Laura C. Polacek

Objectives: This study aimed to refine the content of a new patient-reported outcome (PRO) measure via cognitive interviewing techniques to assess the unique presentation of depressive symptoms in older adults with cancer (OACs). Methods: OACs (≥ 70years) with a history of a depressive disorder were administered a draft measure of the Older Adults with Cancer – Depression (OAC-D) Scale, then participated in a semi-structured cognitive interview to provide feedback on the appropriateness, comprehensibility, and overall acceptability of measure. Interviews were audio-recorded and transcribed, and qualitative methods guided revision of scale content and structure. Results: OACs (N = 10) with a range of cancer diagnoses completed cognitive interviews. Participants felt that the draft measure took a reasonable amount of time to answer and was easily understandable. They favored having item prompts and response anchors repeated with each item for ease of completion, and they helped identify phrasing and wording of key terms consistent with the authors’ intended constructs. From this feedback, a revised version of the OAC-D was created. Significance of results: The OAC-D Scale is the first PRO developed specifically for use with OACs. The use of expert and patient input and rigorous cognitive interviewing methods provides a conceptually accurate means of assessing the unique symptom experience of OACs with depression.

Background: Despite the importance of accurate prognostic understanding in patients with advanced cancer, there is little consensus around how to conceptualize and measure the multidimensional construct. Most studies focus on single aspects of prognostic understanding (e.g., curability) that clinicians have identified as important; no previous research has asked patients how they define “prognosis.” Aim: The present study examined how patients with advanced cancer conceptualize their “prognosis.” It also explored how patients assigned value to prognostic information and the impact of prognosis on life perspectives. Design: A phenomenological approach was used to analyze semi-structured interviews with individuals with advanced cancer to examine how patients define prognosis. Setting/participants: English and Spanish-speaking patients with advanced cancer ( N = 29) were recruited from ambulatory clinics at a comprehensive cancer center in New York City. Results: To conceptualize prognosis, patients focused on concrete medical data, anticipated survival and quality of life, impact on meaningful life events, uncertainty, and physician affect. They discussed the importance of maintaining normalcy despite prognosis, knowledge as a form of coping, information reframing, and altered decision-making as means of coping with prognostic information. Conclusions: Given the range of ways patients define prognosis and assign value to prognostic information, clinicians should incorporate a thorough assessment of patient information preferences, values, and coping styles when engaging in end-of-life discussions. Trainings should emphasize the importance of nonverbal cues (i.e., affect management, body language) in prognostic disclosure.

Purpose Glioblastoma (GBM) is a devastating neuro-oncologic disease with invariably poor prognosis. Despite this, research shows patients have unrealistic perceptions of their prognosis, which may relate in part to communication patterns between patients, caregivers and oncologists. The purpose of this study was to examine communication processes and goals among patients, caregivers, and oncologists to elucidate drivers of prognostic understanding (PU) in the context of recurrent GBM. Methods This was a prospective, multi-center study enrolling adult patients with GBM, caregivers, and oncologists, who independently reported the content of a specific discussion involving the disclosure of GBM recurrence. Communication processes and goals were characterized for each participant, and concordance between all dyads and patient-caregiver-oncologist triads were calculated. Results Seventeen patient, caregiver, and oncologist triads were analyzed. At the individual level, three (17.6%) patients and 8 (47.1%) caregivers reported having discussed prognosis during the clinical encounter, as compared to ten oncologists (58.8%). Seven patients (41.2%) and 5 caregivers (29.4%), versus thirteen oncologists (76.5%) reported ever discussing prognosis or life expectancy at previous appointments. Generally, patient-caregiver concordance (i.e., both answered the same) regarding communication goals and processes was low. Triads showed limited concordant responses in discussing curability (n = 5), prognosis (n = 4), end-of-life treatment goals (n = 4), and ever discussing prognosis (n = 3). Conclusion Patients, caregivers and oncologists had discordant views regarding communication processes and prognostic goals, even when recalling a single discussion. This study highlights the importance of clear and frequent communication about prognosis, and the need for further research on communication and PU in the neuro-oncology setting.

