Dataset Information

Evaluating a couple communication skills training (CCST) intervention for advanced cancer: study protocol for a randomized controlled trial.

ABSTRACT:

Background

For patients and their intimate partners, advanced cancer poses significant challenges that can negatively impact both individuals and their relationship. Prior studies have found evidence that couple-based communication skills interventions can to be beneficial for patients and partners. However, these studies have been limited by reliance on in-person treatment delivery and have not targeted couples at high risk for poor outcomes. This study tests the efficacy of a Couples Communication Skills Training (CCST) intervention delivered via videoconference for couples reporting high levels of holding back from discussing cancer-related concerns, a variable associated with poorer psychological and relationship functioning.

Methods

This RCT is designed to evaluate the efficacy of CCST in improving patient and partner relationship functioning (primary outcome). Secondary outcomes include patient and partner psychological functioning and patient symptoms and health care use. We also examine the role of objective and self-reported communication behaviors as mediators of treatment effects. Two hundred thirty patients with advanced lung, gastrointestinal, genitourinary, and breast cancer and their partners will be randomized to CCST or an education control intervention. Participants in both conditions complete self-reported outcome measures at baseline, mid-treatment, post-treatment, and 3 months post-treatment. Objective measures of communication are derived from video-recorded couple conversations collected at baseline and post-treatment. An implementation-related process evaluation (assessing implementation outcomes and potential barriers to/facilitators of implementation) will be conducted to inform future efforts to implement CCST in real-world settings.

Discussion

This trial can yield important new knowledge about effective ways to improve patient and partner adjustment to advanced cancer.

Trial registration

This study trial is registered at clinicaltrials.gov (Trial # NCT04590885); registration date: October 19, 2020.

SUBMITTER: Porter LS

PROVIDER: S-EPMC9419413 | biostudies-literature | 2022 Aug

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Evaluating a couple communication skills training (CCST) intervention for advanced cancer: study protocol for a randomized controlled trial.

Porter Laura S LS Ramos Katherine K Baucom Donald H DH Steinhauser Karen K Erkanli Alaattin A Strauman Timothy J TJ Zafar S Yousuf SY Check Devon K DK Leo Karena K Liu Evan E Keefe Francis J FJ

Trials 20220826 1

<h4>Background</h4>For patients and their intimate partners, advanced cancer poses significant challenges that can negatively impact both individuals and their relationship. Prior studies have found evidence that couple-based communication skills interventions can to be beneficial for patients and partners. However, these studies have been limited by reliance on in-person treatment delivery and have not targeted couples at high risk for poor outcomes. This study tests the efficacy of a Couples C ...[more]

PMID: 36028908

Similar Datasets

Project description:BackgroundSexual concerns are distressing for breast cancer survivors and interfere with their intimate relationships. This study evaluates the efficacy of a four-session couple-based intervention delivered via telephone, called Intimacy Enhancement (IE). The IE intervention is grounded in social cognitive theory and integrates evidence-based techniques from cognitive behavioral couple therapy and sex therapy to address survivors' sexual concerns and enhance their and their partners' sexual, relationship, and psychological outcomes.MethodsThis trial is designed to evaluate the efficacy of the IE intervention in improving survivors' sexual function, the primary study outcome. Secondary outcomes include survivors' sexual distress, partners' sexual function, and survivors' and partners' relationship intimacy and quality as well as psychological distress (depressive symptoms and anxiety symptoms). Additional aims are to examine whether treatment effects on patient sexual function are mediated by sexual communication and self-efficacy for coping with sexual concerns and to explore whether survivor age and race/ethnicity moderate intervention effects on survivors' sexual function. Eligible adult female breast cancer survivors reporting sexual concerns and their intimate partners are recruited from two academic sites in the USA and are randomized to either the IE intervention or to a control condition of equal length offering education and support around breast cancer-related health topics (Living Healthy Together). The target sample size is 120 couples. Self-report outcome measures are administered to participants in both conditions at baseline (T1), post-treatment (T2), 3 months post-treatment (T3), and 6 months post-treatment (T4).DiscussionEvidence-based interventions are needed to address sexual concerns for breast cancer survivors and to enhance their and their intimate partners' sexual, relationship, and psychological well-being. This randomized controlled trial will allow us to examine the efficacy of a novel couple-based intervention delivered via telephone for breast cancer survivors experiencing sexual concerns and their intimate partners, in comparison with an attention control. Findings of this study could influence clinical care for women with breast cancer and inform theory guiding cancer-related sexual rehabilitation.Trial registrationClinicalTrials.gov, NCT03930797. Registered on 24 April 2019.

Project description:BackgroundTo ensure high quality of nurses' communication as part of patient-centered care, training of communication skills is essential. Previous studies indicate that communication skills trainings can improve communication skills of nurses and have a positive effect on emotional and psychological burden. However, most show methodological limitations, are not specifically developed for nurses or were developed for oncological setting only.MethodsThis study aims to evaluate the effectiveness of a needs-based communication skills training for nursing professionals and to derive indications for future implementation. A two-armed randomized controlled trial including components from both effectiveness and implementation research will be applied. Additionally, a comprehensive process evaluation will be carried out to derive indications for future implementation. Nurses (n=180) of a university medical center in Germany will be randomized to intervention or waitlist-control group. The intervention was developed based on the wishes and needs of nurses, previously assessed via interviews and focus groups. Outcomes to measure effectiveness were selected based on Kirkpatrick's four levels of training evaluation and will be assessed at baseline, post-training and at 4-weeks follow-up. Primary outcome will be nurses' self-reported self-efficacy regarding communication skills. Secondary outcomes include nurses' communication skills assessed via standardized patient assessment, knowledge about patient-centered communication, mental and work-related burden, and participants' satisfaction with training.DiscussionTo our knowledge, this is the first study systematically evaluating the effectiveness of a patient-centered communication skills training for nursing professionals in Germany. Results will yield insight whether a needs-based intervention can improve nurses' self-efficacy regarding communication skills and other secondary outcomes.Trial registrationClinical trial registration number: NCT05700929, trial register: ClinicalTrials.gov (date of registration: 16 November 2022).

Project description:BackgroundProblems with sustained attention, impulsivity, and hyperactivity are the most prominent symptoms of attention-deficit hyperactivity disorder (ADHD), but many children with this diagnosis also present with poor organizational skills that are important in relation to school. These problems tend to increase from childhood to adolescence and are often not well managed by medication. Organizational skills training (OST) is a range of behavioral interventions that specifically target organizational skills deficits. Evidence supports the effect of OST on improving organizational skills, inattention, and academic performance in children with ADHD. Because previous clinical trials included mostly children above the age of 8 years, this trial includes children in the age range 6-13 years to expand the knowledge on the effects of OST in younger children. Previous OST research has also shown improvement on inattention in parent ratings; we will investigate if a change in inattention can be confirmed with neurocognitive tests. Finally, little is known about predictors of treatment response in OST.ObjectivesThe primary objective is to investigate if OST has positive effects on organizational skills in children with ADHD. The primary outcome measurement is the parent-rated Children's Organizational Skills Scale (COSS), collected before and at the end of the 10 week intervention. Secondary and exploratory outcomes include inattention ratings, family and school functioning, and cognitive functions measured before the intervention period, immediately after, and at a 6 month follow-up. Additional objectives are to investigate both neurocognitive outcomes and age as predictors of treatment response.MethodsThis is a randomized clinical superiority trial investigating the effect of OST vs a treatment-as-usual (TAU) control group for children with ADHD in the age range of 6-13 years. All participants (n = 142) receive TAU. OST is administered in a group format of 10 weekly sessions. Adverse events are monitored by study clinicians during weekly therapy sessions and all assessments. Data analyses will be conducted using mixed linear regression models with random intercepts for patients, adjusted for the stratification variables and the baseline value.PerspectivesThis study will provide important new knowledge and expand on existing research in the field of non-pharmacological treatment of children with ADHD. OST can potentially have a significant impact on the lives of children with ADHD by helping them learn how to cope with their present deficits and to become more independent and self-reliant. It is also important to investigate predictors of treatment response in order to optimize OST.Trial registrationClinicalTrials.gov NCT03160378 . Registered on May 19, 2017.

Project description:BACKGROUND:Non-technical skills (NTS), such as communication and professionalism, contribute to the safe and effective completion of procedures. NTS training has previously been shown to improve surgical performance. Moreover, increases in NTS have been associated with improved clinical endoscopic performance. Despite this evidence, NTS training has not been tested as an intervention in endoscopy. OBJECTIVE:The aim of this study is to evaluate the effectiveness of a simulation-based training (SBT) curriculum of NTS on novice endoscopists' performance of clinical colonoscopy. METHODS:Novice endoscopists were randomized to 2 groups. The control group received 4 hours of interactive didactic sessions on colonoscopy theory and 6 hours of SBT. Hours 5 and 6 of the SBT were integrated scenarios, wherein participants interacted with a standardized patient and nurse, while performing a colonoscopy on the virtual reality (VR) simulator. The NTS (intervention) group received the same teaching sessions but the last hour was focused on NTS teaching. The NTS group also reviewed a checklist of tasks relevant to NTS concepts prior to each integrated scenario case and was provided with dedicated feedback on their NTS performance during the integrated scenario practice. All participants were assessed at baseline, immediately after training, and 4 to 6 weeks post-training. The primary outcome measure is colonoscopy-specific performance in the clinical setting. RESULTS:In total, 42 novice endoscopists completed the study. Data collection and analysis is ongoing. We anticipate completion of all assessments by August 2017. Data analysis, manuscript writing, and subsequent submission for publication is expected to be completed by December 2017. CONCLUSIONS:Results from this study may inform the implementation of NTS training into postgraduate gastrointestinal curricula. NTS curricula may improve attitudes towards patient safety and self-reflection among trainees. Moreover, enhanced NTS may lead to superior clinical performance and outcomes in colonoscopy. TRIAL REGISTRATION:Clinicaltrial.gov NCT02877420; https://www.clinicaltrials.gov/ct2/show/NCT02877420 (Archived by WebCite at http://www.webcitation.org/6rw94ubXX NCT02877420).

