This clinical trial tests whether increased activity throughout the day can improve the chronic pain and associated symptoms that breast cancer survivors may experience after surgery. Staying active is a key factor of one's physical, mental, and social health and well-being. Moving more could also reduce pain and associated stress, anxiety, or depression. Using a fitness tracker may help patients to move around more, whether or not they choose to exercise. Information gathered from this study may help researchers learn how the use of a Fitbit tracker with health coaching may improve physical activity and reduce pain in young, Hispanic breast cancer survivors.

开始日期2023-10-20

申办/合作机构

New Mexico Cancer Care Alliance

[+1]

NCT06207864 / RecruitingN/AIIT

Participant Engagement - Cancer Genome Sequencing (PE-CGS) Research Center: Engagement of American Indians of Southwestern Tribal Nations in Cancer Genome Sequencing

This clinical trial studies engagement strategies for recruiting American Indians (AI) of Southwestern Tribal Nations for cancer genome sequencing. American Indians in the Southwest have higher rates of some types of cancer, such as cancers that arise in the liver, kidney, breast, and colon. American Indians with cancer may also live for less time than people from other population groups who have been treated for the same cancer. Damage to the cells of the body, acquired as people live, grow older, and are exposed to the environment, causes genetic changes in cells that can lead to cancer. This study may help researchers learn how these genetic changes in cells cause cancer and understand how and why cancer is arising in American Indians in the Southwest. This may help better prevent and treat cancer in the future.

开始日期2022-03-22

申办/合作机构

New Mexico Cancer Care Alliance

[+1]

NCT05176743 / CompletedN/AIIT

Food Insecurity in Oncology (FIOnc)

This trial will examine the feasibility and preliminary effectiveness of providing unconditional cash transfers to food insecure female breast and gynecologic cancer patients.
Approximately one-third of cancer survivors report food insecurity, characterized by limited access to adequate food for active, healthy living because of a lack of money and other resources. Unconditional cash transfers offer direct monetary assistance that can be used to meet immediate food or other financial needs and may positively impact health care resource utilization and health-related quality of life.

开始日期2021-08-30

申办/合作机构

New Mexico Cancer Care Alliance

[+2]

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2024-04-15·Cancer

A call to action to advance patient‐focused and decentralized clinical trials

Article

作者: Kamboj, Jasmine ; Byatt, Leslie P ; Merrill, Janette K ; Holland, Nicole ; Boehmer, Leigh M ; Brewer, Jamie R ; Harvey, R Donald ; Levit, Laura A ; Hamroun, Leila ; Thota, Ramya ; Pollastro, Teri ; Symington, Banu E ; Rizvi, Mujahid A ; Prindiville, Sheila A ; Waterhouse, David M ; Tap, William D ; Kim, Edward S ; Nowakowski, Grzegorz S ; Black, Lora J ; Fleury, Mark E ; Bruinooge, Suanna S ; Hurley, Patricia A ; Miller, Therica M

This commentary is a call to action for a concerted commitment and effort to transform clinical trials and enable people with cancer to participate in clinical trials closer to home. Three key strategies are identified to address major barriers: confront challenges with the interpretation of US Food and Drug Administration Form 1572 requirements (Statement of Investigator); broaden acceptance of local laboratories and imaging centers; and invest in the creation of effective, sustainable partnerships between research centers and local providers.

2022-06-01·Journal of Clinical Oncology

Availability of data for screening, offering, and consenting patients to cancer clinical trials: Report from an ASCO-ACCC collaboration.

作者: Hurley, Patricia A. ; Fashoyin-Aje, Lola A. ; Boehmer, Leigh ; Pierce, Lori J. ; Ramirez, Amelie G. ; Pressman, Alice R. ; Oyer, Randall A. ; Zwicker, Victoria ; Nowakowski, Grzegorz S. ; Bernick, Lea Ann ; Hanley Williams, Jen Hanley ; Crews, Jennie Robertson ; McCaskill-Stevens, Worta J. ; Patel, Manali I. ; Garrett-Mayer, Elizabeth ; Guerra, Carmen ; Bruinooge, Suanna Steeby ; Byatt, Leslie ; Charlot, Marjory ; Kaltenbaugh, Melinda

