To Enhance Breast Cancer Survivorship of Asian Americans

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02803593

Acronym

TICAA

Enrollment

199

Registered

2016-06-17

Start date

2016-06-30

Completion date

2021-06-09

Last updated

2022-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

technology-based intervention, Asian American, survivorship

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.

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.

Interventions

BEHAVIORALTechnology-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.

BEHAVIORALAmerican 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

21 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.
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.
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

Measure	Time frame	Description
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.
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.
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.
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.
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.
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.

Countries

United States

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.

Participants by arm

Arm	Count
Control 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.	95
TICAA 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.	104
Total	199

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	17	35

Baseline characteristics

Characteristic	Control	TICAA	Total
Acculturation score	3.55 score on a scale STANDARD_DEVIATION 0.87	3.50 score on a scale STANDARD_DEVIATION 0.74	3.52 score on a scale STANDARD_DEVIATION 0.8
Age at immigration	36.92 years STANDARD_DEVIATION 12.32	32.33 years STANDARD_DEVIATION 12.53	34.46 years STANDARD_DEVIATION 12.6
Age, Continuous	53.14 years STANDARD_DEVIATION 13.62	51.60 years STANDARD_DEVIATION 11.38	52.35 years STANDARD_DEVIATION 12.51
Birthplace Not reported	2 Participants	0 Participants	2 Participants
Birthplace Other than United States	79 Participants	94 Participants	173 Participants
Birthplace United States	14 Participants	10 Participants	24 Participants
Breast cancer stage Not reported	4 Participants	2 Participants	6 Participants
Breast cancer stage Stage I	41 Participants	42 Participants	83 Participants
Breast cancer stage Stage II/III	40 Participants	51 Participants	91 Participants
Breast cancer stage Stage IV	4 Participants	4 Participants	8 Participants
Breast cancer stage Unknown	6 Participants	5 Participants	11 Participants
Breast cancer type Invasive	56 Participants	71 Participants	127 Participants
Breast cancer type Non-invasive	28 Participants	27 Participants	55 Participants
Breast cancer type Not reported	11 Participants	6 Participants	17 Participants
Education Completed graduate degree	15 Participants	21 Participants	36 Participants
Education Completed undergraduate degree	47 Participants	62 Participants	109 Participants
Education High school graduation or less	33 Participants	21 Participants	54 Participants
Employment status Employed	34 Participants	38 Participants	72 Participants
Employment status Not employed	52 Participants	55 Participants	107 Participants
Employment status Not reported	9 Participants	11 Participants	20 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants	0 Participants	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	95 Participants	104 Participants	199 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Marital status Married, partnered, or in a permanent relationship	70 Participants	73 Participants	143 Participants
Marital status Not reported	0 Participants	1 Participants	1 Participants
Marital status Single, divorced, or widowed	25 Participants	30 Participants	55 Participants
Mean years living in United States	18.73 years STANDARD_DEVIATION 12.61	19.01 years STANDARD_DEVIATION 11.42	18.88 years STANDARD_DEVIATION 11.95
Medical treatments Chemotherapy	35 Participants	54 Participants	89 Participants
Medical treatments Hormone	46 Participants	50 Participants	96 Participants
Medical treatments Other	4 Participants	8 Participants	12 Participants
Medical treatments Radiation	44 Participants	47 Participants	91 Participants
Medical treatments Surgery	66 Participants	79 Participants	145 Participants
Race/Ethnicity, Customized Self-identified ethnicity Chinese	52 Participants	36 Participants	88 Participants
Race/Ethnicity, Customized Self-identified ethnicity Japanese	29 Participants	40 Participants	69 Participants
Race/Ethnicity, Customized Self-identified ethnicity Korean	12 Participants	26 Participants	38 Participants
Race/Ethnicity, Customized Self-identified ethnicity Not reported	2 Participants	2 Participants	4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	95 Participants	104 Participants	199 Participants
Race (NIH/OMB) Black or African American	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	0 Participants	0 Participants	0 Participants
Region of Enrollment United States	95 Participants	104 Participants	199 Participants
Religion Christian	36 Participants	44 Participants	80 Participants
Religion No religion	42 Participants	47 Participants	89 Participants
Religion Not reported	1 Participants	0 Participants	1 Participants
Religion Other	16 Participants	13 Participants	29 Participants
Sex: Female, Male Female	95 Participants	104 Participants	199 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants
Years since diagnosis	3.73 years STANDARD_DEVIATION 4.05	3.58 years STANDARD_DEVIATION 3.74	3.65 years STANDARD_DEVIATION 3.88

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 95	0 / 104
other Total, other adverse events	0 / 95	0 / 104
serious Total, serious adverse events	0 / 95	0 / 104

Outcome results

Primary

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

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.