Hematological DisorderNCT05828654
Intervention to Address Psychosocial Needs Among Socially Disadvantaged Older Adults With Cancer
A study testing Focus Group Discussions and Semi-structured Interviews and Training community lay navigators in people with Hematological Disorder, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to convene a group of diverse North Carolina-based community representatives (patients, caregivers, leaders of faith-based organizations, social workers, and patient navigators) to inform the adaptation of materials used to train lay navigators in the delivery of psychosocial support… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hematological Disorder
- What is being tested?
- Focus Group Discussions and Semi-structured Interviews and Training community lay navigators
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2023to 28 Sep 2023
- 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
- Patients aged 65 and older diagnosed with hematological cancer for at least one year with stable disease
- Community representative 18 years or older who also identifies as at least one of the following:
- Cancer caregivers
- Social workers, social work students, or patient navigators Community leader (e.g., leader of a faith-based organization)
- Previously or currently serve as a lay navigator/peer supporter, community health worker, or coach
- Have personal experience with any of the following (being Black race, previously or currently facing socioeconomic challenges, or living in a rural community)
- Patient or community representative who is Able to understand and speak in English
Who cannot join
- All participants meeting any of the following exclusion criteria at enrollment will be excluded from the study:
- Inability to read and speak English
- Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent
- All participants meeting any of the following exclusion criteria at enrollment will be excluded from the study:
- Inability to read and speak English
- Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27514
About this study
Official title: Adapting Peer Connect to Train Lay Navigators in Delivering Psychosocial Support to Older Adults With Cancer
The purpose of this study is to convene a group of diverse North Carolina-based community representatives (patients, caregivers, leaders of faith-based organizations, social workers, and patient navigators) to inform the adaptation of materials used to train lay navigators in the delivery of psychosocial support interventions tailored to older socially disadvantaged adults with cancer.
Read the detailed description
This behavioral study will explore community representatives' perspectives on the resources and training needed to support the development of a lay navigation program tailored to older socially disadvantaged adults with cancer.
It was hypothesized that diverse community representatives could inform the adaptation of training materials (Peer Connect) and subsequent training of community lay navigators, who will then be positioned to address the psychosocial needs of older adults with cancer
- Conditions
- Hematological Disorder
- Being tested
- Focus Group Discussions and Semi-structured Interviews, Training community lay navigators
- Keywords
- Socially Disadvantaged, older, Psychosocial, need
- Medical subject headings
- Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus Group Discussions and Semi-structured InterviewsBehavioural
Community representatives will be asked to participate in either 1:1 semi-structured interviews with a research staff member or to engage in focus group discussions with other community members. These interviews and discussions will gather broad perspectives on resource and training needs for community lay navigators and inform the adaptation of existing Peer Connect training materials
Training community lay navigatorsBehavioural
Lay navigators identified from among the recruited community representatives will be trained either in-person or virtually by research staff members in motivational interviewing and other strategies to provide psychosocial support to older socially disadvantaged adults with cancer. For community lay navigators and inform the adaptation of existing Peer Connect training materials.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Other | Community representatives Receives: Behavioral: Focus Group Discussions and Semi-structured Interviews; Behavioral: Training community lay navigators |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adaptation of the existing Peer Connect training materials- interviews
Through semi-structured interviews, feedback will be qualitatively collected from community representatives to guide the adaptation and further refinement of lay navigator training materials.
Measured: 12 months
Adaptation of the existing Peer Connect training materials- focus group discussions
Through focus group discussions, feedback will be qualitatively collected from community representatives to guide the adaptation and further refinement of lay navigator training materials.
Measured: 12 months
Secondary outcomes (2)
Training community lay navigators- training sessions
The ability to train community lay navigators using the newly adapted training content- training sessions will be assessed by the number of training sessions completed by lay navigators and the research staff, allowing for sharing of broad perspectives on training methods, content, and delivery.
