Trial Outcomes & Findings for Simplifying Survivorship Care Planning (NCT NCT03035773)

NCT ID: NCT03035773

Last Updated: 2024-06-27

Results Overview

The primary outcome classifies patients as compliant or non-compliant based on whether they were compliant on all visits, tests/procedures, and non-oral medication recommendations included in their care plans.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 378 participants
• Primary outcome timeframe: 18 Months
• Results posted on: 2024-06-27

Participant Flow

Participant milestones

Measure	ARM A (Care Plan Only) SCP document delivered to the patient \& Primary Care Provider Care Plan Only: Patient participants randomized to Arm A will be sent a copy of the SCP within 3 months of completion of treatment and a copy will be added to their medical record. A copy of the SCP will also be sent to the PCP on record. The SCP will be completed by a nurse, nurse practitioner, or physician assistant. The SCP will be accompanied by a cover letter that will be signed by a member of the clinical team.	ARM B (Care Plan During a Visit) SCP document provided to the patient in an in-person survivorship visit and copy sent to PCP Care Plan During a Visit: Patient participants randomized to Arm B will receive a copy of the SCP during an in-person 'stethoscope free' visit with a nurse, nurse practitioner, or physician assistant. A copy of the SCP will be added to the medical record and a copy will be sent to the primary care provider on record. The visit will be scheduled after consent is signed and will occur between 1 and 3 months after completion of treatment. The visit will focus on review of the SCP content and offer an opportunity for patients to ask questions about any aspect of the plan or associated treatment and survivorship issues.	ARM C (Care Plan During a Visit With an Additional Visit) SCP document provided to the patient in an in-person survivorship visit with an additional follow-up visit and copy of the document sent to PCP Care Plan During a Visit with an Additional Visit: Participants randomized to Arm C will receive a copy of the SCP during an in-person 'stethoscope free' visit with a nurse, nurse practitioner, or physician assistant. A copy of the SCP will be added to the medical record and a copy will be sent to the primary care provider. The visit will be scheduled after consent is signed and will occur between 1-3 months after completion of treatment. The initial visit will focus on review of the SCP content and offer an opportunity for patients to ask questions about any aspect of the plan or associated treatment and survivorship issues. Patients will also receive a follow up survivorship visit 7-10 months after the end of treatment that will focus on a review of the SCP and offer the opportunity to ask about any persistent or emerging issues.
Overall Study STARTED	126	125	127
Overall Study COMPLETED	107	105	104
Overall Study NOT COMPLETED	19	20	23

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Simplifying Survivorship Care Planning

