Health TrialsbyHealthPanel

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

ConditionsBreast CancerLymphomaHodgkin's Lymphoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorMemorial Sloan Kettering Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Women, 18 years of age and older

Premenopausal women at time of diagnosis who have either been pregnant or had at least one menstrual period in the last 12 months

Note: premenopausal women at time of diagnosis who have not been pregnant or have not had at least one menstrual period in the last 12 months are able to participate only if they have had an intrauterine device (IUD) in place within 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.

Disqualifiers

Active secondary cancer requiring cytotoxic chemotherapy

Prior systemic treatment for a malignancy

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • surveys

    Behavioral

    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 +/- 2 months.

  • Blood draw

    Other intervention

    Those patients receiving chemotherapy who consent to the optional blood draw will provide blood at baseline (before start of chemotherapy), 12 months after baseline (+/-1 month) and 24 months after baseline (+/-2 months). All patients in the subset of the premenopausal cohort receiving tamoxifen only will have required blood draws at baseline (before they begin taking tamoxifen), at 6 months post-baseline/start of tamoxifen (+/- 2 weeks), 12 months post-start of tamoxifen (+/-1 month) and 24 months post-start of tamoxifen (+/-2 months). We will ask these participants for blood draws on day 1, 2, 3 or 4 of their menses at baseline and 6 months post-baseline/start of tamoxifen and during months 1 through 5 post-baseline/start of tamoxifen.

  • Transvaginal ultrasounds

    Device

    Transvaginal ultrasounds are used to determine the number of antral follicles in each ovary. They will be performed to evaluate both the number and size of antral follicles of premenopausal women on Tamoxifen as antral follicle count is a good predictor of ovarian reserve and response. All patients in the subset of the premenopausal cohort receiving tamoxifen only will also have required transvaginal ultrasounds at baseline (before they begin taking tamoxifen) and at 6 months post-start of tamoxifen (+/- 2 weeks).

Treatment groups

475 Participants
are divided into 2 treatment groups
Group A: women with breast cancer3 interventions
Group B: women with lymphoma3 interventions

Trial outcomes

Primary outcomes

1

determine the natural history of sexual and reproductive health

Time frame
5 years

Secondary outcomes

1

predictors of sexual dysfunction during and after treatment

Time frame
5 years
2

impact of treatment on self-reported future pregnancy/reproductive health

Time frame
5 years
3

factors that influence decisions regarding fertility preservation

Before treatment and family building after treatment

Time frame
5 years
4

comparison of sexual function between breast cancer and lymphoma patients

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Memorial Sloan Kettering Cancer Center

Lead sponsor

Source ClinicalTrials.gov
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