Women In Steady Exercise Research (WISER) Sister: Study design and methods

Kathryn H. Schmitz; Nancy I. Williams; Despina Kontos; Mindy S. Kurzer; Mitchell Schnall; Susan Domchek; Jill Stopfer; Mary Lou Galantino; Wei Ting Hwang; Knashawn Morales; Shandong Wu; Laura DiGiovanni; Domenick Salvatore; Desire' Fenderson; Jerene Good; Kathleen Sturgeon; Lorita Grant; Cathy J. Bryan; Jess Adelman

doi:10.1016/j.cct.2014.12.016

Women In Steady Exercise Research (WISER) Sister: Study design and methods

Kathryn H. Schmitz, Nancy I. Williams, Despina Kontos, Mindy S. Kurzer, Mitchell Schnall, Susan Domchek, Jill Stopfer, Mary Lou Galantino, Wei Ting Hwang, Knashawn Morales, Shandong Wu, Laura DiGiovanni, Domenick Salvatore, Desire' Fenderson, Jerene Good, Kathleen Sturgeon, Lorita Grant, Cathy J. Bryan, Jess Adelman

Research output: Contribution to journal › Article › peer-review

18 Scopus citations

Abstract

Women at elevated risk for breast cancer are motivated to reduce their risk. Current approaches rely primarily on hormonal intervention. A preventive exercise intervention might address the same hormonal issues, yet have fewer serious side effects and less negative impact on quality of life as compared to prophylactic mastectomy. WISER Sister was a randomized controlled trial which examined effects of two doses of exercise training on endogenous sex hormone exposure, hormonally active breast tissue, and other breast cancer risk factors. Methods: Subjects for this single site trial were recruited from across the U.S., in collaboration with organizations that serve women at elevated risk, via emails, flyers, and letters. Eligibility criteria included age ≥. 18, eumenorrheic, and at elevated risk for breast cancer (e.g. BRCA1 or BRCA2 mutation and/or ≥. 18% lifetime risk according to prediction models). A 1:1:1 randomization scheme was used to allocate participants into: control, low dose (150. min/week), or high dose (300. min/week) home based treadmill exercise. Participants provided first morning urine samples daily for two menstrual cycles at study beginning and end for calculation of endogenous hormone exposure. In addition, women completed breast dynamic contrast enhanced magnetic resonance imaging, a fasting blood draw, a treadmill exercise test, and surveys at baseline and follow-up. Discussion: WISER Sister randomized 139 women, 122 of whom completed the study. The overall drop-out rate was 12%. Findings will be useful in understanding the potential for exercise to assist with reducing risk for breast cancer among women at elevated risk.

Original language	English (US)
Pages (from-to)	17-30
Number of pages	14
Journal	Contemporary Clinical Trials
Volume	41
DOIs	https://doi.org/10.1016/j.cct.2014.12.016
State	Published - Mar 1 2015

Bibliographical note

Funding Information:
The authors wish to acknowledge the advocacy organizations that assisted with recruitment for this study, principally FORCE (Facing Our Risk of Cancer Empowered), the study participants, and the National Institutes of Health/National Cancer Institute for grant R01-CA131333 . This work was also supported by discounts for treadmills from Smooth Fitness, Inc, King of Prussia, PA. The project described was also supported by the National Center for Research Resources and the National Center for Advancing Translational Sciences, National Institutes of Health , through Grant UL1TR000003 . Several study investigators were supported by the Basser Center at the University of Pennsylvania's Abramson Cancer Center. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.

Publisher Copyright:
© 2015 Elsevier Inc.

Keywords

BRCA mutation
Breast cancer
Exercise
MR imaging
Sex hormones

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Publisher link

10.1016/j.cct.2014.12.016

Find It

Find It at U of M Libraries

Cite this

Schmitz, K. H., Williams, N. I., Kontos, D., Kurzer, M. S., Schnall, M., Domchek, S., Stopfer, J., Galantino, M. L., Hwang, W. T., Morales, K., Wu, S., DiGiovanni, L., Salvatore, D., Fenderson, D., Good, J., Sturgeon, K., Grant, L., Bryan, C. J., & Adelman, J. (2015). Women In Steady Exercise Research (WISER) Sister: Study design and methods. Contemporary Clinical Trials, 41, 17-30. https://doi.org/10.1016/j.cct.2014.12.016

