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Rationale and design of extended cancer education for longer term survivors (EXCELS): a randomized control trial of 'high touch' vs. 'high tech' cancer survivorship self-management tools in primary care.

ABSTRACT: BACKGROUND:Breast, colorectal, and prostate cancer survivors are at increased risk for late and long-term effects post-treatment. The post-treatment phase of care is often poorly coordinated and survivors navigate follow-up care with minimal information or guidance from their healthcare team. This manuscript describes the Extended Cancer Education for Longer-term Survivors (EXCELS) in Primary Care protocol. EXCELS is a randomized controlled trial to test the efficacy of patient-level self-management educational strategies on adherence to preventative health service use and cancer survivorship follow-up guidelines. METHODS:The EXCELS trial compares four conditions: (1) EXCELS-website (e.g., a mobile-optimized technology platform); (2) EXCELS-health coaching; (3) EXCELS-website and health coaching; and (4) a print booklet. Approximately 480 breast, colorectal, and prostate survivors will be recruited through the New Jersey Primary Care Research Network (NJPCRN) and New Jersey State Cancer Registry (NJSCR). Eligible survivors (diagnosed stages 1-3) must have completed active treatment, access to a phone and a computer, smartphone or tablet with internet access, and be able to speak and read English. Patient assessments occur at baseline, 6, 12, and 18?months. The primary outcomes are increased engagement in preventive health services and monitoring for cancer recurrence and treatment-related late effects. DISCUSSION:The EXCELS trial is the first to test cancer survivorship educational self-management interventions for cancer survivors in a primary care context. Findings from this trial will inform successful implementation and engagement strategies for longer-term, post-treatment cancer survivors managed in primary care settings. TRIAL REGISTRATION:Registered August 1, 2017 at ClinicalTrials.gov , trial # NCT03233555.

SUBMITTER: Davis SN

PROVIDER: S-EPMC6458696 | biostudies-literature | 2019 Apr

REPOSITORIES: biostudies-literature

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Rationale and design of extended cancer education for longer term survivors (EXCELS): a randomized control trial of 'high touch' vs. 'high tech' cancer survivorship self-management tools in primary care.

Davis Stacy N SN O'Malley Denalee M DM Bator Alicja A Ohman-Strickland Pamela P Clemow Lynn L Ferrante Jeanne M JM Crabtree Benjamin F BF Miller Suzanne M SM Findley Patricia P Hudson Shawna V SV

BMC cancer 20190411 1

<h4>Background</h4>Breast, colorectal, and prostate cancer survivors are at increased risk for late and long-term effects post-treatment. The post-treatment phase of care is often poorly coordinated and survivors navigate follow-up care with minimal information or guidance from their healthcare team. This manuscript describes the Extended Cancer Education for Longer-term Survivors (EXCELS) in Primary Care protocol. EXCELS is a randomized controlled trial to test the efficacy of patient-level sel ...[more]

PMID: 30971205

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Project description:BackgroundSubstantial effort has been undertaken to improve the recruitment and retention of participants in stroke trials. African Americans are disproportionately under-represented in stroke clinical trials as well as clinical trials for other chronic disease conditions. To circumvent barriers to recruitment, clinical trial recruitment strategies used to recruit African Americans have focused on different aspects of community engagement.PurposeThis study examined a community-engaged, multi-phased tailored approach to recruiting African Americans with stroke. The recruitment approach described was designed to support the Community Based Intervention under Nurse Guidance after Stroke (CINGS) trial, part of the Wide Spectrum Investigation of Stroke Outcome Disparities on Multiple Levels (WISSDOM) Center established to explore stroke disparities.MethodsA multiple-phased recruitment approach was undertaken and involved a recruitment planning phase and a recruitment phase. The recruitment planning phase involved the use of focus groups designed to explore barriers and facilitators of stroke recovery. The active recruitment phase included multiple strategies with ongoing evaluation.ResultsInformation gained from focus groups offered insights into strategies critical to recruiting African Americans with stroke for behavioral research during the early recovery period. Strategies to enhance the identification of and recruitment of potential participants included use of: a) a hospital system stroke database, b) system-wide friendly visits/warm handoff approaches, c) electronic health record, d) associated external sites and e) protocol adjustments.ConclusionsDeveloping tailored approaches to curtail barriers to research participation is critical for increasing the probability of reaching African American study participant recruitment and retention goals. Research teams may require training in community-engagement research strategies essential for obtaining achieving target recruitment goals.

Project description:Genetic analysis of pathogenic organisms is a useful tool for linking human cases together and/or to potential environmental sources. The resulting data can also provide information on evolutionary patterns within a targeted species and phenotypic traits. However, the instruments often used to generate genotyping data, such as single nucleotide polymorphisms (SNPs), can be expensive and sometimes require advanced technologies to implement. This places many genotyping tools out of reach for laboratories that do not specialize in genetic studies and/or lack the requisite financial and technological resources. To address this issue, we developed a low cost and low tech genotyping system, termed agarose-MAMA, which combines traditional PCR and agarose gel electrophoresis to target phylogenetically informative SNPs.To demonstrate the utility of this approach for generating genotype data in a resource-constrained area (Madagascar), we designed an agarose-MAMA system targeting previously characterized SNPs within Yersinia pestis, the causative agent of plague. We then used this system to genetically type pathogenic strains of Y. pestis in a Malagasy laboratory not specialized in genetic studies, the Institut Pasteur de Madagascar (IPM). We conducted rigorous assay performance validations to assess potential variation introduced by differing research facilities, reagents, and personnel and found no difference in SNP genotyping results. These agarose-MAMA PCR assays are currently employed as an investigative tool at IPM, providing Malagasy researchers a means to improve the value of their plague epidemiological investigations by linking outbreaks to potential sources through genetic characterization of isolates and to improve understanding of disease ecology that may contribute to a long-term control effort.The success of our study demonstrates that the SNP-based genotyping capacity of laboratories in developing countries can be expanded with manageable financial cost for resource constraint laboratories. This is a practical formula that reduces resource-driven limitations to genetic research and promises to advance global collective knowledge of infectious diseases emanating from resource limited regions of the world.

Project description:PURPOSE:Whether the benefits of exercise during chemotherapy continue into survivorship is not well-known. Here, the aim was to examine the effects of two exercise interventions on self-reported health-related and objectively measured physiological outcomes 12 months following commencement of chemotherapy. METHODS:Two hundred and forty women with breast cancer stage I-IIIa were randomized to 16 weeks of high-intensity aerobic interval training combined with either resistance training (RT-HIIT), or moderate-intensity aerobic training (AT-HIIT), or to usual care (UC). PRIMARY OUTCOME:cancer-related fatigue (CRF); secondary outcomes: quality of life (QoL), symptom burden, muscle strength, cardiorespiratory-fitness, body mass, and return to work. RESULTS:Compared to UC, both RT-HIIT and AT-HIIT significantly counteracted increases in total CRF (ES = - 0.34; ES = - 0.10), daily life CRF (ES=-0.76; ES=-0.50, and affective CRF (ES=-0.60; ES=-0.39). Both RT-HIIT and AT-HIIT reported significantly lower total symptoms (ES = - 0.46, ES = - 0.46), and displayed gains in lower limb (ES = 0.73; ES = 1.03) and handgrip muscle strength (surgery side ES = 0.70, ES = 0.71; non-surgery side ES = 0.57, ES = 0.59). AT-HIIT displayed significant reductions in body mass (ES = - 0.24), improved QoL: role (ES = 0.33) and emotional functioning (ES = 0.40), and a larger proportion had returned to work (p = 0.02) vs UC. CONCLUSION:These findings emphasize the beneficial effects of supervised high-intensity exercise during chemotherapy to improve the health and to reduce societal costs associated with prolonged sick leave for patients with breast cancer several months following chemotherapy. IMPLICATIONS FOR CANCER SURVIVORS:These findings provide important information with substantial positive consequences for breast cancer survivorship. High-intensity exercise programs during chemotherapy and support to maintain physical activity can be a powerful strategy to manage or prevent many of the short- and long-term adverse effects of treatment for the increasing cohort of cancer survivors.

Dataset Information

Rationale and design of extended cancer education for longer term survivors (EXCELS): a randomized control trial of 'high touch' vs. 'high tech' cancer survivorship self-management tools in primary care.

Publications

Rationale and design of extended cancer education for longer term survivors (EXCELS): a randomized control trial of 'high touch' vs. 'high tech' cancer survivorship self-management tools in primary care.

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