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Novel patient-reported outcomes (PROs) used in a pilot and feasibility study of a Cognitive Behavioral Coping Skills (CBCS) group intervention for patients with chronic hepatitis C.

ABSTRACT: Background:Patients with chronic hepatitis C virus (HCV) experience reduced quality of life, HCV-associated symptoms, comorbid conditions, and treatment side effects. The Cognitive Behavioral Coping Skills group intervention for HCV (CBCS-HCV) was developed using the Stage Model of Behavioral Therapies Research. Intervention development and initial feasibility testing in wave 1 participants were previously reported. The primary objective of this subsequent pilot with wave 2-3 participants was to investigate the effect sizes and clinical improvements in patient-reported outcomes (PROs) and trial and intervention feasibility. Methods:A pilot feasibility two-arm randomized controlled trial using block randomization to assign patients to CBCS-HCV or standard of care was conducted. Participants attended nine group sessions: four before HCV treatment and five during treatment. PRO data were collected at five time points: before the CBCS intervention (T1), immediately before HCV treatment (T2), during HCV treatment (T3, T4), and 1 month post-intervention/post-HCV treatment (T5). PROs included quality of life, perceived stress, HCV symptoms, and medication adherence. Cohen's d was used to estimate within-group changes (WGCs) and between-group differences (BGDs), with d?>?0.35 considered potentially clinically significant. Potential mechanisms of change were also evaluated. Results:Several WGCs and BGDs (ES?>?.35) suggest that the CBCS-HCV may promote improvements in PROs: psychological stress, depression, anger, anxiety, sleep disturbance, and fatigue. The intervention did not appear to impact social functioning, pain, or medication adherence. Cognitive behavioral skills and group therapy dynamics, but not HCV treatment self-efficacy, may mediate improvements in PROs. Most aspects of the study trial, including intervention implementation, were feasible. Patient acceptance and retention were exceptional. The greatest feasibility challenge was due to patients needing to initiate treatment as soon as medications were obtained, but often before a full block could be created in wave 3. Challenges with PRO data collection were identified that will be resolved in future studies. Conclusions:The CBCS-HCV intervention warrants future investigation in an efficacy trial to evaluate improvements in selected PROs. The next step is to pilot test the CBCS-HCV delivered via telehealth to an expanded pool of patients to reduce patient barriers, hone technical logistics, and improve intervention reach and effectiveness. Trial registration:NCT03057236 Retrospectively registered.

SUBMITTER: Evon DM

PROVIDER: S-EPMC6020443 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Novel patient-reported outcomes (PROs) used in a pilot and feasibility study of a Cognitive Behavioral Coping Skills (CBCS) group intervention for patients with chronic hepatitis C.

Evon Donna M DM Golin Carol E CE Ruffin Rachel R Ayres Shauna S Fried Michael W MW

Pilot and feasibility studies 20180627

<h4>Background</h4>Patients with chronic hepatitis C virus (HCV) experience reduced quality of life, HCV-associated symptoms, comorbid conditions, and treatment side effects. The Cognitive Behavioral Coping Skills group intervention for HCV (CBCS-HCV) was developed using the Stage Model of Behavioral Therapies Research. Intervention development and initial feasibility testing in wave 1 participants were previously reported. The primary objective of this subsequent pilot with wave 2-3 participant ...[more]

