CancerNCT03271099
Patient Navigation in Cancer Survivorship at a Safety Net Institution
A study testing Navigator in people with Cancer, run by Boston Medical Center at 1 site in United States.
Trial summary
This study seeks to enroll patients receiving a Survivorship Care Plan following curative therapy for cancer. Participants will be randomly assigned to receive usual care or to be followed by a Patient Navigator as part of their Survivorship Care Plan. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Navigator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2017to 10 Sep 2020
- 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
- Stage I, II, III or IVa Cancer diagnosis (may include Solitary plasmacytoma, Diffuse Large B-Cell Lymphoma (DLBCL), ductal carcinoma in situ (DCIS) of the breast)
- Completed treatment with curative intent within the past 12 months. (May be on maintenance therapy.)
Who cannot join
- Distant Metastatic disease
- Non-curable disease
- Recurrence of disease prior to enrollment
- Require ongoing navigation from the treatment navigator
- Enrolled/active in another randomized study (Project SUPPORT)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient Navigation as Part of the Cancer Survivorship Care Plan at a Safety Net Institution
This study seeks to enroll patients receiving a Survivorship Care Plan following curative therapy for cancer. Participants will be randomly assigned to receive usual care or to be followed by a Patient Navigator as part of their Survivorship Care Plan.
Read the detailed description
This study seeks to enroll patients receiving a Survivorship Care Plan following curative therapy for cancer. Participants will be randomly assigned to receive usual care or to be followed by a Patient Navigator as part of their Survivorship Care Plan.
Study participation for all participants will be for up to 9 months, with study visits approximately every 3 months, based on standard clinical follow-up. All participants will be administered quality of life surveys by a Clinical Research Associate at study entry, mid-study (approximately 3-6 months) and at study completion.
The following factors will be compared between arms:
- Missed/kept appointments
- Use of urgent/emergent care
- Quality of Life in relation to survivorship care
- Participants lost to care
- Conditions
- Cancer
- Being tested
- Navigator
- Keywords
- survivorship; navigation
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NavigatorOther
Also called navigation
Patient Navigation services will be provided to try to eliminate barriers in pursuing survivorship surveillance
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Usual care |
| Navigator | Experimental | Patient navigator services provided as part of survivorship care plan Receives: Other: Navigator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Missed appointments
The research team will document the number of cancer care appointments scheduled and of those, how many appointments were missed (obtained by medical record and by patient report in case a visit was outside of study institution).
Measured: 9 months
Secondary outcomes (4)
Urgent/emergent care
The research team will document the number of urgent/emergent care visits attended within the study period of 9 months (obtained by medical record and by patient report in case a visit was outside of study institution).
Measured: 9 months
Cancer Needs Distress
Participants will rate their feelings about 39 specific cancer needs on a 5 point scale from "Not a Problem" to "Very Severe Problem" using the Cancer Needs Distress Inventory (CaNDI) tool. Total scores can range from 39 to 195. Lower scores are associated with less cancer related distress.
Measured: 9 months
New Survivor Survey
Participants will rate their understanding about 16 specific aspects of survivorship care on a 4 point scale from "Strongly Disagree" to "Strongly Agree" using the Preparing for Life as a New Survivor (PLANS) Scale. Total scores can range from 16 to 48. Lower scores are associated with less understanding of the survivorship care process.
Measured: 9 months
Lost to Care
The research team will document the number of participants lost to care, based on consecutive missed cancer care visits.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2017
- Study start16 Oct 2017
- Primary completion10 Sep 2020
- Study completion10 Sep 2020
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 Boston Medical 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard Pilgrim Health Care
- Responsible party
- Sponsor
- Investigators
- Minh Tam Truong, MD, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03271099
- Sponsor's protocol ID
- H-36781
- Status last verified
- Sep 2021
- First submitted
- 31 Aug 2017
- Last updated
- 8 Sep 2021
- 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 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Navigation as Part of the Cancer Survivorship Care Plan at a Safety Net Institution
- ClinicalTrials.gov ID
- NCT03271099
- Acronym / sponsor ID
- H-36781
- Conditions
- Cancer
- Keywords
- survivorship; navigation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- Harvard Pilgrim Health Care
- Study start
- 16 Oct 2017 (actual)
- Primary completion
- 10 Sep 2020 (actual)
- Study completion
- 10 Sep 2020 (actual)
- First posted
- 1 Sep 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.
This study seeks to enroll patients receiving a Survivorship Care Plan following curative therapy for cancer. Participants will be randomly assigned to receive usual care or to be followed by a Patient Navigator as part of their Survivorship Care Plan.
Detailed description
This study seeks to enroll patients receiving a Survivorship Care Plan following curative therapy for cancer. Participants will be randomly assigned to receive usual care or to be followed by a Patient Navigator as part of their Survivorship Care Plan.
Study participation for all participants will be for up to 9 months, with study visits approximately every 3 months, based on standard clinical follow-up. All participants will be administered quality of life surveys by a Clinical Research Associate at study entry, mid-study (approximately 3-6 months) and at study completion.
The following factors will be compared between arms:
- Missed/kept appointments
- Use of urgent/emergent care
- Quality of Life in relation to survivorship care
- Participants lost to 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 |
|---|---|---|
| Usual Care | No intervention | –Usual care |
| Navigator | Experimental | Other: NavigatorPatient navigator services provided as part of survivorship care plan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Stage I, II, III or IVa Cancer diagnosis (may include Solitary plasmacytoma, Diffuse Large B-Cell Lymphoma (DLBCL), ductal carcinoma in situ (DCIS) of the breast)
- Completed treatment with curative intent within the past 12 months. (May be on maintenance therapy.)
Key exclusion criteria (5 listed)
- Distant Metastatic disease
- Non-curable disease
- Recurrence of disease prior to enrollment
- Require ongoing navigation from the treatment navigator
- Enrolled/active in another randomized study (Project SUPPORT)
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 |
|---|---|---|
| NavigatorAlso: navigationPatient Navigation services will be provided to try to eliminate barriers in pursuing survivorship surveillance | Other | Navigator |
Primary outcome
Missed appointments
Time frame: 9 months
The research team will document the number of cancer care appointments scheduled and of those, how many appointments were missed (obtained by medical record and by patient report in case a visit was outside of study institution).
4 secondary outcomes
Urgent/emergent care
Time frame: 9 months
Cancer Needs Distress
Time frame: 9 months
New Survivor Survey
Time frame: 9 months
Lost to Care
Time frame: 9 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 8 Sep 2021.
- 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.
Minh Tam Truong, MD principal investigator
Boston Medical 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 Navigator in people with Cancer, run by Boston Medical 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 2 inclusion and 5 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 8 Sep 2021. 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?
Missed appointments (time frame: 9 months). 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 8 Sep 2021.