Schmitz, KH, Williams, NI, Kontos, D, Kurzer, MS, Schnall, M, Domchek, S, Stopfer, J, Galantino, ML, Hwang, WT, Morales, K, Wu, S, DiGiovanni, L, Salvatore, D, Fenderson, D, Good, J, Sturgeon, K, Grant, L, Bryan, CJ & Adelman, J 2015, 'Women In Steady Exercise Research (WISER) Sister: Study design and methods', Contemporary Clinical Trials, vol. 41, pp. 17-30. https://doi.org/10.1016/j.cct.2014.12.016

@article{5f975b61289e4614b4e7c32ea9c09685,

title = "Women In Steady Exercise Research (WISER) Sister: Study design and methods",

abstract = "Women at elevated risk for breast cancer are motivated to reduce their risk. Current approaches rely primarily on hormonal intervention. A preventive exercise intervention might address the same hormonal issues, yet have fewer serious side effects and less negative impact on quality of life as compared to prophylactic mastectomy. WISER Sister was a randomized controlled trial which examined effects of two doses of exercise training on endogenous sex hormone exposure, hormonally active breast tissue, and other breast cancer risk factors. Methods: Subjects for this single site trial were recruited from across the U.S., in collaboration with organizations that serve women at elevated risk, via emails, flyers, and letters. Eligibility criteria included age ≥. 18, eumenorrheic, and at elevated risk for breast cancer (e.g. BRCA1 or BRCA2 mutation and/or ≥. 18% lifetime risk according to prediction models). A 1:1:1 randomization scheme was used to allocate participants into: control, low dose (150. min/week), or high dose (300. min/week) home based treadmill exercise. Participants provided first morning urine samples daily for two menstrual cycles at study beginning and end for calculation of endogenous hormone exposure. In addition, women completed breast dynamic contrast enhanced magnetic resonance imaging, a fasting blood draw, a treadmill exercise test, and surveys at baseline and follow-up. Discussion: WISER Sister randomized 139 women, 122 of whom completed the study. The overall drop-out rate was 12%. Findings will be useful in understanding the potential for exercise to assist with reducing risk for breast cancer among women at elevated risk.",

keywords = "BRCA mutation, Breast cancer, Exercise, MR imaging, Sex hormones",

author = "Schmitz, {Kathryn H.} and Williams, {Nancy I.} and Despina Kontos and Kurzer, {Mindy S.} and Mitchell Schnall and Susan Domchek and Jill Stopfer and Galantino, {Mary Lou} and Hwang, {Wei Ting} and Knashawn Morales and Shandong Wu and Laura DiGiovanni and Domenick Salvatore and Desire' Fenderson and Jerene Good and Kathleen Sturgeon and Lorita Grant and Bryan, {Cathy J.} and Jess Adelman",

note = "Funding Information: The authors wish to acknowledge the advocacy organizations that assisted with recruitment for this study, principally FORCE (Facing Our Risk of Cancer Empowered), the study participants, and the National Institutes of Health/National Cancer Institute for grant R01-CA131333 . This work was also supported by discounts for treadmills from Smooth Fitness, Inc, King of Prussia, PA. The project described was also supported by the National Center for Research Resources and the National Center for Advancing Translational Sciences, National Institutes of Health , through Grant UL1TR000003 . Several study investigators were supported by the Basser Center at the University of Pennsylvania's Abramson Cancer Center. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH. Publisher Copyright: {\textcopyright} 2015 Elsevier Inc.",

year = "2015",

month = mar,

day = "1",

doi = "10.1016/j.cct.2014.12.016",

language = "English (US)",

volume = "41",

pages = "17--30",

journal = "Contemporary Clinical Trials",

issn = "1551-7144",

publisher = "Elsevier Inc.",

}

TY - JOUR

T1 - Women In Steady Exercise Research (WISER) Sister

T2 - Study design and methods

AU - Schmitz, Kathryn H.

AU - Williams, Nancy I.

AU - Kontos, Despina

AU - Kurzer, Mindy S.

AU - Schnall, Mitchell

AU - Domchek, Susan

AU - Stopfer, Jill

AU - Galantino, Mary Lou

AU - Hwang, Wei Ting

AU - Morales, Knashawn

AU - Wu, Shandong

AU - DiGiovanni, Laura

AU - Salvatore, Domenick

AU - Fenderson, Desire'

AU - Good, Jerene

AU - Sturgeon, Kathleen

AU - Grant, Lorita

AU - Bryan, Cathy J.

