Advanced CancerNCT03763032
Psychosocial Intervention in Latino Patients with Advanced Cancer
A study testing Counseling in people with Advanced Cancer, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Palliative Care focuses on symptom management and quality of life and helps patients with life-limiting illness match goals and preferences for care. While there has been interest in and acknowledgement that palliative care is an important part of training patient navigators, there have been no previous studies… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 2018to 29 Nov 2018
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ages > or = 18 years of age
- Must self-identify as Latino/a
- Have stage III/IV cancer
- Seeking or In treatment for their cancer (ie: not in hospice care)
- Not incarcerated
- Have at least moderate baseline distress (> 4 on the NCCN Distress Thermometer) or positive screen for depression (PHQ-2 score >=3) or anxiety (GAD-2 score >=3)
Who cannot join
- -No exclusion criteria listed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Expanding the Reach of Palliative Care: Pilot Study of a Psychosocial Intervention in Latino Patients with Advanced Cancer
Palliative Care focuses on symptom management and quality of life and helps patients with life-limiting illness match goals and preferences for care. While there has been interest in and acknowledgement that palliative care is an important part of training patient navigators, there have been no previous studies examining the effectiveness of a navigation intervention to improve palliative care for patients. This study will examine the feasibility to implement patient navigator and psychosocial interventions.
- Conditions
- Advanced Cancer
- Being tested
- Counseling
- Keywords
- Palliative Care, Latino, Psychosocial Intervention, Patient Navigation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CounselingBehavioural
The patient navigator will provide educational materials, assessments, and counseling to the patients
| Study group | Role | What they receive |
|---|---|---|
| Stepped Interventions | Experimental | Patient navigation intervention, plus various psychosocial interventions Receives: Behavioral: Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Recruitment: number of patients that are eligible to participate
Assess how likely patients are to join the study through tracking the number of patients that are eligible to participate.
Measured: Start of study to end of study, up to 12 months
Feasibility of Completion: number of patients that complete the study
Assess how likely patients are to adhere to the study through tracking the number of patients that complete the study.
Measured: Start of study to end of study, up to 12 months
Secondary outcomes (1)
Process Measure Assessment
Use the Advance Care Planning Engagement Survey to assess Behavior. 9 item questionnaire based on Change Theory using a 6 point Likert scale. Total score is a mean of all items with a range of 1-6.
Measured: Start of study to end of study, up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2018
- Study start23 Jan 2018
- Primary completion29 Nov 2018
- Study completion29 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All patients will be assigned a patient navigator, who will provide a psychosocial assessment and palliative counselling
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stacy Fischer, MD, Principal investigator, University of Colorado, DenverDavid Bekelman, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03763032
- Sponsor's protocol ID
- 17-1955.cc
- Status last verified
- Sep 2024
- First submitted
- 30 Nov 2018
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanding the Reach of Palliative Care: Pilot Study of a Psychosocial Intervention in Latino Patients with Advanced Cancer
- ClinicalTrials.gov ID
- NCT03763032
- Acronym / sponsor ID
- 17-1955.cc
- Conditions
- Advanced Cancer
- Keywords
- Palliative Care, Latino, Psychosocial Intervention, Patient Navigation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 23 Jan 2018 (actual)
- Primary completion
- 29 Nov 2018 (actual)
- Study completion
- 29 Nov 2018 (actual)
- First posted
- 4 Dec 2018 (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.
Palliative Care focuses on symptom management and quality of life and helps patients with life-limiting illness match goals and preferences for care. While there has been interest in and acknowledgement that palliative care is an important part of training patient navigators, there have been no previous studies examining the effectiveness of a navigation intervention to improve palliative care for patients. This study will examine the feasibility to implement patient navigator and psychosocial interventions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patients will be assigned a patient navigator, who will provide a psychosocial assessment and palliative counselling
| Arm | Type | Receives |
|---|---|---|
| Stepped Interventions | Experimental | Behavioral: CounselingPatient navigation intervention, plus various psychosocial interventions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults ages > or = 18 years of age
- Must self-identify as Latino/a
- Have stage III/IV cancer
- Seeking or In treatment for their cancer (ie: not in hospice care)
- Not incarcerated
Key exclusion criteria (1 listed)
- -No exclusion criteria listed
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 |
|---|---|---|
| CounselingThe patient navigator will provide educational materials, assessments, and counseling to the patients | Behavioural | Stepped Interventions |
Primary outcome
Feasibility of Recruitment: number of patients that are eligible to participate
Time frame: Start of study to end of study, up to 12 months
Assess how likely patients are to join the study through tracking the number of patients that are eligible to participate.
Feasibility of Completion: number of patients that complete the study
Time frame: Start of study to end of study, up to 12 months
Assess how likely patients are to adhere to the study through tracking the number of patients that complete the study.
1 secondary outcome
Process Measure Assessment
Time frame: Start of study to end of study, up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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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.
Stacy Fischer, MD principal investigator
University of Colorado, Denver
David Bekelman, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Counseling in people with Advanced Cancer, run by University of Colorado, Denver 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 6 inclusion and 1 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: finished, as of the sponsor's last update on 19 Sep 2024. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Feasibility of Recruitment: number of patients that are eligible to participate (time frame: Start of study to end of study, up to 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 19 Sep 2024; AzTrials last refreshed its copy on 7 Nov 2026.