TICAA: To Enhance Breast Cancer Survivorship of Asian Americans

Sponsor
Emory University (Other)
Overall Status
Completed
CT.gov ID
NCT02803593
Collaborator
National Cancer Institute (NCI) (NIH)
199
2
2
60.3
99.5
1.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Technology-based information and coaching/support program
  • Behavioral: American Cancer Society information on breast cancer
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
199 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
To Enhance Breast Cancer Survivorship of Asian Americans
Actual Study Start Date :
Jun 1, 2016
Actual Primary Completion Date :
Jun 9, 2021
Actual Study Completion Date :
Jun 9, 2021

Arms and Interventions

Arm Intervention/Treatment
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: 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
  • 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.

    Outcome Measures

    Primary Outcome Measures

    1. Support Care Needs Survey (SCNS) Score [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.

    2. Memorial Symptom Assessment Scale-Short Form (MSAS-SF) Score [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.

    3. Functional Assessment of Cancer Therapy Scale-Breast Cancer (FACT-B) Score [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.

    Secondary Outcome Measures

    1. Questions on Attitudes, Self-Efficacy, Perceived Barriers, and Social Influences (QASPS) Score for Attitudes [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.

    2. Questions on Attitudes, Self-Efficacy, Perceived Barriers, and Social Influences (QASPS) Score for Perceived Barriers [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.

    3. Questions on Attitudes, Self-Efficacy, Perceived Barriers, and Social Influences (QASPS) Score for Social Influences [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.

    4. Cancer Behavior Inventory-Brief Version (CBI-B) Score [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.

    5. Personal Resource Questionnaire (PRQ-2000) Score [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.

    6. Perceived Isolation Scale (PIS) Score [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Emory University Hospital Atlanta Georgia United States 30322
    2 Duke University, School of Nursing Durham North Carolina United States 27710

    Sponsors and Collaborators

    • Emory University
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Eun-Ok Im, PhD, MPH, Emory University

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Eun-Ok Im, Professor, Emory University
    ClinicalTrials.gov Identifier:
    NCT02803593
    Other Study ID Numbers:
    • IRB00117270
    • R01CA203719-01
    First Posted:
    Jun 17, 2016
    Last Update Posted:
    Jun 29, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Eun-Ok Im, Professor, Emory University
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details Participants were recruited from Duke University in Durham, North Carolina, USA, and Emory University in Atlanta, Georgia, USA. Participant enrollment began in June 2016 and all follow up was complete by June 9, 2021.
    Pre-assignment Detail
    Arm/Group Title Control TICAA
    Arm/Group Description Asian American breast cancer survivors randomized to use the information on breast cancer by the American Cancer Society (ACS). Participants were asked to use the online ACS resources for 3 months. Asian American breast cancer survivors randomized to 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 were asked to use the TICAA program for 3 months.
    Period Title: Overall Study
    STARTED 95 104
    Completed Month 1 Assessment 83 76
    COMPLETED 78 69
    NOT COMPLETED 17 35

    Baseline Characteristics

    Arm/Group Title Control TICAA Total
    Arm/Group Description Asian American breast cancer survivors randomized to use the information on breast cancer by the American Cancer Society (ACS). Participants were asked to use the online ACS resources for 3 months. Asian American breast cancer survivors randomized to 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 were asked to use the TICAA program for 3 months. Total of all reporting groups
    Overall Participants 95 104 199
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    53.14
    (13.62)
    51.60
    (11.38)
    52.35
    (12.51)
    Sex: Female, Male (Count of Participants)
    Female
    95
    100%
    104
    100%
    199
    100%
    Male
    0
    0%
    0
    0%
    0
    0%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    0
    0%
    0
    0%
    0
    0%
    Not Hispanic or Latino
    95
    100%
    104
    100%
    199
    100%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    Asian
    95
    100%
    104
    100%
    199
    100%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    0
    0%
    0
    0%
    0
    0%
    White
    0
    0%
    0
    0%
    0
    0%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    Race/Ethnicity, Customized (Count of Participants)
    Chinese
    52
    54.7%
    36
    34.6%
    88
    44.2%
    Korean
    12
    12.6%
    26
    25%
    38
    19.1%
    Japanese
    29
    30.5%
    40
    38.5%
    69
    34.7%
    Not reported
    2
    2.1%
    2
    1.9%
    4
    2%
    Region of Enrollment (Count of Participants)
    United States
    95
    100%
    104
    100%
    199
    100%
    Education (Count of Participants)
    High school graduation or less
    33
    34.7%
    21
    20.2%
    54
    27.1%
    Completed undergraduate degree
    47
    49.5%
    62
    59.6%
    109
    54.8%
    Completed graduate degree
    15
    15.8%
    21
    20.2%
    36
    18.1%
    Religion (Count of Participants)
    No religion
    42
    44.2%
    47
    45.2%
    89
    44.7%
    Christian
    36
    37.9%
    44
    42.3%
    80
    40.2%
    Other
    16
    16.8%
    13
    12.5%
    29
    14.6%
    Not reported
    1
    1.1%
    0
    0%
    1
    0.5%
    Marital status (Count of Participants)
    Married, partnered, or in a permanent relationship
    70
    73.7%
    73
    70.2%
    143
    71.9%
    Single, divorced, or widowed
    25
    26.3%
    30
    28.8%
    55
    27.6%
    Not reported
    0
    0%
    1
    1%
    1
    0.5%
    Employment status (Count of Participants)
    Not employed
    52
    54.7%
    55
    52.9%
    107
    53.8%
    Employed
    34
    35.8%
    38
    36.5%
    72
    36.2%
    Not reported
    9
    9.5%
    11
    10.6%
    20
    10.1%
    Birthplace (Count of Participants)
    United States
    14
    14.7%
    10
    9.6%
    24
    12.1%
    Other than United States
    79
    83.2%
    94
    90.4%
    173
    86.9%
    Not reported
    2
    2.1%
    0
    0%
    2
    1%
    Mean years living in United States (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    18.73
    (12.61)
    19.01
    (11.42)
    18.88
    (11.95)
    Age at immigration (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    36.92
    (12.32)
    32.33
    (12.53)
    34.46
    (12.60)
    Acculturation score (score on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [score on a scale]
    3.55
    (0.87)
    3.50
    (0.74)
    3.52
    (0.80)
    Years since diagnosis (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    3.73
    (4.05)
    3.58
    (3.74)
    3.65
    (3.88)
    Breast cancer type (Count of Participants)
    Invasive
    56
    58.9%
    71
    68.3%
    127
    63.8%
    Non-invasive
    28
    29.5%
    27
    26%
    55
    27.6%
    Not reported
    11
    11.6%
    6
    5.8%
    17
    8.5%
    Breast cancer stage (Count of Participants)
    Stage I
    41
    43.2%
    42
    40.4%
    83
    41.7%
    Stage II/III
    40
    42.1%
    51
    49%
    91
    45.7%
    Stage IV
    4
    4.2%
    4
    3.8%
    8
    4%
    Unknown
    6
    6.3%
    5
    4.8%
    11
    5.5%
    Not reported
    4
    4.2%
    2
    1.9%
    6
    3%
    Medical treatments (Count of Participants)
    Radiation
    44
    46.3%
    47
    45.2%
    91
    45.7%
    Chemotherapy
    35
    36.8%
    54
    51.9%
    89
    44.7%
    Surgery
    66
    69.5%
    79
    76%
    145
    72.9%
    Hormone
    46
    48.4%
    50
    48.1%
    96
    48.2%
    Other
    4
    4.2%
    8
    7.7%
    12
    6%

    Outcome Measures

    1. Primary Outcome
    Title Support Care Needs Survey (SCNS) Score
    Description 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.
    Time Frame Baseline, Month 1, Month 3

    Outcome Measure Data

    Analysis Population Description
    This analysis includes participants who completed the assessment at the indicated time points.
    Arm/Group Title Control TICAA
    Arm/Group Description Asian American breast cancer survivors randomized to use the information on breast cancer by the American Cancer Society (ACS). Participants were asked to use the online ACS resources for 3 months. Asian American breast cancer survivors randomized to 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 were asked to use the TICAA program for 3 months.
    Measure Participants 95 104
    Baseline
    84.15
    (28.77)
    85.01
    (29.44)
    Month 1
    79.27
    (27.21)
    78.20
    (23.94)
    Month 3
    77.20
    (25.95)
    78.33
    (22.71)
    2. Primary Outcome
    Title Memorial Symptom Assessment Scale-Short Form (MSAS-SF) Score
    Description 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.
    Time Frame Baseline, Month 1, Month 3

