Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Behaviors and Mental Disorders

Prostatic Neoplasms

Depression

Depressive Disorder

Erectile Dysfunction

Behavioral Symptoms

Mental Disorders

Psychotic Disorders

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Sexual Dysfunction, Physiological

Sexual Dysfunctions, Psychological

telephone-based intervention

educational intervention

partner-assisted coping skills training

questionnaire administration

psychosocial assessment and care

quality-of-life assessment

Lisa C Campbell, PhD

RATIONALE: Telephone counseling after radical prostatectomy may help African American prostate cancer survivors and their intimate partners cope with the problems and challenges of surgery, and may reduce distress and improve quality of life. It is not yet known which counseling and education program is more effective in helping prostate cancer survivors and their partners.

PURPOSE: This randomized clinical trial is studying effective ways to help African American prostate cancer survivors and their partners cope with challenges after surgery for early-stage prostate cancer.

OBJECTIVES:

Primary

* To develop more effective ways to help both African American prostate cancer survivors and their intimate partners cope with the problems and challenges experienced after radical prostatectomy for prostate cancer.
* To evaluate the efficacy of a new, telephone-based, partner-assisted, coping skills training (CST) protocol for reducing survivor and partner disease-related and overall distress, addressing cancer-related strain and overall distress in survivors' intimate partners, and improving relationship quality between survivors and partners by enhancing intimacy and adjustment within the relationship.

Secondary

* To identify for whom the intervention may be more or less efficacious by exploring the association between initial relationship functioning (i.e., dyadic adjustment scores reported by survivors and partners) and survivor outcomes and between initial relationship functioning and partner outcomes.

OUTLINE: Survivors are stratified according to symptom severity (low vs moderate vs high) and clinical risk category (low vs moderate vs high). Survivor/partner dyads are randomized to 1 of 3 intervention arms.

* Arm I (Partner-assisted coping skills training \[PA-CST\]): Survivor/partner dyads undergo a telephone-based, culturally sensitive PA-CST intervention in six weekly telephone sessions (60-minutes each) over 8 weeks, conducted by African American doctoral level clinical psychologists knowledgeable about prostate cancer and experienced in CST and cancer education. During these sessions, participants are trained in a variety of cognitive and behavioral skills to manage symptom-related distress and to improve their quality of life after prostate cancer treatment. Among these skills are strategies for communication (i.e., effective speaking and listening); behavioral coping methods (i.e., activity pacing, applied relaxation techniques, and goal setting to increase pleasant activities); and skills for managing negative mood and reducing emotional stress. Participants also receive guidance in working cooperatively with their partners to improve symptom management, including joint practicing of coping skills and problem-solving strategies.
* Arm II (Cancer education): Survivor/partner dyads undergo a telephone-based, culturally sensitive cancer education intervention in six weekly telephone sessions (60 minutes each) over 8 weeks, conducted by African American doctoral level clinical psychologists knowledgeable about prostate cancer and experienced in CST and cancer education. During the sessions, participants are educated about symptoms commonly experienced after prostatectomy (i.e., erectile dysfunction, urinary incontinence, nutrition, bowel problems, and fatigue) and medical treatment options for these symptoms. Participants also receive written materials about these information.
* Arm III (Wait-list control): Survivor/partner dyads receive usual care and are placed on a wait-list. After completing the study, survivors and their partners have the option of participating in either the CST or cancer education interventions.

All participants complete questionnaires at baseline, right after intervention (2 months), and 3 months after intervention (5 months). Survivors complete questionnaires over approximately 28 minutes to measure symptom distress/severity, depressed mood, quality of life, self-efficacy for symptom management, relationship quality, and coping strategies. Partners complete questionnaires over approximately 17 minutes to measure caregiver strain, depressed mood, partners' self-efficacy for symptom control, relationship quality, and coping strategies. At each evaluation, physicians provide ratings of illness severity, documentation of medical treatments for cancer and symptom management, and frequency of clinic visits for each survivor.

Helping African American Prostate Cancer Survivors and Their Partners Cope With Challenges After Surgery for Prostate Cancer

Prostate Cancer Recovery Enhancement for African American Men and Their Intimate Partners

National Cancer Institute (NCI)

East Carolina University

Assistant Professor

Symptoms and General Pathology

Gland and Hormone Related Diseases

Nervous System Diseases

Substance Related Disorders

Rare Diseases

Neoplasm Metastasis

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Infertility

Teratoma

Testicular Neoplasms

Neurotoxicity Syndromes

Neoplasms, Germ Cell and Embryonal

Syndrome

Neoplasms by Histologic Type

Poisoning

Chemically-Induced Disorders

Quality of Life

Ovarian Cancer

Ovarian Epithelial Cancer

Germ Cells Tumors

Oculocerebral Syndrome With Hypopigmentation

Ovarian Germ Cell Tumor

Testicular Germ Cell Tumor

Extragonadal Germ Cell Tumor

assessment of therapy complications

Contact Person

Adam Glaser, MD

Gill Levitt, MD

Juliet Hale, MD

Mary P. Gerrard, MBChB, FRCP, FRCPCH

Janice A. Kohler, MD, FRCP

Mary Taj, MD

Veronica Neefjes

W. Hamish Wallace, MD

Milind D. Ronghe, MD

Heidi Traunecker, MD, PhD

RATIONALE: Treatment for pediatric extracranial germ cell tumors may cause side effects and secondary cancers later in life. A study that evaluates patients after receiving combination chemotherapy or surgery may help doctors understand the side effects and secondary cancers that occur later in life.

PURPOSE: This study is looking at treatment outcome and quality of life in patients with pediatric extracranial germ cell tumors previously treated on clinical trial CCLG-GC-1979-01 or CCLG-GC-1989-01.

OBJECTIVES:

* Determine the late effects of treatment and the quality-of-life of patients with germ cell tumors (GCT) previously treated on clinical trial CCLG-GC-1979-01 or CCLG-GC-1989-01.
* Evaluate the late effects of carboplatin, etoposide, and bleomycin in patients treated on clinical trial CCLG-GC-1989-01.
* Determine the toxicity of bleomycin and a combination of either cisplatin and vinblastine, etoposide and cisplatin, or carboplatin and etoposide in patients treated on clinical trial CCLG-GC-1979-01.
* Evaluate tumor-associated/surgical morbidity (bladder, bowel, and lower limb function) in patients with malignant sacrococcygeal tumors treated in these clinical trials.
* Evaluate tumor-associated/surgical morbidity (sexual function/fertility) in patients with malignant gonadal or pelvic GCTs.
* Evaluate tumor-associated/surgical morbidity (respiratory function) in patients with thoracic GCTs.
* Develop a methodology and recommendations for the prospective late evaluation of patients treated on future extracranial GCT clinical trials and those included in this study.
* Inform clinicians about the late effects of treatment of malignant GCTs and advise them on what long-term care these patients require.

OUTLINE: This is a cohort, multicenter study.

Patients complete questionnaires about ototoxicity, bladder and bowel dysfunction, and sexual function and fertility as appropriate. They also complete a health-related quality-of-life questionnaire over 20 minutes.

Treating physicians complete a lower-limb and neurologic dysfunction questionnaire. Data from myelodysplasia, second malignancy, ototoxicity, nephrotoxicity, and pulmonary toxicity assessments are collected from the patient's treating physician.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Treatment Outcome and Quality of Life in Patients With Pediatric Extra-Cranial Germ Cell Tumors Previously Treated on Clinical Trial CCLG-GC-1979-01 or CCLG-GC-1989-01

Cross-Sectional Evaluation of Outcome Following Extra-Cranial Germ Cell Tumors Treated According to UKCCSG GC 7901 (GC I) and GC 8901 (GC II) Protocols

Children's Cancer and Leukaemia Group

Digestive System Diseases

Diarrhea

Intestinal Diseases

Signs and Symptoms, Digestive

Autoimmune Enteropathy

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Cyclophosphamide

Lenograstim

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Young patients with severe autoimmune enteropathy receive cyclophosphamide IV over 1 hour on days 1-4. Patients then receive filgrastim (G-CSF) IV or subcutaneously once daily beginning on day 10 and continuing for 3 days or until blood counts recover

Administered IV or subcutaneously once daily beginning on day 10 and continuing for 3 days or until blood counts recover

filgrastim

cyclophosphamide

David M. Loeb, MD, PhD

Maria Oliva-Hemker, MD

RATIONALE: Cyclophosphamide may help control the symptoms of autoimmune enteropathy .

