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Exposure to a patient-centered, Web-based intervention for managing cancer symptom and quality of life issues: impact on symptom distress.

ABSTRACT: BACKGROUND:Effective eHealth interventions can benefit a large number of patients with content intended to support self-care and management of both chronic and acute conditions. Even though usage statistics are easily logged in most eHealth interventions, usage or exposure has rarely been reported in trials, let alone studied in relationship to effectiveness. OBJECTIVE:The intent of the study was to evaluate use of a fully automated, Web-based program, the Electronic Self Report Assessment-Cancer (ESRA-C), and how delivery and total use of the intervention may have affected cancer symptom distress. METHODS:Patients at two cancer centers used ESRA-C to self-report symptom and quality of life (SxQOL) issues during therapy. Participants were randomized to ESRA-C assessment only (control) or the ESRA-C intervention delivered via the Internet to patients' homes or to a tablet at the clinic. The intervention enabled participants to self-monitor SxQOL and receive self-care education and customized coaching on how to report concerns to clinicians. Overall and voluntary intervention use were defined as having ?2 exposures, and one non-prompted exposure to the intervention, respectively. Factors associated with intervention use were explored with Fisher's exact test. Propensity score matching was used to select a sample of control participants similar to intervention participants who used the intervention. Analysis of covariance (ANCOVA) was used to compare change in Symptom Distress Scale (SDS-15) scores from pre-treatment to end-of-study by groups in the matched sample. RESULTS:Radiation oncology participants used the intervention, overall and voluntarily, more than medical oncology and transplant participants. Participants who were working and had more than a high school education voluntarily used the intervention more. The SDS-15 score was reduced by an estimated 1.53 points (P=.01) in the intervention group users compared to the matched control group. CONCLUSIONS:The intended effects of a Web-based, patient-centered intervention on cancer symptom distress were modified by intervention use frequency. Clinical and personal demographics influenced voluntary use. TRIAL REGISTRATION:Clinicaltrials.gov NCT00852852; http://clinicaltrials.gov/ct2/show/NCT00852852 (Archived by WebCite at http://www.webcitation.org/6YwAfwWl7).

SUBMITTER: Berry DL

PROVIDER: S-EPMC4526904 | biostudies-literature | 2015 Jun

REPOSITORIES: biostudies-literature

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Exposure to a patient-centered, Web-based intervention for managing cancer symptom and quality of life issues: impact on symptom distress.

Berry Donna L DL Blonquist Traci M TM Patel Rupa A RA Halpenny Barbara B McReynolds Justin J

Journal of medical Internet research 20150603 6

<h4>Background</h4>Effective eHealth interventions can benefit a large number of patients with content intended to support self-care and management of both chronic and acute conditions. Even though usage statistics are easily logged in most eHealth interventions, usage or exposure has rarely been reported in trials, let alone studied in relationship to effectiveness.<h4>Objective</h4>The intent of the study was to evaluate use of a fully automated, Web-based program, the Electronic Self Report A ...[more]

PMID: 26041682

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Project description:The electronic self report assessment - cancer (ESRA-C), has been shown to reduce symptom distress during cancer therapy The purpose of this analysis was to evaluate aspects of how the ESRA-C intervention may have resulted in lower symptom distress (SD).Patients at two cancer centers were randomized to ESRA-C assessment only (control) or the Web-based ESRA-C intervention delivered to patients' homes or to a tablet in clinic. The intervention allowed patients to self-monitor symptom and quality of life (SxQOL) between visits, receive self-care education and coaching to report SxQOL to clinicians. Summaries of assessments were delivered to clinicians in both groups. Audio-recordings of clinic visits made 6 weeks after treatment initiation were coded for discussions of 26 SxQOL issues, focusing on patients'/caregivers' coached verbal reports of SxQOL severity, pattern, alleviating/aggravating factors and requests for help. Among issues identified as problematic, two measures were defined for each patient: the percent SxQOL reported that included a coached statement, and an index of verbalized coached statements per SxQOL. The Wilcoxon rank test was used to compare measures between groups. Clinician responses to problematic SxQOL were compared. A mediation analysis was conducted, exploring the effect of verbal reports on SD outcomes.517 (256 intervention) clinic visits were audio-recorded. General discussion of problematic SxQOL was similar in both groups. Control group patients reported a median 75% of problematic SxQOL using any specific coached statement compared to a median 85% in the intervention group (p = .0009). The median report index of coached statements was 0.25 for the control group and 0.31 for the intervention group (p = 0.008). Fatigue, pain and physical function issues were reported significantly more often in the intervention group (all p < .05). Clinicians' verbalized responses did not differ between groups. Patients' verbal reports did not mediate final SD outcomes (p = .41).Adding electronically-delivered, self-care instructions and communication coaching to ESRA-C promoted specific patient descriptions of problematic SxQOL issues compared with ESRA-C assessment alone. However, clinician verbal responses were no different and subsequent symptom distress group differences were not mediated by the patients' reports.NCT00852852; 26 Feb 2009.

