Improving Survivorship Among Minority Cancer Dyads

July 22, 2022 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90059
        • Charles R. Drew University of Medicine & Science

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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).
Behavioral: Change in knowledge, motivation, skills, and resources
Provide/enhance knowledge, modify attitudes, motivate and provide skills and resources to improve survivorship outcomes.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Increase in psychosocial well-being using the Quality of Life: Short Form Health Survey and the Center for Epidemiologic Studies Depression Scale
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Charles Drew University of Medicine and Science

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sharon Cobb, Charles R. Drew University of Medicine & Science

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 22, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 28, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 26, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CancerDyads

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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