PURPOSE: This phase II trial is studying how well cyclophosphamide works in treating young patients with severe autoimmune enteropathy.

OBJECTIVES:

Primary

* Determine the rate of treatment-free remission in young patients with severe autoimmune enteropathy treated with high-dose cyclophosphamide.

Secondary

* Determine the toxic effects of this drug in these patients.

OUTLINE: Patients receive cyclophosphamide IV over 1 hour on days 1-4. Patients then receive filgrastim (G-CSF) IV or subcutaneously once daily beginning on day 10 and continuing for 3 days or until blood counts recover.

After completion of study treatment, patients are followed periodically for up to 1½ years.

PROJECTED ACCRUAL: A total of 7-11 patients will be accrued for this study.

Cyclophosphamide in Treating Young Patients With Severe Autoimmune Enteropathy

High-Dose Cyclophosphamide for the Treatment of Severe Autoimmune Enteropathy

Number of participants off therapy 1 year after study completion without relapse.

Johns Hopkins University

Severe Autoimmune Enteropathy

Young patients with severe autoimmune enteropathy receive cyclophosphamide IV over 1 hour on days 1-4. Patients then receive filgrastim (G-CSF) IV or subcutaneously once daily beginning on day 10 and continuing for 3 days or until blood counts recover.

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Maria Oliva-Hemker MD

Number of Participants With Treatment-free Remission at 1 Year After Study Completion

Young patients with severe autoimmune enteropathy receive cyclophosphamide IV over 1 hour on days 1-4. Patients then receive filgrastim (G-CSF) IV or subcutaneously once daily beginning on day 10 and continuing for 3 days or until blood counts recover

filgrastim: Administered IV or subcutaneously once daily beginning on day 10 and continuing for 3 days or until blood counts recover

cyclophosphamide: Administered IV over 1 hour on days 1-4

Number of Participants Experiencing Intervention-related Adverse Events, as Defined by CTCAE at 1 Month

Overall Study

Acute Graft Versus Host Disease

Anti-Infective Agents

Anti-Inflammatory Agents

Analgesics

Gastrointestinal Agents

Sulfasalazine

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Patients receive oral sulfasalazine twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.

Patients receive oral placebo twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.

sulfasalazine

placebo

Robert C. Miller, MD

RATIONALE: Sulfasalazine may relieve diarrhea in patients with cancer who are undergoing pelvic radiation therapy.

PURPOSE: This randomized phase III trial is studying sulfasalazine to see how well it works in preventing acute diarrhea in patients with cancer who are undergoing pelvic radiation therapy.

OBJECTIVES:

Primary

* To determine whether sulfasalazine is effective in reducing the acute treatment-related diarrhea in patients receiving pelvic radiotherapy as measured by NCI CTC v4.0 in patients receiving pelvic external-beam radiotherapy as adjuvant or primary treatment for malignancy.

Secondary

* To determine whether sulfasalazine can reduce chronic treatment-related bowel dysfunction following completion of therapy.
* To determine whether sulfasalazine causes any toxicity in this situation.

Tertiary

* To bank blood products for future studies, as part of ongoing research for NCCTG studies (Mayo Clinic Rochester only). (Translational)

OUTLINE: This is a multicenter study. Patients are stratified according to history of anterior resection of the rectum (yes vs no); total planned cumulative dosing, including boost fields of external-beam radiotherapy (4500-5350 cGy vs \> 5350 cGy); and concurrent radiosensitizing fluorouracil, capecitabine, or oxaliplatin (yes vs no). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive oral sulfasalazine twice daily during radiotherapy\* and for 4 weeks after completion of radiotherapy.
* Arm II: Patients receive oral placebo twice daily during radiotherapy\* and for 4 weeks after completion of radiotherapy.

NOTE: \*Patients must start study treatment by the third radiotherapy fraction.

Patients may undergo blood sample collection at baseline and then weekly during radiotherapy. All patients complete quality of life and bowel function questionnaires at baseline, weekly during radiotherapy, and at 6 weeks after completion of radiotherapy.

After completion of radiotherapy, patients are followed up at 6 weeks and at 12 and 24 months.

Sulfasalazine in Preventing Acute Diarrhea in Patients With Cancer Who Are Undergoing Pelvic Radiation Therapy

Phase III, Randomized, Study of Sulfasalazine Versus Placebo in the Prevention of Acute Diarrhea in Patients Receiving Pelvic Radiation Therapy

The primary endpoint for this study is the maximal severity of diarrhea toxicity. Severity of diarrhea was graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 4.0. Grade 0 = None; 1=Mild; Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening as measured by the CTCAE version 4.0. Assessments were recorded during the course of RT and for 6 weeks following RT. The table below represents the worst graded diarrhea for each patient.

A two-sided Wilcoxon rank-sum test will be used to test the equality of the distributions of maximum diarrhea severity grades between the two treatment arms.

The maximal severity of each of 5 different adverse even types (Tenesmus, Abdominal Pain, Constipation, Diarrhea, and Rectal Bleeding) were collected as a secondary endpoint. Severity of the events was graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 4.0. Grade 0 = None; 1=Mild; Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening. Adverse events were assessed during the course of RT and for 6 weeks following RT. The table below represents the worst grade for each patient for each type.

Two-sided chi-square tests will be used to compare each percentage variable between treatment arms for each event type.

For each patient, an Area Under the Curve (AUC) summary statistic will be calculated taking into account the individual severity of diarrhea toxicity over time. Severity of diarrhea was graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 4.0. Grade 0 = None; 1=Mild; Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening. The curve was constructed using weekly assessments during and after RT. A separate analysis was done during the course of RT and every week for 6 weeks following RT.

Tenesmus, Abdominal pain, constipation, diarrhea and hemorrhaging were assessed during RT and up to 6 weeks after RT. Severity of these events were graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 4.0. Grade 0 = None; 1=Mild; Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening. For each patient, an average score for each outcome variable during and after RT calculated as follows: The sum of all severity scores for that variable divided by the number of severity scores for that variable recorded for the patient during the course of RT and for 6 weeks following RT.

The number of patients that reported any grade 1 or higher adverse event was divided by the total number of patients evaluated. The analysis was done separately for each of the 5 outcomes and separately during RT and after RT.

Questions that were used in this analysis:

2. Have you had a problem causing you to get up at night to have a bowel movement? 3. Have you had a problem causing you to lose control of your bowel movements? 4. Have you had a problem causing you to have a bowel movement within 30 minutes of a prior bowel movement? 5. Have you had to wear protective clothing or a pad in case you lost control of a bowel movement? 6. Have you had a problem causing you to be unable to tell the difference between stool and gas? 7. Have you had a problem causing you to have stools that are liquid? 1=yes 2=no q08 8. Have you found that once you feel the urge to have a bowel movement, you must do so within 15 minutes to avoid an accident? 9. Have you had cramping with a bowel movement? 10. Have you had blood in your bowel movement?

The number of patients reporting the use of anti-diarrheal medications divided by the number of patients evaluated for this endpoint.

For each arm, the percentage of patients experience clinically significant deficits in overall QOL and fatigue as indicated by a score of 5 or lower on the 0-10 scale. The analysis was done using the questionnaire that was completed during the first week of radiotherapy (RT) and 6 weeks after RT.

Alliance for Clinical Trials in Oncology

Patients receive two 500 mg oral sulfasalazine tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.

Arm I: Sulfasalazine

Arm II: Placebo

Patients receive two oral placebo tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.\>

\> placebo: Given orally

Total

Age, Continuous

Two patients in Arm I and one patient from Arm II were not included in the baseline analysis nor the endpoint analyses due to cancellations and protocol violations.

Robert C. Miller, M.D., M.S.

Grade 0

Grade 1

Grade 2

Grade 3

Grade 4

Patients receive two oral placebo tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.

\>

\> placebo: Given orally

Maximum Severity of Diarrhea Toxicity as Measured by the CTCAE v4.0 During and After Radiotherapy (RT)

Tenesmus during RT

Tenesmus after RT

Abdominal pain during RT

Abdominal pain after RT

Constipation during RT

Constipation after RT

Diarrhea during RT

Diarrhea after RT

Rectal bleeding during RT

Rectal bleeding after RT

Patients receive two oral placebo tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.

Two patients in Arm I and one patient from Arm II were not included in the endpoint analyses due to cancellations and protocol violations. 42 patients from each arm started RT and were used for the analysis. 25 patients from Arm I and 29 patients from Arm II were evaluated after RT. Two patients from Arm 1 provided incomplete data.

Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT

Result comparing Arm I and Arm II during RT.

Result comparing Arm I and Arm II after RT.

During RT

After RT

Two patients in Arm I and one patient from Arm II were not included in the endpoint analyses due to cancellations and protocol violations. 42 patients from each arm started RT and were used in that portion of the analysis. 25 patients from Arm I and 29 patients from Arm II were evaluated after RT. Two patients from Arm 1 provided incomplete data.

Area Under the Curve That Combines the Individual Severity of Diarrhea Toxicity as Measured by the CTCAE v4.0 During and After RT

Average Graded Severity for Tenesmus, Abdominal Pain, Constipation, Diarrhea and Hemorrhage During and After RT as Graded by CTCAE v4.0

Percentage of Patients in Each Arm That Experience Tenesmus, Abdominal Pain, Constipation, Diarrhea and Rectal Bleeding During and After RT

During RT : Q2

During RT : Q3

During RT : Q4

During RT : Q5

During RT : Q6

During RT : Q7

During RT : Q8

During RT : Q9

During RT : Q10

After RT : Q2

After RT : Q3

After RT : Q4

After RT : Q5

After RT : Q6

After RT : Q7

After RT : Q8

After RT : Q9

After RT : Q10

All patients that completed the questionnaire were included in the analysis. Questionnaires used were completed during the last week during RT and 6 weeks after RT.

Percent of Patients in Each Arm That Recorded "Yes" to Each of Questions 2-10 on the Bowel Function Questionnaire

Two patients in Arm I and one patient from Arm II were not included in the endpoint analyses due to cancellations and protocol violations.

Percentage of Patients in Each Arm That Require Any Type of Antidiarrheal Medications.

All completed QOL questionnaires were included in the analysis. Questionnaires used were completed during the first week during RT and 6 weeks after RT. From Arm I, 41 patients completed questionnaires, 39 during and 26 after RT. For Arm II, 42 patients completed the questions, 40 during and 29 after RT.

Percentage of Patients in Each Arm That Experience Clinically Significant Deficits in Overall Quality of Life and Fatigue

Adenocarcinoma

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Helping African American Prostate Cancer Survivors and Their Partners Cope With Challenges After Surgery for Prostate Cancer	NCT00869739	Cancer Survivor Depression Gastrointestina... Male Erectile D... Prostate Cancer Psychosocial Ef... Urinary Complic...	telephone-based... educational int... partner-assiste... questionnaire a... psychosocial as... quality-of-life...	-	East Carolina University
Treatment Outcome and Quality of Life in Patients With Pediatric Extra-Cranial Germ Cell Tumors Previously Treated on Clinical Trial CCLG-GC-1979-01 or CCLG-GC-1989-01	NCT00436774	Childhood Germ ... Extragonadal Ge... Gastrointestina... Infertility Long-term Effec... Neurotoxicity Ovarian Cancer Pulmonary Compl... Sexual Dysfunct... Urinary Complic...	assessment of t... quality-of-life...	5 Years -	National Cancer Institute (NCI)
Cyclophosphamide in Treating Young Patients With Severe Autoimmune Enteropathy	NCT00258180	Diarrhea Gastrointestina... Unspecified Chi...	filgrastim cyclophosphamid...	1 Year - 21 Years	Johns Hopkins University
Helping African American Prostate Cancer Survivors and Their Partners Cope With Challenges After Surgery for Prostate Cancer	NCT00869739	Cancer Survivor Depression Gastrointestina... Male Erectile D... Prostate Cancer Psychosocial Ef... Urinary Complic...	telephone-based... educational int... partner-assiste... questionnaire a... psychosocial as... quality-of-life...	-	East Carolina University
Sulfasalazine in Preventing Acute Diarrhea in Patients With Cancer Who Are Undergoing Pelvic Radiation Therapy	NCT01198145	Diarrhea Gastrointestina... Unspecified Adu...	sulfasalazine placebo	18 Years -	Alliance for Clinical Trials in Oncology
RADICALS - Radiotherapy and Androgen Deprivation In Combination After Local Surgery	NCT00541047	Gastrointestina... Prostate Cancer Sexual Dysfunct... Urinary Complic...	bicalutamide goserelin aceta... leuprolide acet... adjuvant therap... quality-of-life... radiation thera...	0 Years - 120 Years	University College, London

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