Objective: Caregivers of patients with cancer are at significant risk for existential distress. Such distress negatively impacts caregivers’ quality of life and capacity to serve in their role as healthcare proxies, and ultimately, contributes to poor bereavement outcomes. Our team developed Meaning-Centered Psychotherapy for Cancer Caregivers (MCP-C), the first targeted psychosocial intervention that directly addresses existential distress in caregivers. Method: Nine caregivers of patients with glioblastoma multiforme (GBM) enrolled in a pilot randomized controlled trial evaluating the feasibility, acceptability, and effects of MCP-C, and completed in-depth interviews about their experience in the therapy. One focus group with three MCP-C interventionists was also completed. Results: Four key themes emerged from interviews: (1) MCP-C validated caregivers’ experience of caregiving; (2) MCP-C helped participants reframe their “caregiving identity” as a facet of their larger self-identity, by placing caregiving in the context of their life's journey; (3) MCP-C enabled caregivers to find ways to assert their agency through caregiving; and (4) the structure and sequence of sessions made MCP-C accessible and feasible. Feedback from interventionists highlighted several potential manual changes and overall ways in which MCP-C can help facilitate caregivers’ openness to discussing death and engaging in advanced care planning discussions with the patient. Significance of results: The overarching goal of MCP-C is to allow caregivers to concurrently experience meaning and suffering; the intervention does not seek to deny the reality of challenges endured by caregivers, but instead to foster a connection to meaning and purpose alongside their suffering. Through in-depth interviews with caregivers and a focus group with MCP interventionists, we have refined and improved our MCP-C manual so that it can most effectively assist caregivers in experiencing meaning and purpose, despite inevitable suffering.

The Meaning-Centered Psychotherapy training program (MCPT) is a multimodal, intensive, in-person program that trains cancer care providers in the evidence-based psychosocial treatment Meaning-Centered Psychotherapy (MCP). This analysis aimed to identify barriers and facilitators to clinical implementation (CI) at 1 year post-training. Trainee feedback regarding CI was collected via a mixed-methods questionnaire, including rating the ease of CI and free-text response identifying facilitators and barriers to CI. Descriptive statistics and thematic content analysis of follow-up data from the first five MCPT training cohorts (n = 55) were performed to assess CI and its facilitators and barriers. One third of participants indicated that it was at least somewhat difficult to implement MCP in clinical practice. Trainee-identified facilitators and barriers to CI were characterized within four main categories: program, patient, treatment, and institution. Within each of these factors, clinicians reported a variety of components that contributed to or hindered their ability to implement MCP. MCPT itself was reported as a facilitator. Patient access and interest were simultaneously identified as facilitators for some and barriers for others. Some trainees found the MCP treatment structure helpful in addressing important patient psychosocial needs, while others felt it was too restrictive. Institutional support played an important role in whether trainees felt hindered or helped to implement MCP. These initial results provide important insight into the program’s strengths and have fostered improvements to the MCPT program to better facilitate CI. Further study of MCPT CI is warranted, and theme refinement will be possible with a larger sample.

Journal of Medical Internet Research - International Scientific Journal for Medical Research, Information and Communication on the Internet #Preprint #PeerReviewMe: Warning: This is a unreviewed preprint. Readers are warned that the document has not been peer-reviewed by expert/patient reviewers or an academic editor, may contain misleading claims, and is likely to undergo changes before final publication, if accepted, or may have been rejected/withdrawn. Readers with interest and expertise are encouraged to sign up as peer-reviewer, if the paper is within an open peer-review period. Please cite this preprint only for review purposes or for grant applications and CVs (if you are the author). Background: The pace of drug discovery and approvals has led to expanding treatments for cancer patients. While extensive research exists regarding barriers to enrollment on oncology clinical trials, there are limited studies evaluating processes to optimize patient education, oral anti-cancer medications administration and adherence for patients enrolled on clinical trials. In this study, we assess the feasibility of a video-based, personalized webpage for patients enrolled on genitourinary oncology clinical trials involving ≥1 oral anti-cancer medication. Objective: The primary objective of this trial was to assess the differences in the number of patient-initiated violations in the intervention arm compared to a control arm over four treatment cycles. Secondary objectives included patient satisfaction, frequently-asked questions by patients on the intervention arm, patient-initiated calls to study team members, and patient-reported stress levels. Methods: Eligible patients enrolling on a therapeutic clinical for a genitourinary malignancy were randomized 2:1 to the intervention arm or control arm. Patients randomized to the intervention arm received access to a video-based, personalized webpage, which included videos of patients’ own clinic encounters with their providers, instructional videos on medication administration and side effects, and electronic versions of educational documents. Results: 99 patients were enrolled (89 were evaluable; 66 completed 4 cycles). 71% (n=40/56) of patients in the intervention arm had ≥1 patient-initiated violation versus 70% (n=23/33) in the control arm. There was no difference in total number of violations across four cycles between two arms (estimate=-0.0939 with 95% CI -0.6295, 0.4418, P-value=0.7313). Median baseline satisfaction scores for the intervention and control arms were 72 and 73, respectively, indicating high levels of patient satisfaction in both arms. Median baseline patient-reported stress levels were 10 and 13 for the intervention and control arms, respectively, indicating low stress levels in both arms at baseline. Conclusions: This study is among the first to evaluate a video-based, personalized webpage that provides patients with educational videos and video recordings of clinical trial appointments. Despite not meeting the primary endpoint of reduced patient-initiated violations, this study demonstrates the feasibility of a video-based, personalized webpage in clinical trials. Future research assessing this tool may be better suited for realms outside of clinical trials and may consider the use of an endpoint that assesses patient-reported outcomes directly. A major limitation of this study was the lack of prior data for estimating the null hypothesis in this population. Clinical Trial: The DFCI IRB determined that this randomized, phase II trial did not meet the requirements for registration to a WHO accredited trial registry as it was an ancillary, non-invasive trial.

This editorial provides an overview of the clinical presentation of depression in men with prostate cancer, presents potential causal mechanisms, and identifies resources for screening and treatment.

BACKGROUND The pace of drug discovery and approvals has led to expanding treatments for cancer patients. Although extensive research exists regarding barriers to enrollment in oncology clinical trials, there are limited studies evaluating processes to optimize patient education, oral anticancer therapy administration, and adherence for patients enrolled in clinical trials. In this study, we assess the feasibility of a video-based, personalized webpage for patients enrolled in genitourinary oncology clinical trials involving 1 or more oral anticancer therapy. OBJECTIVE The primary objective of this trial was to assess the differences in the number of patient-initiated violations in the intervention arm compared with a control arm over 4 treatment cycles. Secondary objectives included patient satisfaction, frequently asked questions by patients on the intervention arm, patient-initiated calls to study team members, and patient-reported stress levels. METHODS Eligible patients enrolling on a therapeutic clinical trial for a genitourinary malignancy were randomized 2:1 to the intervention arm or control arm. Patients randomized to the intervention arm received access to a video-based, personalized webpage, which included videos of patients’ own clinic encounters with their providers, instructional videos on medication administration and side effects, and electronic versions of educational documents. RESULTS A total of 99 patients were enrolled (89 were evaluable; 66 completed 4 cycles). In total, 71% (40/56) of patients in the intervention arm had 1 or more patient-initiated violation compared with 70% (23/33) in the control arm. There was no difference in the total number of violations across 4 cycles between the 2 arms (estimate=−0.0939, 95% CI−0.6295 to 0.4418, P value=.73). Median baseline satisfaction scores for the intervention and control arms were 72 and 73, respectively, indicating high levels of patient satisfaction in both arms. Median baseline patient-reported stress levels were 10 and 13 for the intervention and control arms, respectively, indicating low stress levels in both arms at baseline. CONCLUSIONS This study is among the first to evaluate a video-based, personalized webpage that provides patients with educational videos and video recordings of clinical trial appointments. Despite not meeting the primary endpoint of reduced patient-initiated violations, this study demonstrates the feasibility of a video-based, personalized webpage in clinical trials. Future research assessing this tool might be better suited for realms outside of clinical trials and might consider the use of an endpoint that assesses patient-reported outcomes directly. A major limitation of this study was the lack of prior data for estimating the null hypothesis in this population.