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Improving Survivorship Among Minority Cancer Dyads

Primary Purpose

Cancer, Breast Cancer, Colon Cancer

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Change in knowledge, motivation, skills, and resources
Sponsored by
Charles Drew University of Medicine and Science
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Charles R. Drew University of Medicine & Science

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Survivorship Management among African American and Latinx Cancer Dyads

Arm Description

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).

Outcomes

Primary Outcome Measures

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.
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. 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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
December 22, 2020
Last Updated
July 22, 2022
Sponsor
Charles Drew University of Medicine and Science
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1. Study Identification

Unique Protocol Identification Number
NCT04685551
Brief Title
Improving Survivorship Among Minority Cancer Dyads
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Study not funded
Study Start Date
July 1, 2021 (Anticipated)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Charles Drew University of Medicine and Science

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Breast Cancer, Colon Cancer, Caregiver Burnout, Lung Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Survivorship Management among African American and Latinx Cancer Dyads
Arm Type
Experimental
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Change in knowledge, motivation, skills, and resources
Intervention Description
Provide/enhance knowledge, modify attitudes, motivate and provide skills and resources to improve survivorship outcomes.
Primary Outcome Measure Information:
Title
Increase in psychosocial well-being using the Quality of Life: Short Form Health Survey and the Center for Epidemiologic Studies Depression Scale
Description
By comparison from baseline to post-intervention, there will be a 25% increase in the psychosocial well-being among study participants.
Time Frame
3 months
Title
Reduction of barriers to symptom management Using the Symptom Distress Scale survey
Description
By comparison from baseline to post-intervention, there will be a 25% decrease in the barriers to symptom management among study participants.
Time Frame
3 months
Title
3. Decrease in unmet needs Using the Barriers to Follow-Up Care Survey and Cancer Survivors Unmet Needs instrument
Description
By comparison from baseline to post-intervention, there will be a 25% decrease in the unmet needs among study participants.
Time Frame
3 months
Title
Reduction in caregiver burden using the Caregiver reaction assessment (CRA) survey
Description
By comparison from baseline to post-intervention, there will be a 25% decrease in the caregiver burden among study participants.
Time Frame
3 months
Title
5. Increase knowledge and utilization of supportive services using the Medical Outcomes Study Social Support Survey
Description
By comparison from baseline to post-intervention, there will be a 25% increase in the knowledge and utilization of supportive services among study participants.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon Cobb
Organizational Affiliation
Charles R. Drew University of Medicine & Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charles R. Drew University of Medicine & Science
City
Los Angeles
State/Province
California
ZIP/Postal Code
90059
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Improving Survivorship Among Minority Cancer Dyads

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