AU - Adelman, Jess

N1 - Funding Information: The authors wish to acknowledge the advocacy organizations that assisted with recruitment for this study, principally FORCE (Facing Our Risk of Cancer Empowered), the study participants, and the National Institutes of Health/National Cancer Institute for grant R01-CA131333 . This work was also supported by discounts for treadmills from Smooth Fitness, Inc, King of Prussia, PA. The project described was also supported by the National Center for Research Resources and the National Center for Advancing Translational Sciences, National Institutes of Health , through Grant UL1TR000003 . Several study investigators were supported by the Basser Center at the University of Pennsylvania's Abramson Cancer Center. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH. Publisher Copyright: © 2015 Elsevier Inc.

PY - 2015/3/1

Y1 - 2015/3/1

N2 - Women at elevated risk for breast cancer are motivated to reduce their risk. Current approaches rely primarily on hormonal intervention. A preventive exercise intervention might address the same hormonal issues, yet have fewer serious side effects and less negative impact on quality of life as compared to prophylactic mastectomy. WISER Sister was a randomized controlled trial which examined effects of two doses of exercise training on endogenous sex hormone exposure, hormonally active breast tissue, and other breast cancer risk factors. Methods: Subjects for this single site trial were recruited from across the U.S., in collaboration with organizations that serve women at elevated risk, via emails, flyers, and letters. Eligibility criteria included age ≥. 18, eumenorrheic, and at elevated risk for breast cancer (e.g. BRCA1 or BRCA2 mutation and/or ≥. 18% lifetime risk according to prediction models). A 1:1:1 randomization scheme was used to allocate participants into: control, low dose (150. min/week), or high dose (300. min/week) home based treadmill exercise. Participants provided first morning urine samples daily for two menstrual cycles at study beginning and end for calculation of endogenous hormone exposure. In addition, women completed breast dynamic contrast enhanced magnetic resonance imaging, a fasting blood draw, a treadmill exercise test, and surveys at baseline and follow-up. Discussion: WISER Sister randomized 139 women, 122 of whom completed the study. The overall drop-out rate was 12%. Findings will be useful in understanding the potential for exercise to assist with reducing risk for breast cancer among women at elevated risk.

AB - Women at elevated risk for breast cancer are motivated to reduce their risk. Current approaches rely primarily on hormonal intervention. A preventive exercise intervention might address the same hormonal issues, yet have fewer serious side effects and less negative impact on quality of life as compared to prophylactic mastectomy. WISER Sister was a randomized controlled trial which examined effects of two doses of exercise training on endogenous sex hormone exposure, hormonally active breast tissue, and other breast cancer risk factors. Methods: Subjects for this single site trial were recruited from across the U.S., in collaboration with organizations that serve women at elevated risk, via emails, flyers, and letters. Eligibility criteria included age ≥. 18, eumenorrheic, and at elevated risk for breast cancer (e.g. BRCA1 or BRCA2 mutation and/or ≥. 18% lifetime risk according to prediction models). A 1:1:1 randomization scheme was used to allocate participants into: control, low dose (150. min/week), or high dose (300. min/week) home based treadmill exercise. Participants provided first morning urine samples daily for two menstrual cycles at study beginning and end for calculation of endogenous hormone exposure. In addition, women completed breast dynamic contrast enhanced magnetic resonance imaging, a fasting blood draw, a treadmill exercise test, and surveys at baseline and follow-up. Discussion: WISER Sister randomized 139 women, 122 of whom completed the study. The overall drop-out rate was 12%. Findings will be useful in understanding the potential for exercise to assist with reducing risk for breast cancer among women at elevated risk.

KW - BRCA mutation

KW - Breast cancer

KW - Exercise

KW - MR imaging

KW - Sex hormones

UR - http://www.scopus.com/inward/record.url?scp=84920744798&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84920744798&partnerID=8YFLogxK

U2 - 10.1016/j.cct.2014.12.016

DO - 10.1016/j.cct.2014.12.016

M3 - Article

C2 - 25559914

AN - SCOPUS:84920744798

SN - 1551-7144

VL - 41

SP - 17

EP - 30

JO - Contemporary Clinical Trials

JF - Contemporary Clinical Trials

ER -

Women In Steady Exercise Research (WISER) Sister: Study design and methods

Abstract

Bibliographical note

Keywords

UN SDGs

Publisher link

Find It

Other files and links

Fingerprint

Cite this