Integrating Symptom Trials: Secondary Analyses
Charles W Given, Professor
Family Medicinemichigan State University
Grant 5K05CA108575-05 from National Cancer Institute IRG: NCI
Abstract: This K05 award seeks protected time for the candidate so that he may achieve the following mentoring and research goals 1) To mentor pre- and post-doctoral students and junior faculty in the health sciences in order to build their careers around advancing the science related to testing cognitive and behavioral trials for managing symptoms and improving quality-of-life of cancer patients; 2) To achieve a set of career development objectives that may be learned through their application to the research plan proposed by the candidate and will result in applying for a Small Business Research Initiation Grant to translate the program of research into practice. The candidate describes his mentoring philosophy, capabilities, and mentoring record. The accomplishments of past mentees and their current positions are summarized in figure three. The candidate describes how the current environment and resources available will enable him to attract new pre- and post-doctoral and junior faculty mentees. Letters from department chairs associate deans and leaders of units are provided to support this mentoring plan. The content of a mentoring practicum is presented and plans for its use with pre and post-doctoral students and junior faculty are presented. Plans for how students and junior faculty will be integrated into all aspects of the proposed research are described. The candidate summarizes his 26 years of consecutive NIH research funding. The contributions of each research project to conceptual and methodological advances in the science and to health policy and practice are presented as well as how each contributed to the candidate´s program of research. These contributions are summarized in Figure 4 in the text. Building on this program of research the candidate´s plan for merging of datasets from four clinical trials where the candidate was either the PI or Co-PI is described. The candidate links his career development objectives to the merged datasets and demonstrates how his learning objectives are critical to developing and applying for a small business grant. The goal of this small business grant will be to involve mentees and collaborators in translating the candidate´s program of research into clinical practice
Project start date: 2005-07-01
Project end date: 2010-06-30
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Integrating Symptom Trials: Secondary Analyses
Charles W Given, Professor
Family Medicinemichigan State University
301 Administration Bldg
east Lansing, Mi 48824
Grant 5K05CA108575-04 from National Cancer Institute IRG: NCI
Abstract: This K05 award seeks protected time for the candidate so that he may achieve the following mentoring and research goals 1) To mentor pre- and post-doctoral students and junior faculty in the health sciences in order to build their careers around advancing the science related to testing cognitive and behavioral trials for managing symptoms and improving quality-of-life of cancer patients; 2) To achieve a set of career development objectives that may be learned through their application to the research plan proposed by the candidate and will result in applying for a Small Business Research Initiation Grant to translate the program of research into practice. The candidate describes his mentoring philosophy, capabilities, and mentoring record. The accomplishments of past mentees and their current positions are summarized in figure three. The candidate describes how the current environment and resources available will enable him to attract new pre- and post-doctoral and junior faculty mentees. Letters from department chairs associate deans and leaders of units are provided to support this mentoring plan. The content of a mentoring practicum is presented and plans for its use with pre and post-doctoral students and junior faculty are presented. Plans for how students and junior faculty will be integrated into all aspects of the proposed research are described. The candidate summarizes his 26 years of consecutive NIH research funding. The contributions of each research project to conceptual and methodological advances in the science and to health policy and practice are presented as well as how each contributed to the candidate´s program of research. These contributions are summarized in Figure 4 in the text. Building on this program of research the candidate´s plan for merging of datasets from four clinical trials where the candidate was either the PI or Co-PI is described. The candidate links his career development objectives to the merged datasets and demonstrates how his learning objectives are critical to developing and applying for a small business grant. The goal of this small business grant will be to involve mentees and collaborators in translating the candidate´s program of research into clinical practice
Keywords: clinical trial, health behavior, health science research analysis /evaluation, meta analysis, patient care management cancer rehabilitation /care, human therapy evaluation, mentoring /mentor, statistics /biometry, telemedicine behavioral /social science research tag, clinical research, human data, patient oriented research
Project start date: 2005-07-01
Project end date: 2010-06-30
5K05CA108575-04 (2008): $125309
5K05CA108575-03 (2007): $122446
5K05CA108575-02 (2006): $119666
Grants awarded to Charles W Given
Automated Telephone Monitoring For Symptom Management
Charles W Given, Professor
Family Medicinemichigan State University
301 Administration Bldg
east Lansing, Mi 48824
Grant 5R01CA030724-06 from National Cancer Institute IRG: NURS
Abstract: To improve the management of symptoms, patients with cancer undergoing chemotherapy are monitored using an automated telephone system to record the severity of seven prevalent symptoms for eight consecutive weeks. When symptom severity reaches two or higher (on a 11 point scale), for one or more symptoms that patient is enrolled into a trial, receives a baseline interview, and is randomized to either an individualized multimodal Patient Assisted Management of Symptoms (PAMS) intervention or to a Telephone Information and Monitoring of Symptoms (TIMS) approach (i.e., enhanced usual care). Both arms of the trial receive a Symptom Management Toolkit (SMT). Patients in the PAMS arm receive 8 weekly calls from a specially trained nurse who will assess all seven symptoms at each contact, and provide individualized interventions using a problem solving approach guided by a computer assisted protocol. Patients in the TIMS arm will receive 8 weekly-automated telephone calls with instructions to refer to specific pages of the SMT and are reminded to call their oncology clinic if symptoms are urgent. At weeks 9 and 15, patients will receive outcome interviews. Following the week 15 interview, patients´ medical records will be audited; treatment, cost and charge data collected. Outcomes include significant reduction in symptom severity and improvement in health states. This research study controls for the method of delivering the intervention (telephone), the intensity (8 weekly contacts), and the use of printed materials in the toolkit (SMT) and seeks to determine the value added by a patient-assisted intervention individualized to meet patients´ needs for symptom management (PAMS) plus a SMT when contrasted with symptom monitoring by telephone (TIMS) and referral to a SMT alone. For this study, 350 patients will be accrued. A 30% drop out rate is expected with 122 patients surviving through the 15-week observation in each arm. Special recruitment strategies are presented for accruing and retaining women and minorities. Analysis strategies address reduction among the seven targeted symptoms, the primary outcome, as well as secondary outcomes. Strategies for collection, exploratory analysis, and comparison of utilization and costs between the two arms are presented
Keywords: cancer rehabilitation /care, nursing intervention, patient care management, telemedicine biomedical automation, health care service evaluation, neoplasm /cancer chemotherapy, oncology nursing, outcomes research, sign /symptom clinical research, human subject, patient oriented research
Project start date: 2003-05-02
Project end date: 2009-10-31
5R01CA030724-06 (2008): $258158
5R01CA030724-05 (2007): $581407
3R01CA030724-04S1 (2006): $108198
5R01CA030724-04 (2006): $130090
3R01CA030724-03S1 (2005): $104259
5R01CA030724-03 (2005): $896126
3R01CA030724-02S2 (2004): $76548
5R01CA030724-02 (2004): $862140
1R01CA030724-01 (2003): $776820
Integrating Symptom Trials: Secondary Analyses
Charles W Given, Professor
Michigan State University 301 Administration Bldg East Lansing, Mi 48824
Grant 1K05CA108575-01A1 from National Cancer Institute IRG: NCI
Abstract: This K05 award seeks protected time for the candidate so that he may achieve the following mentoring and research goals 1) To mentor pre- and post-doctoral students and junior faculty in the health sciences in order to build their careers around advancing the science related to testing cognitive and behavioral trials for managing symptoms and improving quality-of-life of cancer patients; 2) To achieve a set of career development objectives that may be learned through their application to the research plan proposed by the candidate and will result in applying for a Small Business Research Initiation Grant to translate the program of research into practice. The candidate describes his mentoring philosophy, capabilities, and mentoring record. The accomplishments of past mentees and their current positions are summarized in figure three. The candidate describes how the current environment and resources available will enable him to attract new pre- and post-doctoral and junior faculty mentees. Letters from department chairs associate deans and leaders of units are provided to support this mentoring plan. The content of a mentoring practicum is presented and plans for its use with pre and post-doctoral students and junior faculty are presented. Plans for how students and junior faculty will be integrated into all aspects of the proposed research are described. The candidate summarizes his 26 years of consecutive NIH research funding. The contributions of each research project to conceptual and methodological advances in the science and to health policy and practice are presented as well as how each contributed to the candidate s program of research. These contributions are summarized in Figure 4 in the text. Building on this program of research the candidate s plan for merging of datasets from four clinical trials where the candidate was either the PI or Co-PI is described. The candidate links his career development objectives to the merged datasets and demonstrates how his learning objectives are critical to developing and applying for a small business grant. The goal of this small business grant will be to involve mentees and collaborators in translating the candidate s program of research into clinical practice.
Keywords: clinical trial, health behavior, health science research analysis /evaluation, meta analysis, patient care management, cancer rehabilitation /care, human therapy evaluation, mentoring /mentor, statistics /biometry, telemedicine, behavioral /social science research tag, clinical research, human data, patient oriented research
Project start date: 2005-07-01
Project end date: 2010-06-30
1K05CA108575-01A1 (2005): $116967
RURAL PARTNERSHIP LINKAGE FOR CANCER CARE
Charles W Given, Professor
Michigan State University 301 Administration Bldg East Lansing, Mi 48824
Grant 3R01CA056338-05S1 from National Cancer Institute IRG: SRC
Abstract: The goal of this research is to change the patterns of continuing cancer care by creating nurse centered provider networks that will deliver state- of-the-art cancer care in rural communities (STACCRC). These provider networks will link local physicians, hospitals, nurse centered satellite clinics and community health and social agencies. To deliver STACCRC the provider networks in the targeted rural communities will be linked with the Cancer Center at Michigan State University, the Kalamazoo Community Oncology Program, and the Kalamazoo Center for Medical Studies. These programs will deliver needs based professional education, respond with information to providers in the targeted communities, and host the training of nurses in the satellite clinics. The intervention will draw on the rural health initiative for third party reimbursement for nurses. To implement the intervention, community assessment surveys will identify patients and families needs for cancer care, providers needs for professional education and enhanced collaborative arrangements with the tertiary center, and health and social agencies needs for linkage to cancer care networks. In the four targeted communities two classes of patients will be recruited; 1) continuing care patients who have had cancer for varying periods of time; 2) inception patients recruited following diagnoses at the community hospitals or tertiary care center. For comparison, inception patients from a control community will be recruited. The intervention will; 1) credential clinic nurses, as appropriate, 2) link nurses in clinics and local physicians to one another, the tertiary system, and agencies to deliver STACCRC, 3) employ protocols and standards of care for pain, symptoms, and detection of problems and complications. Quarterly assessments of patients and families along with records of all clinic interactions will mark the changes in patterns of care, provider behaviors, agency use, and patient outcomes. Through this intervention we plan to create a model of continuing cancer care that is integrated into, sustainable by, and transferrable to other rural communities once research is concluded.
Keywords: neoplasm /cancer therapy, nursing intervention, rural area, health care personnel education, patient care management, behavioral /social science research tag, human subject
Project start date: 1992-05-08
Project end date: 1998-04-30
3R01CA056338-05S1 (1997): $52789
5R01CA056338-04 (1995): $602124
5R01CA056338-03 (1994): $515308
5R01CA056338-02 (1993): $406001
5R01CA056338-05 (1996): $441440