Download Cancer Patient Navigation Protocol

CANCER PATIENT NAVIGATION
STUDY PROTOCOL
Created by: Rachel Klimmek, RN
Doctoral Student & Research Nurse
Johns Hopkins University School of Nursing
Last Updated: October 30, 2009
Purpose of this Training Module


To PROVIDE AN OVERVIEW of the
Cancer Patient Navigation Study Protocol for
Community Health Workers (CHWs)
who will be involved in the study.
THIS MODULE WILL PRESENT:
 different
parts of the study and how they fit together
 the role of CHWs throughout the study
 key differences in study procedures for participants in
each of the two groups to be studied (those who will
receive cancer patient navigation, and those who will not)
COMMUNITY HEALTH WORKERS
Community Health Workers (referred to in these
slides as CHWs) are study team members with
expertise about the local community who are being
trained to provide cancer patient navigation support
to rural elders
IF YOU ARE REVIEWING THESE SLIDES,
YOU ARE PROBABLY A CHW!
Learning Objectives





Upon Completion of this Module, CHWs will be able to:
Describe the overall purpose of this randomly-controlled trial
Describe the CHW role during each part of this study
Understand what will happen during this study
Describe major differences in procedures for participants in the
study who will receive cancer patient navigation
(TREATMENT GROUP) and
those who will not (RESOURCE EDUCATION GROUP)
Understand WHAT data they will be collecting, WHEN it will
be collected, WHO it will be collected from, and WHY it is
important
What is a Protocol?


A study protocol is a standard set of procedures used
to guide the conduct of a scientific research study
Study protocols are useful for understanding:
 WHAT
WILL HAPPEN during a study
 HOW it will happen
 WHAT data will be collected
 HOW data will be collected & WHO will collect it
 WHEN data will be collected
 ROLES of study team members throughout the study
What is a Randomly-Controlled Trial?


An EXPERIMENTAL study design testing an intervention (patient
navigation support from CHWs)
Two groups of participants:





Treatment Group (TX) receives patient navigation support
Resource Education Group (RE) does not
Participants are RANDOMLY-ASSIGNED to groups
DATA IS COLLECTED at the beginning of the study, throughout the
study, and at the end of the study
Researchers ANALYZE the data to look for DIFFERENCES BETWEEN
THE TWO GROUPS to answer the research question: Did the cancer
patient navigation support make a difference and how?
Your Role as a Community Health Worker

Provide Cancer Navigation Support to Participants
as well as

Collect data (information about participants)
ESSENTIAL to the success of the scientific study
Why are these Data Important?

Without quality data, we cannot know:
 Did
the Cancer Patient Navigation have an impact?
 What was that impact?
 Who benefited?
 How did it happen?
 How might the navigation support be improved?

Without answers to these questions, this program
cannot be expanded or replicated in other places
to help others
Types of Data to be Collected




QUESTIONNAIRES completed by participants
NOTES & LOGS of Interactions with Participants
kept by CHWs
SALIVA SAMPLES
AUDIO TAPES of Support Delivered by Telephone and
Focus Group Discussions at the end of the study
Types of Data to be Collected




QUESTIONNAIRES completed by participants
NOTES & LOGS of Interactions with Participants
kept by CHWs
SALIVA SAMPLES
AUDIO TAPES of Support Delivered by Telephone and
Focus Group Discussions at the end of the study
CHWs will help to collect
THESE DATA IN RED
When Data Will be Collected

AT BASELINE (when participants enroll in study)