6530 Background: Only a small fraction of patients with cancer participate in treatment trials. Patients identifying as members of racial and ethnic minority groups are consistently underrepresented in these trials. A recent systematic review reported that patients, regardless of race and ethnicity, are willing to enroll in trials if asked to participate by their treating clinician. Prospective and longitudinal data and metrics at the site- and clinician-level are necessary to understand whether patients are equitably considered for clinical trials. Methods: ASCO and Association of Community Cancer Centers (ACCC) developed a self-assessment for trial sites to record and gauge the number of patients across races and ethnicities screened, offered, and enrolled into clinical trials. Research sites, from across the US, were recruited through an open call to apply to participate in the ASCO-ACCC Pilot Project. There were 65 sites assigned to this pilot study, which tested the feasibility and utility of the site assessment. Sites were asked to enter 2019 and 2020 aggregate data for each step along the clinical trial enrollment continuum by select races and ethnicities (Black, Hispanic/Latinx, White) and overall. Results: 62 of 65 sites completed the study and represented a range of settings and practice types (61% academic, 26% hospital/health system, 13% independent). Only 2 sites (3%) were able to provide the data requested at each enrollment step in the assessment (table). Sites that collected the data did not do so routinely (table) and most had to compile data through multiple sources and/or manual extraction (40-100% across enrollment steps). Sites with missing data reported they did not collect data at all (36-64% across enrollment steps), did not collect data in a systematic way (0-29% across enrollment steps), or stated it would be too burdensome to manually review charts to extract data (12-29% across enrollment steps). Conclusions: Data collection and routine evaluation of participation metrics, by race and ethnicity, are necessary to assess and monitor equity and diversity in clinical trials. Most sites in this study did not collect, or routinely collect, data for screening, offering, and consenting patients to clinical trials. Without these data, sites are unable to evaluate and monitor whether their patients have equitable access to clinical trials or establish strategies to address any inequities. ASCO and ACCC will continue to partner with sites to better understand their processes and the feasibility of collecting such data in a systematic and automated way, such as through electronic health record systems. [Table: see text]

2021-01-01·JCO Oncology Practice3区 · 医学

Recommendations to Streamline and Standardize Clinical Trial Site Feasibility Assessments: An ASCO Research Statement

3区 · 医学

Article

作者: Dawson, Casey ; Waterhouse, David M. ; Kim, Edward S. ; Robert, Nicholas J. ; MacDougall, A. Kate ; Byatt, Leslie ; Nowakowski, Grzegorz S. ; Bruinooge, Suanna S. ; Dempsey, Kandie ; Thompson, Michael A. ; Kurbegov, Dax ; Hurley, Patricia ; Liu, Jane ; Hofacker, Janie ; Schilsky, Richard L.

PURPOSE: Feasibility assessments (FAs) are important to establish site capabilities to conduct clinical trials and their suitability for specific trials. However, current FA methods used by biotechnology and pharmaceutical (biotech-pharma) trial sponsors and contract research organizations (CROs) are costly, inefficient, unnecessarily burdensome, and resource intensive. These methods delay trial start-up, act as a barrier to site participation, and ultimately reduce timely patient access to clinical trials and novel treatments. METHODS: An ASCO Task Force was convened to assess the specific burdens and challenges with FAs and to develop recommendations to improve their efficiencies and effectiveness. Stakeholders (including trial sites, biotech-pharma sponsors, and CROs) provided insights into challenges and offered solutions through two surveys and an in-person meeting. The Task Force used the feedback to formulate consensus recommendations to improve FAs for oncology clinical trials. RESULTS: Three key recommendations were identified for application across all biotech-pharma sponsored trials: (1) implement a streamlined and uniform FA process across trials and sponsors; (2) minimize and standardize questions; and (3) leverage technology to centralize FAs, facilitate communications, and reduce redundancies. CONCLUSION: There is an urgency to improve the current FA process, which is costly, inconsistent, inefficient, labor intensive, and of uncertain effectiveness. All stakeholders stand to benefit from implementing these recommendations, which aim to minimize burdens and ensure that more trial sites and patients have timely access to oncology clinical trials. To have meaningful impact, adoption and consistent execution of these recommendations across all trials, sponsors, CROs, and sites are essential.

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