NCT03615573

Brief Summary

A survey study to evaluate the financial impact of breast cancer as self-reported by breast cancer patients over a period of 1 year. The study will also look at the health insurance literacy and patient's utilization of support services.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
103

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 6, 2018

Completed
29 days until next milestone

Study Start

First participant enrolled

September 4, 2018

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2022

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2024

Completed
Last Updated

November 7, 2024

Status Verified

November 1, 2024

Enrollment Period

3.8 years

First QC Date

July 31, 2018

Last Update Submit

November 6, 2024

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Change in level of self-reported financial burden

    Will evaluate the change in Comprehensive Score for Financial Toxicity (COST-FACIT) measurements from baseline to 1 year follow up. This survey consists of 14 questions related to finances.Responses include 5 options with lower scores representing worse outcomes. Scores at 1 year will be compared to baseline scores.

    Baseline through 1 year

Secondary Outcomes (2)

  • Change in level of self-reported health insurance literacy

    Baseline through 1 year

  • Self-reported access and utilization of institutional support services

    Baseline through 1 year

Interventions

Quality of Life SurveysOTHER

Patients with breast cancer diagnosis complete questionnaires over 20-30 minutes at baseline and at 3, 6, and 12 months after enrollment.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients seen at rural cancer center with diagnosis of breast cancer or a recurrence of breast cancer within the past 2 years

You may qualify if:

  • years or older
  • Diagnosed with breast cancer or a recurrence of breast cancer within the past 2 years
  • Willing to sign consent
  • Able to read and complete surveys in English

You may not qualify if:

  • Cancer diagnosis other than breast cancer
  • More than 2 years since diagnosis with breast cancer or recurrence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guthrie Medical Group

Sayre, Pennsylvania, 18840, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Cynthia Perry-Keaty, RN FNP AOCNP

    The Guthrie Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2018

First Posted

August 6, 2018

Study Start

September 4, 2018

Primary Completion

June 15, 2022

Study Completion

February 10, 2024

Last Updated

November 7, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)