Measured: 12 months
Training community lay navigators - semi-structured interviews
The ability to train community lay navigators using the newly adapted training content will be assessed through qualitative semi-structured interviews with lay navigators and the research staff, allowing for sharing of broad perspectives on training methods, content, and delivery.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start28 Apr 2023
- Primary completion28 Sep 2023
- Study completion28 Sep 2023
Why it stopped: Investigator left the institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematological DisorderStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shakira Grant, MD, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05828654
- Sponsor's protocol ID
- LCCC2240
- Status last verified
- Oct 2023
- First submitted
- 27 Mar 2023
- Last updated
- 12 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting Peer Connect to Train Lay Navigators in Delivering Psychosocial Support to Older Adults With Cancer
- ClinicalTrials.gov ID
- NCT05828654
- Acronym / sponsor ID
- LCCC2240
- Conditions
- Hematological Disorder
- Keywords
- Socially Disadvantaged, older, Psychosocial, need
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigator left the institution.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 28 Apr 2023 (actual)
- Primary completion
- 28 Sep 2023 (actual)
- Study completion
- 28 Sep 2023 (actual)
- First posted
- 25 Apr 2023 (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.
The purpose of this study is to convene a group of diverse North Carolina-based community representatives (patients, caregivers, leaders of faith-based organizations, social workers, and patient navigators) to inform the adaptation of materials used to train lay navigators in the delivery of psychosocial support interventions tailored to older socially disadvantaged adults with cancer.
Detailed description
This behavioral study will explore community representatives' perspectives on the resources and training needed to support the development of a lay navigation program tailored to older socially disadvantaged adults with cancer.
It was hypothesized that diverse community representatives could inform the adaptation of training materials (Peer Connect) and subsequent training of community lay navigators, who will then be positioned to address the psychosocial needs of older adults with cancer
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Other | Behavioral: Focus Group Discussions and Semi-structured Interviews, Behavioral: Training community lay navigatorsCommunity representatives |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients aged 65 and older diagnosed with hematological cancer for at least one year with stable disease
- Community representative 18 years or older who also identifies as at least one of the following:
Key exclusion criteria (6 listed)
- All participants meeting any of the following exclusion criteria at enrollment will be excluded from the study:
- Inability to read and speak English
- Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent
- All participants meeting any of the following exclusion criteria at enrollment will be excluded from the study:
- Inability to read and speak English
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 |
|---|---|---|
| Focus Group Discussions and Semi-structured InterviewsCommunity representatives will be asked to participate in either 1:1 semi-structured interviews with a research staff member or to engage in focus group discussions with other community members. These interviews and discussions will gather broad perspectives on resource and training needs for community lay navigators and inform the adaptation of existing Peer Connect training materials | Behavioural | Single Arm |
| Training community lay navigatorsLay navigators identified from among the recruited community representatives will be trained either in-person or virtually by research staff members in motivational interviewing and other strategies to provide psychosocial support to older socially disadvantaged adults with cancer. For community lay navigators and inform the adaptation of existing Peer Connect training materials. | Behavioural | Single Arm |
Primary outcome
Adaptation of the existing Peer Connect training materials- interviews
Time frame: 12 months
Through semi-structured interviews, feedback will be qualitatively collected from community representatives to guide the adaptation and further refinement of lay navigator training materials.
Adaptation of the existing Peer Connect training materials- focus group discussions
Time frame: 12 months
Through focus group discussions, feedback will be qualitatively collected from community representatives to guide the adaptation and further refinement of lay navigator training materials.
2 secondary outcomes
Training community lay navigators- training sessions
Time frame: 12 months
Training community lay navigators - semi-structured interviews
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Investigator left the institution.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2023.
- University of North Carolina Lineberger Comprehensive Cancer Center Clinical TrialsLink provided by the sponsor.
- 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.
Shakira Grant, MD principal investigator
UNC Lineberger Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focus Group Discussions and Semi-structured Interviews and Training community lay navigators in people with Hematological Disorder, run by UNC Lineberger Comprehensive Cancer Center 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 7 inclusion and 6 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: stopped early, as of the sponsor's last update on 12 Oct 2023. 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 stopped early (reason given: Investigator left the institution.). Results are not available in the source record.
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?
Adaptation of the existing Peer Connect training materials- interviews (time frame: 12 months). The study lists 2 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 12 Oct 2023.