Longitudinal Sexual and Reproductive Health Study of Women With Breast Cancer and Lymphoma
This study is currently recruiting participants.
Verified April 2013 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Memorial Sloan-Kettering Cancer Center
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01788839
First received: February 7, 2013
Last updated: April 3, 2013
Last verified: April 2013
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Purpose
The purpose of this study is to see how cancer treatment affects sexual and reproductive function.
| Condition | Intervention |
|---|---|
|
Breast Cancer Lymphoma Hodgkin's Lymphoma |
Behavioral: surveys |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Longitudinal Sexual and Reproductive Health Study of Women With Breast Cancer and Lymphoma |
Resource links provided by NLM:
Further study details as provided by Memorial Sloan-Kettering Cancer Center:
Primary Outcome Measures:
- determine the natural history of sexual and reproductive health [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- predictors of sexual dysfunction during and after treatment [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- impact of treatment on self-reported future pregnancy/reproductive health [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- factors that influence decisions regarding fertility preservation [ Time Frame: 5 years ] [ Designated as safety issue: No ]Before treatment and family building after treatment
- comparison of sexual function between breast cancer and lymphoma patients [ Time Frame: 5 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 300 |
| Study Start Date: | February 2013 |
| Estimated Study Completion Date: | February 2016 |
| Estimated Primary Completion Date: | February 2016 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
women with breast cancer
This study is a prospective, observational, longitudinal study assessing the prevalence of sexual dysfunction and distress in premenopausal women with breast cancer. This study will also evaluate the severity, time course, and predictors of sexual dysfunction. Breast cancer patients and survivors will be administered surveys of comprehensive questionnaires related to sexual function.
|
Behavioral: surveys
A survey including the Female Sexual Function Index (FSFI), the Modified Female Sexual Function Index (FSFI-M), the Sexual Activity Questionnaire (SAQ), the Female Sexual Distress Scale (FSDS-R), the Menopausal Symptom Check List (MSCL), Patient-reported Outcomes Measurement Information System Sexual Function Instrument (PROMIS-SF), Abbreviated Dyadic Adjustment Scale for Relationships (ADAS), Reproductive Health Survey-baseline (RHS-B). Reproductive Health Survey-followup and (RHS-F1)Reproductive Health Survey-followup (RHS-F2) will be conducted at the following intervals: baseline/before chemotherapy +/- 1 month, 3 months after baseline +/- 1 month, 6 months after baseline +/- 1 month, 1 year after baseline +/- 1 month, and at intervals during survivorship that include yearly for 5 years +/- 1 month.
|
|
women with lymphoma
This study is a prospective, observational, longitudinal study assessing the prevalence of sexual dysfunction and distress in premenopausal women with Diffuse Large B-cell Lymphoma or Hodgkin's Lymphoma. This study will also evaluate the severity, time course, and predictors of sexual dysfunction. Lymphoma patients and survivors will be administered surveys of comprehensive questionnaires related to sexual function.
|
Behavioral: surveys
A survey including the Female Sexual Function Index (FSFI), the Modified Female Sexual Function Index (FSFI-M), the Sexual Activity Questionnaire (SAQ), the Female Sexual Distress Scale (FSDS-R), the Menopausal Symptom Check List (MSCL), Patient-reported Outcomes Measurement Information System Sexual Function Instrument (PROMIS-SF), Abbreviated Dyadic Adjustment Scale for Relationships (ADAS), Reproductive Health Survey-baseline (RHS-B). Reproductive Health Survey-followup and (RHS-F1)Reproductive Health Survey-followup (RHS-F2) will be conducted at the following intervals: baseline/before chemotherapy +/- 1 month, 3 months after baseline +/- 1 month, 6 months after baseline +/- 1 month, 1 year after baseline +/- 1 month, and at intervals during survivorship that include yearly for 5 years +/- 1 month.
|
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Women ages 18 to 50, who are premenopausal with a new diagnosis of stage 0-III breast cancer or Diffuse Large B-cell Lymphoma or Hodgkin's Lymphoma will be recruited from breast cancer and lymphoma clinics.
Criteria
Inclusion Criteria:
- Premenopausal women at time of diagnosis ages 18 to 50 who have either been pregnant or had at least one menstrual period in the last 12 months
- Women with newly diagnosed breast cancer (stage 0-III) or Diffuse Large B-cell Lymphoma or Hodgkin's Lymphoma within 1 month of starting systemic treatment
- Breast cancer patients with any receptor type
- English speaking
- Able to participate in the informed consent process
Exclusion Criteria:
- Active secondary cancer requiring cytotoxic chemotherapy
- Prior systemic treatment for a malignancy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01788839
Contacts
| Contact: Shari Goldfarb, MD | 646-888-5080 | |
| Contact: Maura Dickler, MD | 646-888-5456 |
Locations
| United States, New Jersey | |
| Memorial Sloan-Kettering at Basking Ridge | Recruiting |
| Basking Ridge, New Jersey, United States, 07920 | |
| Contact: Shari Goldfarb, MD 646-888-5080 | |
| Contact: Maura Dickler, MD 646-888-5456 | |
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center @ Suffolk | Recruiting |
| Commack, New York, United States, 11725 | |
| Contact: Shari Goldfarb, MD 646-888-5080 | |
| Memorial Sloan Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Shari Goldfarb, MD 646-888-5080 | |
| Contact: Maura Dickler, MD 646-888-5456 | |
| Memorial Sloan-Kettering at Mercy Medical Center | Recruiting |
| Rockville Centre, New York, United States | |
| Contact: Shari Goldfarb, MD 646-888-5080 | |
| Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center | Recruiting |
| Sleepy Hollow, New York, United States, 10591 | |
| Contact: Shari Goldfarb, MD 646-888-5080 | |
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
| Principal Investigator: | Shari Goldfarb, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01788839 History of Changes |
| Other Study ID Numbers: | 12-249 |
| Study First Received: | February 7, 2013 |
| Last Updated: | April 3, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Memorial Sloan-Kettering Cancer Center:
|
Sexual and Reproductive Health premenopausal Fertility 12-249 |
Additional relevant MeSH terms:
|
Breast Neoplasms Hodgkin Disease Lymphoma Neoplasms by Site Neoplasms Breast Diseases |
Skin Diseases Neoplasms by Histologic Type Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on June 17, 2013