Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Breast Neoplasms

Infertility

Breast Diseases

Skin Diseases

Genital Diseases

Urogenital Diseases

psychosocial assessment and care

Zora Neskovic-Konstantinovic

RATIONALE: Adjuvant therapy given after surgery for early breast cancer may cause infertility. Assessing young women's attitudes and feelings about the risk of infertility may help improve the ability to plan effective treatment.

PURPOSE: This clinical trial is studying young women's attitudes and feelings about the risk of infertility related to adjuvant therapy for stage I or stage II breast cancer.

OBJECTIVES:

* Determine the attitude toward the risk of infertility related to adjuvant therapy in women with early breast cancer.
* Correlate, if possible, the patient's attitude with the fact that the patient already has children or the time interval between the date of breast cancer diagnosis and the date of study participation.

OUTLINE: This is a multicenter study.

Patients complete a questionnaire administered by a nontreating physician.

PROJECTED ACCRUAL: A total of 385 patients will be accrued for this study.

Assessing Women's Attitudes About the Risk of Infertility Related to Adjuvant Therapy for Early Breast Cancer

A Survey of the Breast International Group (B.I.G.) to Assess the Attitude of Patients Aged Less Than 35 Years, With Early Breast Cancer, Toward the Risk of Loss of Fertility Related to Adjuvant Therapies

German Adjuvant Breast Cancer Group

ETOP IBCSG Partners Foundation

European Organisation for Research and Treatment of Cancer - EORTC

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases, Male

Prostatic Diseases

Male Urogenital Diseases

Patients and their partners receive communication and intimacy-enhancing intervention (IEC) once a week comprising the following five 90-minute sessions: Orientation and Stories of the Cancer Experience; Communication and Listening to Partner's concerns; Communication and Coping with Cancer Issues as a Team; Being Supportive to Solve Concerns; and Reflecting on Changes and Future Adaptation.

Patients and their partners receive a General Health and Wellness intervention focusing on nutrition and physical activity once a week comprising of five 90-minute sessions: Introduction and Nutrition Basics; Nutrition and Prevention of Recurrence; Nutritional Review and Introduction to Relaxation; Physical Activity Basics; Aerobics and Resistance Exercises and Wrap up.

Patients and their partners receive standard psychological and emotional care (usual care \[UC\]) (i.e., social work consultations and referral to a psychiatrist or psychologist, if requested or deemed necessary by the attending physician).

communication intervention

counseling intervention

nutrition intervention

questionnaire administration

Sharon L Manne, Ph.D.

RATIONALE: Participating in a therapy program may enhance communication and intimacy between men with prostate cancer and their partners.

PURPOSE: This randomized clinical trial is studying how well therapy enhances communication and intimacy for men with early stage prostate cancer and for their partners.

Aim 1 A. To evaluate the impact of an Intimacy-Enhancing Couples' intervention (IEC) versus a General Health and Wellness Intervention (GHW) and a Usual care control (UC) on patient and partner psychological and relationship outcomes.

B. To determine whether relationship length, pre-intervention relationship satisfaction, and men's pre-intervention masculinity moderate the effects of IEC on couples' psychological and relationship outcomes

Aim 2 A. To evaluate whether IEC has an effect on couples' communication and intimacy when compared with GHW and UC and to determine whether changes in relationship communication and intimacy mediate changes in couples' psychological and relationship outcomes.

Exploratory Aim:

A. To evaluate the impact of IEC versus GHW on physical activity and fruit and vegetable intake as well as each partner's support for the other partner's adoption of greater physical activity and more fruit and vegetable intake.

Intimacy-Enhancing Couples' Intervention for Localized Prostate Cancer

General psychological functioning is assessed by the MHI-38 and the PHQ-9. Cancer-Specific distress is assessed by using the Impact of Events Scale Revised Cancer-Specific concerns is assessed with a 10 item assessment of commonly-experienced problems.

Relationship satisfaction is assessed using the Dyadic Adjustment Scale

General Relationship Intimacy. The Personal Assessment of Intimacy in Relationships Intimacy scale (PAIR) (94) is a 6 item scale assessing emotional closeness. Cancer-specific Relationship Intimacy (95-96) Participants rate the degree to which they felt close to and emotionally intimate with their partner during discussions about the cancer experience.

