NCT01647607

Brief Summary

The purpose of this study is to address gaps in care of young women with breast cancer by determining whether educational interventions focusing on issues unique to young women with breast cancer and healthy lifestyles for women with breast cancer help to improve care of young breast cancer patients. The investigators believe that if addressed early in a young woman's care, concerns related to fertility, body image, sexual dysfunction, and physical activity will improve the satisfaction with care and quality of life of this vulnerable population. The research will be conducted by exporting refined, previously piloted educational interventions to 14 academic sites and 40 community medical clinics. The investigators will compare how interaction with each intervention affects patients' quality of life and satisfaction with quality of care.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
467

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Jun 2012

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 23, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2017

Completed
Last Updated

July 29, 2020

Status Verified

July 1, 2020

Enrollment Period

3.2 years

First QC Date

July 19, 2012

Last Update Submit

July 28, 2020

Conditions

Breast Cancer

Keywords

Breast CancerYoung WomenFertilityPhysical ActivitySurvivorship

Outcome Measures

Primary Outcomes (1)

  • Comparison of attention rates in the YWI and the PAI

    The YWI and PAI arms will be compared in terms of the attention rate at 3 months using generalized estimated equations (GEEs) to account for clustered binary data. Comparison will be based on testing the term for treatment arm.

    3 Months Post-Enrollment

Secondary Outcomes (7)

  • The effect of the YWI on quality of care measures

    3, 6, and 12 Months Post-Enrollment

  • Effect of the PAI on improvement of exercise behaviors

    3 Months Post-Enrollment

  • Effects of the PAI on changes in physical activity based on MVA at three months

    3 Months Post-Enrollment

  • Relationship between attention rate and quality of care within each arm (YWI and PAI)

    3 Months Post-Enrollment

  • Effect of demographics on the YWI

    3, 6, and 12 Months Post-Enrollment

  • +2 more secondary outcomes

Study Arms (2)

Young Women's Intervention (YWI)

EXPERIMENTAL

This arm involves administration of an educational intervention that focuses on issues unique to young women with breast cancer, including career development, starting/raising a family, body image, and genetic predispositions to breast cancer.

Behavioral: Young Women's Intervention (YWI)

Physical Activity Intervention (PAI)

ACTIVE COMPARATOR

This arm involves administration of an educational intervention that focuses on developing and/or maintaining a healthy lifestyle for young women with breast cancer, including the benefits of exercise and resources to enhance physical activity after diagnosis.

Behavioral: Physical Activity Intervention (PAI)

Interventions

Young Women's Intervention (YWI)BEHAVIORAL

This educational intervention uses print and web-based materials to focus on issues unique to young women with breast cancer, including career development, starting/raising a family, body image, and genetic predispositions to breast cancer.

Young Women's Intervention (YWI)
Physical Activity Intervention (PAI)BEHAVIORAL

This educational intervention uses print and web-based materials that focus on developing and/or maintaining a healthy lifestyle for young women with breast cancer, including the benefits of exercise and resources to enhance physical activity after diagnosis.

Physical Activity Intervention (PAI)

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Female age 18-45 years at diagnosis
  • Within 3 months of stage I-III invasive breast cancer diagnosis
  • No known recurrence of breast cancer or metastatic breast cancer
  • Able to read and write in English
  • Has first appointment with medical oncologist after the provider's practice is enrolled in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Colorado

Aurora, Colorado, 80045, United States

Location

Penrose St. Francis Health Services

Colorado Springs, Colorado, 80907, United States

Location

Presence Resurrection Medical Center

Chicago, Illinois, 60631, United States

Location

Albert Einstein Medical Center

Philadelphia, Pennsylvania, 19141, United States

Location

Related Publications (6)

  • Greaney ML, Sprunck-Harrild K, Ruddy KJ, Ligibel J, Barry WT, Baker E, Meyer M, Emmons KM, Partridge AH. Study protocol for Young & Strong: a cluster randomized design to increase attention to unique issues faced by young women with newly diagnosed breast cancer. BMC Public Health. 2015 Jan 31;15:37. doi: 10.1186/s12889-015-1346-9.

    PMID: 25636332BACKGROUND

  • Partridge AH, Ruddy KJ, Barry WT, Greaney ML, Ligibel JA, Sprunck-Harrild KM, Rosenberg SM, Baker EL, Hoverman JR, Emmons KM. A randomized study to improve care for young women with breast cancer at community and academic medical oncology practices in the United States: The Young and Strong study. Cancer. 2019 Jun 1;125(11):1799-1806. doi: 10.1002/cncr.31984. Epub 2019 Feb 1.

    PMID: 30707756BACKGROUND

  • Tesch ME, Sorouri K, Zheng Y, Rosenberg SM, Ruddy KJ, Emmons KM, Dutton MC, Partridge AH. Contraception use and changes in young women with newly diagnosed breast cancer. Fertil Steril. 2025 Mar;123(3):488-498. doi: 10.1016/j.fertnstert.2024.09.024. Epub 2024 Sep 19.

    PMID: 39306190DERIVED

  • de Kermadec E, Zheng Y, Rosenberg S, Ruddy KJ, Ligibel JA, Emmons KM, Partridge AH. Fertility concerns and treatment decision-making among national sample of young women with breast cancer. Cancer Med. 2024 Jan;13(1):e6838. doi: 10.1002/cam4.6838. Epub 2023 Dec 22.

    PMID: 38131887DERIVED

  • Carroll BR, Zheng Y, Ruddy KJ, Emmons KM, Partridge AH, Rosenberg SM. Satisfaction with Care and Attention to Age-Specific Concerns by Race and Ethnicity in a National Sample of Young Women with Breast Cancer. J Adolesc Young Adult Oncol. 2024 Feb;13(1):105-111. doi: 10.1089/jayao.2023.0068. Epub 2023 Aug 18.

    PMID: 37594766DERIVED

  • Cook EE, Rosenberg SM, Ruddy KJ, Barry WT, Greaney M, Ligibel J, Sprunck-Harrild K, Holmes MD, Tamimi RM, Emmons KM, Partridge AH. Prospective evaluation of the impact of stress, anxiety, and depression on household income among young women with early breast cancer from the Young and Strong trial. BMC Public Health. 2020 Oct 6;20(1):1514. doi: 10.1186/s12889-020-09562-z.

    PMID: 33023562DERIVED

MeSH Terms

Conditions

Breast NeoplasmsMotor Activity

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBehavior

Study Officials

  • Ann H Partridge, MD, MPH

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 19, 2012

First Posted

July 23, 2012

Study Start

June 1, 2012

Primary Completion

August 1, 2015

Study Completion

December 20, 2017

Last Updated

July 29, 2020

Record last verified: 2020-07

Locations

US(4)