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Study protocol: a randomized controlled trial of patient navigation-activation to reduce cancer health disparities.

ABSTRACT: Cancer health disparities affecting low-income and minority patients are well documented. Root-causes are multifactorial, including diagnostic and treatment delays, social and financial barriers, and poor communication. Patient navigation and communication coaching (activation) are potential interventions to address disparities in cancer treatment. The purpose of this clinical trial is to test the effectiveness of an intervention combining patient navigation and activation to improve cancer treatment.The Rochester Patient Navigation Research Program (PNRP) is a National Cancer Institute-sponsored, patient-level randomized trial (RCT) of patient navigation and activation, targeting newly-diagnosed breast and colorectal cancer patients in Rochester, NY. The goal of the program is to decrease cancer health disparities by addressing barriers to receipt of cancer care and promoting patient self-efficacy. The intervention uses trained, paraprofessional patient navigators recruited from the target community, and a detailed training and supervisory program. Recruited patients are randomly assigned to receive either usual care (except for baseline and follow-up questionnaires and interviews) or intervention. The intervention patients receive tailored assistance from their patient navigators, including phone calls, in-person meetings, and behind-the-scenes coordination of care. A total of 344 patients have been recruited. Outcomes measured at three month intervals include timeliness of care, patient adherence, patient satisfaction, quality of life, self-efficacy, health literacy, and cancer knowledge.This unique intervention combining patient navigation and patient activation is designed to address the multifactorial problem of cancer health disparities. If successful, this study will affect the design and implementation of patient navigation programs.clinicaltrials.gov identifier NCT00496678.

SUBMITTER: Hendren S

PROVIDER: S-EPMC2964637 | biostudies-literature | 2010 Oct

REPOSITORIES: biostudies-literature

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Study protocol: a randomized controlled trial of patient navigation-activation to reduce cancer health disparities.

Hendren Samantha S Griggs Jennifer J JJ Epstein Ronald M RM Humiston Sharon S Rousseau Sally S Jean-Pierre Pascal P Carroll Jennifer J Yosha Amanat M AM Loader Starlene S Fiscella Kevin K

BMC cancer 20101013

<h4>Background</h4>Cancer health disparities affecting low-income and minority patients are well documented. Root-causes are multifactorial, including diagnostic and treatment delays, social and financial barriers, and poor communication. Patient navigation and communication coaching (activation) are potential interventions to address disparities in cancer treatment. The purpose of this clinical trial is to test the effectiveness of an intervention combining patient navigation and activation to ...[more]

PMID: 20939928

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Project description:Postoperative bowel paralysis is common after abdominal operations, including colectomy. As a result, hospitalization may be prolonged, thereby leading to increased cost. A recent randomized controlled trial showed that the consumption of regular black coffee after colectomy is associated with a significantly faster resumption of intestinal motility. The mechanism by which coffee stimulates intestinal motility is unknown, but caffeine seems to be the most likely stimulating agent. Thus, the effect of caffeine on postoperative bowel activity after colon surgery will be analyzed in this trial, herein referred to as CaCo.Patients scheduled for elective laparoscopic colectomy or upper rectum resection are eligible to participate in this double-blinded, placebo-controlled, randomized trial. Patients fulfilling all inclusion criteria will be allocated after the surgical procedure to one of three treatment arms: 100 mg caffeine, 200 mg caffeine, or placebo (corn starch). Patients will take the capsules containing the study medication three times daily with a meal. The primary endpoint of the study is the time to a solid bowel movement. The study treatment will be stopped after the patient produces a solid bowel movement or has taken ten capsules, whichever occurs first. To determine the colonic passage time, patients will take a capsule with radiopaque markers at breakfast for the first 3 days after surgery. On the fourth day, the location of the markers will be determined with an abdominal X-ray scan. Further secondary objectives are the postoperative morbidity and mortality, well-being, sleeping behavior, and length of hospital stay. The study size was calculated to be 180 patients with an interim analysis occurring after 60 patients.From a previous study investigating coffee, evidence exists that caffeine might have a positive influence on the postoperative bowel activity. This double-blinded, placebo-controlled, randomized trial tries to show that caffeine will shorten the postoperative bowel paralysis and, thus, will improve recovery and shorten the hospital stay after colon surgery.Clinicaltrials.gov NCT02510911 Swiss National Clinical Trials Portal SNCTP000001131.

