Emotion and Symptom-focused Engagement (EASE): A randomized pilot trial of an integrated psychosocial and palliative care intervention for individuals with acute leukemia (AL).

7041 Background: Individuals diagnosed with AL may experience severe physical and psychological distress due to the illness and its treatment, the threat of relapse and treatment failure, and a high risk of mortality. To alleviate psychological and physical distress in this population, we developed a novel, 8-week, manualized intervention called EASE. This includes: 1) EASE-psy- a tailored psychotherapeutic component to reduce psychological distress; and 2) EASE-phys-symptom screening, with moderate to severe physical symptoms triggering early palliative care. Methods: To assess the feasibility and preliminary efficacy of EASE, patients were recruited within 2 weeks of admission to a comprehensive cancer center and randomized to receive either EASE or usual care (UC). Physical and psychological symptoms were assessed at baseline, 4, 8 (primary endpoint), and 12 weeks. Intervention patients received 6-10 psychotherapy sessions over 8 weeks, weekly assessment of physical symptoms, and consultation and follow-up by palliative care, when needed. One-way ANOVA was performed to assess mean change scores over time between groups. Results: Forty-two patients were randomized to EASE (n = 22) or UC (n = 20). Predefined feasibility outcomes were all met: > 86% (19/22) of EASE participants (goal > 64%) completed > 50% of proposed EASE-psy sessions; 64% (14/22) completed symptom screenings (goal > 50%); and 100% of those with moderate to severe symptoms had > 1 meeting with the EASE-phys team (goal 100%). There were statistically significant findings favoring EASE vs. UC for satisfaction with care at 8 and 12 weeks (Δ: -3.12 vs 7.39, p < 0.04; -6.1910 vs 0.0125 p < 0.03). There were trends favoring EASE vs. UC for traumatic stress symptoms, depressive symptoms, quality of life, attachment security, and number, severity, and distress related to physical symptoms at 4, 8, and 12 weeks. Conclusions: Although not powered for statistical significance, this randomized pilot trial of EASE for AL showed promising reductions in psychological and physical distress and supports the feasibility and need for a larger randomized controlled trial. Clinical trial information: NCT02353559.

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A pilot trial of early specialty palliative care for patients with advanced pancreatic cancer: Challenges encountered and lessons learned.

Journal of Clinical Oncology ◽

10.1200/jco.2016.34.26_suppl.110 ◽

2016 ◽

Vol 34 (26_suppl) ◽

pp. 110-110 ◽

Cited By ~ 1

Author(s):

Yael Schenker ◽

Nathan Bahary ◽

Rene Claxton ◽

Julie Childers ◽

Dio Kavalieratos ◽

...

Keyword(s):

Pancreatic Cancer ◽

Palliative Care ◽

Locally Advanced ◽

Pilot Trial ◽

Advanced Pancreatic Cancer ◽

Comprehensive Cancer Center ◽

Cancer Center ◽

Total N ◽

Care Visit ◽

Oncology Care

110 Background: Palliative care trials face implementation barriers. We describe challenges encountered in a pilot trial of early specialty palliative care for patients with pancreatic cancer. Methods: We conducted a mixed-methods pilot randomized controlled trial of early specialty physician-led palliative care in advanced pancreatic cancer. Recently diagnosed patients with borderline, locally-advanced, or metastatic pancreatic cancer and their caregivers (total N=60) were recruited from clinic at a comprehensive cancer center and randomized (2:1) to receive monthly specialty palliative care visits for 3 months in addition to standard oncology care vs. standard oncology care alone. Feasibility assessments included enrollment and intervention completion rates. Acceptability and perceived effectiveness were assessed via drop-out rates and semi-structured participant interviews. Results: The enrollment target was reached after 50 weeks, with a randomized: approached rate of 27%. Mean patient age was 63 (SD 11) and 50% were male. Mean caregiver age was 62 (SD 12), 47% were male, and 80% were the spouse or partner of a patient. 70% of participants in the intervention group completed at least one specialty palliative care visit and 15% completed 3 palliative care visits within the 3-month time period. Two patients and 3 caregivers withdrew, and 4 patients died prior to 3 months. Enrollment barriers included patients not planning to continue receiving care from a participating oncologist and feeling too overwhelmed at the time of diagnosis to consider research participation. In semi-structured interviews, patients and caregivers noted that long travel times to the cancer center, difficulty scheduling palliative care visits at a convenient time, and lengthy study assessments posed burdens. Oncologists and palliative care physicians recommended more in-person communication between clinicians and tailoring palliative care visit content and schedules to match patient needs. Conclusions: Future palliative care intervention trials must consider implementation challenges related to recruitment, retention, intervention fidelity, and participant burden. Clinical trial information: NCT01885884.

