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result(s) for
"McLouth, Laurie E."
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Psychosocial interventions for cancer survivors: A meta-analysis of effects on positive affect
by
Berendsen, Mark
,
Moskowitz, Judith T
,
Pustejovsky, James E
in
Affect (Psychology)
,
Cancer
,
Clinical trials
2019
PurposePositive affect has demonstrated unique benefits in the context of health-related stress and is emerging as an important target for psychosocial interventions. The primary objective of this meta-analysis was to determine whether psychosocial interventions increase positive affect in cancer survivors.MethodsWe coded 28 randomized controlled trials of psychosocial interventions assessing 2082 cancer survivors from six electronic databases. We calculated 76 effect sizes for positive affect and conducted synthesis using random effects models with robust variance estimation. Tests for moderation included demographic, clinical, and intervention characteristics.ResultsInterventions had a modest effect on positive affect (g = 0.35, 95% CI [0.16, 0.54]) with substantial heterogeneity of effects across studies (τ̂=0.40\\[ \\hat{\\tau}=0.40 \\]; I2 = 78%). Three significant moderators were identified: in-person interventions outperformed remote interventions (P = .046), effects were larger when evaluated against standard of care or wait list control conditions versus attentional, educational, or component controls (P = .009), and trials with survivors of early-stage cancer diagnoses yielded larger effects than those with advanced-stage diagnoses (P = .046). We did not detect differential benefits of psychosocial interventions across samples varying in sex, age, on-treatment versus off-treatment status, or cancer type. Although no conclusive evidence suggested outcome reporting biases (P = .370), effects were smaller in studies with lower risk of bias.ConclusionsIn-person interventions with survivors of early-stage cancers hold promise for enhancing positive affect, but more methodological rigor is needed.Implications for Cancer SurvivorsPositive affect strategies can be an explicit target in evidence-based medicine and have a role in patient-centered survivorship care, providing tools to uniquely mobilize human strengths.
Journal Article
A Phase I Dose Escalation and Expansion Study of Epidiolex (Cannabidiol) in Patients with Biochemically Recurrent Prostate Cancer
2023
Purpose: Cannabinoids (CBD) have anti-tumor activity against prostate cancer (PCa). Preclinical studies have demonstrated a significant decrease in prostate specific antigen (PSA) protein expression and reduced tumor growth in xenografts of LNCaP and DU-145 cells in athymic mice when treated with CBD. Over-the-counter CBD products may vary in activity without clear standardization, and Epidiolex is a standardized FDA-approved oral CBD solution for treatment of certain types of seizures. We aimed to assess the safety and preliminary anti-tumor activity of Epidiolex in patients with biochemically recurrent (BCR) PCa. Experimental design: This was an open-label, single center, phase I dose escalation study followed by a dose expansion in BCR patients after primary definitive local therapy (prostatectomy +/− salvage radiotherapy or primary definitive radiotherapy). Eligible patients were screened for urine tetrahydrocannabinol prior to enrollment. The starting dose level of Epidiolex was 600 mg by mouth once daily and escalated to 800 mg daily with the use of a Bayesian optimal interval design. All patients were treated for 90 days followed by a 10-day taper. The primary endpoints were safety and tolerability. Changes in PSA, testosterone levels, and patient-reported health-related quality of life were studied as secondary endpoints. Results: Seven patients were enrolled into the dose escalation cohort. There were no dose-limiting toxicities at the first two dose levels (600 mg and 800 mg). An additional 14 patients were enrolled at the 800 mg dose level into the dose expansion cohort. The most common adverse events were 55% diarrhea (grade 1–2), 25% nausea (grade 1–2), and 20% fatigue (grade 1–2). The mean PSA at baseline was 2.9 ng/mL. At the 12-week landmark time-point, 16 out of 18 (88%) had stable biochemical disease, one (5%) had partial biochemical response with the greatest measurable decline being 41%, and one (5%) had PSA progression. No statistically significant changes were observed in patient-reported outcomes (PROs), but PROs changed in the direction of supporting the tolerability of Epidiolex (e.g., emotional functioning improved). Conclusion: Epidiolex at a dose of 800 mg daily appears to be safe and tolerable in patients with BCR prostate cancer supporting a safe dose for future studies.
