Dataset Information

In-person vs. web-based administration of a problem-solving skills intervention for parents of children with cancer: Report of a randomized noninferiority trial.

ABSTRACT: Background:Bright IDEAS (BI) problem-solving skills training is an evidence-based intervention designed to help parents manage the demands of caring for a child with cancer. However, the resource intensiveness of this in-person intervention has limited its widespread delivery. We conducted a multicenter, randomized trial with a noninferiority design to evaluate whether a web-based version of BI requiring fewer resources is noninferior to in-person administration. Methods:621 caregivers of children with newly diagnosed cancer were randomly assigned to standard BI delivered face-to-face or a web-based version delivered via mobile device. The primary outcome was caregiver-reported problem-solving skills. The noninferiority margin was defined as 0.2 standard deviation units of the change from baseline to end of intervention. Secondary outcomes included caregiver-reported mood disturbance, depression, and posttraumatic stress symptoms. The study was registered with ClinicalTrials.gov Identifier: NCT01711944. Findings:The effect of the standard treatment was preserved; parents in the standard BI arm improved their problem-solving (effect size = 0.53, t = 8.88, p < .001). Parents in the web-based BI group also improved their problem-solving (effect size = 0.32, t = 5.32, p < .001). Although the web-based intervention preserved 60% of the standard treatment effect, the test of noninferiority was non-significant (effect size = -0.21, p = 0.55). Similarly, the web-based intervention preserved > 60% of the standard intervention effect on all secondary outcomes; however, tests of noninferiority were non-significant. Interpretation:Noninferiority of web-based BI relative to standard face-to-face administration was not established. Further development of the web-based BI is needed before it can be recommended as a stand-alone intervention. However, the documented benefits of the web-based intervention as well as the advantages of low resource utilization and ease of delivery suggest that further development of web-based BI is indicated, and that it may play a valuable role in alleviating distress in caregivers of children with serious or chronic illness. Funding:National Institutes of Health (U.S.), R01 CA159013 (P.I. Sahler).

SUBMITTER: Phipps S

PROVIDER: S-EPMC7327899 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

In-person vs. web-based administration of a problem-solving skills intervention for parents of children with cancer: Report of a randomized noninferiority trial.

Phipps Sean S Fairclough Diane L DL Noll Robert B RB Devine Katie A KA Dolgin Michael J MJ Schepers Sasja A SA Askins Martha A MA Schneider Nicole M NM Ingman Kathleen K Voll Megan M Katz Ernest R ER McLaughlin Jeffery J Sahler Olle Jane Z OJZ

EClinicalMedicine 20200627

<h4>Background</h4>Bright IDEAS (BI) problem-solving skills training is an evidence-based intervention designed to help parents manage the demands of caring for a child with cancer. However, the resource intensiveness of this in-person intervention has limited its widespread delivery. We conducted a multicenter, randomized trial with a noninferiority design to evaluate whether a web-based version of BI requiring fewer resources is noninferior to in-person administration.<h4>Methods</h4>621 careg ...[more]

PMID: 32637901

Similar Datasets

Project description:BackgroundIndividuals with diabetes mellitus have difficulty solving problems in meaningful occupations and have similar difficulties with self-care regimens. We examined the effects of an occupation-based intervention supported with problem-solving therapy in individuals with type 2 diabetes mellitus on participation in and satisfaction with meaningful occupations, diabetes-related psychosocial self-efficacy, preferred coping strategies and individual well-being.MethodsThis study was planned as a single-blind, randomised controlled study with a 3-month follow-up involving 67 adults with type 2 diabetes. The Canadian Occupational Performance Measure, Diabetes Empowerment Scale, Brief COPE and five-item World Health Organisation Well-Being Index were used. This programme included evaluations, diabetes education, and problem-solving therapy. The intervention was conducted for 6 weeks, and each weekly session lasted approximately 60 min. Differences between groups were analysed using the Mann-Whitney U test, and the Friedman test was used to calculate group-time interaction differences (i.e., baseline, after 6 weeks and after 3 months).ResultsAll participants identified the most significant occupational performance problems in self-care as personal care. Significant improvement was reported in the intervention group compared to the control group regarding participation in meaningful occupation, satisfaction with performance, psychosocial self-efficacy, and well-being results (p < 0.001) after the programme and 3 months of follow-up. Participant use of effective coping strategies, active coping and acceptance strategies, and self-efficacy, as revealed by the results, suggested improvement in favour of the intervention group (p < 0.05).ConclusionsOccupation-based problem-solving therapy encourages participation in meaningful occupations and improves psychosocial self-efficacy, effective coping styles, and well-being in patients with type 2 diabetes mellitus. Problem-solving therapies that incorporate individuals' priorities via meaningful occupation can be used to lead to a meaningful and quality life for individuals with type 2 diabetes mellitus.Trial registrationClinicalTrials.gov Identifier: NCT03783598 . Retrospectively Registered. First Posted-December 21, 2018, Last Update Posted-February 18, 2020.

