cancer patient navigation study protocol created by: rachel klimmek, rn doctoral student &...
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CANCER PATIENT NAVIGATION STUDY PROTOCOLCreated 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 (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!
COMMUNITY HEALTH WORKERS
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
CHW SCREENS
PARTICIPANT
CHW ENROLLS
PARTICIPANT
CHW COLLECTS BASELINE
DATA
CHW RANDOMIZES PARTICIPANT TO
(TX) OR (RE) GROUP
CHW COLLECTS MID-TREATMENT
DATA FROM PARTICIPANT
PARTICIPANT COMPLETES
HIS/HER CANCER TREATMENT
CHW CALLS/VISITS EVERY 2 WEEKS &
KEEPS NOTES
CHW CALLS/VISITS EVERY 2 WEEKS &
KEEPS NOTES
CHW COLLECTS 1-MONTH POST-
TREATMENT DATA
WHEN A PARTICIPANT IS ENROLLED IN THE STUDY (WITHIN 60 DAYS OF DIAGNOSIS):
TO MID-WAY THROUGH PARTICIPANTS’ CANCER TREATMENT:
TO 1-MONTH AFTER PARTICIPANTS’ CANCER TREATMENT IS COMPLETED:
A STEP BY STEP GUIDE TO DATA COLLECTION, WHAT IT MEANS, AND THE
COMMUNITY HEALTH WORKER (CHW) ROLE
HOW CHWs WILL COLLECT DATA
SCREENING DATA
CHW SCREENS
PARTICIPANTS
WHEN A PARTICIPANT IS ENROLLED IN THE STUDY (WITHIN 60 DAYS OF DIAGNOSIS):
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
CHW SCREENS
PARTICIPANT
CHW ENROLLS
PARTICIPANT
CHW COLLECTS BASELINE
DATA
WHEN A PARTICIPANT IS ENROLLED IN THE STUDY (WITHIN 60 DAYS OF DIAGNOSIS):
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
CHW SCREENS
PARTICIPANT
CHW ENROLLS
PARTICIPANT
CHW COLLECTS BASELINE
DATA
CHW RANDOMIZES PARTICIPANT TO
(TX) OR (RE) GROUP
WHEN A PARTICIPANT IS ENROLLED IN THE STUDY (WITHIN 60 DAYS OF DIAGNOSIS):
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
Culturally-appropriate resource materials designed specifically with this group in mind
CHWs WILL GIVE Cancer Navigation Support
Standard, generic resource materials
CHWs WILL NOT give Cancer Navigation Support
Treatment Group (TX) Resource Education Group (RE)
CHW CONTACTS EVERY 2 WEEKS
CHW SCREENS
PARTICIPANT
CHW ENROLLS
PARTICIPANT
CHW COLLECTS BASELINE
DATA
CHW RANDOMIZES PARTICIPANT TO
(TX) OR (RE) GROUP
CHW CALLS/VISITS EVERY 2 WEEKS &
KEEPS NOTES
WHEN A PARTICIPANT IS ENROLLED IN THE STUDY (WITHIN 60 DAYS OF DIAGNOSIS):
TO MID-WAY THROUGH PARTICIPANTS’ CANCER TREATMENT:TYPES OF DATA CHW WILL HELP TO COLLECT: CHWs will keep logs of their calls or visits with participants in the TX and RE groups. These visits or calls will occur every 2 weeks from the time a participant enrolls in the study until they complete their cancer treatment. More about how 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
CHW SCREENS
PARTICIPANT
CHW ENROLLS
PARTICIPANT
CHW COLLECTS BASELINE
DATA
CHW RANDOMIZES PARTICIPANT TO
(TX) OR (RE) GROUP
CHW COLLECTS MID-TREATMENT
DATA FROM PARTICIPANT
CHW CALLS/VISITS EVERY 2 WEEKS &
KEEPS NOTES
WHEN A PARTICIPANT IS ENROLLED IN THE STUDY (WITHIN 60 DAYS OF DIAGNOSIS):
TO MID-WAY THROUGH PARTICIPANTS’ CANCER TREATMENT:TIMING: Will occur mid-way through a participants’ cancer treatment, as determined by research RNs TYPES OF DATA CHW WILL HELP TO COLLECT: Questionnaires completed by elders & their support personsWHAT 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
CHW SCREENS
PARTICIPANT
CHW ENROLLS
PARTICIPANT
CHW COLLECTS BASELINE
DATA
CHW RANDOMIZES PARTICIPANT TO
(TX) OR (RE) GROUP
CHW COLLECTS MID-TREATMENT
DATA FROM PARTICIPANT
CHW CALLS/VISITS EVERY 2 WEEKS &
KEEPS NOTES
CHW CALLS/VISITS EVERY 2 WEEKS &
KEEPS NOTES
WHEN A PARTICIPANT IS ENROLLED IN THE STUDY (WITHIN 60 DAYS OF DIAGNOSIS):
TO MID-WAY THROUGH PARTICIPANTS’ CANCER TREATMENT:
TO 1-MONTH AFTER PARTICIPANTS’ CANCER TREATMENT IS COMPLETED:
TYPES OF DATA CHW WILL HELP TO COLLECT: CHWs will continue to keep logs of their calls or visits to study participants after participants have completed mid-treatment questionnaires. These calls/visits will continue to occur every 2 weeks until the participant completes his or her cancer treatment.
