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CANCER PATIENT NAVIGATION STUDY PROTOCOL Created by: Rachel Klimmek, RN Doctoral Student & Research Nurse Johns Hopkins University School of Nursing Last.

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Presentation on theme: "CANCER PATIENT NAVIGATION STUDY PROTOCOL Created by: Rachel Klimmek, RN Doctoral Student & Research Nurse Johns Hopkins University School of Nursing Last."— Presentation transcript:

1 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

2 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)

3 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

4 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

5 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

6 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?

7 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

8 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

9 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

10 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

11 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

12 CHW ROLE DURING STUDY

13 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:

14 A STEP BY STEP GUIDE TO DATA COLLECTION, WHAT IT MEANS, AND THE COMMUNITY HEALTH WORKER (CHW) ROLE HOW CHWs WILL COLLECT DATA

15 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?

16 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

17 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

18 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)

19 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: Whats going on with participants (elders or support persons), & issues they are having that might require support.

20 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 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?)

21 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: Whats going on with participants (elders or support persons), & issues they are having that might require support.

22 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 persons Financial journals maintained by cancer patients during study WHAT 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?)

23 Example #1: Treatment Group Participant Putting It All Together

24 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)

25 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

26 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

27 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 MRs cancer treatment. CHW also reminds MR & SR to complete their first saliva samples when they get home. SPECIAL RESOURCE MATERIALS

28 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.

29 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 MRs 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.

30 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.

31 Ms. Robinson says shes 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 MRs treatment, as well as supplies for one more set of saliva samples.

32 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.

33 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

34 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.

35 EXAMPLE #2: Resource Education (RE) Group Participant PUTTING IT ALL TOGETHER

36 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

37 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

38 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).

39 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 JSs progress through cancer treatment. CHW also reminds MR & SR to complete their first saliva samples when they get home. GENERIC RESOURCE MATERIALS

40 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 JSs 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.

41 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 weeks 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.

42 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.

43 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.

44 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.

45 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.

46 Congratulations! Youve made it through the Study Protocol for CHWs. Now lets review. Review of Study Protocol

47 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:

48 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.

49 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

50 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)

51 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

52 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 participants home) Situations where the elder or the support person appear to be in serious distress, for any reason

53 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

54 Other Modules You Might Want to Review After This One Consent Procedures Active Listening Skills & Techniques Establishing & Maintaining Professional Boundaries Saliva Collection Protocol

55 Thanks for Your Attention! Dont forget to take the Post-test!


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