NCT02770469

Brief Summary

The objective of the TOGETHER (Together Overcome and Get Empowered Through Health Education and Relationships) program was to examine the effectiveness of one of the first linguistically and culturally tailored intervention programs to increase quality of life among Korean American breast cancer survivors.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Feb 2014

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

Study Start

First participant enrolled

February 1, 2014

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

May 10, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 12, 2016

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

December 27, 2023

Status Verified

December 1, 2023

Enrollment Period

2.3 years

First QC Date

May 10, 2016

Last Update Submit

December 20, 2023

Conditions

Keywords

Breast CancerKorean AmericansSurvivorshipQuality of LifeCoping SkillsPerceived Stress

Outcome Measures

Primary Outcomes (1)

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

    changes in quality of life during baseline, 7 weeks, and 14 weeks

Secondary Outcomes (3)

  • Cancer Behavior Inventory- Brief Version (CBI-B)

    changes in self-efficacy for coping with cancer during baseline, 7 weeks, and 14 weeks

  • Perceived Stress Scale (PSS)

    changes in stress during baseline, 7 weeks, and 14 weeks

  • Additional items to assess improvement in skills/knowledge covered by the intervention program

    changes in responses during baseline, 7 weeks, and 14 weeks

Study Arms (2)

Standard Intervention

ACTIVE COMPARATOR

The standard intervention group received linguistically and culturally tailored information regarding breast cancer and survivorship.

Behavioral: Linguistically and Culturally Tailored Information

Enhanced Intervention

EXPERIMENTAL

The enhanced intervention group received linguistically and culturally tailored information regarding breast cancer and survivorship as well as cognitive-behavioral stress management.

Behavioral: Linguistically and Culturally Tailored InformationBehavioral: Cognitive-Behavioral Stress Management

Interventions

Participants received linguistically and culturally tailored information on diet and nutrition, physical activity, managing treatment side effects, follow-up care plans, complementary and alternative medicine, reducing environmental exposure to estrogen, navigating cancer-related financial issues, family history, body image, sexuality, and advances in breast cancer research.

Enhanced InterventionStandard Intervention

Participants learned and practiced skills related to mindfulness, relaxation, stress reduction, rational thinking, improving coping, enhancing social support, anger management, and assertiveness training.

Enhanced Intervention

Eligibility Criteria

Age25 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Living in Maryland, Northern Virginia, or the Washington D.C. metropolitan area
  • Have been diagnosed with breast cancer
  • Have had surgery, completed treatment within the last two years, or still receiving adjuvant therapies

You may not qualify if:

  • Unable to understand Korean

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Sunmin Lee, ScD

    University of Maryland School of Public Health

    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
SPONSOR

Study Record Dates

First Submitted

May 10, 2016

First Posted

May 12, 2016

Study Start

February 1, 2014

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

December 27, 2023

Record last verified: 2023-12