Perceived self-disclosure. The scale assesses the degree to which they disclose thoughts, information, and feelings about the cancer experience in the past week.

Perceived partner disclosure. The scale assesses the degree to which their partner disclosed thoughts, information, and feelings.

Perceived partner responsiveness. The scale assesses the degree to which the participant felt their partner understood and empathized with their disclosures.Mutual Constructive Communication. This subscale of the Communication Pattern Questionnaire (CPQ) is a 5-item scale that has been adapted.

Holding back. Participants rate the degree to which they held back from talking to their partner about 11 domains of concern.

Demand-Withdraw. The CPQ Demand-Withdraw subscale is a 6-item scale adapted.

Mutual Avoidance. The CPQ Mutual Avoidance subscale is an adapted 6-item scale.

Rutgers Cancer Institute of New Jersey

Memorial Sloan Kettering Cancer Center

Fox Chase Cancer Center

Rutgers, The State University of New Jersey

Professor of Medicine

Symptoms and General Pathology

Adenocarcinoma

Recurrence

All Drugs and Chemicals

Urological Agents

Antineoplastic Agents

Hormones

Finasteride

Flutamide

5-alpha Reductase Inhibitors

Enzyme Inhibitors

Hormone Antagonists

Androgens

Androgen Antagonists

Antineoplastic Agents, Hormonal

Treatment of prostate cancer pts post radiation or surgery with potency sparing hormones

finasteride

flutamide

Assessment survey administered at baseline, and 3 \& 6 months post initiation of treatment

quality-of-life assessment

Joel Picus, MD

RATIONALE: Male hormones can stimulate the growth of prostate cancer cells. Hormone therapy using flutamide and finasteride may fight prostate cancer by reducing the production of male hormones.

PURPOSE: Phase II trial to study the effectiveness of flutamide and finasteride in treating prostate cancer patients with high PSA levels who were previously treated with radiation therapy or radical prostatectomy.

OBJECTIVES:

* Determine the efficacy of finasteride and flutamide in suppressing prostate specific antigen (PSA) levels in patients with elevated PSA after definitive radiation therapy or radical prostatectomy for prostate cancer.
* Assess sexual function and other quality of life issues during this therapy.
* Estimate the response to flutamide withdrawal in this group of patients who have not had a major reduction in circulating testosterone levels.
* Measure the response rate to further hormonal manipulation with combined androgen blockade after the failure of this therapy.
* Obtain data that may predict more aggressive disease.

OUTLINE: This is a multicenter study.

Patients receive finasteride and flutamide by mouth three times a day. Patients experiencing recurrence or a greater than 4 nu/mL (above 50%) increase in PSA level will discontinue flutamide treatments. Otherwise, patients continue therapy in the absence of unacceptable toxicity or disease progression.

Quality of life is assessed prior to therapy and at 3 and 6 months.

Patients are followed every 3 months for one year and every 6 months thereafter.

PROJECTED ACCRUAL: This study will accrue 100 patients over 2 years.

Hormone Therapy in Treating Patients With Prostate Cancer

A Phase II Trial of Potency-Sparing Hormonal Therapy in Patients With Elevated Serum PSA After Radiation Therapy or Radical Prostatectomy for Prostate Cancer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Assessing Women's Attitudes About the Risk of Infertility Related to Adjuvant Therapy for Early Breast Cancer	NCT00062400	Breast Cancer Psychosocial Ef... Sexual Dysfunct... Sexuality and R...	psychosocial as...	- 35 Years	European Organisation for Research and Treatment of Cancer - EORTC
Intimacy-Enhancing Couples' Intervention for Localized Prostate Cancer	NCT01982058	Prostate Cancer Sexual Dysfunct... Sexuality	communication i... counseling inte... nutrition inter... questionnaire a...	18 Years -	Rutgers, The State University of New Jersey
Hormone Therapy in Treating Patients With Prostate Cancer	NCT00003323	Prostate Cancer Sexual Dysfunct...	finasteride flutamide quality-of-life...	-	Alliance for Clinical Trials in Oncology
Intimacy-Enhancing Couples' Intervention for Localized Prostate Cancer	NCT01982058	Prostate Cancer Sexual Dysfunct... Sexuality	communication i... counseling inte... nutrition inter... questionnaire a...	18 Years -	Rutgers, The State University of New Jersey

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