Project description:Background:Germline genetic testing is standard practice in oncology. Outcomes of telephone disclosure of a wide range of cancer genetic test results, including multigene panel testing (MGPT) are unknown. Methods:Patients undergoing cancer genetic testing were recruited to a multicenter, randomized, noninferiority trial (NCT01736345) comparing telephone disclosure (TD) of genetic test results with usual care, in-person disclosure (IPD) after tiered-binned in-person pretest counseling. Primary noninferiority outcomes included change in knowledge, state anxiety, and general anxiety. Secondary outcomes included cancer-specific distress, depression, uncertainty, satisfaction, and screening and risk-reducing surgery intentions. To declare noninferiority, we calculated the 98.3% one-sided confidence interval of the standardized effect; t tests were used for secondary subgroup analyses. Only noninferiority tests were one-sided, others were two-sided. Results:A total of 1178 patients enrolled in the study. Two hundred eight (17.7%) participants declined random assignment due to a preference for in-person disclosure; 473 participants were randomly assigned to TD and 497 to IPD; 291 (30.0%) had MGPT. TD was noninferior to IPD for general and state anxiety and all secondary outcomes immediately postdisclosure. TD did not meet the noninferiority threshold for knowledge in the primary analysis, but it did meet the threshold in the multiple imputation analysis. In secondary analyses, there were no statistically significant differences between arms in screening and risk-reducing surgery intentions, and no statistically significant differences in outcomes by arm among those who had MGPT. In subgroup analyses, patients with a positive result had statistically significantly greater decreases in general anxiety with telephone disclosure (TD -0.37 vs IPD +0.87, P = .02). Conclusions:Even in the era of multigene panel testing, these data suggest that telephone disclosure of cancer genetic test results is as an alternative to in-person disclosure for interested patients after in-person pretest counseling with a genetic counselor.

Project description:OBJECTIVES:Family caregivers of hospice patients have multiple needs as they try to cope during a stressful time. Translatable interventions effective in improving caregiver outcomes are greatly needed. Our objective was to assess the impact of a problem-solving intervention (called Problem-Solving Intervention to Support Caregivers in End-of-Life Care Settings [PISCES]) to support hospice caregivers on caregiver quality of life and anxiety, and compare its effectiveness delivered face to face and via videoconferencing. DESIGN:In this 4-year randomized clinical trial, caregivers were randomly assigned to a group receiving standard care with added "friendly calls" (attention control [AC] group), a group receiving standard care and PISCES delivered face to face (F2F), or a group receiving standard care and PISCES delivered via videoconferencing (VC). SETTING:Home hospice. PARTICIPANTS:A total of 514 caregivers participated (172 in AC, 171 in F2F, and 171 in VC). Caregivers were predominantly female (75%); mean age was 60.3 years. INTERVENTION:PISCES includes a structured curriculum delivered in three sessions and motivates caregivers to adopt a positive attitude, define problems by obtaining facts, set goals, and generate and evaluate solutions. MEASUREMENTS:Quality of life was measured by the Caregiver Quality of Life Index-Revised; anxiety was measured by the Generalized Anxiety Disorder 7-Item. Other measures included the Caregiver Reaction Assessment scale, demographic data, and an exit interview. RESULTS:Compared with AC, caregivers in the F2F condition had postintervention reduced anxiety (-1.31 [95% confidence interval [CI]?=?-2.11 to .50]; p?=?.004) and improved social (.57 [95% CI?=?.19-.95]; p?=?.01), financial (.57 [95% CI?=?.21-.93]; p?=?.004), and physical quality of life (.53 [95% CI?=?.19-.87]; p?=?.01). There were no differences in caregivers in the VC condition compared with the AC condition. CONCLUSION:The PISCES intervention improves caregiver outcomes and is effective when delivered in person. How to integrate technology to reduce the intervention delivery cost warrants further investigation.

Dataset Information

In-person vs. web-based administration of a problem-solving skills intervention for parents of children with cancer: Report of a randomized noninferiority trial.

Publications

In-person vs. web-based administration of a problem-solving skills intervention for parents of children with cancer: Report of a randomized noninferiority trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets