NCT04685551

Brief Summary

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2021

Typical duration for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 28, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

July 26, 2022

Status Verified

July 1, 2022

Enrollment Period

3 years

First QC Date

December 22, 2020

Last Update Submit

July 22, 2022

Conditions

Outcome Measures

Primary Outcomes (5)

  • Increase in psychosocial well-being using the Quality of Life: Short Form Health Survey and the Center for Epidemiologic Studies Depression Scale

    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

    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

    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

    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

    By comparison from baseline to post-intervention, there will be a 25% increase in the knowledge and utilization of supportive services among study participants.

    3 months

Study Arms (1)

Survivorship Management among African American and Latinx Cancer Dyads

EXPERIMENTAL

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).

Behavioral: Change in knowledge, motivation, skills, and resources

Interventions

Provide/enhance knowledge, modify attitudes, motivate and provide skills and resources to improve survivorship outcomes.

Survivorship Management among African American and Latinx Cancer Dyads

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals ages 18 and older
  • identify as African American or Latinx
  • identify as a cancer survivor and/or caregiver
  • speak and/or understand English

You may not qualify if:

  • 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:
  • Individuals ages 18 and older
  • identify as a healthcare provider
  • provide care to cancer patients in current provider role
  • speak and/or understand English
  • 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:
  • Individuals ages 18 and older
  • +20 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charles R. Drew University of Medicine & Science

Los Angeles, California, 90059, United States

Location

MeSH Terms

Conditions

NeoplasmsBreast NeoplasmsColonic NeoplasmsCaregiver BurdenLung Neoplasms

Interventions

Health Resources

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesStress, PsychologicalBehavioral SymptomsBehaviorRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Health PlanningHealth Care Economics and OrganizationsDelivery of Health CareHealth Care Quality, Access, and Evaluation

Study Officials

  • Sharon Cobb

    Charles R. Drew University of Medicine & Science

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2020

First Posted

December 28, 2020

Study Start

July 1, 2021

Primary Completion

June 30, 2024

Study Completion

December 31, 2024

Last Updated

July 26, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations