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Research & Trial Information

SCHEMA NRG-CC004

Protocol #: NRG -CC004

Cancer Type: Cancer Control Gynecology

Eligibility Criteria:

  1. Diagnosis of breast or gynecologic cancer (DCIS, ovarian, endometrial, vulvar, cervical and vaginal)

2. Completed definitive therapy consisting of surgery, chemotherapy or radiation therapy at least 180 days ago (may continue on Herceptin or endocrine therapy)

3. Post menopausal as defined by at least ONE of the following:

• 12 months (365 days) without a period,

• Bilateral oophorectomy,

• At least one ovary and woman has had hysterectomy, must have FSH (>30mIU/mL) and estradiol in menopausal range per institution’s laboratory (<10 for ultra sensitive assay: <25-30 otherwise);

• At least one ovary intact and 180 days without a period with FSH (>30mIU/mL) and estradiol in menopausal range per institution’s laboratory (<10 for ultra sensitive assay: <25-30 otherwise)

4. Age ≥ 18

5. History, Physical and Performance Status of 2 or less within 180 days prior to registration.

6. For breast cancer patients only, endocrine therapies are allowed (such as aromatase inhibitors, but tamoxifen is not allowed).

7. Vaginal estrogen is allowed, for all protocol disease sites, if dose equal to or less than that in estring (<7.5 mcg) and it has been used for at least 30 days with no plans to stop or alter use during the course of the study.

8. Antidepressants for mood and hot flashes, including SSRI’s will be allowed if patients have been on a stable dose for the last 60 days and the dose is not expected to change during the course of the study. Only subthreshold or low dose antidepressants will be allowed (i.e. Effexor 37.5 -75 mg or Lexapro 5-10 mg or Celexa 10 – 20 mg).

9. Women who report that their motivation/desire for sexual intimacy has decreased since her cancer diagnosis.

10. Able to swallow whole capsules.

 



Research & Trial Information

SCHEMA AFT-39

Protocol #: AFT-39

Cancer Type: Cancer Control

Inclusion Criteria:

  1. Adults (21+) with advanced/metastatic cancer of any type (EXCEPT leukemia or indolent [slow growing] lymphoma)

2. Receiving outpatient systemic cancer treatment for non-curative/palliative intent, including chemotherapy, targeted therapy, or immunotherapy.

3. Enrolled at any point in their treatment trajectory, meaning during any line of treatment, and at any point during a course or cycle of treatment.

Exclusion Criteria:

  1. Cognitive deficits that would preclude understanding of consent form and/or questionnaires.

2. Current participation in a therapeutic clinical trial (because these often involve PRO questionnaires and intensive monitoring).

3. Patients being treated with curative intent (e.g., adjuvant chemotherapy for breast, lung, or ovarian cancer; primary curative therapy for testis cancer or lymphoma).

4. Receiving hormonal therapy only (e.g., tamoxifen or aromatase inhibitors in breast cancer; androgen deprivation therapy in prostate cancer; or octreotide in neuroendocrine cancers; ibrance/palbociclib).

5. Indolent lymphomas (due to their prolonged time courses that may be minimally symptomatic).

6. Leukemias (time courses inconsistent with other tumor types in chronic and acute leukemias).

 



Research & Trial Information

SCHEMA EAQ162CD

Protocol #: EAQ162CD

Cancer Type: Cancer Control GI

Eligibility Criteria for Patient Participants:

  1. Age ≥ 18 years.

2. Patients must have a life expectancy of ≥ 24 months.

3. ECOG PS 0-3.

4. Patients must have a newly diagnosed colon or rectal cancer (initial diagnosis, either a biopsy or curative surgery, whichever is most recent) within 60 days of registration and have not yet received radiation or chemotherapy.

5. Patients must have Stage I, II, or III disease at the time of enrollment and will be treated with curative-intent. This can be defined either clinically or pathologically if they have already undergone surgery. For staging of both colon and rectal cancer, the definition of stage I-III is based on the seventh edition (2010) or an updated version of the TNM staging system.

6. Patients are not eligible if they are already enrolled on a treatment clinical trial at the time of registration. They can remain on the study if they subsequently enroll on a treatment clinical trial during the study time period.