PMID: 29983993

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Project description:Background: Pain from advanced cancer can greatly reduce patients' physical, emotional, and spiritual well-being. Objective: To examine the feasibility and acceptability of a behavioral pain management intervention, Meaning-Centered Pain Coping Skills Training (MCPC). Design: This trial used a single-arm feasibility design. Setting/Subjects: Thirty participants with stage IV solid tumor cancer, moderate-to-severe pain, and clinically elevated distress were enrolled from a tertiary cancer center in the United States. The manualized protocol was delivered across four 45- to 60-minute videoconference sessions. Measurements: Feasibility and acceptability were assessed through accrual, session/assessment completion, intervention satisfaction, and coping skills usage. Participants completed validated measures of primary outcomes (i.e., pain severity, pain interference, and spiritual well-being) and secondary outcomes at baseline, post-intervention, and four-week follow-up. Results: Eighty-eight percent (38/43) of patients who completed screening met inclusion criteria, and 79% (30/38) consented and completed baseline assessment. Sixty-seven percent (20/30) of participants were female (mean age = 57). Most participants were White/Caucasian (77%; 23/30) or Black/African American (17%; 5/30) with at least some college education (90%; 27/30). Completion rates for intervention sessions and both post-intervention assessments were 90% (27/30), 87% (26/30), and 77% (23/30), respectively. At the post-intervention assessment, participants reported a high degree of intervention satisfaction (mean = 3.53/4.00; SD = 0.46), and 81% (21/26) reported weekly use of coping skills that they learned. Participants also showed improvement from baseline on all primary outcomes and nearly all secondary outcomes at both post-intervention assessments. Conclusions: MCPC demonstrated strong feasibility and acceptability. Findings warrant further evaluation of MCPC in a randomized controlled trial. ClinicalTrials.gov Identifier: NCT03207360.

Project description:BackgroundDeveloping communication skills is a key competency for residents. Coaching, broadly accepted as a training modality in medical education, has been proven a successful tool for teaching communication skills. Little research is available thus far to investigate virtual coaching on communication skills for telemedicine encounters. The purpose of the study was to test the hypothesis that virtually coaching residents on communication skills is feasible and acceptable. We surveyed 21 resident-faculty pairs participating in a "fully virtual" coaching session (patient, coach, and resident were virtual).MethodsWe asked 50 neurology resident-faculty coach pairs to complete one "fully virtual" coaching session between May 20 and August 31, 2020. After each session, the resident and coach completed a 15-item survey, including Likert-style scale and open-ended questions, assessing feasibility and acceptability. Descriptive statistics and qualitative content and thematic analyses were performed.ResultsForty-two percent (21/50) of all eligible residents completed "fully virtual" coaching sessions. The overall survey response rate was 91 % (38/42). The majority of respondents agreed that the direct observation and debriefing conversation were easy to schedule and occurred without technical difficulties and that debriefing elements (self-reflection, feedback, takeaways) were useful for residents. Ninety-five percent of respondents rated the coach's virtual presence to be not at all disruptive to the resident-patient interaction. Virtual coaching alleviated resident stress associated with observation and was perceived as an opportunity for immediate feedback and a unique approach for resident education that will persist into the future.ConclusionsIn this pilot study, residents and faculty coaches found virtual coaching on communication skills feasible and acceptable for telemedicine encounters. Many elements of our intervention may be adoptable by other residency programs. For example, residents may share their communication goals with clinic faculty supervisors and then invite them to directly observe virtual encounters what could facilitate targeted feedback related to the resident's goals. Moreover, virtual coaching on communication skills in both the in-person and telemedicine settings may particularly benefit residents in challenging encounters such as those with cognitively impaired patients or with surrogate decision-makers.

