- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04685551
Improving Survivorship Among Minority Cancer Dyads
22. juli 2022 oppdatert av: Charles Drew University of Medicine and Science
Improving Survivorship Outcomes for African American and Latinx Cancer Survivors and Caregiver Dyads Through A Culturally Based Training Program for Underserved Health Professional Students
This proposed intervention centers on improving survivorship outcomes among African American and Latinx cancer survivor and caregiver dyads.
As a result, there will be four major outcomes.
First, as a result of partnership with minority social institutions (e.g.
faith leaders), we will develop an in-depth culturally sensitive curriculum and survivorship care plan for Cancer Survivorship and Caregiver Leaders Aimed for Minority Populations (CSC LAMPs).
Second, we will increase knowledge and skills by evaluating a comprehensive cancer survivorship training program designed for underserved health professional students.
Third, the implementation of this program will improve survivorship outcomes among African American and Latinx cancer survivors with advanced stage cancer and their caregivers.
Lastly, this study will build sustainability for underserved minorities with the training of 30 future healthcare providers as a valuable community resource for improving cancer survivorship outcomes.
The long-term outcomes of the CSC LAMPs program will generate workforce capacity and diversity in cancer-based clinical practice, research, and community advocacy for underserved minority cancer survivors and caregivers.
Studieoversikt
Status
Tilbaketrukket
Intervensjon / Behandling
Studietype
Intervensjonell
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
California
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Los Angeles, California, Forente stater, 90059
- Charles R. Drew University of Medicine & Science
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Aim 1 Focus Group for Cancer Survivors and Caregivers:
Inclusion Criteria
- Individuals ages 18 and older
- identify as African American or Latinx
- identify as a cancer survivor and/or caregiver
- speak and/or understand English
Exclusion Criteria
- individuals ages 17 years or younger
- does not identify as African American or Latinx
- unable to speak or understand English
- does not identify as a cancer survivor or caregiver
Aim 1 Focus Group for Oncology Healthcare Providers:
Inclusion Criteria
- Individuals ages 18 and older
- identify as a healthcare provider
- provide care to cancer patients in current provider role
- speak and/or understand English
Exclusion Criteria
- individuals ages 17 years or younger
- unable to speak or understand English
- does not provide care to cancer patients
- does not identify as a healthcare provider
Aim 2:
Inclusion Criteria
- Individuals ages 18 and older
- registered as a CDU student
- speak and/or understand English
- considered to be underserved, which include a) identifying as an underrepresented minority: Asian, Pacific Islander, African American, Hispanic, and Native American/Alaskan Native and/or b) from a medically underserved population (i.e. faced economic, cultural or linguistic barriers to health care)
Exclusion Criteria
- individuals ages 17 years or younger
- not registered as a CDU student
- unable to speak or understand English
- not considered to be underserved
For Aim 3:
Inclusion Criteria
- cancer survivor with a participating caregiver
- stage III or stage IV cancer diagnosis
- breast, lung, or colorectal cancer diagnosis
- identify as African American or Latinx
- speak and/or understand English
Exclusion Criteria
- individuals ages 17 years or younger
- does not identify as African American or Latinx
- unable to speak or understand English
- does not identify as a cancer survivor
- cancer survivor does not identify a caregiver
- does not have a breast, lung, or colorectal cancer diagnosis
- not diagnosed with a stage III or stage IV cancer diagnosis
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Survivorship Management among African American and Latinx Cancer Dyads
This arm will implement a "one group pre-test and posttest" design to improve health outcomes of African American and Latinx cancer survivors and caregivers in collaboration with health professional students trained as Cancer Survivorship and Caregiver Leaders Aimed for Minority Populations (CSC LAMPs).
|
Provide/enhance knowledge, modify attitudes, motivate and provide skills and resources to improve survivorship outcomes.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Increase in psychosocial well-being using the Quality of Life: Short Form Health Survey and the Center for Epidemiologic Studies Depression Scale
Tidsramme: 3 months
|
By comparison from baseline to post-intervention, there will be a 25% increase in the psychosocial well-being among study participants.
|
3 months
|
|
Reduction of barriers to symptom management Using the Symptom Distress Scale survey
Tidsramme: 3 months
|
By comparison from baseline to post-intervention, there will be a 25% decrease in the barriers to symptom management among study participants.
|
3 months
|
|
3. Decrease in unmet needs Using the Barriers to Follow-Up Care Survey and Cancer Survivors Unmet Needs instrument
Tidsramme: 3 months
|
By comparison from baseline to post-intervention, there will be a 25% decrease in the unmet needs among study participants.
|
3 months
|
|
Reduction in caregiver burden using the Caregiver reaction assessment (CRA) survey
Tidsramme: 3 months
|
By comparison from baseline to post-intervention, there will be a 25% decrease in the caregiver burden among study participants.
|
3 months
|
|
5. Increase knowledge and utilization of supportive services using the Medical Outcomes Study Social Support Survey
Tidsramme: 3 months
|
By comparison from baseline to post-intervention, there will be a 25% increase in the knowledge and utilization of supportive services among study participants.
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3 months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Sharon Cobb, Charles R. Drew University of Medicine & Science
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Forventet)
1. juli 2021
Primær fullføring (Forventet)
30. juni 2024
Studiet fullført (Forventet)
31. desember 2024
Datoer for studieregistrering
Først innsendt
22. desember 2020
Først innsendt som oppfylte QC-kriteriene
22. desember 2020
Først lagt ut (Faktiske)
28. desember 2020
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
26. juli 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
22. juli 2022
Sist bekreftet
1. juli 2022
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CancerDyads
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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