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Self-management intervention for head and neck cancer couples: Results of a randomized pilot trial.

ABSTRACT: BACKGROUND:Patients with head and neck cancer (HNC) experience significant physical and psychological morbidity during radiotherapy (RT) that contributes to treatment interruptions and a poor quality of life. Although spouses/partners can help by encouraging patient self-management (eg, self-care) during RT, they often experience high psychological distress rates, lack basic health care knowledge and skills, and report increased marital conflict regarding patient self-management. The current pilot study examined the feasibility and acceptability of a 6-session telephone-based intervention called Spouses coping with the Head And neck Radiation Experience (SHARE), which teaches self-management, communication, and coping skills to patients with HNC and their spouses. The treatment effects of SHARE compared with usual medical care (UMC) in controlling patient physical symptoms and improving patient/spouse psychological and marital functioning also were examined. METHODS:Thirty patients who initiated RT and their spouses (60 participants; 40% of whom were racial/ethnic minorities) were randomized to SHARE or UMC, and preintervention and postintervention assessments were completed. RESULTS:Solid recruitment (70%) and low attrition rates (7%) demonstrated feasibility. Strong program evaluations and homework completion rates (72%) supported acceptability. Significant treatment effects (medium in magnitude) were observed for SHARE compared with UMC with regard to HNC-specific physical symptom burden (Cohen's d, -0.89) and symptom interference (Cohen's d, -0.86). Medium to large effects favoring SHARE also were found for patient and spouse depressive symptoms (Cohen's d, -0.84) and cancer-specific distress (Cohen's d, -1.05). CONCLUSIONS:The findings of the current study support the feasibility, acceptability, and preliminary efficacy of SHARE. They also suggest that programs that empower HNC couples with the necessary skills to coordinate care and manage the challenges of RT together hold great promise for controlling a patient's physical symptoms and improving the psychological functioning of both partners.

SUBMITTER: Badr H

PROVIDER: S-EPMC6420382 | biostudies-literature | 2019 Apr

REPOSITORIES: biostudies-literature

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Self-management intervention for head and neck cancer couples: Results of a randomized pilot trial.

Badr Hoda H Herbert Krista K Chhabria Karishma K Sandulache Vlad C VC Chiao Elizabeth Y EY Wagner Timothy T

Cancer 20181206 7

<h4>Background</h4>Patients with head and neck cancer (HNC) experience significant physical and psychological morbidity during radiotherapy (RT) that contributes to treatment interruptions and a poor quality of life. Although spouses/partners can help by encouraging patient self-management (eg, self-care) during RT, they often experience high psychological distress rates, lack basic health care knowledge and skills, and report increased marital conflict regarding patient self-management. The cur ...[more]

PMID: 30521075

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Project description:Background:Atrial fibrillation (AF) is the most common arrhythmia worldwide. Despite effective treatment, it is characterized by frequent recurrences. Optimal therapeutic management of AF requires active participation and self-management from patients. Two major components of self-management are self-monitoring and sign-and-symptom management. Pulse self-palpation (PSP) is a method of self-monitoring; however, not all AF patients are capable of successfully performing PSP. Due to a lack of interventions on this topic, a nurse-led intervention for patients with AF (PSPAF intervention) was developed to foster self-monitoring and to enhance self-management through PSP. The purpose of this pilot study was to test the acceptability, feasibility, and potential effects of this intervention on the capability of patients' PSP and sign-and-symptom management. Moreover, we aimed at gathering data on the feasibility of applied research methods to aid in the design of future studies. Methods:The pilot trial involved 20 adult patients with AF, randomized to an intervention or usual care group. At baseline and during a home visit 3-5?weeks later, we collected data using questionnaires, checklists, field notes, a mobile ECG device, and a diary. Acceptability and feasibility measures were validated through predefined cut-off points. Effect size estimates were expressed as relative risks (RR) and the number needed to treat (NNT). Results:The PSPAF intervention seemed feasible, but only partly acceptable. There were limitations in terms of potential effectiveness, suitability, addressing participants' willingness to implement its content in daily life, and adherence. Estimations of effect sizes suggest a large effect of the intervention on patients' PSP capability (RR = 6.0; 95% CI = [0.83, 43.3]; NNT = 2.4), but almost no effect on sign-and-symptom management (RR = 1.5; 95% CI = [0.7, 3.1]; NNT = 4.0). The feasibility of applied research methods showed minor limitations on recruitment and participant burden. Conclusions:Despite some limitations, the intervention seemed to be applicable and promising. Taking into account the suggestions and amendments we have made, we recommend conducting a full-scale trial to examine the efficacy of the PSPAF intervention. Trial registration:This pilot study was registered in the German Clinical Trials Register at September 4, 2017 (Main ID: DRKS00012808).

Project description:Most adults undergoing cardiac surgery suffer from moderate to severe pain for up to 6 days after surgery. Individual barriers and attitudes regarding pain and its relief make patients reluctant to report their pain and ask for analgesic medication, which results in inadequate pain management. More innovative educational interventions for postoperative pain relief are needed. We developed a Web-based nursing intervention to influence patient's involvement in postoperative pain management. The intervention (SOULAGE-TAVIE) includes a preoperative 30-minute Web-based session and 2 brief face-to-face postoperative booster sessions. The Web application generates reflective activities and tailored educational messages according to patients' beliefs and attitudes. The messages are transmitted through videos of a virtual nurse, animations, stories, and texts.The aim of this single-blinded pilot randomized trial was to investigate the preliminary effects of a virtual nursing intervention (SOULAGE-TAVIE) to improve pain relief in patients undergoing cardiac surgery.Participants (N = 60) were adults scheduled for their first cardiac surgery. They were randomly assigned to the experimental group using SOULAGE-TAVIE (n = 30) or the control group using usual care, including an educational pamphlet and postoperative follow-up (n = 30). Data were collected through questionnaires at the time of admission and from day 1 to day 7 after surgery with the help of a blinded research assistant. Outcomes were pain intensity, pain interference with daily activities, patients' pain barriers, tendency to catastrophize in face of pain, and analgesic consumption.The two groups were comparable at baseline across all demographic measures. Results revealed that patients in the experimental group did not experience less intense pain, but they reported significantly less pain interference when breathing/coughing (P = .04). A severe pain interference with breathing/coughing (pain ranked ? 7/10) was reported on day 3 after surgery by 15% of the patients in the experimental group (4/27), as compared to 44% (7/16) in the control group. On day 7 after surgery, participants in the experimental group also exhibited fewer pain-related barriers as measured by the Barriers Questionnaire-II (mean 10.6, SD 8.3) than patients in the control group (mean 15.8, SD 7.3, P = .02). No difference was found for pain catastrophizing. However, in both groups, means revealed a lower tendency to catastrophize pain before surgery as measured by the Pain Catastrophizing Scale (control group mean 1.04, SD 0.74; experimental group mean 1.10, SD 0.95) and after surgery (control group mean score 1.19, SD 0.94; experimental group mean score 1.08, SD 0.99). Finally, the experimental group consumed more opioid medication (mean 31.2 mg, SD 23.2) than the control group (mean 18.8 mg, SD 15.3, P = .001).This pilot study provides promising results to support the benefits of this new Web-tailored approach that can increase accessibility to health education and promote pain relief without generating more costs.Clinicaltrials.gov NCT01084018; http://www.clinicaltrials.gov/ct2/show/NCT01084018 (Archived by WebCite® at http://www.webcitation.org/6CoTBkIoT).