    Outcome Measure Data

    Analysis Population Description
    This analysis includes participants who completed the assessment at the indicated time points.
    Arm/Group Title Control TICAA
    Arm/Group Description Asian American breast cancer survivors randomized to use the information on breast cancer by the American Cancer Society (ACS). Participants were asked to use the online ACS resources for 3 months. Asian American breast cancer survivors randomized to 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 were asked to use the TICAA program for 3 months.
    Measure Participants 95 104
    Baseline
    1.68
    (0.46)
    1.84
    (0.55)
    Month 1
    1.71
    (0.55)
    1.74
    (0.41)
    Month 3
    1.69
    (0.47)
    1.66
    (0.39)
    3. Primary Outcome
    Title Functional Assessment of Cancer Therapy Scale-Breast Cancer (FACT-B) Score
    Description 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.
    Time Frame Baseline, Month 1, Month 3

    Outcome Measure Data

    Analysis Population Description
    This analysis includes participants who completed the assessment at the indicated time points.
    Arm/Group Title Control TICAA
    Arm/Group Description Asian American breast cancer survivors randomized to use the information on breast cancer by the American Cancer Society (ACS). Participants were asked to use the online ACS resources for 3 months. Asian American breast cancer survivors randomized to 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 were asked to use the TICAA program for 3 months.
    Measure Participants 95 104
    Baseline
    102.97
    (21.43)
    98.72
    (23.13)
    Month 1
    102.92
    (22.14)
    103.05
    (26.37)
    Month 3
    100.86
    (22.29)
    102.03
    (22.30)
    4. Secondary Outcome
    Title Questions on Attitudes, Self-Efficacy, Perceived Barriers, and Social Influences (QASPS) Score for Attitudes
    Description 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.
    Time Frame Baseline, Month 1, Month 3

    Outcome Measure Data

    Analysis Population Description
    This analysis includes participants who completed the assessment at the indicated time points.
    Arm/Group Title Control TICAA
    Arm/Group Description Asian American breast cancer survivors randomized to use the information on breast cancer by the American Cancer Society (ACS). Participants were asked to use the online ACS resources for 3 months. Asian American breast cancer survivors randomized to 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 were asked to use the TICAA program for 3 months.
    Measure Participants 95 104
    Baseline
    -3.44
    (10.82)
    -0.57
    (10.21)
    Month 1
    -3.15
    (9.66)
    -1.60
    (9.53)
    Month 3
    -3.85
    (9.43)
    -1.76
    (8.84)
    5. Secondary Outcome
    Title Questions on Attitudes, Self-Efficacy, Perceived Barriers, and Social Influences (QASPS) Score for Perceived Barriers
    Description 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.
    Time Frame Baseline, Month 1, Month 3

    Outcome Measure Data

    Analysis Population Description
    This analysis includes participants who completed the assessment at the indicated time points.
    Arm/Group Title Control TICAA
    Arm/Group Description Asian American breast cancer survivors randomized to use the information on breast cancer by the American Cancer Society (ACS). Participants were asked to use the online ACS resources for 3 months. Asian American breast cancer survivors randomized to 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 were asked to use the TICAA program for 3 months.
    Measure Participants 95 104
    Baseline
    27.49
    (8.45)
    30.50
    (9.57)
    Month 1
    28.00
    (8.12)
    29.48
    (8.54)
    Month 3
    29.05
    (7.97)
    28.65
    (8.12)
    6. Secondary Outcome
    Title Questions on Attitudes, Self-Efficacy, Perceived Barriers, and Social Influences (QASPS) Score for Social Influences
    Description 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.
    Time Frame Baseline, Month 1, Month 3

