NCT02463474

Brief Summary

This research study will test whether a series of video clips with breast cancer information improves knowledge of breast cancer, breast cancer treatment and living with breast cancer. Questionnaires will be completed to learn if the videos are helpful and pleasant to watch.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2015

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 4, 2015

Completed
27 days until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 16, 2017

Status Verified

January 1, 2017

Enrollment Period

1.4 years

First QC Date

May 29, 2015

Last Update Submit

January 13, 2017

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Breast Cancer Knowledge

    Breast cancer knowledge will be assessed using the Knowledge subscales of the Breast Cancer Surgery Decision Quality Instrument, short version 2 (BCS-DQI, SV2) developed by Massachusetts General Hospital. The knowledge subscale has twelve multiple choice or fill in the blank items about breast cancer, treatment options, recurrence, survival and side effects.

    Baseline assessment (Week 1) to post-intervention assessment (Week 10)

Secondary Outcomes (4)

  • Perceived Involvement in Care Scale

    Baseline assessment (Week 1) to post-intervention assessment (Week 10)

  • Perceived Stress Scale

    Baseline assessment (Week 1) to post-intervention assessment (Week 10)

  • Functional Assessment of Cancer Therapy-Breast (FACT-B)

    Baseline assessment (Week 1) to post-intervention assessment (Week 10)

  • Acceptability

    Baseline assessment (Week 1) to post-intervention assessment (Week 10)

Study Arms (1)

mHealth Intervention

EXPERIMENTAL

Each week for 10 weeks, participants will receive two text messages on their cell phone. The first text message will contain a link to a culturally tailored, informational video clip about living with breast cancer. The second text message that provides a supportive message about the video content.

Behavioral: mHealth Intervention

Interventions

mHealth InterventionBEHAVIORAL

Ten, short, engaging, entertaining and culturally relevant videos delivered to participants' cell phones provide breast cancer health information.

mHealth Intervention

Eligibility Criteria

Age21 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 21 years or older
  • Race/Ethnicity: Black from any cultural background (e.g., African American, Caribbean Islander, Haitian, Black Hispanic, etc.)
  • Diagnosed with breast cancer stages 0-III in the past 6 months
  • Life Expectancy: ≥12 months
  • Income: at or below 200% of the federal poverty line
  • Have access to a cellphone
  • Able to receive text messages on cell phone
  • Able to view video clips on cell phone.

You may not qualify if:

  • Previous diagnosis of any type of cancer
  • Conditions or behaviors likely to affect the conduct of the trial: unwilling or unable to give informed consent; unable to understand spoken English at the 8th grade level; unwilling to travel to University of Florida Health Shands hospital or HealthStreet for baseline and follow-up assessment appointments; inpatient psychiatric treatment for major psychiatric disorder in the past year; substance use disorder in the past year; and other conditions which in the opinion of study staff would adversely affect participation in the trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UF Health Shands Hospital

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Nicole Ennis Whitehead, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2015

First Posted

June 4, 2015

Study Start

July 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

January 16, 2017

Record last verified: 2017-01

Locations

US(1)