Baseline characteristics by cohort

Measure	ARM A - Care Plan Only n=126 Participants SCP document delivered to the patient \& Primary Care Provider Care Plan Only: Patient participants randomized to Arm A will be sent a copy of the SCP within 3 months of completion of treatment and a copy will be added to their medical record. A copy of the SCP will also be sent to the PCP on record. The SCP will be completed by a nurse, nurse practitioner, or physician assistant. The SCP will be accompanied by a cover letter that will be signed by a member of the clinical team.	ARM B - Care Plan During a Visit n=125 Participants SCP document provided to the patient in an in-person survivorship visit and copy sent to PCP Care Plan During a Visit: Patient participants randomized to Arm B will receive a copy of the SCP during an in-person 'stethoscope free' visit with a nurse, nurse practitioner, or physician assistant. A copy of the SCP will be added to the medical record and a copy will be sent to the primary care provider on record. The visit will be scheduled after consent is signed and will occur between 1 and 3 months after completion of treatment. The visit will focus on review of the SCP content and offer an opportunity for patients to ask questions about any aspect of the plan or associated treatment and survivorship issues.	ARM C - Care Plan During a Visit With an Additional Visit n=127 Participants SCP document provided to the patient in an in-person survivorship visit with an additional follow-up visit and copy of the document sent to PCP Care Plan During a Visit with an Additional Visit: Participants randomized to Arm C will receive a copy of the SCP during an in-person 'stethoscope free' visit with a nurse, nurse practitioner, or physician assistant. A copy of the SCP will be added to the medical record and a copy will be sent to the primary care provider. The visit will be scheduled after consent is signed and will occur between 1-3 months after completion of treatment. The initial visit will focus on review of the SCP content and offer an opportunity for patients to ask questions about any aspect of the plan or associated treatment and survivorship issues. Patients will also receive a follow up survivorship visit 7-10 months after the end of treatment that will focus on a review of the SCP and offer the opportunity to ask about any persistent or emerging issues.	Total n=378 Participants Total of all reporting groups
Age, Continuous	63.1 years STANDARD_DEVIATION 10.6 • n=5 Participants	61.5 years STANDARD_DEVIATION 12.0 • n=7 Participants	60.8 years STANDARD_DEVIATION 12.1 • n=5 Participants	61.8 years STANDARD_DEVIATION 11.6 • n=4 Participants
Sex: Female, Male Female	62 Participants n=5 Participants	66 Participants n=7 Participants	64 Participants n=5 Participants	192 Participants n=4 Participants
Sex: Female, Male Male	64 Participants n=5 Participants	59 Participants n=7 Participants	63 Participants n=5 Participants	186 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	13 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	120 Participants n=5 Participants	122 Participants n=7 Participants	123 Participants n=5 Participants	365 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants	10 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	24 Participants n=5 Participants	28 Participants n=7 Participants	23 Participants n=5 Participants	75 Participants n=4 Participants
Race (NIH/OMB) White	97 Participants n=5 Participants	97 Participants n=7 Participants	98 Participants n=5 Participants	292 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	126 Participants n=5 Participants	125 Participants n=7 Participants	127 Participants n=5 Participants	378 Participants n=4 Participants

PRIMARY outcome

Timeframe: 18 Months

Population: The primary analysis was by intention to treat. To be included, participants had to have received an SCP and have data from 18 months of follow-up. Four patients (3 from Arm A and 1 from ARM C) were not included in the primary outcome analysis because there were no recommendations listed in their care plans.

The primary outcome classifies patients as compliant or non-compliant based on whether they were compliant on all visits, tests/procedures, and non-oral medication recommendations included in their care plans.

Outcome measures

Measure	ARM A - Care Plan Only n=104 Participants SCP document delivered to the patient \& Primary Care Provider Care Plan Only: Patient participants randomized to Arm A will be sent a copy of the SCP within 3 months of completion of treatment and a copy will be added to their medical record. A copy of the SCP will also be sent to the PCP on record. The SCP will be completed by a nurse, nurse practitioner, or physician assistant. The SCP will be accompanied by a cover letter that will be signed by a member of the clinical team.	ARM B - Care Plan During a Visit n=105 Participants SCP document provided to the patient in an in-person survivorship visit and copy sent to PCP Care Plan During a Visit: Patient participants randomized to Arm B will receive a copy of the SCP during an in-person 'stethoscope free' visit with a nurse, nurse practitioner, or physician assistant. A copy of the SCP will be added to the medical record and a copy will be sent to the primary care provider on record. The visit will be scheduled after consent is signed and will occur between 1 and 3 months after completion of treatment. The visit will focus on review of the SCP content and offer an opportunity for patients to ask questions about any aspect of the plan or associated treatment and survivorship issues.	ARM C - Care Plan During a Visit With an Additional Visit n=103 Participants SCP document provided to the patient in an in-person survivorship visit with an additional follow-up visit and copy of the document sent to PCP Care Plan During a Visit with an Additional Visit: Participants randomized to Arm C will receive a copy of the SCP during an in-person 'stethoscope free' visit with a nurse, nurse practitioner, or physician assistant. A copy of the SCP will be added to the medical record and a copy will be sent to the primary care provider. The visit will be scheduled after consent is signed and will occur between 1-3 months after completion of treatment. The initial visit will focus on review of the SCP content and offer an opportunity for patients to ask questions about any aspect of the plan or associated treatment and survivorship issues. Patients will also receive a follow up survivorship visit 7-10 months after the end of treatment that will focus on a review of the SCP and offer the opportunity to ask about any persistent or emerging issues.
Number of Participants Compliant With Follow-up Care Visits	47 Participants	53 Participants	44 Participants

SECONDARY outcome

Timeframe: 18 Months

This secondary outcome classifies participants as having had an annual physical exam based on medical record review. This outcome was operationalized as a dichotomous variable (received recommended primary care: yes/no). Participants were included in this analysis if they had a primary care visit recommended on their survivorship care plan.

