Recruiting

Observational Study

Sponsor:

University of South Carolina

Code:

NCT05981716

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

No intervention

Study Details

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

Study ID

NCT05981716

Start date

Jan 10, 2023

Status verified date

Aug, 2023

Completion date

Dec 31, 2023

Anticipated

Primary completion date

Dec 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 60

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

384 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

No intervention

This is an observational study. There is no intervention.

Primary outcome measure

  • Score on Health-related Quality of Life Measure [ Time Frame: Measured at one point in time, from 0-10 years after diagnosis ]
  • Number of Participants with Treatment Adherence Compared to those without Treatment Adherence [ Time Frame: Up to 2 years post-diagnosis of breast cancer ]

Central Contacts and Locations

Central contacts

Locations

University of South Carolina

Recruiting

Columbia, South Carolina, United States, 29208

Contacts

Ella Gustafson

ellabg@email.sc.edu

More Information

Sponsor

University of South Carolina

Last update posted

Aug 14, 2023

Last verified

Aug, 2023

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of South Carolina on 2023-08-14.