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To Enhance Breast Cancer Survivorship of Asian Americans (TICAA)

28 czerwca 2022 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

199

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

21 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Kobieta

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie podtrzymujące
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: 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.
Behawioralne: 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.
Eksperymentalny: 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.
Behawioralne: 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.
Behawioralne: 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.
Inne nazwy:
  • TICAA

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Support Care Needs Survey (SCNS) Score
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Questions on Attitudes, Self-Efficacy, Perceived Barriers, and Social Influences (QASPS) Score for Attitudes
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Emory University

Współpracownicy

National Cancer Institute (NCI)

Śledczy

  • Główny śledczy: Eun-Ok Im, PhD, MPH, Emory University

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

1 czerwca 2016

Zakończenie podstawowe (Rzeczywisty)

9 czerwca 2021

Ukończenie studiów (Rzeczywisty)

9 czerwca 2021

Daty rejestracji na studia

Pierwszy przesłany

14 czerwca 2016

Pierwszy przesłany, który spełnia kryteria kontroli jakości

14 czerwca 2016

Pierwszy wysłany (Oszacować)

17 czerwca 2016

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

29 czerwca 2022

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

28 czerwca 2022

Ostatnia weryfikacja

1 czerwca 2022

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • IRB00117270
  • R01CA203719-01 (Grant/umowa NIH USA)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

Nie

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Rak piersi

Badania kliniczne na American Cancer Society information on breast cancer

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