Simplifying Survivorship Care Planning

NCT03035773 | Completed Results

• 3 other identifiers: J16117IRB00110605R-1410-24904
• Study Type: interventional
• Target: 378
• Locations: 1 country
• Sites: 2

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.

Conditions

Cancer

Keywords

Oncology; Survivorship

Outcome Measures

Primary Outcomes (1)

• Number of Participants Compliant With Follow-up Care Visits

  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.

  18 Months

Secondary Outcomes (6)

• Number of Participants Who Received an Annual Physical Exam

  18 Months

• Number of Participants Who Received Tests and Procedures Recommended on Their Survivorship Care Plan

  18 Months

• Number of Participants Who Received Cancer-related Tests Consistent With Overuse

  18 Months

• Patient-reported Outcomes: Preparing for Life as a (New) Survivor (PLANS)

  18 Months

• Patient-reported Outcomes: Assessment of Survivor Concerns (ASC)

  18 Months

Study Arms (3)

ARM A; Care Plan Only

EXPERIMENTAL

SCP document delivered to the patient \& Primary Care Provider

Behavioral: Care Plan Only

ARM B; Care Plan During Visit

EXPERIMENTAL

SCP document provided to the patient in an in-person survivorship visit and copy sent to PCP

Behavioral: Care Plan During a Visit

ARM C; Care Plan During Visit + Additional Visit

EXPERIMENTAL

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

Interventions

Care Plan Only BEHAVIORAL

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.

Also known as: Arm A

ARM A; Care Plan Only

Care Plan During a Visit BEHAVIORAL

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.

Also known as: Arm B

ARM B; Care Plan During Visit

Care Plan During a Visit with an Additional Visit BEHAVIORAL

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.

Also known as: Arm C

ARM C; Care Plan During Visit + Additional Visit

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (2)

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231, United States

Location

Peninsula Regional Medical Center

Salisbury, Maryland, 21801, United States

Location

Related Publications (9)

• Beckjord EB, Arora NK, McLaughlin W, Oakley-Girvan I, Hamilton AS, Hesse BW. Health-related information needs in a large and diverse sample of adult cancer survivors: implications for cancer care. J Cancer Surviv. 2008 Sep;2(3):179-89. doi: 10.1007/s11764-008-0055-0. Epub 2008 Jun 3.

  PMID: 18792791 BACKGROUND

• 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.

  BACKGROUND

• Gotay CC, Pagano IS. Assessment of Survivor Concerns (ASC): a newly proposed brief questionnaire. Health Qual Life Outcomes. 2007 Mar 13;5:15. doi: 10.1186/1477-7525-5-15.

  PMID: 17352831 BACKGROUND

• Hershman DL, Greenlee H, Awad D, Kalinsky K, Maurer M, Kranwinkel G, Brafman L, Jayasena R, Tsai WY, Neugut AI, Crew KD. Randomized controlled trial of a clinic-based survivorship intervention following adjuvant therapy in breast cancer survivors. Breast Cancer Res Treat. 2013 Apr;138(3):795-806. doi: 10.1007/s10549-013-2486-1. Epub 2013 Mar 31.

  PMID: 23542954 BACKGROUND

• Hewitt, M., Greenfield, S., & Stovall, E. (Eds.). (2005). From cancer patient to cancer survivor: lost in transition. National Academies Press.

  BACKGROUND

• Kent EE, Arora NK, Rowland JH, Bellizzi KM, Forsythe LP, Hamilton AS, Oakley-Girvan I, Beckjord EB, Aziz NM. Health information needs and health-related quality of life in a diverse population of long-term cancer survivors. Patient Educ Couns. 2012 Nov;89(2):345-52. doi: 10.1016/j.pec.2012.08.014. Epub 2012 Sep 28.

  PMID: 23021856 BACKGROUND

• Mallinger JB, Griggs JJ, Shields CG. Patient-centered care and breast cancer survivors' satisfaction with information. Patient Educ Couns. 2005 Jun;57(3):342-9. doi: 10.1016/j.pec.2004.09.009.

  PMID: 15893218 BACKGROUND

• Nelson DE, Kreps GL, Hesse BW, Croyle RT, Willis G, Arora NK, Rimer BK, Viswanath KV, Weinstein N, Alden S. The Health Information National Trends Survey (HINTS): development, design, and dissemination. J Health Commun. 2004 Sep-Oct;9(5):443-60; discussion 81-4. doi: 10.1080/10810730490504233.

  PMID: 15513791 BACKGROUND

• Smith KC, Tolbert E, Hannum SM, Radhakrishnan A, Zorn K, Blackford A, Greco S, Smith K, Snyder CF. Comparing Web-Based Provider-Initiated and Patient-Initiated Survivorship Care Planning for Cancer Patients: A Randomized Controlled Trial. JMIR Cancer. 2016 Aug 30;2(2):e12. doi: 10.2196/cancer.5947.

  PMID: 28410187 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Results Point of Contact

• Title: Dr. Katherine C. Smith
• Organization: Johns Hopkins School of Public Health/SKCCC

ksmit103@jhu.edu

443.927.3350

Study Officials

• Katherine C Smith, PhD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2016
• First Posted: January 30, 2017
• Study Start: October 1, 2015
• Primary Completion: December 1, 2020
• Study Completion: March 31, 2021
• Last Updated: June 27, 2024
• Results First Posted: June 27, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)