MID-WAY through participants’ cancer treatment

ONE-MONTH FOLLOWING the end of treatment
AND

THROUGHOUT THE STUDY, WHENEVER
a CHW has an interaction with a study
participant, in-person or via telephone
CHW ROLE DURING STUDY
Overview of CHW Role during Study
WHEN A PARTICIPANT IS ENROLLED IN THE STUDY (WITHIN 60 DAYS OF DIAGNOSIS):
CHW
SCREENS
PARTICIPANT
CHW
COLLECTS
BASELINE
DATA
CHW
ENROLLS
PARTICIPANT
CHW RANDOMIZES
PARTICIPANT TO
(TX) OR (RE) GROUP
TO MID-WAY THROUGH PARTICIPANTS’ CANCER TREATMENT:
CHW CALLS/VISITS
EVERY 2 WEEKS &
KEEPS NOTES
CHW COLLECTS
MID-TREATMENT DATA
FROM PARTICIPANT
TO 1-MONTH AFTER PARTICIPANTS’ CANCER TREATMENT IS COMPLETED:
CHW CALLS/VISITS
EVERY 2 WEEKS &
KEEPS NOTES
PARTICIPANT
COMPLETES HIS/HER
CANCER TREATMENT
CHW COLLECTS
1-MONTH POSTTREATMENT DATA
HOW CHWs WILL COLLECT DATA
A STEP BY STEP GUIDE TO DATA COLLECTION, WHAT IT MEANS, AND THE
COMMUNITY HEALTH WORKER (CHW) ROLE
SCREENING DATA
WHEN A PARTICIPANT IS ENROLLED IN THE STUDY (WITHIN 60 DAYS OF DIAGNOSIS):
CHW
SCREENS
PARTICIPANTS
TIMING:
Before participants are enrolled.
TYPES OF DATA CHW WILL HELP COLLECT:
Discussed during Consent Module (Screening & Consent Forms)
WHAT DATA TELLS US:
Are the participants (elders with cancer and their support persons)
eligible for the study?
COLLECTS BASELINE DATA
WHEN A PARTICIPANT IS ENROLLED IN THE STUDY (WITHIN 60 DAYS OF DIAGNOSIS):
CHW
SCREENS
PARTICIPANT
CHW
ENROLLS
PARTICIPANT
CHW
COLLECTS
BASELINE
DATA
TIMING: Immediately following enrollment
TYPES OF DATA CHW WILL HELP COLLECT:
•Questionnaires Filled out by Elders and their Support Persons
•Saliva Samples collected at home by Elders & their Support Persons; CHWs will
instruct participants on how to do this and give them the equipment they need (more
on this in Saliva Sample Module)
WHAT THE DATA WILL TELL US:
•Demographic characteristics of Participants (who they are)
•Levels of Physical Health, Anxiety or Depression, Health Literacy, Social Support,
Functional Status & Quality of Life of Participants
CHW Randomizes Participant
WHEN A PARTICIPANT IS ENROLLED IN THE STUDY (WITHIN 60 DAYS OF DIAGNOSIS):
CHW
SCREENS
PARTICIPANT
CHW
ENROLLS
PARTICIPANT
CHW
COLLECTS
BASELINE
DATA
CHW RANDOMIZES
PARTICIPANT TO
(TX) OR (RE) GROUP
RANDOMIZATION:
CHWs will randomly assign participants to either:
- TREATMENT GROUP (group that will receive cancer navigation) or
- RESOURCE EDUCATION GROUP (will not receive navigation)
RANDOMIZATION MEANS each participant has an equal chance
of being assigned to either group
PARTICIPANTS WILL BE GIVEN DIFFERENT RESOURCES &
SUPPORT BY THE CHW based on which group they are assigned to
CHWs will give RESOURCE MATERIALS
to participants AFTER randomization
Treatment Group (TX)


Culturally-appropriate
resource materials
designed specifically
with this group in mind
CHWs WILL GIVE
Cancer Navigation
Support
Resource Education Group (RE)