Project description:BackgroundPatients with Systemic Lupus Erythematosus (SLE) often experience pain and other symptoms that negatively impact quality of life. Interventions that enhance the use of behavioral and cognitive coping strategies may lead to improved outcomes among patients with SLE. Pain coping skills training (PCST) programs have been shown to improve outcomes among patients with other rheumatic conditions, but there have been no trials of PCST among patients with SLE. This study was a preliminary assessment of the feasibility and efficacy of painTRAINER, an automated, internet-based PCST program, among patients with SLE.MethodsParticipants (n = 60) with SLE from one health care system were randomly assigned with equal allocation to painTRAINER or a wait list control group. PainTRAINER involves 8 modules; participants were instructed to complete one module weekly, along with practice activities for each cognitive or behavioral coping skill. Outcome measures were assessed at baseline and 9-week follow-up, including the Pain Catastrophizing Scale, PROMIS Subscales (Pain Interference, Physical Function, Sleep Disturbance, Anxiety, Depression, Fatigue and Participation), and the LupusPRO questionnaire. Mean changes in outcomes from baseline to follow up and Cohen's d effect sizes were computed.ResultsEffect sizes for the painTRAINER group (relative to the wait list group) were small, with changes being greatest for the PROMIS Depression score (d = - 0.32). Among those randomized to the painTRAINER group, 50% accessed the program ("painTRAINER users"). Most of those who did not access the program stated that they did not receive instructions via email. Effect sizes for "painTRAINER users" (relative to wait list) were larger than for the whole painTRAINER group: Pain Catastrophizing d = - 0.60, PROMIS Pain Interference d = - 0.3., PROMIS Depression d = - 0.44, LupusPRO Health-Related Quality of Life d = 0.30.ConclusionsPainTRAINER users reported meaningful improvements in multiple physical and psychological outcomes, supporting the potential of PCST programs to benefit individuals with SLE. However, strategies are needed to improve engagement with the program and tailor content to comprehensively address key SLE symptoms and challenges.Trial registrationNCT03933839 , May 1, 2019.

Project description:BackgroundDepression is a common mental health problem with significant personal and social consequences. Studies have suggested that cognitive behavioral therapy (CBT) is an effective treatment for depression and anxiety when delivered one-to-one by an expert practitioner, but access to this talking therapy is often limited, and waiting lists can be long. However, a range of low-intensity interventions that can increase access to services are available including guided CBT self-help materials delivered via books, classes, and online packages.ObjectiveThis project aimed to pilot a randomized controlled trial (RCT) of an online CBT-based life skills course with community-based individuals experiencing depression.MethodsIndividuals with symptoms of depression were recruited directly from the community via newspaper advertisements. Participants were remotely randomized to receive either immediate access (IA) or delayed access (DA) to a research version of the Living Life to the Full online CBT-based life skills package (3rd edition) with telephone support provided by nonspecialist, charity-based workers while they used the online intervention. The primary end point was at 3 months postrandomization, at which point, the DA group were offered the intervention. Levels of depression, anxiety, social functioning, and satisfaction were assessed.ResultsThere were effective recruitment, randomization, and uptake, with 19 IA and 17 DA control participants entering the pilot study via newspaper advertisements and 13 of the 19 participants taking up the intervention. Overall, 72% (26/36) were not currently under the care of their general practitioner. The online package was acceptable to participants; the mean satisfaction score on the Client Satisfaction Questionnaire was 21 out of 32 (SD 8.89). At 3 months, data collection was achieved from 78% (28/36) of the participants. The efficacy and retention data were used for a power calculation indicating that 72 participants in total will be required for a future substantive RCT.ConclusionsThe research design successfully tested the recruitment, data collection, and intervention delivery. The pilot study has provided data for the required sample size for the full RCT.Trial registrationISRCTN registry ISRCTN12890709; https://doi.org/10.1186/ISRCTN12890709.International registered report identifier (irrid)RR2-10.1186/s13063-016-1336-y.

Project description:Background: Imparting communication skills has been given great importance in medical curricula. In addition to standardized assessments, students should communicate with real patients in actual clinical situations during workplace-based assessments and receive structured feedback on their performance. The aim of this project was to pilot a formative testing method for workplace-based assessment. Our investigation centered in particular on whether or not physicians view the method as feasible and how high acceptance is among students. In addition, we assessed the reliability of the method. Method: As part of the project, 16 students held two consultations each with chronically ill patients at the medical practice where they were completing GP training. These consultations were video-recorded. The trained mentoring physician rated the student's performance and provided feedback immediately following the consultations using the Berlin Global Rating scale (BGR). Two impartial, trained raters also evaluated the videos using BGR. For qualitative and quantitative analysis, information on how physicians and students viewed feasibility and their levels of acceptance was collected in written form in a partially standardized manner. To test for reliability, the test-retest reliability was calculated for both of the overall evaluations given by each rater. The inter-rater reliability was determined for the three evaluations of each individual consultation. Results: The formative assessment method was rated positively by both physicians and students. It is relatively easy to integrate into daily routines. Its significant value lies in the personal, structured and recurring feedback. The two overall scores for each patient consultation given by the two impartial raters correlate moderately. The degree of uniformity among the three raters in respect to the individual consultations is low. Discussion: Within the scope of this pilot project, only a small sample of physicians and students could be surveyed to a limited extent. There are indications that the assessment can be improved by integrating more information on medical context and student self-assessments. Despite the current limitations regarding test criteria, it is clear that workplace-based assessment of communication skills in the clinical setting is a valuable addition to the communication curricula of medical schools.