Outcome measures

Measure	ARM A - Care Plan Only n=66 Participants SCP document delivered to the patient \& Primary Care Provider Care Plan Only: Patient participants randomized to Arm A will be sent a copy of the SCP within 3 months of completion of treatment and a copy will be added to their medical record. A copy of the SCP will also be sent to the PCP on record. The SCP will be completed by a nurse, nurse practitioner, or physician assistant. The SCP will be accompanied by a cover letter that will be signed by a member of the clinical team.	ARM B - Care Plan During a Visit n=56 Participants SCP document provided to the patient in an in-person survivorship visit and copy sent to PCP Care Plan During a Visit: Patient participants randomized to Arm B will receive a copy of the SCP during an in-person 'stethoscope free' visit with a nurse, nurse practitioner, or physician assistant. A copy of the SCP will be added to the medical record and a copy will be sent to the primary care provider on record. The visit will be scheduled after consent is signed and will occur between 1 and 3 months after completion of treatment. The visit will focus on review of the SCP content and offer an opportunity for patients to ask questions about any aspect of the plan or associated treatment and survivorship issues.	ARM C - Care Plan During a Visit With an Additional Visit n=61 Participants SCP document provided to the patient in an in-person survivorship visit with an additional follow-up visit and copy of the document sent to PCP Care Plan During a Visit with an Additional Visit: Participants randomized to Arm C will receive a copy of the SCP during an in-person 'stethoscope free' visit with a nurse, nurse practitioner, or physician assistant. A copy of the SCP will be added to the medical record and a copy will be sent to the primary care provider. The visit will be scheduled after consent is signed and will occur between 1-3 months after completion of treatment. The initial visit will focus on review of the SCP content and offer an opportunity for patients to ask questions about any aspect of the plan or associated treatment and survivorship issues. Patients will also receive a follow up survivorship visit 7-10 months after the end of treatment that will focus on a review of the SCP and offer the opportunity to ask about any persistent or emerging issues.
Number of Participants Who Received an Annual Physical Exam	48 Participants	40 Participants	43 Participants

SECONDARY outcome

Timeframe: 18 Months

Population: Only participants who had any tests or procedures recommended on their personalized survivorship care plan were included in the analysis

These data are generated through electronic medical record review. This outcome is operationalized as a dichotomous variable (received recommended tests and procedures: yes/no).

Outcome measures

Measure	ARM A - Care Plan Only n=104 Participants SCP document delivered to the patient \& Primary Care Provider Care Plan Only: Patient participants randomized to Arm A will be sent a copy of the SCP within 3 months of completion of treatment and a copy will be added to their medical record. A copy of the SCP will also be sent to the PCP on record. The SCP will be completed by a nurse, nurse practitioner, or physician assistant. The SCP will be accompanied by a cover letter that will be signed by a member of the clinical team.	ARM B - Care Plan During a Visit n=101 Participants SCP document provided to the patient in an in-person survivorship visit and copy sent to PCP Care Plan During a Visit: Patient participants randomized to Arm B will receive a copy of the SCP during an in-person 'stethoscope free' visit with a nurse, nurse practitioner, or physician assistant. A copy of the SCP will be added to the medical record and a copy will be sent to the primary care provider on record. The visit will be scheduled after consent is signed and will occur between 1 and 3 months after completion of treatment. The visit will focus on review of the SCP content and offer an opportunity for patients to ask questions about any aspect of the plan or associated treatment and survivorship issues.	ARM C - Care Plan During a Visit With an Additional Visit n=100 Participants SCP document provided to the patient in an in-person survivorship visit with an additional follow-up visit and copy of the document sent to PCP Care Plan During a Visit with an Additional Visit: Participants randomized to Arm C will receive a copy of the SCP during an in-person 'stethoscope free' visit with a nurse, nurse practitioner, or physician assistant. A copy of the SCP will be added to the medical record and a copy will be sent to the primary care provider. The visit will be scheduled after consent is signed and will occur between 1-3 months after completion of treatment. The initial visit will focus on review of the SCP content and offer an opportunity for patients to ask questions about any aspect of the plan or associated treatment and survivorship issues. Patients will also receive a follow up survivorship visit 7-10 months after the end of treatment that will focus on a review of the SCP and offer the opportunity to ask about any persistent or emerging issues.
Number of Participants Who Received Tests and Procedures Recommended on Their Survivorship Care Plan	82 Participants	78 Participants	73 Participants

SECONDARY outcome

Timeframe: 18 Months

Population: Only participants with a history of breast, colorectal, or prostate cancer were analyzed. The protocol specified that this analysis would be by cancer type, not study arm as surveillance tests analyzed were not specified on survivorship care plans.

This analysis compared potential overuse of surveillance tests between cancer types (breast, prostate and colorectal). This outcome will be operationalized as a dichotomous variable (did not receive inappropriate care: yes/no). The outcome relates to participants who received care not specified on their care plan and on a guideline predetermined list of "not recommended surveillance. This was determined through a physician chart review.

Outcome measures

Measure	ARM A - Care Plan Only n=137 Participants SCP document delivered to the patient \& Primary Care Provider Care Plan Only: Patient participants randomized to Arm A will be sent a copy of the SCP within 3 months of completion of treatment and a copy will be added to their medical record. A copy of the SCP will also be sent to the PCP on record. The SCP will be completed by a nurse, nurse practitioner, or physician assistant. The SCP will be accompanied by a cover letter that will be signed by a member of the clinical team.	ARM B - Care Plan During a Visit n=67 Participants SCP document provided to the patient in an in-person survivorship visit and copy sent to PCP Care Plan During a Visit: Patient participants randomized to Arm B will receive a copy of the SCP during an in-person 'stethoscope free' visit with a nurse, nurse practitioner, or physician assistant. A copy of the SCP will be added to the medical record and a copy will be sent to the primary care provider on record. The visit will be scheduled after consent is signed and will occur between 1 and 3 months after completion of treatment. The visit will focus on review of the SCP content and offer an opportunity for patients to ask questions about any aspect of the plan or associated treatment and survivorship issues.	ARM C - Care Plan During a Visit With an Additional Visit n=112 Participants SCP document provided to the patient in an in-person survivorship visit with an additional follow-up visit and copy of the document sent to PCP Care Plan During a Visit with an Additional Visit: Participants randomized to Arm C will receive a copy of the SCP during an in-person 'stethoscope free' visit with a nurse, nurse practitioner, or physician assistant. A copy of the SCP will be added to the medical record and a copy will be sent to the primary care provider. The visit will be scheduled after consent is signed and will occur between 1-3 months after completion of treatment. The initial visit will focus on review of the SCP content and offer an opportunity for patients to ask questions about any aspect of the plan or associated treatment and survivorship issues. Patients will also receive a follow up survivorship visit 7-10 months after the end of treatment that will focus on a review of the SCP and offer the opportunity to ask about any persistent or emerging issues.
Number of Participants Who Received Cancer-related Tests Consistent With Overuse	22 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 18 Months

Population: Analysis includes participants who completed the PLANS data at 18 months post baseline

PLANS is a cancer survivorship questionnaire with 2 items specifically related to survivorship care planning. These items are 'I feel prepared for what to expect over the next year' (score range 1-4 with 4 being a more positive score) and 'There is a well-coordinated plan for my cancer care' (score range 1-10 with 1 being "Not at all confident and 10 being "Extremely confident".