Standard, generic
resource materials
CHWs WILL NOT give
Cancer Navigation
Support
CHW CONTACTS EVERY 2 WEEKS
WHEN A PARTICIPANT IS ENROLLED IN THE STUDY (WITHIN 60 DAYS OF DIAGNOSIS):
CHW
SCREENS
PARTICIPANT
CHW
ENROLLS
PARTICIPANT
CHW
COLLECTS
BASELINE
DATA
CHW RANDOMIZES
PARTICIPANT TO
(TX) OR (RE) GROUP
TO MID-WAY
THROUGH
PARTICIPANTS’
TREATMENT:
TYPES
OF DATA
CHW WILL
HELP TO CANCER
COLLECT:
CHWs will keep logs of their calls or visits with participants in the TX and RE
CHW CALLS/VISITS
groups. These visits or calls will occur every 2 weeks from the time a participant
EVERY 2 WEEKS &
enrolls in the study until
they
complete their cancer treatment. More about how
KEEPS
NOTES
these sessions will be conducted is covered in the Navigation module.
WHAT DATA WILL TELL US:
What’s going on with participants (elders or support persons), & issues they are
having that might require support.
COLLECTS MID-TREATMENT DATA
WHEN A PARTICIPANT IS ENROLLED IN THE STUDY (WITHIN 60 DAYS OF DIAGNOSIS):
CHW
SCREENS
PARTICIPANT
CHW
ENROLLS
PARTICIPANT
CHW
COLLECTS
BASELINE
DATA
CHW RANDOMIZES
PARTICIPANT TO
(TX) OR (RE) GROUP
TO MID-WAY THROUGH PARTICIPANTS’ CANCER TREATMENT:
TIMING:
Will occur mid-way
through a participants’
cancer
treatment, as
CHW CALLS/VISITS
CHW
COLLECTS
2 WEEKS
MID-TREATMENT DATA
determined byEVERY
research
RNs&
FROM PARTICIPANT
TYPES OF DATAKEEPS
CHWNOTES
WILL HELP TO COLLECT:
Questionnaires completed by elders & their support persons
WHAT DATA TELLS US:
•Levels of Physical Health, Anxiety or Depression, Health Literacy,
Social Support, Functional Status & Quality of Life of Participants
(In other words, how are they doing so far?)
CHW CONTACTS EVERY 2 WEEKS
WHEN A PARTICIPANT IS ENROLLED IN THE STUDY (WITHIN 60 DAYS OF DIAGNOSIS):
CHW
SCREENS
PARTICIPANT
CHW
ENROLLS
PARTICIPANT
CHW
COLLECTS
BASELINE
DATA
CHW RANDOMIZES
PARTICIPANT TO
(TX) OR (RE) GROUP
TO MID-WAY
THROUGH
PARTICIPANTS’
CANCER
TREATMENT:
TYPES
OF DATA
CHW
WILL HELP
TO COLLECT:
CHWs will continue
to keep logs of theirCHW
callsCOLLECTS
or visits to study
CHW CALLS/VISITS
EVERY
2 WEEKS & have completed
MID-TREATMENT
DATA
participants after
participants
mid-treatment
KEEPS NOTES
FROM PARTICIPANT
questionnaires. These
calls/visits will continue
to occur every 2
weeks until the participant completes his or her cancer treatment.
TO 1-MONTH AFTER PARTICIPANTS’ CANCER TREATMENT IS COMPLETED:
WHAT
TELLS US:
CHWDATA
CALLS/VISITS
EVERYgoing
2 WEEKS
What’s
on &with participants (elders or support persons), &
issues KEEPS
they NOTES
are having that might require support.
1-MONTH POST-TREATMENT DATA
WHEN A PARTICIPANT IS ENROLLED IN THE STUDY (WITHIN 60 DAYS OF DIAGNOSIS):
CHW
SCREENS
TIMING:
PARTICIPANT
CHW
ENROLLS
PARTICIPANT
CHW
COLLECTS
BASELINE
DATA has
participant
CHW RANDOMIZES
PARTICIPANT TO
(TX) OR (RE) GROUP
Will occur one month after a
completed their
cancer treatment (as determined by the research RNs)
TO MID-WAY THROUGH PARTICIPANTS’ CANCER TREATMENT:
CHW
CALLS/VISITS
CHW COLLECTS
TYPES OF DATA
CHW
WILL HELP TO COLLECT:
2 WEEKS &
MID-TREATMENT DATA
QuestionnairesEVERY
completed
by
elders
&
their
support persons
KEEPS NOTES
FROM PARTICIPANT
Financial journals maintained by cancer patients during study
WHAT DATA TELLS US:
TO 1-MONTH AFTER PARTICIPANTS’ CANCER TREATMENT IS COMPLETED:
• Participants’ Levels of Physical Health, Anxiety or Depression,
CHWLiteracy,
CALLS/VISITS
CHW COLLECTS
Health
Social Support,PARTICIPANT
Functional Status & Quality
of Life,
EVERY 2 WEEKS &
COMPLETES HIS/HER
1-MONTH POST& out
of
pocket
costs
during
treatment
KEEPS NOTES
CANCER TREATMENT
TREATMENT DATA
(How did things turn out?)
Putting It All Together
Example #1:
Treatment Group Participant
Marian Robinson (MR) and her daughter Sasha (SR)
MR is a 67 year old woman with Stage I breast cancer. She would
like to enroll in the study, and her daughter, SR, who she identifies as
her primary support person, also agrees to participate.
Screening, Consent,
& Baseline Data Collection