7. Patients who choose to not receive radiation and/or chemotherapy after a curative-intent surgery are eligible to participate.

8. Patients with a history of previous malignancy (except non-melanoma skin or cervical in-situ cancer) treated (with either surgery, chemotherapy, and/or radiation) within the last 3 years are not eligible because it is possible that their employment and burden due to cancer care may be impacted by their previous malignancy and therefore add heterogeneity to the study.

9. Patients must be able to complete questionnaires in English.

 

 



Research & Trial Information

SCHEMA WF 97116

Protocol #: Wake Forest – WF97116

Cancer Type: Cancer Control Breast

Inclusion Criteria:

  1. Women ≥18 years old with history of invasive breast cancer
  2. Must have completed at least 4 cycles of adjuvant/neo-adjuvant cytotoxic chemotherapy between 1 and 5 years prior to enrollment (Ongoing herceptin or other chronic HER 2 directed therapies are allowed).
  3. Patients receiving ongoing hormonal therapy for breast cancer must be on the same hormonal agent for at least 3 months prior to study enrollment and plan to continue for the duration of the study (9 months).
  4. Use of psychotropic medications (anti-depressants, anxiolytics, sleeping aids, narcotics) is permitted (patient will be asked to list any that have been taken within the last 3 days on the recent medication sheet) if dose is stable over previous 12 weeks.
  5. Self-reported cognitive problem plus a measured memory deficit (score <7 on single trial of Eligibility Pre-screen HVLT-R Form C).
  6. ECOG performance status 0-2
  7. Must be able to speak English

Exclusion Criteria:

  1. Evidence or suspected recurrent or metastatic disease. Prior brain irradiation is not allowed.
  2. Patients may not currently be taking Quinidine, Certinib, Highest Risk QTc-Prolonging Agents, MiFEPRIStone, or Succinylcholine.
  3. History of dementia, Alzheimer’s disease, multi-infarct dementia or CVA (history of transient ischemic attack (TIA is allowed)
  4. Current use of donepezil, galantamine, rivastigmine, tacrine, memantine, methylphenidate, dextroamphetamine, or any other specific cognition enhancing drugs are not allowed. For patients who have used these medications they must not have used them within 4 weeks prior to enrollment.
  5. History of allergic reactions attributed to compounds of similar chemical or biologic composition to donepezil. Hypersensitivity to donepezil.
  6. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, recent myocardial infarction, cardiac arrhythmia.
  7. Traumatic brain injury, multiple sclerosis, acute severe fatigue, chronic fatigue syndrome or fibromyalgia.
  8. Psychiatric illness/social situations that would limit compliance with study requirements including but not limited to a history of schizophrenia, psychosis or substance abuse.
  9. Untreated current severe depression. Currently treated depression is permitted if treatment is stable.
  10. Patients with bradycardia, seizure disorder or peptic ulcer disease (PUD)


Research & Trial Information

SCHEMA S1417CD

Protocol#: SWOG – S1417CD

Cancer Type: Cancer Control/Prevention 

ELIGIBILITY CRITERIA

When calculating time frame for date of diagnosis, the date that the pathological diagnosis was made is considered Day 0. If Day 30 or 120 falls on a weekend or holiday, the limit may be extended to the next working day.

  1. Patients must have newly diagnosed metastatic colon or rectal cancer (mCRC) (de novo metastatic diagnosis) or metastatic recurrence after prior treatment for Stage I-III disease and be ≤ 120 days after diagnosis at time of registration.
  2. Systemic chemotherapy and/or systemic biologic therapy must be planned to be administered ≤ 30 days after registration OR must have been initiated ≤ 60 days prior to registration. Patients who are planning palliative or hospice care only (no chemotherapy or biologic therapy) are not eligible.
  3. Patients must be at least 18 years of age.
  4. Patients must plan to receive treatment at the registering site. Registering site must be an NCORP site.
  5. Patients must be able to complete questionnaires in English.
  6. Patients must provide their full name, primary address in the U.S., birth date and social security number at registration for the purposes of accessing credit report data.

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