Date: 2017-12-27
Type of
information: Publication of results in a medical journal
phase:
Announcement: publication of results in Melanoma Research
Company: Provectus Pharmaceuticals (USA - TN)
Product:
Action
mechanism:
Disease: locally advanced cutaneous melanoma
Therapeutic
area: Cancer - Oncology
Country: Australia, USA
Trial
details:
Latest
news:
- • On December 27, 2017, Provectus Biopharmaceuticals announced that Melanoma Research published results from a Provectus-sponsored study to understand the daily experiences of patients with locally advanced cutaneous melanoma. Physical and emotional experiences, symptom management, and subsequent impacts on quality of life historically have not been well understood or sufficiently described for this patient population.
- Interviews of adults with Stage IIIB, IIIC or IV M1a cutaneous melanoma at three cancer centers in the U.S. (Moffitt Cancer Center, Tampa, Florida and Huntsman Cancer Institute, Salt Lake City, Utah) and Australia (Melanoma Institute Australia, Sydney) were conducted to assess how locoregionally advanced cutaneous melanoma impacted everyday life. According to the article, [e]motional health/self-perception issues were the most commonly identified (41% of patient impact expressions), including worry, concern, embarrassment, self-consciousness, fear, and thoughts of death. Limitations of lifestyle and activities were also identified (28% of expressions) including leisure and social activities, physical functioning, general functioning, and personal care. Coping strategies such as modified clothing choices, increased use of pain and/or anti-inflammatory medications, and avoidance/protection from the sun represented 20% of all impact expressions.
- Study investigators collected information on disease-specific patient-reported assessment of symptoms and quality of life (patient-reported outcomes, or PROs) that may provide a basis for supporting the clinical significance of objective response parameters such as progression-free survival (PFS) and complete response.
- The article also noted that "both the US Food and Drug Administration and the European Medicines Agency have highlighted the value of establishing content validity in the development of tools to assess patient-reported outcomes. Such PRO-geared tools can extract critical concepts and impacts pertinent to the patient experience. Focus groups and interview sessions can be among those tools to elicit the patient experience.
Is
general: Yes