Journal Article
Patient‐reported tolerability of veliparib combined with cisplatin and etoposide for treatment of extensive stage small cell lung cancer: Neurotoxicity and adherence data from the ECOG ACRIN cancer research group E2511 phase II randomized trial
by
Lash, Bradley W.
,
Leach, Joseph W.
,
Wagner, Lynne I.
in
Aged
,
Aged, 80 and over
,
Antineoplastic Combined Chemotherapy Protocols - adverse effects
2020
Objectives The ECOG‐ACRIN Cancer Research Group trial E2511 recently demonstrated a potential benefit for the addition of veliparib to cisplatin‐etoposide (CE) in patients with extensive stage small cell lung cancer (ES‐SCLC) in a phase II randomized controlled trial. Secondary trial endpoints included comparison of the incidence and severity of neurotoxicity, hypothesized to be lower in the veliparib arm, and tolerability of the addition of veliparib to CE. Physician‐rated and patient‐reported neurotoxicity was also compared. Materials and Methods Patients randomized to veliparib plus CE (n = 64) or placebo plus CE (n = 64) completed the 11‐item Functional Assessment of Cancer Therapy Gynecologic Oncology Group Neurotoxicity (questionnaire pre‐treatment, end of cycle 4 [ie 3 months after randomization] and 3 months post‐treatment [ie 6‐months]). Adherence analysis was based on treatment forms. Results and Conclusion No significant differences in mean or magnitude of change in neurotoxicity scores were observed between treatment arms at any time point. However, patients in the placebo arm reported worsening neurotoxicity from baseline to 3‐months (M difference = −1.5, P = .045), compared to stable neurotoxicity in the veliparib arm (M difference = −0.2, P = .778). Weakness was the most common treatment‐emergent (>50%) and moderate to severe (>16%) symptom reported, but did not differ between treatment arms. The proportion of adherence to oral therapy in the overall sample was 75%. Three percent of patients reported clinically significant neurotoxicity that was not captured by physician assessment. Neurotoxicity scores were not different between treatment arms. The addition of veliparib to CE appeared tolerable, though weakness should be monitored. ClinicalTrials.gov Identifier NCT01642251. We examined patient‐reported tolerability of the addition of a PARP inhibitor, veliparib, to cisplatin‐etoposide for treatment of extensive stage small cell lung cancer in randomized controlled trial E2511. The addition of veliparib to cisplatin‐etoposide was tolerable according to a patient‐reported outcome and adherence. Future studies should assess whether veliparib may have a protective effect against chemotherapy‐induced peripheral neuropathy.
Journal Article
An eHealth, Positive Emotion Skills Intervention for Enhancing Psychological Well-Being in Young Adult Cancer Survivors: Results from a Multi-Site, Pilot Feasibility Trial
by
Cohn, Michael
,
Moskowitz, Judith T
,
Little-Greene, Denisha
in
Breast cancer
,
Cancer
,
Clinical significance
2023
BackgroundYoung adult (YA) cancer survivors experience clinically significant distress and have limited access to psychosocial support. Given growing evidence for unique adaptive benefits of positive emotion in the context of health-related and other life stress, we developed an eHealth positive emotion skills intervention for post-treatment survivors called EMPOWER (Enhancing Management of Psychological Outcomes With Emotion Regulation) and evaluated feasibility and proof of concept for reducing distress and enhancing well-being.MethodIn this single-arm pilot feasibility trial, post-treatment YA cancer survivors (ages 18–39) participated in the EMPOWER intervention which included 8 skills (e.g., gratitude, mindfulness, acts of kindness). Participants completed surveys at baseline (pre-intervention), 8 weeks (post-intervention), and 12 weeks (1-month follow-up). Primary outcomes included feasibility (assessed by participation percentage) and acceptability (would recommend EMPOWER skills to a friend). Secondary outcomes included psychological well-being (mental health, positive affect, life satisfaction, meaning/purpose, general self-efficacy) and distress (depression, anxiety, anger).ResultsWe assessed 220 YAs for eligibility; 77% declined. Of those screened, 44 (88%) were eligible and consented, 33 began the intervention, and 26 (79%) completed the intervention. Overall retention was 61% at 12 weeks. Average acceptability ratings were high (8.8/10). Participants (M = 30.8 years, SD = 6.6) were 77% women, 18% racial/ethnic minorities, and 34% breast cancer survivors. At 12 weeks, EMPOWER was associated with improved mental health, positive affect, life satisfaction, meaning/purpose, and general self-efficacy (ps < .05, ds = .45 to .63) and decreased anger (p < .05, d = − 0.41).ConclusionEMPOWER demonstrated evidence of feasibility and acceptability as well as proof of concept for enhancing well-being and reducing distress. Self-guided, eHealth interventions show promise for addressing YA cancer survivors’ needs and warrant additional research to optimize survivorship care.Trial RegistrationClinicalTrials .gov NCT02832154, https://clinicaltrials.gov/ct2/show/NCT02832154
Journal Article
Palliative care use and utilization determinants among patients treated for advanced stage lung cancer care in the community and academic medical setting
by
McFarlin, Jessica
,
Shearer, Andrew
,
Studts, Jamie L.
in
Advanced stage
,
Cancer
,
Cancer patients
2023
Purpose
Despite clinical guidelines, palliative care is underutilized during advanced stage lung cancer treatment. To inform interventions to increase its use, patient-level barriers and facilitators (i.e., determinants) need to be characterized, especially among patients living in rural areas or those receiving treatment outside academic medical centers.
Methods
Between 2020 and 2021, advanced stage lung cancer patients (
n
= 77; 62% rural; 58% receiving care in the community) completed a one-time survey assessing palliative care use and its determinants. Univariate and bivariate analyses described palliative care use and determinants and compared scores by patient demographic (e.g., rural vs. urban) and treatment setting (e.g., community vs. academic medical center) factors.
Results
Roughly half said they had never met with a palliative care doctor (49.4%) or nurse (58.4%) as part of cancer care. Only 18% said they knew what palliative care was and could explain it; 17% thought it was the same as hospice. After palliative care was distinguished from hospice, the most frequently cited reasons patients stated they would not seek palliative care were uncertainty about what it would offer (65%), concerns about insurance coverage (63%), difficulty attending multiple appointments (60%), and lack of discussion with an oncologist (59%). The most common reasons patients stated they would seek palliative care were a desire to control pain (62%), oncologist recommendation (58%), and coping support for family and friends (55%).
Conclusion
Interventions should address knowledge and misconceptions, assess care needs, and facilitate communication between patients and oncologists about palliative care.
Journal Article
Clinician perspectives on delivering primary and specialty palliative care in community oncology practices
by
McFarlin, Jessica
,
Shearer, Andrew
,
Studts, Jamie L.
in
Adult
,
Attitude of Health Personnel
,
Cancer
2024
Purpose
Clinical guidelines recommend early palliative care for patients with advanced lung cancer. In rural and underserved community oncology practices with limited resources, both primary palliative care from an oncologist and specialty palliative care are needed to address patients’ palliative care needs. The aim of this study is to describe community oncology clinicians’ primary palliative care practices and perspectives on integrating specialty palliative care into routine advanced lung cancer treatment in rural and underserved communities.
Methods
Participants were clinicians recruited from 15 predominantly rural community oncology practices in Kentucky. Participants completed a one-time survey regarding their primary palliative care practices and knowledge, barriers, and facilitators to integrating specialty palliative care into advanced-stage lung cancer treatment.
Results
Forty-seven clinicians (30% oncologists) participated. The majority (72.3%) of clinicians worked in a rural county. Over 70% reported routinely asking patients about symptom and physical function concerns, whereas less than half reported routinely asking about key prognostic concerns. Roughly 30% held at least one palliative care misconception (e.g., palliative care is for only those who are stopping cancer treatment). Clinician-reported barriers to specialty palliative care referrals included fear a referral would send the wrong message to patients (77%) and concern about burdening patients with appointments (53%). Notably, the most common clinician-reported facilitator was a patient asking for a referral (93.6%).
Conclusion
Educational programs and outreach efforts are needed to inform community oncology clinicians about palliative care, empower patients to request referrals, and facilitate patients’ palliative care needs assessment, documentation, and standardized referral templates.
Journal Article
Outcomes of Brain Metastasis from Lung Cancer
by
Reddy, Niharika
,
Magsam, Julia B.
,
Mobley, James M.
in
Alcohol abuse
,
Cancer
,
Cancer patients
2025
Background/Objectives: Little information has been published on patients diagnosed with brain metastasis secondary to lung cancer. Correlating outcome patterns (hospice care, lost to follow-up, death before hospice care or treatment) and specific characteristics of treated and untreated patients may identify subsets of patients who may benefit from treatment. Methods: We evaluated data from the Kentucky Cancer Registry and identified 284 cases who were diagnosed with brain metastasis secondary to non-small cell lung cancer (NSCLC) between 1 August 2016, and 31 December 2019. We evaluated type and timing of treatment received, as well as focused on those patients who did not receive treatment. For those patients who did not receive treatment, various characteristics that may have impacted their decision or ability to undergo follow-up were also evaluated. This included social history, disease burden, as well as oncology treatment timelines. Lastly, due to the high smoking rate in Kentucky, we conducted an analysis of patient tobacco use. Results: Our results show that 61 cases (21.8%) never received treatment for lung cancer with brain metastasis. Further analysis of the non-treated cases demonstrated that 19 cases (31.1%) never met with an oncology team while in the hospital or after discharge; 14 of the 61 cases (23.0%) were too sick to receive treatment and died prior to having the option of treatment; and 47 of the 61 cases (77.0%) may have had the option of treatment but declined. Conclusions: Historically, patients with brain metastases have faced poor prognoses and limited treatment options. However, advancements in systemic chemoimmunotherapy and targeted therapies have introduced new treatment possibilities, offering improved symptom control and the potential for prolonged survival. This analysis is crucial for identifying potential barriers to care, optimizing resource allocation, and guiding future research.
Journal Article
Patient-reported tolerability of adjuvant ipilimumab (3 or 10 mg/kg) versus high-dose interferon alfa-2b for resected high-risk stage III–IV melanoma in phase III trial E1609
2023
Purpose
Trial E1609 demonstrated superior overall survival with ipilimumab 3 mg/kg (ipi3) compared to high-dose interferon (HDI) for patients with resected high-risk melanoma. To inform treatment tolerability, we compared health-related quality of life (HRQoL), gastrointestinal (GI), and treatment-specific physical and cognitive/emotional symptoms. We also compared treatment-specific concerns between all arms.
Methods
We assessed HRQoL using the Functional Assessment of Cancer Therapy-General, physical and cognitive/emotional concerns using the FACT-Biologic Response Modifier subscale, and GI symptoms with the Functional Assessment of Chronic Illness Therapy-Diarrhea subscale pre-treatment and every 3 months. The primary outcome was the difference in HRQoL at 3 months between ipi3/ipi10 vs. HDI.
Results
549 patients (
n
= 158 ipi3;
n
= 191 ipi10;
n
= 200 HDI) were analyzed. 3-month completion was 58.7%. Compared to HDI, ipilimumab patients reported better HRQoL (ipi3 = 87.5 ± 14.6 vs. HDI = 74.7 ± 15.4,
p
< .001; ipi10 = 84.9 ± 16.5 vs. HDI,
p
< .001) and fewer physical (ipi3 = 22.3 ± 4.6 vs. HDI = 17.1 ± 5.4,
p
< .001; ipi10 = 21.8 ± 5.0 vs. HDI
p
< .001) and cognitive/emotional (ipi3 = 18.6 ± 4.4 vs. HDI = 15.0 ± 5.3,
p
< .001; ipi10 = 17.7 ± 4.8 vs. HDI
p
< .001) concerns, but worse GI symptoms (ipi3 = 40.8 ± 5.0 vs. HDI = 42.2 ± 2.9,
p
=
.
011; ipi10 = 39.5 ± 7.0 vs. HDI,
p
< .001). Fewer ipilimumab patients reported worsening treatment-specific concerns (e.g., 52% of ipi3 and 58% of ipi10 reported worsening fatigue vs. 82% HDI,
p’s
< .001).
Conclusion
PROs demonstrated less toxicity of ipi3 compared to HDI and ipi10. Priorities for symptom management among patients receiving ipilimumab include GI toxicities, fatigue, weakness, appetite loss, arthralgia, and depression.
Trial Registration:
NCT01274338, January 11, 2011 (first posted date)
https://clinicaltrials.gov/ct2/show/NCT01274338?term=NCT01274338&draw=2&rank=1
.
Journal Article
A Web-Based, Positive Emotion Skills Intervention for Enhancing Posttreatment Psychological Well-Being in Young Adult Cancer Survivors (EMPOWER): Protocol for a Single-Arm Feasibility Trial
2020
Adolescent and young adult cancer survivors (AYAs) experience clinically significant distress and have limited access to supportive care services. Interventions to enhance psychological well-being have improved positive affect and reduced depression in clinical and healthy populations but have not been routinely tested in AYAs.
The aim of this protocol is to (1) test the feasibility and acceptability of a Web-based positive emotion skills intervention for posttreatment AYAs called Enhancing Management of Psychological Outcomes With Emotion Regulation (EMPOWER) and (2) examine proof of concept for reducing psychological distress and enhancing psychological well-being.
The intervention development and testing are taking place in 3 phases. In phase 1, we adapted the content of an existing, Web-based positive emotion intervention so that it would be suitable for AYAs. EMPOWER targets 8 skills (noticing positive events, capitalizing, gratitude, mindfulness, positive reappraisal, goal setting, personal strengths, and acts of kindness) and is delivered remotely as a 5-week, Web-based intervention. Phase 2 consisted of a pilot test of EMPOWER in a single-arm trial to evaluate feasibility, acceptability, retention, and adherence and to collect data on psychosocial outcomes for proof of concept. In phase 3, we are refining study procedures and conducting a second pilot test.
The project was part of a career development award. Pilot work began in June 2015, and data collection was completed in March 2019. The analysis is ongoing, and results will be submitted for publication by May 2020.
If this intervention proves feasible and acceptable, EMPOWER will be primed for a subsequent large, multisite randomized controlled trial. As a scalable intervention, it will be ideally suited for AYA survivors who would otherwise not have access to supportive care interventions to help manage posttreatment distress and enhance well-being.
ClinicalTrials.gov NCT02832154, https://clinicaltrials.gov/ct2/show/NCT02832154.
DERR1-10.2196/17078.
Journal Article
Factors Associated with Interest in Gene-Panel Testing and Risk Communication Preferences in Women from BRCA1/2 Negative Families
2017
Scientific advances have allowed the development of multiplex gene-panels to assess many genes simultaneously in women who have tested negative for
BRCA1/2
. We examined correlates of interest in testing for genes that confer modest and moderate breast cancer risk and risk communication preferences for women from
BRCA
negative families. Female first-degree relatives of breast cancer patients who tested negative for
BRCA1/2
mutations (
N
= 149) completed a survey assessing multiplex genetic testing interest and risk communication preferences. Interest in testing was high (70 %) and even higher if results could guide risk-reducing behavior changes such as taking medications (79 %). Participants preferred to receive genomic risk communications from a variety of sources including: primary care physicians (83 %), genetic counselors (78 %), printed materials (71 %) and the web (60 %). Factors that were independently associated with testing interest were: perceived lifetime risk of developing cancer (odds ratio (OR) = 1.67: 95 % confidence interval (CI) 1.06–2.65) and high cancer worry (OR = 3.12: CI 1.28–7.60). Findings suggest that women from
BRCA1/2
negative families are a unique population and may be primed for behavior change. Findings also provide guidance for clinicians who can help develop genomic risk communications, promote informed decision making and customize behavioral interventions.
Journal Article