Project description:BackgroundPhysicians work in a highly demanding work setting where ongoing changes affect their work and challenge their employability (ie, their ability and willingness to continue working). In this high-pressure environment, physicians could benefit from proactively managing or crafting their careers; however, they tend not to show this behavior. The new concept of career crafting concerns proactively making choices and adapting behavior regarding both short-term job design (ie, job crafting) as well as longer-term career development (ie, career self-management). However, so far, no intervention studies have aimed at enhancing career crafting behavior among physicians. Given that proactive work and career behavior have been shown to be related to favorable outcomes, we designed an intervention to support career crafting behavior and employability of physicians.ObjectiveThe objectives of this study were to describe (1) the development and (2) the design of the evaluation of a randomized controlled career crafting intervention to increase job crafting, career self-management, and employability.MethodsA randomized controlled intervention study was designed for 141 physicians in two Dutch hospitals. The study was designed and will be evaluated based on parts of the intervention mapping protocol. First, needs of physicians were assessed through 40 interviews held with physicians and managers. This pointed to a need to support physicians in becoming more proactive regarding their careers as well as in building awareness of proactive behaviors in order to craft their current work situation. Based on this, a training program was developed in line with their needs. A number of theoretical methods and practical applications were selected as the building blocks of the training. Next, participants were randomly assigned to either the waitlist-control group (ie, received no training) or the intervention group. The intervention group participated in a 4-hour training session and worked on four self-set goals. Then, a coaching conversation took place over the phone. Digital questionnaires distributed before and 8 weeks after the intervention assessed changes in job crafting, career self-management, employability, and changes in the following additional variables: job satisfaction, career satisfaction, work-home interference, work ability, and performance. In addition, a process evaluation was conducted to examine factors that may have promoted or hindered the effectiveness of the intervention.ResultsData collection was completed in March 2020. Evaluation of outcomes and the research process started in April 2020. Study results were submitted for publication in September 2020.ConclusionsThis study protocol gives insight into the systematic development and design of a career crafting training intervention that is aimed to enhance job crafting, career self-management, and employability. This study will provide valuable information to physicians, managers, policy makers, and other researchers that aim to enhance career crafting.International registered report identifier (irrid)RR1-10.2196/18432.

Project description:BACKGROUND:African Americans bear a disproportionate burden of osteoarthritis (OA), with higher prevalence rates, more severe pain, and more functional limitations. One key barrier to addressing these disparities has been limited engagement of African Americans in the development and evaluation of behavioral interventions for management of OA. Pain Coping Skills Training (CST) is a cognitive-behavioral intervention with shown efficacy to improve OA-related pain and other outcomes. Emerging data indicate pain CST may be a promising intervention for reducing racial disparities in OA symptom severity. However, there are important gaps in this research, including incorporation of stakeholder perspectives (e.g. cultural appropriateness, strategies for implementation into clinical practice) and testing pain CST specifically among African Americans with OA. This study will evaluate the effectiveness of a culturally enhanced pain CST program among African Americans with OA. METHODS/DESIGN:This is a randomized controlled trial among 248 participants with symptomatic hip or knee OA, with equal allocation to a pain CST group and a wait list (WL) control group. The pain CST program incorporated feedback from patients and other stakeholders and involves 11 weekly telephone-based sessions. Outcomes are assessed at baseline, 12 weeks (primary time point), and 36 weeks (to assess maintenance of treatment effects). The primary outcome is the Western Ontario and McMaster Universities Osteoarthritis Index, and secondary outcomes include self-efficacy, pain coping, pain interference, quality of life, depressive symptoms, and global assessment of change. Linear mixed models will be used to compare the pain CST group to the WL control group and explore whether participant characteristics are associated with differential improvement in the pain CST program. This research is in compliance with the Helsinki Declaration and was approved by the Institutional Review Boards of the University of North Carolina at Chapel Hill, Durham Veterans Affairs Medical Center, East Carolina University, and Duke University Health System. DISCUSSION:This culturally enhanced pain CST program could have a substantial impact on outcomes for African Americans with OA and may be a key strategy in the reduction of racial health disparities. TRIAL REGISTRATION:ClinicalTrials.gov, NCT02560922 , registered 9/22/2015.

Dataset Information

Evaluating a couple communication skills training (CCST) intervention for advanced cancer: study protocol for a randomized controlled trial.

Background

Methods

Discussion

Trial registration

Publications

Evaluating a couple communication skills training (CCST) intervention for advanced cancer: study protocol for a randomized controlled trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets