CancerNCT04685551
Improving Survivorship Among Minority Cancer Dyads
A study testing Change in knowledge, motivation, skills, and resources in people with Cancer and Breast Cancer, run by Charles Drew University of Medicine and Science at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer, Breast Cancer, Colon Cancer
- What is being tested?
- Change in knowledge, motivation, skills, and resources
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2021to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals ages 18 and older
- identify as African American or Latinx
- identify as a cancer survivor and/or caregiver
- speak and/or understand English
- Individuals ages 18 and older
- identify as a healthcare provider
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- provide care to cancer patients in current provider role
- speak and/or understand English
- 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)
- 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
Who cannot join
- 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 17 years or younger
Show all 22Show fewer
- unable to speak or understand English
- does not provide care to cancer patients
- does not identify as a healthcare provider
- Aim 2:
- 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:
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Charles R. Drew University of Medicine & Science
Los Angeles, California, 90059
About this study
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
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.
- Conditions
- Cancer, Breast Cancer, Colon Cancer, Caregiver Burnout, Lung Cancer
- Being tested
- Change in knowledge, motivation, skills, and resources
- Medical subject headings
- Neoplasms, Breast Neoplasms, Colonic Neoplasms, Caregiver Burden, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Change in knowledge, motivation, skills, and resourcesBehavioural
Provide/enhance knowledge, modify attitudes, motivate and provide skills and resources to improve survivorship outcomes.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Change in knowledge, motivation, skills, and resources |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study start1 Jul 2021 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Why it stopped: Study not funded
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles Drew University of Medicine and Science
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sharon Cobb, Principal investigator, Charles R. Drew University of Medicine & Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04685551
- Sponsor's protocol ID
- CancerDyads
- Status last verified
- Jul 2022
- First submitted
- 22 Dec 2020
- Last updated
- 26 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04685551
- Acronym / sponsor ID
- CancerDyads
- Conditions
- Cancer, Breast Cancer, Colon Cancer, Caregiver Burnout, Lung Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study not funded
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Charles Drew University of Medicine and ScienceUniversity, hospital or other
- Study start
- 1 Jul 2021 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 28 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Survivorship Management among African American and Latinx Cancer Dyads | Experimental | Behavioral: Change in knowledge, motivation, skills, and resourcesThis 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Individuals ages 18 and older
- identify as African American or Latinx
- identify as a cancer survivor and/or caregiver
- speak and/or understand English
- Individuals ages 18 and older
Key exclusion criteria (22 listed)
- 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
- individuals ages 17 years or younger
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Change in knowledge, motivation, skills, and resourcesProvide/enhance knowledge, modify attitudes, motivate and provide skills and resources to improve survivorship outcomes. | Behavioural | Survivorship Management among African American and Latinx Cancer Dyads |
Primary outcome
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.
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. 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.
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. 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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharon Cobb principal investigator
Charles R. Drew University of Medicine & Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Change in knowledge, motivation, skills, and resources in people with Cancer and Breast Cancer, run by Charles Drew University of Medicine and Science at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2022.