To Enhance Breast Cancer Survivorship of Asian Americans (TICAA)

June 28, 2022 updated by: Eun-Ok Im, Emory University
The purpose of this randomized intervention study is to test the efficacy of the technology-based information and coaching/support program for Asian American breast cancer survivors (TICAA) in enhancing the women's breast cancer survivorship experience.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Despite few studies on Asian American breast cancer survivors, it is well known that these women shoulder unnecessary burden of breast cancer because they rarely complain about symptoms or pain, delay seeking help, and rarely ask or get support due to their cultural values and beliefs and language barriers. This demonstrates a definite need for support in this specific population. However, survivorship programs that are increasingly instituted at cancer centers have serious impediments to providing information and coaching/support because of the lack of staff time and insurance reimbursement. Furthermore, the pressure of fast-paced clinical patient-provider interactions leaves little time for health care providers to provide up-to-date information and coaching or support for these women based on their cultural attitudes. All these circumstances necessitate an innovative and creative delivery method of information and coaching/support. A technology-based approach using computers and mobile devices (smart phones and tablets) promises to meet this necessity with high flexibility and accessibility, and minimizes the cost of the intervention in busy and costly health care settings. Also, a technology-based intervention that does not involve face-to-face interactions could work better for many women from cultures where breast cancer is still a stigmatizing experience. Therefore, based on preliminary studies, the research team has developed and pilot-tested a theory-driven technology-based information and coaching/support program that is culturally tailored to Asian American breast cancer survivors using multiple features. The purpose of the proposed randomized intervention study is to test the efficacy of the technology-based information and coaching/support program for Asian American breast cancer survivors (TICAA) in enhancing the women's breast cancer survivorship experience. The specific aims are to: a) determine whether the intervention group will show significantly greater improvements than the control group in primary outcomes (needs for help, physical and psychological symptoms, and quality of life) from baseline (pre-test) to Time Points 1 (post 1-month) and 2 (post 3-months); b) identify theory-based variables (attitudes, self-efficacy, perceived barriers, and social influences related to breast cancer survivorship) that mediate the intervention effects of the TICAA on the primary outcomes at the three time points (pre-test, post 1-month and post 3-months); and c) determine whether the effects of the TICAA on the primary outcomes are moderated by background characteristics and disease factors. The proposed study will be guided by the Bandura's Theory of Behavioral Change. This study adopts a randomized repeated measures pretest/posttest control group design in 330 Asian American breast cancer survivors. The long-term goals are to: (a) implement the program into various health care settings; (b) determine if the TICAA will lead to long-term improved health outcomes; and (c) fundamentally enhance the methodology/paradigm of culturally tailored technology-based interventions for ethnic minority groups of breast cancer survivors.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
199

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University, School of Nursing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Self-reported Asian American women aged 21 years and older who identify their sub-ethnicity as Chinese, Korean, or Japanese
  • Have had a breast cancer diagnosis
  • Can read and write English, Mandarin Chinese, Korean or Japanese
  • Have access to the Internet through computers or mobile devices (smart phones and tablets)

Exclusion Criteria:

  • Those under 21 years old are excluded because their cancer experience would be different from adults

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Control
Asian American breast cancer survivors who do not use the TICAA, but use the information on breast cancer by the American Cancer Society (ACS). Participants are asked to use the online ACS resources for 3 months.
Behavioral: American Cancer Society information on breast cancer
The American Cancer Society (ACS) webpage has a wide range of information on breast cancer including prevention, treatment, and ways to connect with breast cancer survivors.
Experimental: TICAA Intervention
Asian American breast cancer survivors who use the TICAA intervention and the information by the ACS. The intervention is a technology-based information and coaching/support program to enhance survivorship experience of Asian American breast cancer survivors. Participants are asked to use the TICAA program for 3 months.
Behavioral: American Cancer Society information on breast cancer
The American Cancer Society (ACS) webpage has a wide range of information on breast cancer including prevention, treatment, and ways to connect with breast cancer survivors.
Behavioral: Technology-based information and coaching/support program
The TICAA has three components in four languages (English, Mandarin Chinese, Korean, and Japanese): (a) social media sites; (b) interactive online educational sessions; and (c) online resources. The social media sites provide a mechanism by which participants can receive coaching/support from culturally matched peers and health care providers. The educational sessions provide information about general and sub-ethnic- specific topics related to breast cancer survivorship. The online resources include 35 Web links to resources related to breast cancer survivorship from scientific authorities and from general and sub-ethnic-specific health organizations/institutes.
Other Names:
  • TICAA

