Supportive Care Clinical Trials

Trial MenuList of Available Clinical Trials:

 

CINJOG 131107: “RCT of an Online Multimedia Program to Boost Coping & Function for Pca Survivors. A Study of The Cancer Institute of New Jersey Oncology Group (CINJOG)”

Focus Group (Phase 1) Eligibility Criteria:

Nine focus groups (three from each site) will be conducted with data from each group being used to inform and refine the subsequent groups. At each site, the three focus groups will reflect different treatment modalities: Group 1 – Radical Prostatectomy;

Group 2 – Radiation Therapy; Group 3 – Either therapy. Focus groups will consist of racially and ethnically diverse prostate cancer survivors (N=90), with some individual interviews occurring if needed. Eligibility for this phase includes:

  • A diagnosis of localized disease confined to the prostate, with no regional lymph node or distant metastasis (stages T1, T1a, T1b, T2, T2a, T2b; [3]).
     
  • Completed either radical prostatectomy (Group 1 or Group 3) or radiation therapy (external beam radiation therapy or brachytherapy; Group 2 or Group 3) within past 9 months.
     
  • Age 18 years or older.
     
  • Able to communicate in English.
     
  • Able to give consent.
     
  • Are within traveling distance to FCCC, MSMC, or CINJ.

User Testing (Phase 2) Eligibility Criteria

A total of 30 prostate cancer survivors (10 from each site) will provide feedback on the VSRCPC components. Eligibility includes:

  • A diagnosis of localized disease confined to the prostate, with no regional lymph node or distant metastasis (stages T1, T1a, T1b, T2, T2a, T2b; [3]).
     
  • Completed either radical prostatectomy or radiation therapy (external beam radiation therapy or brachytherapy) within past 9 months.
     
  • Age 18 years or older.
     
  • Able to communicate in English.
     
  • Able to give consent.
     
  • Are within traveling distance to FCCC, MSMC, or CINJ.

Usability Testing (Phase 3) Eligibility Criteria

A total of 15 participants matching the characteristics of most prostate cancer survivors will provide feedback on the VSRC-PC components or prototype. Because this study phase will assess the functionality of the program prototype, this phase does not require prostate cancer

survivors to serve as participants. Eligibility includes:

  • Age between 55 and 85 years of age.
     
  • Able to communicate in English.
     
  • Able to give consent.

RCT (Phase 4) Eligibility Criteria:

The target sample (N=600) will be men who have recently been treated for prostate cancer. A multi-ethnic survivor group will be recruited from all three participating sites. According to the tumor registry data, on average a total of 1000 eligible prostate cancer patients are seen per year at the three recruitment sites. Of these, about 50% (n=500) are expected to have Internet access [63]. Based on our prior experience with the prostate population [47], we assume that 48% of eligible patients will agree to enroll in the study, yielding a total of approximately 240 participants per year at the three recruitment sites. We therefore conservatively estimate that we can accrue 20 participants per month over a 30‑month period across the three sites to reach our goal of 600 participants. In addition, if unanticipated problems with accrual occur, we will have ready access to recruit survivors through FCCC and CINJ partner hospitals. This added source of accrual will provide us with a significant cushion, which has not been figured into our accrual calculations. We also project that we will retain approximately 80% of the participants whom we recruit, allowing us to conservatively estimate that 480 participants will complete the study. Power analysis indicates that with 480 participants, the study will be powered to detect a modest effect size (0.1) with at least 84% statistical power (see Section 7.4 of the protocol). With regard to minority recruitment, we project that approximately 20% of the recruited participants will be African American (n=120) men.

  • Received a diagnosis of localized disease confined to the prostate, with no regional lymph node or distant metastasis (stages T1, T1a, T1b, T2, T2a, T2b; [3]).
     
  • Completed either radical prostatectomy or radiation therapy (external beam radiation therapy or brachytherapy) within one month of recruitment.
     
  • Have access to an IBM-compatible or Macintosh personal computer with Internet access (either in home or at a community center).
     
  • 18 years of age or older.
     
  • Able to communicate in English.
     
  • Able to give consent.