Project description:BackgroundAlthough colorectal cancer (CRC) screening is effective in reducing CRC mortality, screening rates in vulnerable populations served by community health centers (CHCs) remain below national targets. CHCs in North Carolina are challenged to reach CRC screening targets as they tend to be under-resourced, have limited capacity to implement and sustain population health interventions, and typically operate independently from one another and from regional colonoscopy providers. The Scaling Colorectal Cancer Screening Through Outreach, Referral, and Engagement (SCORE) project is designed to address barriers to CRC screening in partnership with CHCs by implementing a multilevel intervention that includes centralized support infrastructure for mailed fecal immunochemical test (FIT) outreach and patient navigation to follow-up colonoscopy. This paper describes protocols for the SCORE implementation trial.MethodsWe will conduct a type 2 hybrid effectiveness-implementation trial that will assess effectiveness at increasing CRC screening and follow-up rates while also assessing implementation outcomes. The planned trial sample will include 4000 CHC patients who are at average CRC risk and due for screening. Participants will be randomized 1:1 to receive either usual care or a multilevel intervention that includes mailed FIT outreach and patient navigation support to follow-up colonoscopy for those with abnormal FIT. The primary effectiveness outcome is completion of any CRC screening test at six months after randomization. We will also conduct a multilevel assessment of implementation outcomes and determinants.DiscussionThis hybrid effectiveness-implementation trial will evaluate the effectiveness and implementation of an intervention that provides centralized infrastructure for mailed FIT screening and patient navigation for CHCs that operate independently of other healthcare facilities. Findings from this research will enhance understanding of the effectiveness of a centralized approach and factors that determine successful implementation in vulnerable patient populations.Trial registrationThe trial was registered on May 28, 2020, at ClinicalTrials.gov (identifier NCT04406714).

Project description:BACKGROUND:Mental health and substance use disorders are the main causes of disability among adolescents and young adults yet fewer than half experiencing these problems seek professional help. Young people frequently search the Web for health information and services, suggesting that Web-based modalities might promote help-seeking among young people who need it. To support young people in their help-seeking, we developed a Web-based mental health service navigation website called Link. Link is based on the Theory of Planned Behavior and connects young people with treatment based on the type and severity of mental health symptoms that they report. OBJECTIVE:The study aimed to investigate the effect of Link on young people's positive affect (PA) compared with usual help-seeking strategies immediately post intervention. Secondary objectives included testing the effect of Link on negative affect (NA), psychological distress, barriers to help-seeking, and help-seeking intentions. METHODS:Young people, aged between 18 and 25 years, were recruited on the Web from an open access website to participate in a randomized controlled trial. Participants were stratified by gender and psychological distress into either the intervention arm (Link) or the control arm (usual help-seeking strategies). Baseline, immediate postintervention, 1-month, and 3-month surveys were self-reported and administered on the Web. Measures included the PA and NA scales, Kessler psychological distress scale (K10), barriers to adolescent help-seeking scale (BASH), and the general help-seeking questionnaire (GHSQ). RESULTS:In total 413 young people were recruited to the trial (intervention, n=205; control, n=208) and 78% (160/205) of those randomized to the intervention arm visited the Link website. There was no evidence to support a difference between the intervention and control arms on the primary outcome, with PA increasing equally by approximately 30% between baseline and 3 months in both arms. NA decreased for the intervention arm compared with the control arm with a difference of 1.4 (95% CI 0.2-2.5) points immediately after the intervention and 2.6 (95% CI 1.1-4.1) at 1 month. K10 scores were unchanged and remained high in both arms. No changes were found on the BASH or GHSQ; however, participants in the intervention arm appeared more satisfied with their help-seeking process and outcomes at 1 and 3 months postintervention. CONCLUSIONS:The process of prompting young people to seek mental health information and services appears to improve their affective state and increase help-seeking intentions, regardless of whether they use a Web-based dedicated youth-focused tool, such as Link, or their usual search strategies. However, young people report greater satisfaction using tools designed specifically for them, which may encourage future help-seeking. The ability of Web-based tools to match mental health needs with appropriate care should be explored further. CLINICAL TRIAL:Australian New Zealand Clinical Trials Registry ACTRN12614001223628; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366731.

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Study protocol: a randomized controlled trial of patient navigation-activation to reduce cancer health disparities.

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Study protocol: a randomized controlled trial of patient navigation-activation to reduce cancer health disparities.

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