Step 1: CHW Screens MR & SR to participate
CHW determines MR & SR are eligible to participate
Step 2: CHW enrolls MR & SR by giving them informed
consent and having them sign consent forms
Step 3: CHW obtains Baseline Data from MR & SR
CHW instructs MR & SR on how to collect baseline saliva
samples at home; gives them proper supplies to do this
 CHW helps MR to complete Patient Questionnaire



Gives MR the Patient Baseline Questionnaire Packet
CHW helps SR to complete Support Person Questionnaire

Gives SR the Support Person Baseline Questionnaire Packet
Randomization &
Assignment to Treatment Group

Step 4: CHW Randomizes MR & SR
When the CHW meets MR & SR, she does not know
which group (TX or RE) they will be assigned to.
The CHW follows instructions provided by the study
team to determine how MR & SR will be assigned.
For example, she might flip a coin – heads means MR
& SR are assigned to the treatment group, tails
means they are assigned to the RE group.
The CHW flips the coin and determines that MR & SR
will participate in the treatment (TX) group
Given Resource Materials



Step 5: The CHW gives the participants their written resource
materials.
Since MR & SR are in the treatment (TX) group, they will receive
culturally-appropriate resource materials designed with them in
mind.
The CHW reviews these materials with them.
SPECIAL RESOURCE
MATERIALS

Step 6: The CHW also informs MR & SR that she will be available
to them to provide Cancer Patient Navigation Support throughout
MR’s cancer treatment. CHW also reminds MR & SR to complete
their first saliva samples when they get home.
Bi-Weekly Calls or
Visits from the CHW


Step 7: The CHW calls or visits MR & SR every 2
weeks to provide Cancer Patient Navigation
Support. CHW keeps notes & logs of these
interactions.
More information on how to provide
Navigation is reviewed in the
Navigation Training Module.
Ms. Robinson approaches the mid-point
of her treatment


Step 8: Ms. Robinson has received surgery to
remove the lump in her breast, and now she is
receiving chemotherapy as recommended by her
treatment team. As the mid-point of MR’s treatment
approaches, the CHW reminds MR & SR that she
will be sending them another packet of
questionnaires to complete.
CHW answers questions MR & SR have about the
questionnaires, and reminds them to send them back
to the study team.
Bi-Weekly Calls or
Visits from the CHW

Step 9: The CHW continues to call or visit MR & SR
every 2 weeks to provide Cancer Patient
Navigation Support. CHW keeps notes & logs of
these interactions.
Ms. Robinson says she’s about to
complete her treatment



During their last phone call, Ms. Robinson shared with
the CHW that she is excited to be completing the last of
her chemotherapy next week!
Step 9: CHW informs the Research RNs that MR will be
completing her treatment, and the date this will happen.
Step 10: CHW lets MR & SR know that they will receive
a visit from a study team member one-month following
the completion of MR’s treatment, as well as supplies for
one more set of saliva samples.
1-month after Ms. Robinson
completes her treatment

