Patient and Provider Initiated Survivorship Care Planning

NCT02405819 | Completed

• 2 other identifiers: J14178IRB00057614
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 2

Brief Summary

Objective: to describe and compare the implementation of two cancer survivorship care tools: (1) 'My Care Plan': a patient-initiated tool and (2) 'Survivorship Care Plan Builder': a provider-initiated tool. The results of this study will be used to (1) provide an initial assessment of the two survivorship care planning tools and (2) inform the design and conduct of a larger study.

Conditions

Cancer

Keywords

Cancer; Oncology; Survivorship; Care; Plan

Outcome Measures

Primary Outcomes (1)

• Patient in receipt of a complete survivorship care plan

  As this study explores the feasibility of the survivorship care planning process, the primary outcome measure is whether or not the patient receives a complete survivorship care plan.

  16 weeks

Secondary Outcomes (2)

• Change in score for the CaSUN (Cancer Survivors' Unmet Needs) assessment tool

  16 weeks

• Change in score on the PLANS (Preparing for Life as a New Survivor) assessment tool

  16 weeks

Study Arms (2)

Patient Directed

OTHER

We will collect baseline data, including sociodemographic information for the patients and an assessment of each patient's baseline supportive care needs and knowledge about survivorship care. Sociodemographic information will be self completed. All other data collection will be interviewer administered. The instruments used at baseline and follow-up are adapted from previously published surveys (Hodgkinson et al, 2007; Sprague et al, 2013; Griggs et al). The research team will direct patients to their assigned condition by providing a hand-out directing them to the planning tool. After 2 months, we will re-contact all randomized patients to determine whether the survivorship care planning occurred as intended.

Other: 'My Care Plan'

Clinician Directed

OTHER

We will collect baseline data, including sociodemographic information for the patients and an assessment of each patient's baseline supportive care needs and knowledge about survivorship care. Sociodemographic information will be self completed. All other data collection will be interviewer administered. The instruments used at baseline and follow-up are adapted from previously published surveys (Hodgkinson et al, 2007; Sprague et al, 2013; Griggs et al). The provider will be provided a hand-out with their patient's assigned condition and is responsible for implementing the survivorship care plan process. After 2 months, we will re-contact all randomized patients to determine whether the survivorship care planning occurred as intended.

Other: 'Survivorship Care Plan Builder'

Interventions

'My Care Plan' OTHER

'My Care Plan' is a patient-initiated survivorship care planning tool.

Patient Directed

'Survivorship Care Plan Builder' OTHER

'Survivorship Care Plan Builder' is a provider-initiated survivorship care planning tool.

Clinician Directed

Eligibility Criteria

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

You may qualify if:

• Have you diagnosed with non-metastatic (i.e., stages I - III) cancer (non-melanoma skin cancer)
• Have you completed acute treatment with intent to cure within the past 2 months (ongoing long-term maintenance therapy such as adjuvant hormonal therapy is allowed)
• What clinician primarily managed your cancer treatment? (must be a participating Sibley or Suburban clinician)

You may not qualify if:

• \. Do you show any evidence of disease?

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• Genentech, Inc.: collaborator
• WellPoint, Inc.: collaborator

Study Sites (2)

Sibley Memorial Hospital

Washington D.C., District of Columbia, 20016, United States

Location

Suburban Hospital

Bethesda, Maryland, 20814, United States

Location

Related Publications (4)

• Griggs, J. et al. PLANS ("Preparing for Life as a New Survivor")

  BACKGROUND

• Hodgkinson K, Butow P, Hunt GE, Pendlebury S, Hobbs KM, Lo SK, Wain G. The development and evaluation of a measure to assess cancer survivors' unmet supportive care needs: the CaSUN (Cancer Survivors' Unmet Needs measure). Psychooncology. 2007 Sep;16(9):796-804. doi: 10.1002/pon.1137.

  PMID: 17177268 BACKGROUND

• Sprague BL, Dittus KL, Pace CM, Dulko D, Pollack LA, Hawkins NA, Geller BM. Patient satisfaction with breast and colorectal cancer survivorship care plans. Clin J Oncol Nurs. 2013 Jun;17(3):266-72. doi: 10.1188/13.CJON.17-03AP.

  PMID: 23722604 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 DERIVED

Related Links

• Journey Forward is a cancer survivorship program for healthcare providers and patients who have finished active treatment.

MeSH Terms

Conditions

Neoplasms; Neuroaxonal Dystrophies

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Katherine C Smith, Ph.D.

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

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: March 13, 2015
• First Posted: April 1, 2015
• Study Start: February 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: April 21, 2016

Record last verified: 2015-11

Locations

US (2)