Project description:To evaluate the feasibility of a phase 3 randomised controlled trial (RCT) of a website (Living Well with Asthma) to support self-management.Phase 2, parallel group, RCT, participants recruited from 20 general practices across Glasgow, UK. Randomisation through automated voice response, after baseline data collection, to website access for minimum 12 weeks or usual care.Adults (age≥16 years) with physician diagnosed, symptomatic asthma (Asthma Control Questionnaire (ACQ) score ≥1). People with unstable asthma or other lung disease were excluded.'Living Well with Asthma' is a desktop/laptop compatible interactive website designed with input from asthma/ behaviour change specialists, and adults with asthma. It aims to support optimal medication management, promote use of action plans, encourage attendance at asthma reviews and increase physical activity.Primary outcomes were recruitment/retention, website use, ACQ and mini-Asthma Quality of Life Questionnaire (AQLQ). Secondary outcomes included patient activation, prescribing, adherence, spirometry, lung inflammation and health service contacts after 12 weeks. Blinding postrandomisation was not possible.Recruitment target met. 51 participants randomised (25 intervention group). Age range 16-78 years; 75% female; 28% from most deprived quintile. 45/51 (88%; 20 intervention group) followed up. 19 (76% of the intervention group) used the website, for a mean of 18 min (range 0-49). 17 went beyond the 2 'core' modules. Median number of logins was 1 (IQR 1-2, range 0-7). No significant difference in the prespecified primary efficacy measures of ACQ scores (-0.36; 95% CI -0.96 to 0.23; p=0.225), and mini-AQLQ scores (0.38; -0.13 to 0.89; p=0.136). No adverse events.Recruitment and retention confirmed feasibility; trends to improved outcomes suggest use of Living Well with Asthma may improve self-management in adults with asthma and merits further development followed by investigation in a phase 3 trial.ISRCTN78556552; Results.

Project description:BackgroundDespite pharmacological treatment, individuals with inflammatory bowel disease (IBD) experience a variety of symptoms, including abdominal pain, fatigue, anxiety, and depression. Few nonmedical self-management interventions are available for people with IBD. A validated comprehensive self-management (CSM) intervention is effective for patients with irritable bowel syndrome who can have symptoms similar to those of individuals with IBD. We created a modified CSM intervention tailored to individuals with IBD (CSM-IBD). The CSM-IBD is an 8-session program delivered over 8-12 weeks with check-ins with a registered nurse.ObjectiveThe primary objective of this pilot study is to determine the feasibility and acceptability of study procedures and the CSM-IBD intervention and to evaluate preliminary efficacy on quality of life and daily symptoms for a future randomized controlled trial. Additionally, we will examine the association of socioecological, clinical, and biological factors with symptoms at baseline and response to intervention.MethodsWe are conducting a pilot randomized controlled trial of the CSM-IBD intervention. Participants aged 18-75 years who are experiencing at least 2 symptoms are eligible for inclusion. We plan to enroll 54 participants who will be randomized (2:1) into the CSM-IBD program or usual care. Patients in the CSM-IBD program will have 8 intervention sessions. Primary study outcomes include the feasibility of recruitment, randomization, and data or sample collection, as well as the acceptability of study procedures and interventions. Preliminary efficacy outcome variables include quality of life and symptoms. Outcomes data will be assessed at baseline, immediately post intervention, and 3 months post intervention. Participants in the usual care group will have access to the intervention after study participation.ResultsThis project is funded by the National Institutes of Nursing Research and reviewed by the University of Washington's institutional review board. Recruitment began in February 2023. As of April 2023, we have enrolled 4 participants. We expect the study to be completed by March 2025.ConclusionsThis pilot study will evaluate the feasibility and efficacy of a self-management intervention (a web-based program with weekly check-ins with a registered nurse) that aims to improve symptom management in individuals with IBD. In the long term, we aim to validate a self-management intervention to improve patient quality of life, reduce direct and indirect costs related to IBD, and be culturally appropriate and accessible, particularly in rural and underserved communities.Trial registrationClinicalTrials.gov NCT05651542; https://clinicaltrials.gov/ct2/show/NCT05651542.International registered report identifier (irrid)PRR1-10.2196/46307.

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Self-management intervention for head and neck cancer couples: Results of a randomized pilot trial.

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Self-management intervention for head and neck cancer couples: Results of a randomized pilot trial.

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