CancerNCT03226405
Patient Navigation to Improve Patient-Centered Cancer Care
A study testing Patient Navigation Program in people with Cancer, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The MGH Cancer Center's patient navigation (PN) program, utilizes specially trained community-based personnel to improve cancer care in underserved communities by increasing cancer screening and removing barriers to timely care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Patient Navigation Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2017to 2 Oct 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (age 18 and older)
- Newly diagnosed with cancer referred from Massachusetts General Hospital (MGH) community health centers in
- Revere
- Chelsea
- Charlestown
- surrounding communities referred to receive cancer treatment at the MGH Cancer Center
Who cannot join
- -Patients that primary care providers exclude
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02215
Emma Whited, 617-724-1968, ewhited@mgh.harvard.edu
Sanja Percac-Lima, MD, PhD
About this study
The MGH Cancer Center's patient navigation (PN) program, utilizes specially trained community-based personnel to improve cancer care in underserved communities by increasing cancer screening and removing barriers to timely care. This program incorporate rigorous evaluation to demonstrate the impact of innovation in healthcare delivery.
Read the detailed description
This program allow cancer patients from MGH Community Health Centers (CHC) and surrounding communities who experience barriers to accessing care, including poverty, and limited English proficiency, and provide them navigation to receive timely, guideline-concordant treatment at MGH Cancer Center. By offering these vulnerable individuals a patient-centered approach to treatment, The investigators aim to promote patient engagement and increase access throughout the continuum of cancer care.
- Conditions
- Cancer
- Being tested
- Patient Navigation Program, Usual Care
- Keywords
- Cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Navigation ProgramOther
PN program improve access, timeliness and adherence with cancer treatment
Usual CareOther
the standard of care provided by the institution
| Study group | Role | What they receive |
|---|---|---|
| Patient Navigation Program | Experimental | * The study team will identify, track, and provide navigation for all adult patients referred to Cancer Center from the CHC and community partners for cancer treatment.
* The Patient Navigation Program include
* Education,
* Appointment reminders,
* Help with insurance,
* Transportation,
* Navigating the Cancer Center,
* Assisting in finding appropriate child care,
* Interpreting,
* Connecting the patient to psychosocial and/or palliative care teams,
* Physically escorting the patient to appointments Receives: Other: Patient Navigation Program |
| Standard of Care | Active comparator | * The patients will receive enhanced usual care,
* This consist of personal phone call reminders about upcoming appointments at the MGH Cancer Center Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence With Cancer Treatment
Adherence with cancer treatment will be measured as no-show rate to scheduled oncology appointments.
Measured: 2 years
The Time From Cancer Diagnosis To First Oncology Appointment
Length of time in days from cancer diagnosis to first completed oncology appointment.
Measured: 2 Years
Secondary outcomes (11)
Health Related Quality Of Life
Health related quality of life measured via the validated Functional Assessment of Cancer Therapy - General (FACT-G).
Measured: 2 years
Overall Survival
Overall survival rate of the study population.
Measured: 2 years
Proportion Of Patients Enrolled In Clinical Trials
Proportion of participants in the study that enroll on a clinical trial.
Measured: 2 years
Overall Missed Health Care Visits
Number of scheduled health care visits missed by enrolled patients.
Measured: 2 years
Emergency Department Visits
Number of emergency department visits by enrolled patients.
Measured: 2 years
Unplanned Hospitalizations/Readmissions
Number of unplanned hospitalizations and/or readmissions by enrolled patients.
Measured: 2 years
Inpatient Hospitalization Length Of Stay.
Number of days enrolled patients spent as a hospitalized inpatient.
Measured: 2 years
Patient Satisfaction With Patient Navigation Program (PNP)
Patient satisfaction with patient navigation program (PNP) to be measured via the validated Patient Satisfaction with Navigation - 1 (PSN-1).
Measured: 2 years
Patient Engagement In Care
Patient engagement in care will be measured using the validated Perceived Efficacy in Patient-Physician Interactions (PEPPI) metric.
Measured: 2 years
Patient's Financial Burden
Patient financial burden will be measured using the validated Comprehensive Score for Financial Toxicity (COST) instrument.
Measured: 2 years
Patient Satisfaction with Cancer Care
Patient satisfaction with cancer care to be measured using the validated Cancer-Related Care Survey.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start1 Nov 2017
- Primary completion2 Oct 2020 (estimated)
- Study completion2 Oct 2023 (estimated)
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.
- More trials run by Massachusetts General HospitalThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sanja Percac-Lima, MD, Massachusetts General Hospital
- Investigators
- Sanja Percac-Lima, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03226405
- Sponsor's protocol ID
- 17-183
- Status last verified
- Apr 2020
- First submitted
- 19 Jul 2017
- Last updated
- 21 Apr 2020
- 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 21 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Navigation to Improve Patient-Centered Cancer Care
- ClinicalTrials.gov ID
- NCT03226405
- Acronym / sponsor ID
- 17-183
- Conditions
- Cancer
- Keywords
- Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 2 Oct 2020 (estimated)
- Study completion
- 2 Oct 2023 (estimated)
- First posted
- 21 Jul 2017 (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 MGH Cancer Center's patient navigation (PN) program, utilizes specially trained community-based personnel to improve cancer care in underserved communities by increasing cancer screening and removing barriers to timely care. This program incorporate rigorous evaluation to demonstrate the impact of innovation in healthcare delivery.
Detailed description
This program allow cancer patients from MGH Community Health Centers (CHC) and surrounding communities who experience barriers to accessing care, including poverty, and limited English proficiency, and provide them navigation to receive timely, guideline-concordant treatment at MGH Cancer Center. By offering these vulnerable individuals a patient-centered approach to treatment, The investigators aim to promote patient engagement and increase access throughout the continuum of cancer care.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Navigation Program | Experimental | Other: Patient Navigation Program* The study team will identify, track, and provide navigation for all adult patients referred to Cancer Center from the CHC and community partners for cancer treatment. * The Patient Navigation Program include * Education, * Appointment reminders, * Help with insurance, * Transportation, * Navigating the Cancer Center, * Assisting in finding appropriate child care, * Interpreting, * Connecting the patient to psychosocial and/or palliative care teams, * Physically escorting the patient to appointments |
| Standard of Care | Active comparator | Other: Usual Care* The patients will receive enhanced usual care, * This consist of personal phone call reminders about upcoming appointments at the MGH Cancer Center |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patients (age 18 and older)
- Newly diagnosed with cancer referred from Massachusetts General Hospital (MGH) community health centers in
Key exclusion criteria (1 listed)
- -Patients that primary care providers exclude
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 |
|---|---|---|
| Patient Navigation ProgramPN program improve access, timeliness and adherence with cancer treatment | Other | Patient Navigation Program |
| Usual Carethe standard of care provided by the institution | Other | Standard of Care |
Primary outcome
Adherence With Cancer Treatment
Time frame: 2 years
Adherence with cancer treatment will be measured as no-show rate to scheduled oncology appointments.
The Time From Cancer Diagnosis To First Oncology Appointment
Time frame: 2 Years
Length of time in days from cancer diagnosis to first completed oncology appointment.
11 secondary outcomes
Health Related Quality Of Life
Time frame: 2 years
Overall Survival
Time frame: 2 years
Proportion Of Patients Enrolled In Clinical Trials
Time frame: 2 years
Overall Missed Health Care Visits
Time frame: 2 years
Emergency Department Visits
Time frame: 2 years
Unplanned Hospitalizations/Readmissions
Time frame: 2 years
Inpatient Hospitalization Length Of Stay.
Time frame: 2 years
Patient Satisfaction With Patient Navigation Program (PNP)
Time frame: 2 years
Patient Engagement In Care
Time frame: 2 years
Patient's Financial Burden
Time frame: 2 years
Patient Satisfaction with Cancer Care
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2020.
- 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.
Sanja Percac-Lima, MD, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Navigation Program in people with Cancer, run by Massachusetts General Hospital 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: status not confirmed, as of the sponsor's last update on 21 Apr 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emma Whited (617-724-1968, ewhited@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence With Cancer Treatment (time frame: 2 years). 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 21 Apr 2020.