WHAT DATA TELLS US: What’s going on with participants (elders or support persons), & issues they are having that might require support.
1-MONTH POST-TREATMENT DATA
CHW SCREENS
PARTICIPANT
CHW ENROLLS
PARTICIPANT
CHW COLLECTS BASELINE
DATA
CHW RANDOMIZES PARTICIPANT TO
(TX) OR (RE) GROUP
CHW COLLECTS MID-TREATMENT
DATA FROM PARTICIPANT
PARTICIPANT COMPLETES
HIS/HER CANCER TREATMENT
CHW CALLS/VISITS EVERY 2 WEEKS &
KEEPS NOTES
CHW CALLS/VISITS EVERY 2 WEEKS &
KEEPS NOTES
CHW COLLECTS 1-MONTH POST-
TREATMENT DATA
WHEN A PARTICIPANT IS ENROLLED IN THE STUDY (WITHIN 60 DAYS OF DIAGNOSIS):
TO MID-WAY THROUGH PARTICIPANTS’ CANCER TREATMENT:
TO 1-MONTH AFTER PARTICIPANTS’ CANCER TREATMENT IS COMPLETED:
TIMING: Will occur one month after a participant has completed their cancer treatment (as determined by the research RNs)
TYPES OF DATA CHW WILL HELP TO COLLECT: Questionnaires completed by elders & their support personsFinancial journals maintained by cancer patients during studyWHAT DATA TELLS US: • Participants’ Levels of Physical Health, Anxiety or
Depression, Health Literacy, Social Support, Functional Status & Quality of Life, & out of pocket costs during treatment
(How did things turn out?)
Example #1:Treatment Group Participant
Putting It All Together
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.
Marian Robinson (MR) and her daughter Sasha (SR)
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.
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.
SPECIAL RESOURCE MATERIALS
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.
EXAMPLE #2:Resource Education (RE) Group Participant
PUTTING IT ALL TOGETHER
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.
Story of John Snow
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.
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.
GENERIC RESOURCE MATERIALS
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 post-treatment 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.
Congratulations! You’ve made it through the Study Protocol for CHWs. Now let’s review.
Review of Study Protocol
Overview of CHW Role during Study
CHW SCREENS
PARTICIPANT
CHW ENROLLS
PARTICIPANT
CHW COLLECTS BASELINE
DATA
CHW RANDOMIZES PARTICIPANT TO
(TX) OR (RE) GROUP
CHW COLLECTS MID-TREATMENT
DATA FROM PARTICIPANT
PARTICIPANT COMPLETES
HIS/HER CANCER TREATMENT
CHW CALLS/VISITS EVERY 2 WEEKS &
KEEPS NOTES
CHW CALLS/VISITS EVERY 2 WEEKS &
KEEPS NOTES
CHW COLLECTS 1-MONTH POST-
TREATMENT DATA
WHEN A PARTICIPANT IS ENROLLED IN THE STUDY (WITHIN 60 DAYS OF DIAGNOSIS):
TO MID-WAY THROUGH PARTICIPANTS’ CANCER TREATMENT:
TO 1-MONTH AFTER PARTICIPANTS’ CANCER TREATMENT IS COMPLETED:
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
Culturally-appropriate resource materials designed specifically with this group in mind
CHWs WILL GIVE Cancer Navigation Support
Standard, generic resource materials
CHWs WILL NOT give Cancer Navigation Support
Treatment Group (TX) Resource Education Group (RE)
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!