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Improving Survivorship Among Minority Cancer Dyads

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04685551
Recruitment Status : Not yet recruiting
First Posted : December 28, 2020
Last Update Posted : December 28, 2020
Sponsor:
Information provided by (Responsible Party):
Charles Drew University of Medicine and Science

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cancer Breast Cancer Colon Cancer Caregiver Burnout Lung Cancer Behavioral: Change in knowledge, motivation, skills, and resources Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Improving Survivorship Outcomes for African American and Latinx Cancer Survivors and Caregiver Dyads Through A Culturally Based Training Program for Underserved Health Professional Students
Estimated Study Start Date : July 1, 2021
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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. 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.

  4. 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.

  5. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04685551


Contacts
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Contact: Sharon Cobb, PhD 3235683329 sharoncobb1@cdrewu.edu

Locations
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United States, California
Charles R. Drew University of Medicine & Science
Los Angeles, California, United States, 90059
Sponsors and Collaborators
Charles Drew University of Medicine and Science
Investigators
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Principal Investigator: Sharon Cobb Charles R. Drew University of Medicine & Science
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Charles Drew University of Medicine and Science
ClinicalTrials.gov Identifier: NCT04685551    
Other Study ID Numbers: CancerDyads
First Posted: December 28, 2020    Key Record Dates
Last Update Posted: December 28, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Caregiver Burden
Stress, Psychological
Behavioral Symptoms