Protocol - Hormonal Therapy

Description

Female participants are asked whether they have ever used prescription female hormones (number of months taken, types, dosage) and then asked whether they are currently using it. They are asked whether they are using any over-the-counter preparations for hormone replacement or post-menopause symptoms.

Specific Instructions

Note: the prepopulated/embedded dates of the original study protocol were removed for clarity of Toolkit users.

Availability

This protocol is freely available; permission not required for use.

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Protocol

1. Have you used prescription female hormones? (Not including contraceptives.)

[ ] Yes

a) How many months did you use hormones?

[ ] 1 - 4 months

[ ] 5 - 9 months

[ ] 10 - 14 months

[ ] 15 - 19 months

[ ] 20 - 25 months

[ ] 26 - 30 months

[ ] 31 - 35 months

[ ] 36+ months

b) Are you currently using them (within the last month)?

[ ] Yes

[ ] No

If no, skip to part d

c) Mark the type(s) of hormones you are CURRENTLY using:

[ ] Combined:

[ ] Prempro,

[ ] Premphase,

[ ] Combipatch,

[ ] FemHRT

[ ] Estrogen

[ ] Oral Premarin or Conjugated estrogen

[ ] Patch Estrogen

[ ] Vaginal Estrogen

[ ] Estrace

[ ] Estrogen gels, creams, or sprays on skin

[ ] Estratest

[ ] Other Estrogen Specify:____________

[ ] Progesterone/Progestin:

[ ] Provera/Cycrin/MPA

[ ] Vaginal

[ ] Micronized (e.g., Prometrium)

[ ] Other progesterone (specify type):___________

d) If you used oral conjugated estrogen (e.g., Premarin), what dose did you usually take?

[ ] 0.30 mg/day or less

[ ] 0.45 mg/day

[ ] 0.625 mg/day

[ ] 0.9 mg/day

[ ] 1.25 mg/day or higher

[ ] Unsure

[ ] Did not take oral conjugated estrogen

[ ] No (skip to 2)

2. Are you currently using any of these over-the-counter (OTC) preparations for hormone replacement?

[ ] Soy estrogen products

[ ] Black cohosh (e.g., Remifemin)

[ ] Natural progesterone cream/wild yam

[ ] Other OTC

Personnel and Training Required

None

Equipment Needs

Pencil and paper

Requirements

Requirement Category	Required
Major equipment	No
Specialized training	No
Specialized requirements for biospecimen collection	No
Average time of greater than 15 minutes in an unaffected individual	No

Mode of Administration

Self-administered questionnaire

Lifestage

Adult

Participants

Women aged 25-42 in 1989.

Selection Rationale

Among several vetted national surveys of hormonal therapy, this protocol is the most comprehensive, while not being too burdensome within the context of a general survey.

Language

English

Standards

Standard	Name	ID	Source
Human Phenotype Ontology	Premature ovarian insufficiency	HP:0008209	HPO
caDSR Form	PhenX PX100702 - Hormonal Therapy	6872468	caDSR Form

Derived Variables

None

Process and Review

The Expert Review Panel #5 (ERP 5) reviewed the measures in the Reproductive Health domain.

Guidance from ERP 5 includes the following:

• Updated protocol

• New Data Dictionary

Back-compatible: there are changes to the Data Dictionary, previous version of the Data Dictionary and Variable mapping in Toolkit archive (link)

Protocol Name from Source

Nurses Health Study II (NHS II), 2015

Source

Harvard Medical School. (2015). Nurses’ Health Study II, 2015. Boston, MA. Question numbers 7-8.

General References

Townsend, M. K., Curhan, G. C., Resnick, N. M., & Grodstein, F. (2009). Postmenopausal hormone therapy and incident urinary incontinence in middle-aged women. American Journal of Obstetrics and Gynecology, 200(1), 86.e1-5.

Protocol ID

100702

Variables

Export Variables

Variable Name	Variable ID	Variable Description	dbGaP Mapping
PX100702_Hormonal_Therapy_Over_The_Counter_OTC
	PX100702020000	Are you currently using any of these more over-the-counter (OTC) preparations for hormone replacement? show less	N/A
PX100702_Hormonal_Therapy_Prescription_Female_Hormones
	PX100702010100	Have you used prescription female hormones? more (Not including contraceptives.) show less	N/A
PX100702_Hormonal_Therapy_Prescription_Female_Hormones_Currently_Using
	PX100702010300	Are you currently using them (within the more last month)? show less	N/A
PX100702_Hormonal_Therapy_Prescription_Female_Hormones_Currently_Using_Type_Other
	PX100702010402	Mark the type(s) of hormones you are more CURRENTLY using: show less	N/A

Reproductive Health

Measure Name

Hormonal Therapy

Release Date

April 11, 2017

Definition

A question to determine whether a female has ever taken hormonal therapy for treatment or prevention of cancer or for another reason. As hormonal therapy is known to affect risk of cardiovascular disease and cancer, it is an important environmental risk factor for women.

Purpose

To assess use of hormonal therapy.

Keywords

Reproductive health, estrogen, Nurses’ Health Study, NHS

Measure Protocols

Protocol ID	Protocol Name
100702	Hormonal Therapy