Conceptual assessment of HRQOL among Japanese non-metastatic castration-resistant prostate cancer (nmCRPC) patients.

OBJECTIVE: The study objectives were to understand how patients view the quality of life in non-metastatic castration-resistant prostate cancer (nmCRPC), including unmet needs and what patients consider most important in treatment outcomes. A gap analysis was conducted on existing patient-reported outcomes (PROs) measures versus what is missing from the patient perspective, to guide future development of PRO-based real-world evidence for nmCRPC in Japan. A conceptual model for nmCRPC Japanese patients' HRQOL was also created. METHODS: This non-interventional, qualitative study consisted of a targeted literature review, PRO instrument review, and interviews with 20 nmCRPC patients and five treating physicians. Triangulation of the gap analysis, evidence from the targeted review of the literature, and qualitative interview findings were employed to assess the comprehensiveness of current nmCRPC and HRQOL measures. RESULTS: Symptoms most reported by patients were frequent urination (70%), nocturia (65%), and general pain (65%). Others reported included lack of strength (30%). HRQOL impacts most reported were anxiety (45%) and worry (50%) about their diagnosis. Additional impacts mentioned were weight changes, loss of sleep, difficulty walking, loss of appetite, and difficulty traveling and seeking toilets in public. The gap analysis revealed 31 symptoms and 33 impacts not covered in existing prostate cancer-specific PRO instruments. Patients mentioned musculoskeletal symptoms such as fractures, leg pain, cramps, numbness, and loss of leg bone strength. Impacts not previously discussed in the literature or in outcome measures were feelings of self-consciousness around diagnosis, stigma around illness, and the impact on mobility including traveling. CONCLUSION: Key results reveal pain and urinary symptoms are the most experienced by Japanese nmCRPC patients. The diagnosis and treatment of disease leads to significant impacts in patient lives. Analysis revealed that symptoms and life impacts are missing in the current literature and outcome measures. Testing and debriefing of specific items could further substantiate these dimensions.

A qualitative research study in Japan investigating patients' experience with metastatic castration-resistant prostate cancer: from diagnosis to decision for Ra-223 treatment.

Aim: This qualitative study aimed to reveal symptoms and impacts among bone metastatic castration-resistant prostate cancer (or mCRPC) Japanese patients, prior to Radium-223 (Ra-223) treatment. Materials & Methods: Twenty-three mCRPC patients designated to receive Ra-223 and three treating physicians (Ra-223 prescribers) in Japan, were interviewed. All interview data were assessed for concept frequency, themes and saturation. Results: Forty-five percent of the patients (mean age: 75.8 years) were symptomatic at the time of enrollment. Interviews with all patients revealed 47 mCRPC symptoms, including back pain and bone-specific pain, and 45 life impacts, including worry about disease progression and the impact on daily, physical activities. Conclusion: The symptoms and impacts of living with mCRPC and the associated burden of bone metastasis and skeletal-related symptoms are varied and are important considerations for treatment.

Lay abstract Aim: This study looked at symptoms and impacts among patients with a type of prostate cancer called metastatic castration-resistant prostate cancer. This cancer has spread to other parts of the body including patients' bones. Patients' prostate-specific antigen levels continue to rise despite surgical or medical treatment and their doctors decided the next best treatment is Radium-223 (Ra-223), a radiopharmaceutical therapy. Materials & methods: Twenty-three metastatic castration-resistant prostate cancer patients designated to receive Ra-223 and three treating physicians (Ra-223 prescribers) in Japan, were interviewed. All interview data were assessed for the number of times some words or themes are mentioned by the patients. Results: Ten of the 23 patients (average age of 76 years) had symptoms when the study started. Interviewed patients talked about symptoms including back pain and pain in their bones, and how their cancer caused them to worry about their physical activities and disease progression. Conclusion: The symptoms impact on patients' daily living and the burden of bone metastasis and bone-related symptoms are varied and are important considerations for treatment.

Personalized Cancer Medicine in the Media: Sensationalism or Realistic Reporting?

BACKGROUND: Given that media coverage can shape healthcare expectations, it is essential that we understand how the media frames "personalized medicine" (PM) in oncology, and whether information about unproven technologies is widely disseminated. METHODS: We conducted a content analysis of 396 news reports related to cancer and PM published between 1 January 1998 and 31 December 2011. Two coders independently coded all the reports using a pre-defined framework. Determination of coverage of "standard" and "non-standard" therapies and tests was made by comparing the media print/broadcast date to the date of Federal Drug Administration approval or incorporation into clinical guidelines. RESULTS: Although the term "personalized medicine" appeared in all reports, it was clearly defined only 27% of the time. Stories more frequently reported PM benefits than challenges (96% vs. 48%, p < 0.001). Commonly reported benefits included improved treatment (89%), prediction of side effects (30%), disease risk prediction (33%), and lower cost (19%). Commonly reported challenges included high cost (28%), potential for discrimination (29%), and concerns over privacy and regulation (21%). Coverage of inherited DNA testing was more common than coverage of tumor testing (79% vs. 25%, p < 0.001). Media reports of standard tests and treatments were common; however, 8% included information about non-standard technologies, such as experimental medications and gene therapy. CONCLUSION: Confusion about personalized cancer medicine may be exacerbated by media reports that fail to clearly define the term. While most media stories reported on standard tests and treatments, an emphasis on the benefits of PM may lead to unrealistic expectations for cancer genomic care.