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The project ENABLE II randomized controlled trial to improve palliative care for rural patients with advanced cancer: Baseline findings, methodological challenges, and solutions

Palliative & Supportive Care ◽

10.1017/s1478951509000108 ◽

2009 ◽

Vol 7 (1) ◽

pp. 75-86 ◽

Cited By ~ 103

Author(s):

Marie Bakitas ◽

Kathleen Doyle Lyons ◽

Mark T. Hegel ◽

Stefan Balan ◽

Kathleen N. Barnett ◽

...

Keyword(s):

Palliative Care ◽

Missing Data ◽

Controlled Trial ◽

Comprehensive Cancer Center ◽

Cancer Center ◽

Control Group ◽

Randomized Controlled ◽

Methodological Challenges

ABSTRACTObjective:There is a paucity of randomized controlled trials (RCTs) to evaluate models of palliative care. Although interventions vary, all have faced a variety of methodological challenges including adequate recruitment, missing data, and contamination of the control group. We describe the ENABLE II intervention, methods, and sample baseline characteristics to increase intervention and methodological transparency, and to describe our solutions to selected methodological issues.Methods:Half of the participants recruited from our rural U.S. comprehensive cancer center and affiliated clinics were randomly assigned to a phone-based, nurse-led educational, care coordination palliative care intervention model. Intervention services were provided to half of the participants weekly for the first month and then monthly until death, including bereavement follow-up call to the caregiver. The other half of the participants were assigned to care as usual. Symptoms, quality of life, mood, and functional status were assessed every 3 months until death.Results:Baseline data of 279 participants were similar to normative samples. Solutions to methodological challenges of recruitment, missing data, and “usual care” control group contamination are described.Significance of results:It is feasible to overcome many of the methodological challenges to conducting a rigorous palliative care RCT.

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A Pilot Trial of Symptom Screening With Targeted Early Palliative Care (STEP) for Patients With Advanced Cancer

Case Medical Research ◽

10.31525/ct1-nct04044040 ◽

2019 ◽

Author(s):

Keyword(s):

Palliative Care ◽

Advanced Cancer ◽

Pilot Trial ◽

Early Palliative Care ◽

Symptom Screening

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Enhancing Patient-Provider Communication With the Electronic Self-Report Assessment for Cancer: A Randomized Trial

Journal of Clinical Oncology ◽

10.1200/jco.2010.30.3909 ◽

2011 ◽

Vol 29 (8) ◽

pp. 1029-1035 ◽

Cited By ~ 204

Author(s):

Donna L. Berry ◽

Brent A. Blumenstein ◽

Barbara Halpenny ◽

Seth Wolpin ◽

Jesse R. Fann ◽

...

Keyword(s):

Controlled Trial ◽

Clinic Visit ◽

Self Report ◽

Comprehensive Cancer Center ◽

Cancer Center ◽

Control Group ◽

Cancer Symptoms ◽

Patient Reported ◽

Life Issues ◽

Clinic Visits

Purpose Although patient-reported cancer symptoms and quality-of-life issues (SQLIs) have been promoted as essential to a comprehensive assessment, efficient and efficacious methods have not been widely tested in clinical settings. The purpose of this trial was to determine the effect of the Electronic Self-Report Assessment–Cancer (ESRA-C) on the likelihood of SQLIs discussed between clinicians and patients with cancer in ambulatory clinic visits. Secondary objectives included comparison of visit duration between groups and usefulness of the ESRA-C as reported by clinicians. Patients and Methods This randomized controlled trial was conducted in 660 patients with various cancer diagnoses and stages at two institutions of a comprehensive cancer center. Patient-reported SQLIs were automatically displayed on a graphical summary and provided to the clinical team before an on-treatment visit (n = 327); in the control group, no summary was provided (n = 333). SQLIs were scored for level of severity or distress. One on-treatment clinic visit was audio recorded for each participant and then scored for discussion of each SQLI. We hypothesized that problematic SQLIs would be discussed more often when the intervention was delivered to the clinicians. Results The likelihood of SQLIs being discussed differed by randomized group and depended on whether an SQLI was first reported as problematic (P = .032). Clinic visits were similar with regard to duration between groups, and clinicians reported the summary as useful. Conclusion The ESRA-C is the first electronic self-report application to increase discussion of SQLIs in a US randomized clinical trial.

