Young and Strong: An Education and Supportive Care Intervention Study for Young Women With Breast Cancer (Y&S)
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ClinicalTrials.gov Identifier: NCT01647607 |
Recruitment Status
:
Active, not recruiting
First Posted
: July 23, 2012
Last Update Posted
: May 15, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Cancer | Behavioral: Young Women's Intervention (YWI) Behavioral: Physical Activity Intervention (PAI) | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 610 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Supportive Care |
Official Title: | Young and Strong: An Education and Supportive Care Intervention Study for Young Women With Breast Cancer |
Study Start Date : | June 2012 |
Actual Primary Completion Date : | August 2015 |
Estimated Study Completion Date : | August 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: Young Women's Intervention (YWI)
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.
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Behavioral: Young Women's Intervention (YWI)
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.
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Active Comparator: Physical Activity Intervention (PAI)
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.
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Behavioral: Physical Activity Intervention (PAI)
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.
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- Comparison of attention rates in the YWI and the PAI [ Time Frame: 3 Months Post-Enrollment ]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.
- The effect of the YWI on quality of care measures [ Time Frame: 3, 6, and 12 Months Post-Enrollment ]To describe the effect of the YWI on other important quality of care measures (attention to genetic issues and attention to emotional health), we will estimate proportions for each arm and report 95% Confidence Intervals (CIs), evaluating the measures separately.
- Effect of the PAI on improvement of exercise behaviors [ Time Frame: 3 Months Post-Enrollment ]To examine the effects of the PAI on improvement of exercise behaviors, the mean change in MVPA at 3 months (post - pre) will be evaluated in each of the arms. Estimates of mean change and 95% CIs will be determined using GEEs accounting for a stratum effect and clustering within practice.
- Effects of the PAI on changes in physical activity based on MVA at three months [ Time Frame: 3 Months Post-Enrollment ]To examine the effects of the PAI on change in exercise behaviors based on other measures of physical activity, the mean change in MVA at 3 months and the change in LSI at 3 months will be evaluated in each of the arms. Change at 3 months is change from recalled pre-intervention to 3 months (post - pre). Estimates of mean change and 95% CIs will be determined using GEEs accounting for a stratum effect and clustering within practice.
- Relationship between attention rate and quality of care within each arm (YWI and PAI) [ Time Frame: 3 Months Post-Enrollment ]To describe the relationship of the attention rate at 3 months with other quality of care measures at 3 months, the quality of care measures will be dichotomized by the median or an established cutoff (high score vs. low score) and the attention rate within each group will be estimated with 95% CIs, accounting for clustering within practice and not for stratification. Quality of care measures will be evaluated separately and relationships will be described for each arm separately.
- Effect of demographics on the YWI [ Time Frame: 3, 6, and 12 Months Post-Enrollment ]To further describe the YWI treatment effect, exploratory analyses may include adjustment for patient demographics and, if appropriate, including variables in the secondary analyses as well as practice-level characteristics such as setting (urban, suburban, rural) and size of practice.
- Effect of the YWI on maintenance of the attention rate [ Time Frame: 6 Months Post-Enrollment ]To examine the effects of the YWI on maintenance of the attention rate, we will determine the attention rate at 6 months and 95% CI. There will be separate estimates for each arm.
- Effect of the PAI on maintenance of exercise behaviors [ Time Frame: 6 and 12 Months Post-Enrollment ]To examine the effects of the PAI on maintenance of exercise behaviors, the arms will be evaluated in terms of mean change in MVPA at 6 and 12 months (post - pre). Time points will be evaluated separately. Descriptive analyses will use GEE models similar to those evaluating change at 3 months.

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01647607
United States, Colorado | |
University of Colorado | |
Aurora, Colorado, United States, 80045 | |
Penrose St. Francis Health Services | |
Colorado Springs, Colorado, United States, 80907 | |
United States, Illinois | |
Presence Resurrection Medical Center | |
Chicago, Illinois, United States, 60631 | |
United States, Pennsylvania | |
Albert Einstein Medical Center | |
Philadelphia, Pennsylvania, United States, 19141 |
Principal Investigator: | Ann H Partridge, MD, MPH | Dana-Farber Cancer Institute |
Publications:
Responsible Party: | Ann H. Partridge, MD, MPH, Principal Investigator, Dana-Farber Cancer Institute |
ClinicalTrials.gov Identifier: | NCT01647607 History of Changes |
Other Study ID Numbers: |
DFCI 12-101 |
First Posted: | July 23, 2012 Key Record Dates |
Last Update Posted: | May 15, 2017 |
Last Verified: | May 2017 |
Keywords provided by Ann H. Partridge, MD, MPH, Dana-Farber Cancer Institute:
Breast Cancer Young Women Fertility Physical Activity Survivorship |
Additional relevant MeSH terms:
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |