Young Breast Cancer Survivors Study

NCT05981716 | Unknown

• 1 other identifier: YBCSS-2023
• Study Type: observational
• Target: 384
• Locations: 1 country
• Sites: 1

Brief Summary

Despite significant overall reductions in mortality rates for breast cancer over the past decade, both incidence and mortality rates have steadily climbed in adults diagnosed before age 50. This research project addresses factors associated with quality of life among and treatment response in early-age-at-onset breast cancer patients. The overall objective is collect information from early-onset breast cancer patients using an online questionnaire and examine factors related to cancer survival, (i.e.,better quality of life, better treatment adherence, less adverse treatment responses). Aim 1: Identify dietary patterns related to health-related quality of life in early-age-at-onset breast cancer patients. The investigators hypothesize that diet quality is related to better health-related quality of life among young breast cancer survivors. Aim 2. Identify demographic, social determinants, and geographic factors associated with treatment adherence. The investigators hypothesize that social determinants such as poverty-to-income ratio, education, and proximity to cancer treatment facilities are associated with treatment adherence in early-onset breast cancer.

Conditions

Breast Cancer

Keywords

Nutrition; Breast Cancer; Cancer Survivors; Quality of Life; Treatment Adherence; Social Determinants

Outcome Measures

Primary Outcomes (2)

• Score on Health-related Quality of Life Measure

  For Aim 1, health-related quality of life (HRQoL) is a multidimensional concept that not only includes physical, psychological and social domains, but may also encompass other domains such as cognitive functioning. Cancer patients also exhibit many symptoms (e.g., fatigue, pain, sleep disturbance) that are not measurable directly from laboratory tests. Thus, assessing HRQoL and these symptom burdens among cancer survivors will need to rely on patients' self-reports, measured by validated instruments especially for patients with breast cancer. Participants will complete the 37-item Functional Assessment of Cancer Therapy-B with a 5-point Likert-type scale capturing the domains of Physical Well-being, Social/Family Well-being, Emotional Well-being, Functional Well-being, and a Breast Cancer Subscale. Item responses are scored according to scoring guidelines ranging from scores of 0 to 148, with a higher score representing better quality of life.

  Measured at one point in time, from 0-10 years after diagnosis

• Number of Participants with Treatment Adherence Compared to those without Treatment Adherence

  For Aim 2, the primary outcome is treatment adherence (at patient-level), which will be determined as per National Comprehensive Cancer Network (NCCN) guidelines and eventually categorized as treatment adherent/non-adherent.

  Up to 2 years post-diagnosis of breast cancer

Study Arms (1)

Young Breast Cancer Survivors

The investigators will enroll approximately 384 female breast cancer patients. Only non-institutionalized, English literate, female breast cancer patients diagnosed within the previous ten years and younger than 50 years old at the time of diagnosis will be eligible.

Other: No intervention

Interventions

No intervention OTHER

This is an observational study. There is no intervention.

Young Breast Cancer Survivors

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: Only female breast cancer survivors will be considered for the study. There is a much lower prevalence of breast cancer among men; therefore, the study will target a female survivor population.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The investigators plan to enroll 384 women who were previously diagnosed with breast cancer prior to the age of 50 years.

You may qualify if:

• Non-institutionalized
• English literate
• Female breast cancer survivors
• Diagnosed with breast cancer within the past 10 years and diagnosed younger than age 50 years

You may not qualify if:

• Male breast cancer survivors
• Breast cancer survivors diagnosed with breast cancer after the age of 50 years

Sponsors & Collaborators

• University of South Carolina: lead

Study Sites (1)

University of South Carolina

Columbia, South Carolina, 29208, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Health Behavior; Behavior

Study Officials

• Susan Steck, PhD, MPH, RD

  University of South Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susan Steck, PhD, MPH, RD

CONTACT

8037771527; stecks@mailbox.sc.edu

Ella Gustafson

CONTACT

7034736473; ellabg@email.sc.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 12, 2023
• First Posted: August 8, 2023
• Study Start: January 10, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available at the conclusion of the study after the publication of the main results.
• Access Criteria: Contact the Principal Investigator for all requests: Dr. Susan Steck at stecks@mailbox.sc.edu

Locations

US (1)