Outcome measures

Measure	ARM A - Care Plan Only n=71 Participants SCP document delivered to the patient \& Primary Care Provider Care Plan Only: Patient participants randomized to Arm A will be sent a copy of the SCP within 3 months of completion of treatment and a copy will be added to their medical record. A copy of the SCP will also be sent to the PCP on record. The SCP will be completed by a nurse, nurse practitioner, or physician assistant. The SCP will be accompanied by a cover letter that will be signed by a member of the clinical team.	ARM B - Care Plan During a Visit n=71 Participants SCP document provided to the patient in an in-person survivorship visit and copy sent to PCP Care Plan During a Visit: Patient participants randomized to Arm B will receive a copy of the SCP during an in-person 'stethoscope free' visit with a nurse, nurse practitioner, or physician assistant. A copy of the SCP will be added to the medical record and a copy will be sent to the primary care provider on record. The visit will be scheduled after consent is signed and will occur between 1 and 3 months after completion of treatment. The visit will focus on review of the SCP content and offer an opportunity for patients to ask questions about any aspect of the plan or associated treatment and survivorship issues.	ARM C - Care Plan During a Visit With an Additional Visit n=69 Participants SCP document provided to the patient in an in-person survivorship visit with an additional follow-up visit and copy of the document sent to PCP Care Plan During a Visit with an Additional Visit: Participants randomized to Arm C will receive a copy of the SCP during an in-person 'stethoscope free' visit with a nurse, nurse practitioner, or physician assistant. A copy of the SCP will be added to the medical record and a copy will be sent to the primary care provider. The visit will be scheduled after consent is signed and will occur between 1-3 months after completion of treatment. The initial visit will focus on review of the SCP content and offer an opportunity for patients to ask questions about any aspect of the plan or associated treatment and survivorship issues. Patients will also receive a follow up survivorship visit 7-10 months after the end of treatment that will focus on a review of the SCP and offer the opportunity to ask about any persistent or emerging issues.
Patient-reported Outcomes: Preparing for Life as a (New) Survivor (PLANS) Feel prepared for what to expect in the coming year	3.3 score on a scale Standard Deviation 0.6	3.2 score on a scale Standard Deviation 0.7	3.1 score on a scale Standard Deviation 0.7
Patient-reported Outcomes: Preparing for Life as a (New) Survivor (PLANS) There is a well-coordinated plan for your cancer care	7.7 score on a scale Standard Deviation 1.8	7.4 score on a scale Standard Deviation 2.3	7.4 score on a scale Standard Deviation 2.3

SECONDARY outcome

Timeframe: 18 Months

Population: Participants who completed Patient Reported Outcomes data at 18 months

The outcome is a sum score of a 5-item scale with a minimum score of 5 and a maximum score of 20 with a higher score indicating greater worry (worse outcome).

Outcome measures

Measure	ARM A - Care Plan Only n=71 Participants SCP document delivered to the patient \& Primary Care Provider Care Plan Only: Patient participants randomized to Arm A will be sent a copy of the SCP within 3 months of completion of treatment and a copy will be added to their medical record. A copy of the SCP will also be sent to the PCP on record. The SCP will be completed by a nurse, nurse practitioner, or physician assistant. The SCP will be accompanied by a cover letter that will be signed by a member of the clinical team.	ARM B - Care Plan During a Visit n=71 Participants SCP document provided to the patient in an in-person survivorship visit and copy sent to PCP Care Plan During a Visit: Patient participants randomized to Arm B will receive a copy of the SCP during an in-person 'stethoscope free' visit with a nurse, nurse practitioner, or physician assistant. A copy of the SCP will be added to the medical record and a copy will be sent to the primary care provider on record. The visit will be scheduled after consent is signed and will occur between 1 and 3 months after completion of treatment. The visit will focus on review of the SCP content and offer an opportunity for patients to ask questions about any aspect of the plan or associated treatment and survivorship issues.	ARM C - Care Plan During a Visit With an Additional Visit n=69 Participants SCP document provided to the patient in an in-person survivorship visit with an additional follow-up visit and copy of the document sent to PCP Care Plan During a Visit with an Additional Visit: Participants randomized to Arm C will receive a copy of the SCP during an in-person 'stethoscope free' visit with a nurse, nurse practitioner, or physician assistant. A copy of the SCP will be added to the medical record and a copy will be sent to the primary care provider. The visit will be scheduled after consent is signed and will occur between 1-3 months after completion of treatment. The initial visit will focus on review of the SCP content and offer an opportunity for patients to ask questions about any aspect of the plan or associated treatment and survivorship issues. Patients will also receive a follow up survivorship visit 7-10 months after the end of treatment that will focus on a review of the SCP and offer the opportunity to ask about any persistent or emerging issues.
Patient-reported Outcomes: Assessment of Survivor Concerns (ASC)	11.2 score on a scale Standard Deviation 3.6	11.2 score on a scale Standard Deviation 4.0	11.1 score on a scale Standard Deviation 3.5

