NCT03645005

Brief Summary

The purpose of this study is to examine the effects of a developed psychosocial eHealth intervention on the proposed primary outcomes, health-related quality of life and symptom burden, among Hispanic breast cancer survivors. The intervention components include breast cancer knowledge, stress awareness and management, social support, and enhanced communication and intimacy skills. The intervention will be delivered via a Smartphone application over an 8-week period. Participants are randomized into either an intervention application (described above) or a control application (health information and health promotion strategies). Aside from using the Smartphone application for the recommended 8 weeks, participation in this study includes three assessments: baseline (at the beginning of the research study), 6-week follow-up, and 8-week follow-up.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

March 25, 2015

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

April 24, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 24, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2019

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2019

Completed
Last Updated

August 13, 2020

Status Verified

August 1, 2020

Enrollment Period

4.1 years

First QC Date

April 24, 2018

Last Update Submit

August 11, 2020

Conditions

Cancer-related Problem/ConditionQuality of LifeStress, Emotional

Keywords

eHealthHealth Related Quality of LifeSymptom BurdenBreast CancerHispanic

Outcome Measures

Primary Outcomes (2)

  • Health Related Quality of Life will be evaluated with The Functional Assessment of Cancer Therapy-Breast (FACT-B)

    The FACT-B has been used extensively to measure HRQoL, and has been translated to and validated in Spanish. The FACT-B assesses participant's wellbeing in physical, emotional, social, functional, and breast cancer related concerns in the last seven days using a five-point response scale.

    HRQoL will be first assessed at baseline (T1), initial HRQoL changes will be assessed at 6 weeks post-baseline (T2), and finally any additional HRQoL changes will be captured 8 weeks post-baseline (T3)

  • Symptom Burden will be evaluated with The Breast Cancer Prevention Trial symptom questionnaire (BCPT)

    The BCPT measures participants' symptom burden. The BCPT asks participants to report their level of discomfort with 25 breast cancer related symptoms during the past four weeks using a five-point response scale.

    Symptom Burden will be first assessed at baseline (T1), initial changes will be assessed at 6 weeks post-baseline (T2), and finally any additional changes will be captured 8 weeks post-baseline (T3)

Secondary Outcomes (4)

  • Cancer-Specific Distress will be evaluated using The Impact of Event Scale (IES)

    Cancer-Specific Distress will be first assessed at baseline (T1), initial changes will be assessed at 6 weeks post-baseline (T2), and finally any additional changes will be captured 8 weeks post-baseline (T3)

  • Breast Cancer Related Knowledge will be evaluated with the Knowledge about Breast Cancer Questionnaire

    Breast Cancer Knowledge will be first assessed at baseline (T1), initial changes will be assessed at 6 weeks post-baseline (T2), and finally any additional changes will be captured 8 weeks post-baseline (T3)

  • Breast Cancer Related Communication and Attitudinal Self-Efficacy will be evaluated using the Communication and Attitudinal Self-Efficacy scale for cancer (CASE-cancer)

    Breast Cancer Related Communication and Attitudinal Self-Efficacy will be first assessed at baseline (T1), initial changes will be assessed at 6 weeks post-baseline (T2), and finally any additional changes will be captured 8 weeks post-baseline (T3)

  • Stress Management Skills will be evaluated with the Brief COPE Inventory

    Stress Management Skills will be first assessed at baseline (T1), initial changes will be assessed at 6 weeks post-baseline (T2), and finally any additional changes will be captured 8 weeks post-baseline (T3)

Study Arms (2)

My Guide (psychoeducation & self-management program)

EXPERIMENTAL
Behavioral: "My Guide" (psychoeducation & self-management program)

My Health (health education program)

ACTIVE COMPARATOR
Behavioral: "My Health" (health education program)

Interventions

"My Guide" (psychoeducation & self-management program)BEHAVIORAL

"My Guide" is a Smartphone application incorporating elements informed by the extant literature, designed to improve quality of life and symptom burden among Hispanic breast cancer survivors. "My Guide" components are designed to improve breast cancer knowledge, cancer-relevant self-efficacy, stress and symptom management skills, Both intervention and active comparator conditions are administered to participants for 8 weeks.

My Guide (psychoeducation & self-management program)
"My Health" (health education program)BEHAVIORAL

"My Health" is a health promotion Smartphone application with health education content on nutrition, and general advice on lifestyle choices and prevention. The "My Health" control content was based on similar content tested in other psychosocial interventions with cancer survivors. Both intervention and active comparator conditions are administered to participants for 8 weeks.

My Health (health education program)

Eligibility Criteria

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

You may qualify if:

  • Female
  • Diagnosis of breast cancer, non-metastatic, stage 0-IIIA; for women diagnosed with stage 0, either radiation or chemotherapy is required as an additional treatment to surgery
  • Completed active treatment for breast cancer (surgery, chemotherapy and/or radiation therapy, current hormonal treatment allowed)
  • No current evidence of disease
  • Within 3 to 24 months post-active treatment \[e.g., surgery, chemotherapy, radiation, or combination of the two or three\]
  • at least 21 years of age
  • Able to speak and read English or Spanish
  • Able to provide informed consent
  • Elevated score on breast cancer symptom burden and HRQoL, measured by the Functional Assessment of Cancer Therapy-Breast using an established cut-off score for clinically meaningful, compromised HRQoL
  • Self-identified Hispanic/Latina ethnicity.

You may not qualify if:

  • Visual, hearing, voice, or motor impairment that would prevent completion of study procedures
  • diagnosis of an unmanaged psychotic disorder, bipolar disorder, dissociative disorder, or other diagnosis for which participation in this trial is either inappropriate or dangerous - this includes patients who have life-threatening illness (e.g., end-stage kidney disease) or diagnosis of a chronic disease that is associated with a major functional impairment (e.g., fibromyalgia)
  • Illicit substance or alcohol dependence
  • Suicidal ideation, plan, intent
  • Alzheimer's, dementia or history of stroke
  • Scheduled reconstruction surgery within 1 month of any study procedures or involvement.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Illinois Cancer Center

Chicago, Illinois, 60608, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

  • Baik SH, Oswald LB, Buscemi J, Buitrago D, Iacobelli F, Perez-Tamayo A, Guitelman J, Penedo FJ, Yanez B. Patterns of Use of Smartphone-Based Interventions Among Latina Breast Cancer Survivors: Secondary Analysis of a Pilot Randomized Controlled Trial. JMIR Cancer. 2020 Dec 8;6(2):e17538. doi: 10.2196/17538.

    PMID: 33289669DERIVED

MeSH Terms

Conditions

Stress, PsychologicalBreast Neoplasms

Interventions

Self-Management

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

RehabilitationHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Betina Yanez, Ph.D.

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 24, 2018

First Posted

August 24, 2018

Study Start

March 25, 2015

Primary Completion

April 24, 2019

Study Completion

May 15, 2019

Last Updated

August 13, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

US(2)