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Longitudinal Sexual and Reproductive Health Study of Women With Breast Cancer and Lymphoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01788839
First received: February 7, 2013
Last updated: October 23, 2014
Last verified: October 2014

February 7, 2013
October 23, 2014
February 2013
February 2016   (final data collection date for primary outcome measure)
determine the natural history of sexual and reproductive health [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01788839 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Longitudinal Sexual and Reproductive Health Study of Women With Breast Cancer and Lymphoma
Longitudinal Sexual and Reproductive Health Study of Women With Breast Cancer and Lymphoma

The purpose of this study is to see how cancer treatment affects sexual and reproductive function. The patient will also be asked to participate in blood draws to see if and how cancer treatment affects the ovaries and the ability to have children (fertility). These blood draws are optional and the patient can still participate in the questionnaire portion of the study even if they choose not to have their blood drawn.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

blood draw is optional

Non-Probability Sample

Women for both the premenopausal and postmenopausal cohorts diagnosed with stage 0-III breast cancer or any aggressive lymphpoma will be recruited from breast cancer and lymphoma clinics.

  • Breast Cancer
  • Lymphoma
  • Hodgkin's Lymphoma
  • Behavioral: surveys
    A survey including the Female Sexual Function Index (FSFI), the Modified Female Sexual Function Index (FSFI-M), the Modified Female Sexual Function Index Follow-Up (FSFI-M Follow-Up) 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.
  • Other: Blood draw (optional)
  • women with breast cancer
    This study is a prospective, observational, longitudinal study assessing the prevalence of sexual dysfunction and distress in premenopausal and postmenopausal 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.
    Interventions:
    • Behavioral: surveys
    • Other: Blood draw (optional)
  • women with lymphoma
    This study is a prospective, observational, longitudinal study assessing the prevalence of sexual dysfunction and distress in premenopausal and postmenopausal 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.
    Interventions:
    • Behavioral: surveys
    • Other: Blood draw (optional)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
February 2016
February 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

Subject Inclusion Criteria for Cohort of Premenopausal Women with Early Stage Breast Cancer and Lymphoma

  • 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) who are within 1 month of starting systemic treatment or women with any aggressive lymphoma being treated with first line therapy with curative intent.
  • Breast cancer patients with any receptor type
  • English speaking
  • Able to participate in the informed consent process

Subject Inclusion Criteria for Cohort of Postmenopausal Women with Early Stage Breast Cancer and Lymphoma

  • Postmenopausal women at time of diagnosis > age 50 who have been without period for ≥ 2 years.
  • Women with newly diagnosed breast cancer (stage 0-III) who are within 1 month of starting systemic treatment or women with any aggressive lymphoma being treated with first line therapy with curative intent.
  • Breast cancer patients with any receptor type
  • English speaking
  • Able to participate in the informed consent process

Exclusion Criteria:

Subject Exclusion Criteria for both Pre and Postmenopausal Women with Early Stage Breast Cancer and Lymphoma

  • Active secondary cancer requiring cytotoxic chemotherapy
  • Prior systemic treatment for a malignancy
Female
18 Years and older
No
Contact: Shari Goldfarb, MD 646-888-5080
Contact: Maura Dickler, MD 646-888-5456
United States
 
NCT01788839
12-249
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
Not Provided
Principal Investigator: Shari Goldfarb, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP