The Deliverability, Acceptability, and Perceived Effect of the Macmillan Approach to Weight Loss and Eating Difficulties: A Phase II, Cluster-Randomized, Exploratory Trial of a Psychosocial Intervention for Weight- and Eating-Related Distress in People with Advanced Cancer

Abstract Evidence-based behavioral weight loss treatment is under-utilized. To increase initiation of treatment, we developed a single-session, online, primary care-based intervention (“mobilization tool”). We evaluated the mobilization tool's acceptability for primary care patients with obesity, trial design feasibility, and signal of an effect of the tool on treatment initiation. In this cluster randomized feasibility trial, primary care providers (PCPs) were randomized to a mobilization tool or comparator tool arm. Patients with obesity and a scheduled appointment with a randomized PCP were assigned to complete the mobilization or comparator tool prior to their appointment. The online mobilization tool asks patients to answer questions about a variety of weight-related topics and then provides automated, tailored feedback that addresses psychosocial determinants of weight loss treatment initiation. The comparator tool provided a nontailored description of treatments. All participants were offered free enrollment in behavioral weight loss treatments. Six PCPs were randomized. Sixty patients (57% female; 66% white; aged 55 ± 13 years) participated in this study of 296 contacted for eligibility evaluation (20.2%). Six-month follow-up assessments were completed by 65% (22/34) of the mobilization and 73% (19/26) of comparator tool participants. Participants completing the acceptability survey reported that the mobilization tool was usable, enjoyable, informative, and useful. Weight loss treatment was initiated by 59% (n = 19) of mobilization and 33% (n = 8) of comparator tool participants. The mobilization tool shows promise for increasing treatment initiation among primary care patients, which may increase population weight loss. Trial Registration: Clinicaltrials.gov identifier: NCT02708121.

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EffenDys—Fentanyl Buccal Tablet for the Relief of Episodic Breathlessness in Patients With Advanced Cancer: A Multicenter, Open-Label, Randomized, Morphine-Controlled, Crossover, Phase II Trial

Journal of Pain and Symptom Management ◽

10.1016/j.jpainsymman.2016.05.023 ◽

2016 ◽

Vol 52 (5) ◽

pp. 617-625 ◽

Cited By ~ 13

Author(s):

Steffen T. Simon ◽

Marianne Kloke ◽

Bernd Alt-Epping ◽

Jan Gärtner ◽

Martin Hellmich ◽

...

Keyword(s):

Advanced Cancer ◽

Phase Ii ◽

Phase Ii Trial ◽

Open Label ◽

Fentanyl Buccal Tablet ◽

Buccal Tablet ◽

Crossover Phase

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Prognostic understanding, hospitalization, and hospice use among older patients with advanced cancer.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.12037 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. 12037-12037

Author(s):

Kah Poh Loh ◽

Christopher Seplaki ◽

Reza Yousefi Nooraie ◽

Jennifer Leigh Lund ◽

Ronald M. Epstein ◽

...

Keyword(s):