ENROLLMENT TARGET: 735 

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Available only through CTSU Registration

CALGB-70807: “The Men's Eating and Living (MEAL) Study: A Randomized Trial of Diet to Alter Disease Progression in Prostate Cancer Patients on Active Surveillance”

ELIGIBILITY:

Disease Characteristics:

  • Biopsy-proven (consisting of ≥ 10 tissue cores) adenocarcinoma of the prostate diagnosed within 24 months prior to presentation
    • < 25% of biopsy tissue cores positive for cancer
       
    • ≤ 50% of any one biopsy tissue core positive for cancer
       
  • Clinical stage ≤ T2a
     
  • Patients who have prostate cancer with distant metastases are not eligible
     
  • For men ≤ 70 years, biopsy Gleason score ≤ 6; for men > 70 years, biopsy Gleason score ≤ (3 + 4) = 7
     
  • Serum PSA < 10 ng/mL
    • Baseline PSA for determination of eligibility must be measured after discontinuation of any 5-alpha reductase inhibitors
       
  • Patients are offered registration to the correlative study CALGB-151105

Prior/Concurrent Therapy:

  • Patients who have had prior treatment for prostate cancer by surgery, irradiation, local ablative (i.e., cryosurgery or high‑intensity focused ultrasound), or androgen-deprivation therapy are not eligible
     
  • Patients who are currently taking vitamin supplements including lycopene and beta-carotene are eligible
     
  • Patients who are currently taking Coumadin are not eligible
     
  • Patients consuming ≥ 6 servings per day of fruits and vegetables (not including juices), as measured by the run-in dietary recalls, are not eligible
     
  • Patients receiving treatment with 5-alpha reductase inhibitors within 90 days prior to preregistration are not eligible.

Patient Characteristics:

  • Life expectancy of at least 3 years
     
  • Patients must be able to read and comprehend English language text and be able to understand spoken English over the phone
     
  • Patients who have had a history of non-cutaneous malignancy (other than nonmelanoma skin cancer) in the previous 5 years are not eligible
     
  • Successful completion of three 24-hour dietary recalls during the run-in period

This is a multicenter study. Patients are stratified according to age (≤ 70 years vs > 70 years), race (African American vs other), and time of baseline prostate biopsy (0-12 months before registration vs > 12-24 months before registration). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive the MEAL program intervention with dietary education and telephone counseling sessions for 24 months. Patients receive the "Participant Notebook", which provides written material describing the counseling program. It also outlines the dietary targets, offers supporting information on strategies to achieve these targets, supplies referent tools to help patients accurately estimate servings of target foods, and offers recipes and articles about diet and prostate cancer. The counseling sessions are divided into 4 phases, with the first three phases completed in 7 months and the fourth phase continuing for 17 months.

The first phase comprises 6 counseling calls focusing on education and the rapid development of self-efficacy, the second phase comprises 4 calls over a 2-month period focusing on practical and consistent implementation of the dietary pattern, the third phase comprises 4 calls over a 4‑month period helping patients habituate to the dietary pattern by providing regular performance reviews, and the fourth phase comprises 8 calls over a 17-month period and is a maintenance phase.

Patients are encouraged to achieve 7 servings per day of vegetables (2 cruciferous, 2 tomato products, 3 other vegetables), 2 servings per day of whole grains, 1 serving per day of beans or other legumes, and 2 servings per day of fruit. Patients also receive 8 regularly scheduled newsletters over the course of 24 months. The newsletters focus on study goals and progress and provide tips on achieving and maintaining diet change. They also include information on diet and cancer, the challenges of diet change, the advances in prostate cancer control, and new recipes.

  • Arm II: Patients receive standard United States Department of Agriculture dietary guidelines for Americans. Patients also receive 8 regularly scheduled newsletters over the course of 24 months. The newsletters contain general information about diet and healthy lifestyle.

Blood (plasma and serum) and tissue samples are collected at baseline and at 12 and 24 months for biomarker and pharmacogenomic studies.  Patients complete quality-of-life assessments (Personal Habits Questionnaire, Functional Assessment of Cancer Therapy Scale-Prostate (FACT-P), Memorial Anxiety Scare for Prostate Cancer (Max-PC), International Prostate Symptom Score (IPSS), Expanded Prostate Cancer Index Composite 26 (EPIC-26), and Nutrition Self-Efficacy and Satisfaction with the MEAL Program) at baseline and at 6, 12, 18, and 24 months.

After study entry, patients are followed up every 3 months for 2 years.

National Enrollment to Date: 284/464

Available only through CTSU Registration

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