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Simplifying Survivorship Care Planning (SSCP)

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ClinicalTrials.gov Identifier: NCT03035773
Recruitment Status : Recruiting
First Posted : January 30, 2017
Last Update Posted : September 11, 2018
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary:
OBJECTIVE: The purpose of this study is to identify an SCP process that is patient-centered, effective in promoting appropriate survivorship care and can be successfully implemented for patients with different types of cancer who are being treated in a broad range of clinical settings. There is a need for research related to SCP that prioritizes outcomes that are most highly valued by patients, caregivers and clinical stakeholders.

Condition or disease Intervention/treatment Phase
Cancer Behavioral: Care Plan Only Behavioral: Care Plan During a Visit Behavioral: Care Plan During a Visit with an Additional Visit Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 375 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Simplifying Survivorship Care Planning; Comparing the Efficacy and Patient-Centeredness of Three Care Delivery Models
Study Start Date : October 2015
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Arm Intervention/treatment
Experimental: ARM A
SCP document delivered to the patient & Primary Care Provider
Behavioral: 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.

Experimental: ARM B
SCP document provided to the patient in an in-person survivorship visit and copy sent to PCP
Behavioral: 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.

Experimental: ARM C
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
Behavioral: 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.




Primary Outcome Measures :
  1. Receipt of appropriate cancer-related follow-up care [ Time Frame: 18 Months ]
    The primary endpoint of this study will be the proportion of patients who receive appropriate cancer-related follow-up care (based on the individual's SCP). The outcome will be operationalized as a dichotomous variable (received recommended care: yes/no). This endpoint will be used to determine the preferable delivery modality (study arm).


Secondary Outcome Measures :
  1. Receipt of appropriate primary care [ Time Frame: 18 Months ]
    This outcome will be operationalized as a dichotomous variable (received recommended primary care: yes/no).

  2. Receipt of appropriate preventive care [ Time Frame: 18 Months ]
    This outcome will be operationalized as a dichotomous variable (received recommended preventive care: yes/no).

  3. Not receiving tests that are not recommended [ Time Frame: 18 Months ]
    This outcome will be operationalized as a dichotomous variable (did not receive inappropriate care: yes/no).

  4. Receipt of individual care services. [ Time Frame: 18 Months ]
    For example, the primary dichotomous outcome for colorectal cancer patients may include receipt of colonoscopy and CEA testing; we will examine receipt of each of those services separately. Each of these outcomes will be operationalized as a dichotomous variable (received colonoscopy: yes/no).

  5. Patient-reported Outcomes: Preparing for Life as a (New) Survivor (PLANS) [ Time Frame: 18 Months ]

    Scores will be compared at different timepoints for the assessment:

    Preparing for Life as a (New) Survivor (PLANS): 11 knowledge items rated on a 4-point Likert scale that was developed at the University of Michigan and was used by our team in a previous survivorship care planning evaluation (Dunn, R., Crowley, S., & Janz, N., 2011; Smith et al., 2016).


  6. Patient-reported Outcomes: Assessment of Survivor Concerns (ASC) [ Time Frame: 18 Months ]

    Scores will be compared at different timepoints for the assessment:

    Assessment of Survivor Concerns (ASC): a 5-item questionnaire that assesses two subscales: cancer worry and general health worry (Gotay, C. C., & Pagano, I. S., 2007; Hershman, D. L., et al., 2013).


  7. Patient-reported Outcomes: Follow-up Care Use among Survivors (FOCUS)-Information Needs Module [ Time Frame: 18 Months ]

    Scores will be compared at different timepoints for the assessment:

    Follow-up Care Use among Survivors (FOCUS)-Information Needs Module (Kent, E. E., et al., 2012): an information needs questionnaire that asks about the need for information regarding 12 topics; developed by the National Cancer Institute based on previously published information needs questionnaires (Beckjord, E. B., et al., 2008; Mallinger, et al., 2005; Nelson, et al., 2004).




Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 21 years or older;
  • Diagnosed with breast, colorectal, or prostate cancer (stages I-III);
  • Treated with intent to cure
  • People who are on long-term (>1 year) chronic treatment are eligible;
  • No evidence of disease;
  • Able to complete the study data collection in English;
  • Had their cancer care primarily managed by either JHMI or PRMC, with JHMI or PRMC primarily responsible for the patients' survivorship care; and
  • Has private insurance, or covered by Medicare or Medicaid.

Exclusion Criteria:

  • Younger than 21 years of age;
  • Diagnosed with in situ or metastatic breast, prostate or colorectal cancer (i.e. Stage 0 or IV);
  • Not treated with intent to cure;
  • Did not have cancer care primarily managed within one of the 4 participating clinics, or JHMI or PRMC is not primarily responsible for the patients' survivorship care; and
  • Does not have health insurance at screening.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03035773


Contacts
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Contact: Elliott Tolbert, PhD (410) 955-9867 etolber2@jhmi.edu
Contact: Katherine C Smith, PhD (410) 502-3715 ksmit103@jhu.edu

Locations
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United States, Maryland
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21231
Contact: Amy Goodrich, CRNP    410-614-5540    GOODRAM@jhmi.edu   
Peninsula Regional Medical Center Recruiting
Salisbury, Maryland, United States, 21801
Contact: Thomas DeMarco, MD    410-912-6307    thomas.demarco@peninsula.org   
Contact: Nancy Mayonado, MS    410-912-6307    NANCY.MAYONADO@peninsula.org   
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Katherine C Smith, PhD Johns Hopkins Bloomberg School of Public Health

Publications:
Dunn, R., Crowley, S., & Janz, N. (2011). Impact of a transition visit on addressing quality of life and readiness to assume greater self-management among breast cancer survivors. Psycho-Oncology, 20(S1), S91.
Hewitt, M., Greenfield, S., & Stovall, E. (Eds.). (2005). From cancer patient to cancer survivor: lost in transition. National Academies Press.

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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT03035773     History of Changes
Other Study ID Numbers: J16117
IRB00110605 ( Other Identifier: JHMIRB )
R-1410-24904 ( Other Grant/Funding Number: Patient-Centered Outcomes Research Institution )
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
Oncology
Survivorship