Young and Strong: An Education and Supportive Care Intervention Study for Young Women With Breast Cancer (Y&S)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Breast Cancer	Behavioral: Young Women's Intervention (YWI); Behavioral: Physical Activity Intervention (PAI)	Not Applicable

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Study Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.	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.
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.	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.

Outcome Measures

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Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Criteria

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

Contacts and Locations

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Locations

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

Sponsors and Collaborators

Dana-Farber Cancer Institute

American Society of Clinical Oncology

Investigators

Principal Investigator:	Ann H Partridge, MD, MPH	Dana-Farber Cancer Institute

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

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.

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
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