Ms. Robinson & Sasha receive a visit from a study
team member (the CHW or a Research RN), during
which they complete the final questionnaire packets
and receive supplies to collect final saliva samples.
Focus Groups

After completing their participation in the
Treatment Group, MR & SR may be invited to
participate in a focus group where they will be
asked what they thought about the cancer patient
navigation support they received during the study
One Month After Treatment Ends…



After completing the last of the questionnaires & saliva
samples for the study, MR & SR MIGHT be asked to
participate in an additional part of the study that involves a
couple face-to-face interviews with a Research Nurse & one
more questionnaire
The Purpose of these Interviews & Questionnaires would be
to discuss their experiences of cancer treatment and early
survivorship.
The Research Nurse will talk to MR & SR about this
opportunity and what it would mean for them if they choose
to participate.
PUTTING IT ALL TOGETHER
EXAMPLE #2:
Resource Education (RE) Group Participant
Story of John Snow
Mr. Snow (JS) is a 70-year-old man who has recently been diagnosed with
prostate cancer. His wife, Beverly (BS), heard about the study from a friend and
told Mr. Snow about it. Now they would both like to participate.
Screening, Consent,
& Baseline Data Collection




Step 1: CHW Screens John (JS) & Beverly (BS)
CHW determines JS & BS are eligible to participate
Step 2: CHW enrolls JS & BS by giving them informed
consent and having them sign consent forms
Step 3: CHW obtains Baseline Data from JS & BS
CHW instructs JS & BS on how to collect baseline saliva
samples at home; gives them proper supplies to do this
 CHW helps JS to complete Patient Questionnaire



Gives JS Patient Baseline Questionnaire Packet
CHW helps BS to complete Support Person Questionnaire

Gives BS the Support Person Baseline Questionnaire Packet
Randomization &
Assignment to Treatment Group

Step 4: CHW Randomizes JS & BS
The CHW flips the coin and determines that
JS & BS will participate in the resource
education group. (This means they will not
be receiving Cancer Patient Navigation
Support while JS is in treatment).
Given Resource Materials


Step 5: The CHW gives the participants their written
resource materials.
Since JS & BS are in the resource education (RE) group, they
will receive generic resource materials. The CHW does not
review these materials with them.
GENERIC RESOURCE
MATERIALS

Step 6: The CHW also informs JS & BS that she will be
calling them every 2 weeks to ask about JS’s progress
through cancer treatment. CHW also reminds MR & SR to
complete their first saliva samples when they get home.
Bi-Weekly Calls or
Visits from the CHW

Step 7: The CHW calls or visits JS & BS every 2
weeks to ask if they have any questions about JS’s
treatment. The CHW DOES NOT offer Cancer
Patient Navigation Support to JS & BS. This is
ensured by following a
standardized script for
interactions with these
participants.
Mr. Snow approaches the
mid-point of his treatment


Mr. Snow had a number of radioactive seeds placed by
surgeons to treat his prostate cancer 4 weeks ago. The
Research Nurse has noted that JS is mid-way through his
treatment, and lets the CHW know this.
Step 8: During this week’s call, the CHW lets JS & BS
know they will be receiving another set of
questionnaires to complete, and reminds them to send
them back to the study team.
Bi-Weekly Calls or
Visits from the CHW

Step 9: The CHW continues to call or visit JS & BS,
to check in on if they have questions about the
cancer treatment. CHW keeps notes &
logs of these interactions.
It has been almost 8 weeks since
Mr. Snow had seeds implanted



It has been 8 weeks since Mr. Snow had seeds implanted to
treat his prostate cancer. This is called, ‘brachytherapy’. The
research nurse has determined that due to the unique nature
of this treatment, 8 weeks is an appropriate amount of time
to wait for the treatment to be considered ‘complete’.
Step 9: The research nurse tells the CHW that it is almost
time for Mr. Snow and his wife to complete the posttreatment data collection.
Step 10: CHW lets Mr. & Mrs. Snow know that they will
receive a visit from a study team member to collect the last
of the study data, as well as supplies for one more set of
saliva samples.
1-month after Ms. Robinson
completes her treatment

Mr. and Mrs. Snow receive a visit from a study team
member (the CHW or a Research RN), during which
they complete the final questionnaire packets and
receive supplies to collect final saliva samples.
Offering of Navigation Post-treatment



Now that Mr. & Mrs. Snow have completed the data
collection for the study, they are offered the
opportunity to receive Navigation Support
Mr. & Mrs. Snow accept the offer
Step 11: The CHW continues to contact Mr. & Mrs.
Snow every 2 weeks, now offering Cancer
Navigation Support.
Review of Study Protocol
Congratulations! You’ve made it through the
Study Protocol for CHWs. Now let’s review.
Overview of CHW Role during Study
WHEN A PARTICIPANT IS ENROLLED IN THE STUDY (WITHIN 60 DAYS OF DIAGNOSIS):
CHW
SCREENS
PARTICIPANT
CHW
COLLECTS
BASELINE
DATA
CHW
ENROLLS
PARTICIPANT
CHW RANDOMIZES
PARTICIPANT TO
(TX) OR (RE) GROUP
TO MID-WAY THROUGH PARTICIPANTS’ CANCER TREATMENT:
CHW CALLS/VISITS
EVERY 2 WEEKS &
KEEPS NOTES
CHW COLLECTS
MID-TREATMENT DATA
FROM PARTICIPANT
TO 1-MONTH AFTER PARTICIPANTS’ CANCER TREATMENT IS COMPLETED:
CHW CALLS/VISITS
EVERY 2 WEEKS &
KEEPS NOTES
PARTICIPANT
COMPLETES HIS/HER
CANCER TREATMENT
CHW COLLECTS
1-MONTH POSTTREATMENT DATA
After Treatment is Completed

Upon completion of 1-month Post-treatment
Data Collection, two things will happen:
 Participants
who did not receive Patient Navigation
Support during the study will be offered it.
 Participants
in BOTH GROUPS may be asked to
participate in additional interviews with a Research
Nurse, and to complete one final set of questionnaires
several months later.
BOTH OPTIONS WILL BE COMPLETELY VOLUNTARY.
CHW Role



PROVIDE NAVIGATION SUPPORT (every 2 weeks)
throughout treatment for participants in the Treatment
Group
Maintain REGULAR CONTACT (every 2 weeks) with
Participants in the Resource Education Group throughout
treatment, without providing Navigation Support
COLLECT DATA by keeping detailed notes & logs of
interactions with participants throughout the study, and
by instructing participants on how to complete
questionnaires and saliva samples
Differences between TX & RE Groups
Treatment Group (TX)


Culturally-appropriate
resource materials
designed specifically
with this group in mind
CHWs WILL GIVE
Cancer Navigation
Support
Resource Education Group (RE)


Standard, generic
resource materials
CHWs WILL NOT give
Cancer Navigation
Support
What Successful Data Collection
Allows Us to Do



Determine whether this
program really works,
for who, and how
Prove that funds
supporting this research
have been used well
Obtain additional
support to continue and
expand this program to
help other elders with
cancer and those who
support them
IMPORTANT THINGS TO REPORT

For EVERY participant, regardless of which group they
have been assigned to, the following information should
be REPORTED IMMEDIATELY to the Principal Investigator
(Jennifer Wenzel):

Situations that might be hazardous to the participant or to
other study team members (For example, unsafe conditions
in the participant’s home)

Situations where the elder or the support person appear to
be in serious distress, for any reason
Purpose of Study


To test a culturally appropriate
patient navigation intervention
designed to provide support for
rural African Americans
undergoing cancer treatment.
To assess treatment completion,
stress, and economic and social
outcomes among rural African
American elderly cancer patients
randomized to one of two groups
(treatment or resource education).
Print: Healing Dance
Other Modules You Might
Want to Review After This One




Consent Procedures
Active Listening Skills & Techniques
Establishing & Maintaining Professional Boundaries
Saliva Collection Protocol
Thanks for Your Attention!
Don’t forget to take the Post-test!