DoD-NCI TRICARE Feasibility Study
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 35 - 74 |
| Updated: | 11/14/2018 |
| Start Date: | August 18, 2018 |
| End Date: | September 22, 2020 |
| Contact: | Catherine Schairer, Ph.D. |
| Email: | schairec@mail.nih.gov |
| Phone: | (301) 435-3979 |
The NCI-DoD TriCare Feasibility Study
Background:
- Researchers at the National Cancer Institute and the Department of Defense are trying to
learn more about what causes cancer, heart disease, and other health problems. To do this,
they gather data on risk factors and biological markers. They get these data from large
groups of people in long-running studies. As these groups of people age, researchers must
form new groups. TRICARE is a health insurance program for uniformed service members and
their families. It is a major part of the Military Health System. Researchers hope to form a
new study group from TRICARE members. This study will test if TRICARE members will take part
in a research study.
Objectives:
- To test if TRICARE members will take part in a research study.
Eligibility:
- TRICARE members aged 35 74 with military primary care providers at Walter Reed National
Military Medical Center. They must not have a prior diagnosis of cancer other than
non-melanoma skin cancer.
Design:
- Participants will fill out a survey. It will ask about their risk factors for cancer and
other chronic diseases. Their medical records will be reviewed. They will give a blood
sample.
- If a larger study is formed, then participants data will be used in the larger study.
They may be asked to give more samples.
- Researchers at the National Cancer Institute and the Department of Defense are trying to
learn more about what causes cancer, heart disease, and other health problems. To do this,
they gather data on risk factors and biological markers. They get these data from large
groups of people in long-running studies. As these groups of people age, researchers must
form new groups. TRICARE is a health insurance program for uniformed service members and
their families. It is a major part of the Military Health System. Researchers hope to form a
new study group from TRICARE members. This study will test if TRICARE members will take part
in a research study.
Objectives:
- To test if TRICARE members will take part in a research study.
Eligibility:
- TRICARE members aged 35 74 with military primary care providers at Walter Reed National
Military Medical Center. They must not have a prior diagnosis of cancer other than
non-melanoma skin cancer.
Design:
- Participants will fill out a survey. It will ask about their risk factors for cancer and
other chronic diseases. Their medical records will be reviewed. They will give a blood
sample.
- If a larger study is formed, then participants data will be used in the larger study.
They may be asked to give more samples.
DCEG has a long history of developing and running major cohort studies, and these form the
backbone of the research portfolio in the Division. Existing cohorts, including but not
limited to
AARP, PLCO and USRT, have been extremely productive and have generated a wealth of
information about potential cancer risk factors and biological markers. In the next decade,
these cohorts will reach the end of their natural lifetime due to the length of time since
the baseline questionnaire, the average age of the participants, and the depletion of
biological samples. There is the need, therefore, to start planning for the next generation
of cohorts that will be able to continue to address current and future hypotheses about the
etiology of cancer. A working group within DCEG was formed to discuss potential settings, and
a cohort study within the US military setting was selected as one of the promising
possibilities. Attractive features conducive to conducting a cohort study using the TriCare
health insurance system was the possibility of linkage to numerous electronic databases,
including those that maintain addresses and enrollment status, pharmacy databases, medical
records databases, and cancer registry and mortality databases. Tricare is a health care
insurance program for uniformed service members (active, Guard/Reserve, retired) and their
families.
Our overarching, long-term, objective is to build a new prospective multi-center adult cohort
among the membership of the Tricare insurance plan. The cohort will have rich exposure
information and accurate outcome information that will be used as a Divisionwide resource to
investigate novel hypotheses about the etiology of cancer, using questionnaire data, medical
records, tumor tissue and serial biospecimens. Given the large-scale nature of the
anticipated cohort study, we plan to begin the work by conducting a feasibility study at
military treatment facility, Walter Reed National Medical Center (WRNMMC).
The goal of the feasibility study is to help us determine what will be possible in a larger
effort.
Several other feasibility studies are being conducted by other groups in DCEG. Depending on
the outcome of these studies, DCEG senior leadership will make a decision on whether one
large cohort or several smaller cohorts should move forward.
The feasibility study will have two parts: Part 1) we will randomly select and invite to
participate, by post, a stratified sample of 1,000 eligible beneficiaries aged 35-74 years
old. All participants will be asked to access a study website, complete an on-line consent
form which includes consent for access to electronic health records, complete an on-line
questionnaire, and provide a blood specimen within three months of enrolling in the study.