The development of the ICIQ-UAB: A patient reported outcome measure for underactive bladder.

AIMS: To present the development of the International Consultation on Incontinence Questionnaire-underactive bladder (ICIQ-UAB) as the first patient reported outcome measure for the assessment of the symptoms and impact on the health-related quality of life of UAB developed in-line with the Food and Drug Administration Guidance for Industry. METHODS: Draft items were developed following 44 semi-structured concept elicitation interviews in the UK and refined using 36 cognitive interviews. A pilot study was designed to assess the draft ICIQ-UAB's initial psychometric properties with 54 patients recruited from European hospitals. Further concept elicitation interviews were also carried out with 11 patients in the US and 10 patients in Japan. All participants had a prior urodynamic diagnosis of detrusor underactivity. RESULTS: The cognitive interviews confirmed the initial items to be understood and interpreted as intended. Pilot testing showed that both internal consistency (Cronbach's α ≥ 0.85) and test-retest reliability (stable patients; intraclass correlation coefficient ≥ 0.88) were high. The interviews in the US and Japan elicited symptoms and impacts that support previous findings in the UK and provided further insight into the experiences of patients in those countries. The developmental ICIQ-UAB was refined using the evidence from all substudies. CONCLUSIONS: The validity and reliability of the ICIQ-UAB were supported in a pilot study setting and the wider cultural applicability by the additional interviews in the US and Japan. Following further validation in future clinical trials, the developmental ICIQ-UAB is envisaged as an important tool for the monitoring of future UAB treatment strategies.

Patient-reported treatment-related symptom burden for patients with advanced melanoma in Canada.

BACKGROUND: Little is known on the impact of emerging treatments for advanced melanoma (stages III and IV) on patients' functioning and well-being. The objective of this study was to describe the patient-reported treatment-related symptom (TRS) burden in advanced melanoma. METHOD: Twenty-nine in-depth, qualitative interviews were conducted among adult patients with advanced melanoma in Canada using a semi-structured interview method. Interviews were transcribed verbatim, and key concepts were identified using a grounded theory analytic approach. RESULTS: The 29 patients reported 13 unique treatment journeys involving the following drug therapy categories: cytotoxic chemotherapies, CTLA-4 inhibitors, BRAF or MEK inhibitors, and PD-1 inhibitors. Patients typically underwent multiple treatment episodes over time. Common TRSs included nausea, fatigue, diarrhea or constipation, and skin rashes. Patients described these as impacting their physical functioning, ability to perform activities of daily living, social functioning, and overall quality of life. CONCLUSION: Our findings provide a description of the patient's experience with treatment for advanced melanoma. Our sample included patients typically diagnosed in mid-life, facing an urgent sequence of medical procedures and a pharmacological treatment journey that was burdensome. There is a need for less toxic and more efficacious treatments earlier in the patient journey to alleviate the impact of advanced melanoma treatment on patients' health-related quality of life.

Humanistic burden of disease for patients with advanced melanoma in Canada.

BACKGROUND: Metastatic melanoma is a highly aggressive cancer, often striking in the prime of life. This study provides new information directly from advanced melanoma (stage III and IV) patients on how their disease impacts their health-related quality of life (HRQL). METHODS: Twenty-nine in-depth, qualitative interviews were conducted with adult patients with advanced melanoma in Canada. A semi-structured interview guide was used. Interviews were transcribed verbatim and key concepts were identified using a grounded theory analytic approach. RESULTS: Many patients' journeys began with the startling diagnosis of an invasive disease and a vastly shortened life expectancy. By the time they reached an advanced stage of melanoma, these patients' overall functioning and quality of life had been greatly diminished by this quickly progressing cancer. The impact was described in terms of physical pain and disability, emotional distress, diminished interactions with friends and family, and burden on caregivers. CONCLUSION: Our findings provide evidence of signs, symptoms, and functional impacts of advanced melanoma. Signs and symptoms reported (physical, mental, and social) confirm and expand on those reported in the existing clinical literature. Primary care physicians should be better trained to identify melanomas early. Oncology care teams can improve on their current approaches for helping patients navigate treatment options, with information about ancillary services to mitigate disease impacts on HRQL, such as mental health and social supports, as well as employment or financial support services.