Project description:BackgroundAlthough smoking cessation apps have become popular, few have been tested in randomized clinical trials or undergone formative evaluation with target users.ObjectiveWe developed a cessation app targeting tobacco-dependent cancer patients. Game design and behavioral rehearsal principles were incorporated to help smokers identify, model, and practice coping strategies to avoid relapse to smoking. In this randomized pilot trial, we examined feasibility (recruitment and retention rates), acceptability (patient satisfaction), quitting self-confidence, and other cessation-related indices to guide the development of a larger trial.MethodsWe randomized 42 English-speaking cancer patients scheduled for surgical treatment to either the Standard Care (SC; telecounseling and cessation pharmacotherapies) or the experimental QuitIT study arm (SC and QuitIT game). Gameplay parameters were captured in-game; satisfaction with the game was assessed at 1-month follow-up. We report study screening, exclusion, and refusal reasons; compare refusal and attrition by key demographic and clinical variables; and report tobacco-related outcomes.ResultsFollow-up data were collected from 65% (13/20) patients in the QuitIT and 61% (11/18) in SC arms. Study enrollees were 71% (27/38) females, 92% (35/38) white people, and 95% (36/38) non-Hispanic people. Most had either lung (12/38, 32%) or gastrointestinal (9/38, 24%) cancer. Those dropping out were less likely than completers to have used a tablet (P<.01) and have played the game at all (P=.02) and more likely to be older (P=.05). Of 20 patients in the QuitIT arm, 40% (8/20) played the game (system data). There were no differences between those who played and did not play by demographic, clinical, technology use, and tobacco-related variables. Users completed an average of 2.5 (SD 4.0) episodes out of 10. A nonsignificant trend was found for increased confidence to quit in the QuitIT arm (d=0.25, 95% CI -0.56 to 1.06), and more participants were abstinent in the QuitIT group than in the SC arm (4/13, 30%, vs 2/11, 18%). Satisfaction with gameplay was largely positive, with most respondents enjoying use, relating to the characters, and endorsing that gameplay helped them cope with actual smoking urges.ConclusionsRecruitment and retention difficulties suggest that the perihospitalization period may be a less than ideal time for delivering a smoking cessation app intervention. Framing of the app as a "game" may have decreased receptivity as participants may have been preoccupied with hospitalization demands and illness concerns. Less tablet experience and older age were associated with participant dropout. Although satisfaction with the gameplay was high, 60% (12/20) of QuitIT participants did not play the game. Paying more attention to patient engagement, changing the intervention delivery period, providing additional reward and support for use, and improving cessation app training may bolster feasibility for a larger trial.Trial registrationClinicalTrials.gov NCT01915836; https://clinicaltrials.gov/ct2/show/NCT01915836 (Archived by WebCite at http://www.webcitation.org/73vGsjG0Y).

Dataset Information

Novel patient-reported outcomes (PROs) used in a pilot and feasibility study of a Cognitive Behavioral Coping Skills (CBCS) group intervention for patients with chronic hepatitis C.

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Novel patient-reported outcomes (PROs) used in a pilot and feasibility study of a Cognitive Behavioral Coping Skills (CBCS) group intervention for patients with chronic hepatitis C.

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