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Support Care Needs Survey (SCNS) Score
Time Frame: Baseline, Month 1, Month 3
The SCNS uses 57 items to measure how much help the respondent needs. Responses are given on a scale from 1 to 5 where 1 = no help is needed and 5 = high need for help. Total scores range from 57 to 285 and higher scores indicate greater need for help.
Baseline, Month 1, Month 3
Memorial Symptom Assessment Scale-Short Form (MSAS-SF) Score
Time Frame: Baseline, Month 1, Month 3
Physical and psychological symptoms are assessed using the Memorial Symptom Assessment Scale-Short Form (MSAS-SF). The MSAS-SF asks if the respondent has experienced any of 32 specific symptoms during the past week, with the opportunity for the participant to enter additional symptoms. The degree of distress experienced by 28 of the symptoms is measured on a scale from 0 (not at all) to 4 (very much). The total score is the average of the responses to the distress scale items and and ranges from 0 to 4 with higher values indicating greater distress experienced from symptoms.
Baseline, Month 1, Month 3
Functional Assessment of Cancer Therapy Scale-Breast Cancer (FACT-B) Score
Time Frame: Baseline, Month 1, Month 3
Quality of life is assessed using the FACT-B. The FACT-B includes 41 items which are responded to on a scale from 0 to 4, where 0 = not at all and 4 = very much. The total score ranges from 0 to 164 and higher scores indicate better quality of life.
Baseline, Month 1, Month 3

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Questions on Attitudes, Self-Efficacy, Perceived Barriers, and Social Influences (QASPS) Score for Attitudes
Time Frame: Baseline, Month 1, Month 3
Attitudes related to breast cancer survivorship are measured using the Questions on Attitudes, Self-Efficacy, Perceived Barriers, and Social Influences (QASPS). The Attitudes section of this questionnaire includes 6 items scaled from -3 to 3, where -3 is the most negative score and 3 is the most positive score. There are also 7 qualitative questions. The total score for the scaled items ranges from -18 to 18 and higher scores indicate a better attitude towards breast cancer survivorship.
Baseline, Month 1, Month 3
Questions on Attitudes, Self-Efficacy, Perceived Barriers, and Social Influences (QASPS) Score for Perceived Barriers
Time Frame: Baseline, Month 1, Month 3
Perceived barriers related to breast cancer survivorship are measured using the Questions on Attitudes, Self-Efficacy, Perceived Barriers, and Social Influences (QASPS). The Perceived Barriers section of this questionnaire includes 16 items where responses are given on a 4-point scale where 1 = never and 4 = always. Total scores range from 16 to 64 and higher scores indicate greater perceived barriers related to breast cancer survivorship.
Baseline, Month 1, Month 3
Questions on Attitudes, Self-Efficacy, Perceived Barriers, and Social Influences (QASPS) Score for Social Influences
Time Frame: Baseline, Month 1, Month 3
Social influences related to breast cancer survivorship are measured using the Questions on Attitudes, Self-Efficacy, Perceived Barriers, and Social Influences (QASPS). The Social Influences section of this questionnaire includes 3 items where responses are given on a 7-point scale where 1 = disapproval from social support and 7 = approval from social support. Total scores range from 3 to 21 and higher scores indicate greater positive support from social influences.
Baseline, Month 1, Month 3
Cancer Behavior Inventory-Brief Version (CBI-B) Score
Time Frame: Baseline, Month 1, Month 3
Self-efficacy related to breast cancer survivorship is measured using the Cancer Behavior Inventory-Brief Version (CBI-B). The CBI-B has 12 items assessing the degree of confidence respondents have with certain coping behaviors on a scale from 1 (not at all confident) to 9 (totally confident). Total scores range from 12 to 108 where higher scores indicate greater self-efficacy concerning cancer behaviors.
Baseline, Month 1, Month 3
Personal Resource Questionnaire (PRQ-2000) Score
Time Frame: Baseline, Month 1, Month 3
The Personal Resource Questionnaire (PRQ-2000) is a 15-item survey asking how much participants agree or disagree with statements related to social resources on a scale from 1 (strongly disagree) to 7 (strongly agree). Total scores range from 15 to 105 and higher scores indicate greater social resources.
Baseline, Month 1, Month 3
Perceived Isolation Scale (PIS) Score
Time Frame: Baseline, Month 1, Month 3
The Perceived Isolation Scale (PIS) includes 9 items asking questions about how social connectedness. Responses are rated on a 3-point scale where 1 = hardly ever, 2 = some of the time, and 3 = often. The total score is the average of the responses to the PIS items and ranges from 1 to 3 with lower scores indicating greater social connectedness.
Baseline, Month 1, Month 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Emory University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Eun-Ok Im, PhD, MPH, Emory University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 9, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 9, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 14, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 17, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 29, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00117270
  • R01CA203719-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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