Project description:BACKGROUND: Stereotactic radiosurgery (SRS) is a common treatment for recurrent or residual pituitary adenomas. The persistence of symptoms and treatment related complications may impair the patient's quality of life (QOL). PURPOSE: The purpose of this study was to examine symptom distress, QOL, and the relationship between them among patients with pituitary tumors who had undergone SRS. METHODS: This study used a cross-sectional design and purposive sampling. We enrolled patients diagnosed with pituitary tumors who had undergone SRS. Data were collected at the CyberKnife Center at a medical center in Northern Taiwan in 2012. A questionnaire survey was used for data collection. Our questionnaire consisted of 3 parts the Pituitary Tumor Symptom Distress Questionnaire, the World Health Organization Quality of Life Instrument Short-Form (WHOQOL-BREF), and a demographic questionnaire. RESULTS: Sixty patients were enrolled in the study. The most common symptoms reported by patients after SRS were memory loss, fatigue, blurred vision, headache, sleep problems, and altered libido. The highest and lowest scores for QOL were in the environmental and psychological domains, respectively. Age was positively correlated with general health and the psychological domains. Level of symptom distress was negatively correlated with overall QOL, general health, physical health, and the psychological and social relationships domains. The scores in the psychological and environmental domains were higher in males than in females. Patients with ≤6 symptoms had better overall QOL, general health, physical health, and psychological and social relationships than those with >6 symptoms. CONCLUSION: Symptom distress can affect different aspects of patient QOL. Levels of symptom distress, number of symptoms, age, and gender were variables significantly correlated with patient QOL. These results may be utilized by healthcare personnel to design educational and targeted interventional programs for symptom management to improve patient QOL.

Project description:BACKGROUND:The primary objective of this randomised controlled trial (RCT) is to establish the effectiveness of a novel online quality of life (QoL) intervention tailored for people with late stage (? 10 episodes) bipolar disorder (BD) compared with psychoeducation. Relative to early stage individuals, this late stage group may not benefit as much from existing psychosocial treatments. The intervention is a guided self-help, mindfulness based intervention (MBI) developed in consultation with consumers, designed specifically for web-based delivery, with email coaching support. METHODS/DESIGN:This international RCT will involve a comparison of the effectiveness and cost-effectiveness of two 5-week adjunctive online self-management interventions: Mindfulness for Bipolar 2.0 and an active control (Psychoeducation for Bipolar). A total of 300 participants will be recruited primarily via social media channels. Main inclusion criteria are: a diagnosis of BD (confirmed via a phone-administered structured diagnostic interview), no current mood episode, history of 10 or more mood episodes, no current psychotic features or active suicidality, under the care of a medical practitioner. Block randomisation will be used for allocation to the interventions, and participants will retain access to the program for 6 months. Evaluations will be conducted at pre- and post- treatment, and at 3- and 6- months follow-up. The primary outcome measure will be the Brief Quality of Life in Bipolar Disorder Scale (Brief QoL.BD), collected immediately post-intervention at 5 weeks (T1). Secondary measures include BD-related symptoms (mania, depression, anxiety, stress), time to first relapse, functioning, sleep quality, social rhythm stability and resource use. Measurements will be collected online and via telephone assessments at baseline (T0), 5 weeks (T1), three months (T2) and six months (T3). Candidate moderators (diagnosis, anxiety or substance comorbidities, demographics and current treatments) will be investigated as will putative therapeutic mechanisms including mindfulness, emotion regulation and self-compassion. A cost-effectiveness analysis will be conducted. Acceptability and any unwanted events (including adverse treatment reactions) will be documented and explored. DISCUSSION:This definitive trial will test the effectiveness and cost-effectiveness of a novel QoL focused, mindfulness based, online guided self-help intervention for late stage BD, and investigate its putative mechanisms of therapeutic action. TRIAL REGISTRATION:ClinicalTrials.gov : NCT03197974 . Registered 23 June 2017.

Dataset Information

Exposure to a patient-centered, Web-based intervention for managing cancer symptom and quality of life issues: impact on symptom distress.

Publications

Exposure to a patient-centered, Web-based intervention for managing cancer symptom and quality of life issues: impact on symptom distress.

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