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Screening for Palliative Care: Implementation of the NCCN Guideline at a Comprehensive Cancer Center (418-A)

Journal of Pain and Symptom Management ◽

10.1016/j.jpainsymman.2011.12.123 ◽

2012 ◽

Vol 43 (2) ◽

pp. 387-388 ◽

Cited By ~ 1

Author(s):

Paul Glare ◽

Kathy Plakovic ◽

Barbara Egan ◽

David Kelsen

Keyword(s):

Palliative Care ◽

Comprehensive Cancer Center ◽

Cancer Center

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Impact of a half-day multidisciplinary symptom control and palliative care outpatient clinic in a comprehensive cancer center on recommendations, symptom intensity, and patient satisfaction: A retrospective descriptive study

Journal of Pain and Symptom Management ◽

10.1016/j.jpainsymman.2003.10.011 ◽

2004 ◽

Vol 27 (6) ◽

pp. 481-491 ◽

Cited By ~ 106

Author(s):

Florian Strasser ◽

Catherine Sweeney ◽

Jie Willey ◽

Susanne Benisch-Tolley ◽

J.Lynn Palmer ◽

...

Keyword(s):

Palliative Care ◽

Patient Satisfaction ◽

Outpatient Clinic ◽

Symptom Control ◽

Descriptive Study ◽

Comprehensive Cancer Center ◽

Cancer Center ◽

Symptom Intensity

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Antineoplastic therapy use in patients with advanced cancer admitted to an acute palliative care unit at a comprehensive cancer center

Cancer ◽

10.1002/cncr.24942 ◽

2010 ◽

Vol 116 (8) ◽

pp. 2036-2043 ◽

Cited By ~ 34

Author(s):

David Hui ◽

Ahmed Elsayem ◽

Zhijun Li ◽

Maxine De La Cruz ◽

J. Lynn Palmer ◽

...

Keyword(s):

Palliative Care ◽

Antineoplastic Therapy ◽

Advanced Cancer ◽

Palliative Care Unit ◽

Comprehensive Cancer Center ◽

Cancer Center

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A randomized controlled trial of supplemental oxygen versus air in cancer patients with dyspnea

Palliative Medicine ◽

10.1191/0269216303pm826oa ◽

2003 ◽

Vol 17 (8) ◽

pp. 659-663

Author(s):

Eduardo Bruera ◽

Catherine Sweeney ◽

Jie Willey ◽

J Lynn Palmer ◽

Florian Strasser ◽

...

Keyword(s):

Controlled Trial ◽

Treatment Phase ◽

Supplemental Oxygen ◽

Comprehensive Cancer Center ◽

Cancer Center ◽

Walk Test ◽

Shortness Of Breath ◽

Double Blind ◽

6 Minute Walk Test ◽

Minute Walk

Context: The symptomatic benefits of oxygen in patients with cancer who have nonhypoxic dyspnea are not well defined. Objective: To determine whether or not oxygen is more effective than air in decreasing dyspnea and fatigue and increasing distance walked during a 6-minute walk test. Patients and methods: Patients with advanced cancer who had no severe hypoxemia (i.e., had an O2 saturation level of] / 90%) at rest and had a dyspnea intensity of] / 3 on a scale of 0–10 (03/4/no shortness of breath, 103/4/worst imaginable shortness of breath) were recruited from an outpatient thoracic clinic at a comprehensive cancer center. This was a double-blind, randomized crossover trial. Supplemental oxygen or air (5 L/min) was administered via nasal cannula during a 6-minute walk test. The outcome measures were dyspnea at 3 and 6 minutes, fatigue at 6 minutes, and distance walked. We also measured oxygen saturation levels at baseline, before second treatment phase, and at the end of study. Results: In 33 evaluable patients (31 with lung cancer), no significant differences between treatment groups were observed in dyspnea, fatigue, or distance walked (dyspnea at 3 minutes: P = 0.61; dyspnea, fatigue, and distance walked at 6 minutes: P = 0.81, 0.37, and 0.23, respectively). Conclusions: Currently, the routine use of supplemental oxygen for dyspnea during exercise in this patient population cannot be recommended.

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