Older Adults ◽

Advanced Cancer ◽

Generalized Estimating Equations ◽

Older Patients ◽

Cluster Randomized Trial ◽

Response Options ◽

Lower Odds ◽

Poor Understanding ◽

Cluster Randomized ◽

Hospice Use

12037 Background: Poor prognostic understanding of curability is associated with lower hospice use in patients with advanced cancer. Little is known if this holds true for older adults specifically. In addition, prognostic understanding are variably assessed and defined in prior studies. We evaluated the associations of poor prognostic understanding and patient-oncologist discordance in both curability and survival estimates with hospitalization and hospice use in older patients with advanced cancer. Methods: We utilized data from a national geriatric assessment cluster-randomized trial (URCC 13070: PI Mohile) that recruited 541 patients aged ≥70 with incurable solid tumor or lymphoma considering any line of cancer treatment and their oncologists. At enrollment, patients and oncologists were asked about their beliefs about cancer curability (options: 100%, > 50%, 50/50, < 50%, 0%, and uncertain) and estimates of patient’s survival (options: 0-6 months, 7-12 months, 1-2 years, 2-5 years, and > 5 years). Non-0% options were considered poor understanding of curability (uncertain was removed from the analysis) and > 5 years was considered poor understanding of survival estimates. Any difference in response options was considered discordant. We used generalized estimating equations to estimate adjusted odds ratios (AOR) assessing associations of poor prognostic understanding and discordance with hospitalization and hospice use at 6 months, adjusting for covariates and practice clusters. Results: Poor prognostic understanding of curability and survival estimates occurred in 59% (206/348) and 41% (205/496) of patients, respectively. Approximately 60% (202/336) and 72% (356/492) of patient-oncologist dyads were discordant in curability and survival estimates, respectively. In the first 6 months after enrollment, 24% were hospitalized and 15% utilized hospice. Poor prognostic understanding of survival estimates was associated with lower odds of hospice use (AOR 0.30, 95% CI 0.16-0.59) (Table). Discordance in survival estimates was associated with greater odds of hospitalization (AOR 1.64, 95% CI 1.01-2.66). Conclusions: Prognostic understanding may be associated with hospitalization or hospice use depending on how patients were queried about their prognosis and whether oncologists’ estimates were considered.[Table: see text]

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A cluster randomized controlled trial comparing Virtual Learning Collaborative and Technical Assistance strategies to implement an early palliative care program for patients with advanced cancer and their caregivers: a study protocol

Implementation Science ◽

10.1186/s13012-021-01086-3 ◽

2021 ◽

Vol 16 (1) ◽

Author(s):

Lisa Zubkoff ◽

Kathleen Doyle Lyons ◽

J. Nicholas Dionne-Odom ◽

Gregory Hagley ◽

Maria Pisu ◽

...

Keyword(s):

Palliative Care ◽

Advanced Cancer ◽

Technical Assistance ◽

Controlled Trial ◽

Implementation Strategies ◽

Care Program ◽

Early Palliative Care ◽

Randomized Controlled ◽

Community Oncology ◽

Cluster Randomized

Abstract Background Virtual Learning Collaboratives (VLC), learning communities focused on a common purpose, are used frequently in healthcare settings to implement best practices. Yet, there is limited research testing the effectiveness of this approach compared to other implementation strategies. This study evaluates the effectiveness of a VLC compared to Technical Assistance (TA) among community oncology practices implementing ENABLE (Educate, Nurture, Advise, Before Life Ends), an evidence-based, early palliative care telehealth, psycho-educational intervention for patients with newly diagnosed advanced cancer and their caregivers. Methods Using Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) and Proctor’s Implementation Outcomes Frameworks, this two-arm hybrid type-III cluster-randomized controlled trial (RCT) will compare two implementation strategies, VLC versus TA, among the 48 National Cancer Institute Community Oncology Research Program (NCORP) practice clusters that have not historically provided palliative care to all patients with advanced cancer. Three cohorts of practice clusters will be randomized to the study arms. Each practice cluster will recruit 15–27 patients and a family caregiver to participate in ENABLE. The primary study outcome is ENABLE uptake (patient level), i.e., the proportion of eligible patients who complete the ENABLE program (receive a palliative care assessment and complete the six ENABLE sessions over 12 weeks). The secondary outcome is overall program implementation (practice cluster level), as measured by the General Organizational Index at baseline, 6, and 12 months. Exploratory aims assess patient and caregiver mood and quality of life outcomes at baseline, 12, and 24 weeks. Practice cluster randomization will seek to keep the proportion of rural practices, practice sizes, and minority patients seen within each practice balanced across the two study arms. Discussion This study will advance the field of implementation science by evaluating VLC effectiveness, a commonly used but understudied, implementation strategy. The study will advance the field of palliative care by building the capacity and infrastructure to implement an early palliative care program in community oncology practices. Trial registration Clinicaltrials.gov. NCT04062552; Pre-results. Registered: August 20, 2019. https://clinicaltrials.gov/ct2/show/NCT04062552?term=NCT04062552&draw=2&rank=1

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