The letter will offer a paper-based option for consent and questionnaire completion for those
unwilling or unable to access the website. The following outcomes will be evaluated: %
enrollment, % questionnaire completion, % agreement to blood draw, % completion of blood
draws, the time between enrollment and blood draw, duration of enrollment in Tricare, % with
supplemental civilian insurance, feasibility of linking electronic patient databases to each
other and to the questionnaire data, and available characteristics of the participants and
the non-participants; Part 2) Using MDR files, the Defense Health Agency (DHA) will provide
frequencies on place of cancer diagnosis and treatment (military treatment facility vs.
civilian hospital) and availability of treatment data for eligible beneficiaries with a
diagnosis of cancer other than nonmelanoma skin cancer within the past 12 months. No
individual level data will be collected. The protocol is formatted for submission to the
WRNMMC.
backbone of the research portfolio in the Division. Existing cohorts, including but not
limited to
AARP, PLCO and USRT, have been extremely productive and have generated a wealth of
information about potential cancer risk factors and biological markers. In the next decade,
these cohorts will reach the end of their natural lifetime due to the length of time since
the baseline questionnaire, the average age of the participants, and the depletion of
biological samples. There is the need, therefore, to start planning for the next generation
of cohorts that will be able to continue to address current and future hypotheses about the
etiology of cancer. A working group within DCEG was formed to discuss potential settings, and
a cohort study within the US military setting was selected as one of the promising
possibilities. Attractive features conducive to conducting a cohort study using the TriCare
health insurance system was the possibility of linkage to numerous electronic databases,
including those that maintain addresses and enrollment status, pharmacy databases, medical
records databases, and cancer registry and mortality databases. Tricare is a health care
insurance program for uniformed service members (active, Guard/Reserve, retired) and their
families.
Our overarching, long-term, objective is to build a new prospective multi-center adult cohort
among the membership of the Tricare insurance plan. The cohort will have rich exposure
information and accurate outcome information that will be used as a Divisionwide resource to
investigate novel hypotheses about the etiology of cancer, using questionnaire data, medical
records, tumor tissue and serial biospecimens. Given the large-scale nature of the
anticipated cohort study, we plan to begin the work by conducting a feasibility study at
military treatment facility, Walter Reed National Medical Center (WRNMMC).
The goal of the feasibility study is to help us determine what will be possible in a larger
effort.
Several other feasibility studies are being conducted by other groups in DCEG. Depending on
the outcome of these studies, DCEG senior leadership will make a decision on whether one
large cohort or several smaller cohorts should move forward.
The feasibility study will have two parts: Part 1) we will randomly select and invite to
participate, by post, a stratified sample of 1,000 eligible beneficiaries aged 35-74 years
old. All participants will be asked to access a study website, complete an on-line consent
form which includes consent for access to electronic health records, complete an on-line
questionnaire, and provide a blood specimen within three months of enrolling in the study.
The letter will offer a paper-based option for consent and questionnaire completion for those
unwilling or unable to access the website. The following outcomes will be evaluated: %
enrollment, % questionnaire completion, % agreement to blood draw, % completion of blood
draws, the time between enrollment and blood draw, duration of enrollment in Tricare, % with
supplemental civilian insurance, feasibility of linking electronic patient databases to each
other and to the questionnaire data, and available characteristics of the participants and
the non-participants; Part 2) Using MDR files, the Defense Health Agency (DHA) will provide
frequencies on place of cancer diagnosis and treatment (military treatment facility vs.
civilian hospital) and availability of treatment data for eligible beneficiaries with a
diagnosis of cancer other than nonmelanoma skin cancer within the past 12 months. No
individual level data will be collected. The protocol is formatted for submission to the
WRNMMC.
- INCLUSION CRITERIA:
Participants will be selected according to the MTF, gender, age, and race/ethnicity.
Beneficiaries aged 35-74 years with military primary care providers at WRNMMC or FBCH or
beneficiaries living in these catchment or service areas.
EXCLUSION CRITERIA:
Beneficiaries less than 35 years of age will be excluded because cancer incidence at these
ages is low and therefore it is unlikely to be feasible from a cost/information perspective
to include them. Beneficiaries 75 years of age or older will be excluded because it is
unlikely they will have long-term follow-up.
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