SECONDARY outcome

Timeframe: 18 Months

Population: Analysis is of the participants who completed Patient Reported Outcomes data collection at 18 month timepoints

Questionnaire asking about informational needs on 12 topics. Responses for each question can be yes/no/not sure. Reported the total number of health needs responded to as "yes". Outcome is a sum of reported needs. Score range from 0-12 with a higher score reflecting more informational needs.

Outcome measures

Measure	ARM A - Care Plan Only n=71 Participants SCP document delivered to the patient \& Primary Care Provider Care Plan Only: Patient participants randomized to Arm A will be sent a copy of the SCP within 3 months of completion of treatment and a copy will be added to their medical record. A copy of the SCP will also be sent to the PCP on record. The SCP will be completed by a nurse, nurse practitioner, or physician assistant. The SCP will be accompanied by a cover letter that will be signed by a member of the clinical team.	ARM B - Care Plan During a Visit n=71 Participants SCP document provided to the patient in an in-person survivorship visit and copy sent to PCP Care Plan During a Visit: Patient participants randomized to Arm B will receive a copy of the SCP during an in-person 'stethoscope free' visit with a nurse, nurse practitioner, or physician assistant. A copy of the SCP will be added to the medical record and a copy will be sent to the primary care provider on record. The visit will be scheduled after consent is signed and will occur between 1 and 3 months after completion of treatment. The visit will focus on review of the SCP content and offer an opportunity for patients to ask questions about any aspect of the plan or associated treatment and survivorship issues.	ARM C - Care Plan During a Visit With an Additional Visit n=69 Participants SCP document provided to the patient in an in-person survivorship visit with an additional follow-up visit and copy of the document sent to PCP Care Plan During a Visit with an Additional Visit: Participants randomized to Arm C will receive a copy of the SCP during an in-person 'stethoscope free' visit with a nurse, nurse practitioner, or physician assistant. A copy of the SCP will be added to the medical record and a copy will be sent to the primary care provider. The visit will be scheduled after consent is signed and will occur between 1-3 months after completion of treatment. The initial visit will focus on review of the SCP content and offer an opportunity for patients to ask questions about any aspect of the plan or associated treatment and survivorship issues. Patients will also receive a follow up survivorship visit 7-10 months after the end of treatment that will focus on a review of the SCP and offer the opportunity to ask about any persistent or emerging issues.
Patient-reported Outcomes: Follow-up Care Use Among Survivors (FOCUS)-Information Needs Module	3.7 units on a scale Standard Deviation 3.4	3.8 units on a scale Standard Deviation 3.6	3.9 units on a scale Standard Deviation 3.7

Adverse Events

ARM A - Care Plan Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

ARM B - Care Plan During a Visit

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

ARM C - Care Plan During a Visit an Additional Visit

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Katherine C. Smith

Johns Hopkins School of Public Health/SKCCC

Phone: 443.927.3350

Email: ksmit103@jhu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place