# Presentation: 099264

## MS/AL Radiation Oncology Research Partnership

- W. Sam Dennis, MD, PhD
-  P.I., Singing River Hospital System
- Sharon Spencer, MD
- P.I., University of Alabama – Birmingham
- Maggie Clarkson, RN, MS
- Grants Program Director, Singing River Hospital System

**MS/AL RADIATION THERAPY RESEARCH PROGRAM**
**STAFFING PLAN**
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** **
**	****SRHCC****	****	****	****	****	****UABCCC**
** **
**	****	****P.I. – Dennis (10%)- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -  - - - - - P.I. - Spencer****	****	****	**
** **_** **_
_**CO – P.I.**_**	****	****GRANTS ADMIN (.5 FTE)****	****	****PROGRAM DIRECTOR (1 FTE)****	**
**Clarkson (3%)****	****	****	****	****	****	****	****	**
**Hull (3%)**
**Sariego (2.5%)****	****	****	****	****	****	****	**
**Lyell (2.5%)****	****	**_**RESEARCH STAFF**_**	**_**OUTREACH STAFF (*)**_**	**_**PATIENT NAVIGATORS**_
**	****	****	****Research Nurse (1 FTE)****	****Health Educator/RN (1 FTE)****	****Patient Advocate/Van Driver (2 FTE)**
**	****	****	****Data Manager****	****(1 FTE)****	****	****	****	****	****	****	**
** **
** **
**CONTRACT: Biostatistician @ $5000.00/year ****	****	****	**
*** Shared oversight with Director, Community and Corporate Wellness Program**
** **

## Partnership/Mentor Relationship

- Program Steering Committee
- Scientific Review Committee
- TeleSynergy programs
- Investigator-initiated Studies
- Workshops for investigators and grant staff
- Medical and Support Staff training opportunities

## Clinical Research

- Development of Activation Prioritization List for Cooperative Group Studies: RTOG, SWOG, NSABP, GOG, CTSU
- Patient Population Data for SRHS-RCC reviewed against Active studies listings for study groups and:
- Scientific questions of interest for medical staff
- Standard treatment remains sub-optimal for site/stage
- Treatment regimens inclusive of RT
- Annual Accrual Goals
- Long-term Clinical Research Office Goals

## Slide 5

## Slide 6

**SINGING RIVER HOPSITAL REGIONAL CANCER CENTER – OPEN CLINICAL TRIALS LIST**
**ANAL/RECTAL****	** RTOG 0315	A Randomized Double Blind Placebo-controlled Phase III Study to Determine the Efficacy of Sandostatin Lar Depot (Octreotide Acetate)
- 	 in Preventing or Reducing the Severity of Chemoradiation-Induced **Diarrhea** in Patients with Anal or Rectal Cancer. (IRB ok 9/20/05)**BREAST**** **NSABP B-35	A Clinical Trial Comparing Anastrozole with Tamoxifen in Postmenopausal Patients with Ductal Carcinoma In Situ **(DCIS**)
- 	Undergoing Lumpectomy with Radiation Therapy (IRB ok 4/12/06) NSABP B-36	A Clinical Trial of Adjuvant Therapy Comparing Six Cycles of 5-Fluorouracil, Epirubicin and Cyclophosphamide (FEC) to Four Cycles
- 	of Adriamycin and Cyclophosphamide (AC) in Patients with **Node-negative** Breast Cancer (IRB ok 10/11/05) NSABP B-38	A Phase III, Adjuvant Trial Coparing Three Chemotherapy Regimens in Women with **Node-positive** Breast Cancer:
- 	 Docetaxel/Doxorubicin/Cyclophosphamide (TAC); Dose-dense (DD) Doxorubicin/Cyclophosphamide followed by DD Paclitaxel (DD AC→P);
- 	 DD AC Followed by DD Paclitaxel Plus Gemcitabine (DD AC→PG) (IRB ok 10/11/05) SWOG S0221	Phase III Trial of Continuous Schedule AC + G vs. Every 2 Week Schedule AC, Followed by Paclitaxel Given Either Every 2 Weeks
- 	 or Weekly for 12 Weeks as Post-operative Adjuvant Therapy in **Node-positive or High-risk Node-negative** Breast Cancer 	(IRB ok 10/11/05) **COLON** NSABP C08	A Phase III Clinical Trial Comparing Infusional 5-Fluorouracil (5-FU), Leucovorin and Oxaliplatin (mFOLFOX6) every Two Weeks
- 	 with Bevacizumab to the Same Regimen without Bevacizumab for the Treatment of Patients with **Resected Stages II and III** Carcinoma
- 	of the Colon. (IRB ok 9/20/05) **LUNG**
** **
- SWOG S9925	SWOG S9925	Lung Cancer Specimen Repository Protocol, Ancillary (IRB ok 10/11/05)
**PROSTATE****	****	**
- RTOG 0126	A Phase III Randomized Study of High Dose 3D-CRT/IMRT versus Standard Dose 3D-CRT/IMRT in Patients Treated for **Localized**
- 	Prostate Cancer  (IRB ok 9/20/05)

## Investigator-Initiated Studies

- Phase I/II Trial of Alternative Dose Schedule of 1650cGy in 3 fractions for Palliative Radiation treatment of Bone Metastases
- Development of Geriatric Assessment Profile to Support Accrual of Elderly Patients onto Clinical Research Trials
- Impact of Cancer Screening Recruitment Model using Prior Participants as Advocates Among Minorities
- ?? Immobilization Methods for Prostate IMRT
- ?? Geriatric Oncology Issues

## Community Involvement Focus

- Internal
- Community & Corporate Wellness
- Pharmacy/Social Services/Dietary/PT/OT/Financial Services
- Transportation
- External
- Health-related Organizations
- Faith-based Organizations
- Business/Corporate
- Civic/Community Service Organizations
- Educational Institutions
- Medical Community
- Focus on Clinical Research Issues
- Cancer Center referral base

## Patient Navigator Services

- Team approach with oncologist/RN
- Involvement post-treatment planning
- Supportive needs assessments
- Document categories of needs
- Referrals to internal/external resources
- Transportation assistance using van
- Assist with Community Outreach programs
- Monitor outcomes

## Community Outreach

- Focus on minorities and underserved
- Develop cancer control education/awareness/screening activities appropriate to specific target populations
- Develop outcomes measures/monitoring methods to determine impact on participation in risk reduction activities
- Develop ongoing cancer patient education programs and services for SRHS
- Facilitate/coordinate support group activities
- Support development of patient advocacy program

## Impact of Hurricane Katrina on Our Community:The Good, The Bad, the Ugly