    Outcome Measure Data

    Analysis Population Description
    This analysis includes participants who completed the assessment at the indicated time points.
    Arm/Group Title Control TICAA
    Arm/Group Description Asian American breast cancer survivors randomized to use the information on breast cancer by the American Cancer Society (ACS). Participants were asked to use the online ACS resources for 3 months. Asian American breast cancer survivors randomized to 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 were asked to use the TICAA program for 3 months.
    Measure Participants 95 104
    Baseline
    17.12
    (4.28)
    16.18
    (4.18)
    Month 1
    17.19
    (3.82)
    16.39
    (4.14)
    Month 3
    16.32
    (4.23)
    16.82
    (3.71)
    7. Secondary Outcome
    Title Cancer Behavior Inventory-Brief Version (CBI-B) Score
    Description 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.
    Time Frame Baseline, Month 1, Month 3

    Outcome Measure Data

    Analysis Population Description
    This analysis includes participants who completed the assessment at the indicated time points.
    Arm/Group Title Control TICAA
    Arm/Group Description Asian American breast cancer survivors randomized to use the information on breast cancer by the American Cancer Society (ACS). Participants were asked to use the online ACS resources for 3 months. Asian American breast cancer survivors randomized to 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 were asked to use the TICAA program for 3 months.
    Measure Participants 95 104
    Baseline
    86.04
    (21.14)
    84.53
    (22.00)
    Month 1
    89.53
    (19.91)
    86.23
    (18.01)
    Month 3
    87.22
    (17.71)
    88.49
    (16.52)
    8. Secondary Outcome
    Title Personal Resource Questionnaire (PRQ-2000) Score
    Description 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.
    Time Frame Baseline, Month 1, Month 3

    Outcome Measure Data

    Analysis Population Description
    This analysis includes participants who completed the assessment at the indicated time points.
    Arm/Group Title Control TICAA
    Arm/Group Description Asian American breast cancer survivors randomized to use the information on breast cancer by the American Cancer Society (ACS). Participants were asked to use the online ACS resources for 3 months. Asian American breast cancer survivors randomized to 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 were asked to use the TICAA program for 3 months.
    Measure Participants 95 104
    Baseline
    84.67
    (13.46)
    80.01
    (16.45)
    Month 1
    84.14
    (12.99)
    80.47
    (14.23)
    Month 3
    84.15
    (11.00)
    82.17
    (13.24)
    9. Secondary Outcome
    Title Perceived Isolation Scale (PIS) Score
    Description 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.
    Time Frame Baseline, Month 1, Month 3

    Outcome Measure Data

    Analysis Population Description
    This analysis includes participants who completed the assessment at the indicated time points.
    Arm/Group Title Control TICAA
    Arm/Group Description Asian American breast cancer survivors randomized to use the information on breast cancer by the American Cancer Society (ACS). Participants were asked to use the online ACS resources for 3 months. Asian American breast cancer survivors randomized to 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 were asked to use the TICAA program for 3 months.
    Measure Participants 95 104
    Baseline
    1.61
    (0.34)
    1.73
    (0.47)
    Month 1
    1.62
    (0.38)
    1.70
    (0.38)
    Month 3
    1.62
    (0.39)
    1.68
    (0.40)

    Adverse Events

    Time Frame Information on adverse events was collected from the time consent to participate in the study was given through the final assessment at Month 3.
    Adverse Event Reporting Description
    Arm/Group Title Control TICAA
    Arm/Group Description Asian American breast cancer survivors randomized to use the information on breast cancer by the American Cancer Society (ACS). Participants were asked to use the online ACS resources for 3 months. Asian American breast cancer survivors randomized to 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 were asked to use the TICAA program for 3 months.
    All Cause Mortality
    Control TICAA
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/95 (0%) 0/104 (0%)
    Serious Adverse Events
    Control TICAA
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/95 (0%) 0/104 (0%)
    Other (Not Including Serious) Adverse Events
    Control TICAA
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/95 (0%) 0/104 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Dr. Eun Ok Im
    Organization Emory University
    Phone 404-712-9805
    Email eun.ok.im@emory.edu
    Responsible Party:
    Eun-Ok Im, Professor, Emory University
    ClinicalTrials.gov Identifier:
    NCT02803593
    Other Study ID Numbers:
    • IRB00117270
    • R01CA203719-01
    First Posted:
    Jun 17, 2016
    Last Update Posted:
    Jun 29, 2022
    Last Verified:
    Jun 1, 2022