, and linguistically valid instruments facilitate identification of unique unmet needs of Hispanic cancer survivors that, in turn, can be addressed with evidence-based interventions. As cancer centers continue to develop survivorship programs, the S-CaSUN may be useful for a growing group of cancer survivors.