N/A
N=378
Simplifying Survivorship Care Planning
Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03035773 ↗Enrolled (actual)
378
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcome: Primary: Number of Participants Compliant With Follow-up Care Visits — 47; 53; 44 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Care Plan Only (Behavioral); Care Plan During a Visit (Behavioral); Care Plan During a Visit with an Additional Visit (Behavioral)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Compliant With Follow-up Care Visits |
47; 53; 44 | — |
| SECONDARY Number of Participants Who Received an Annual Physical Exam |
48; 40; 43 | — |
| SECONDARY Number of Participants Who Received Tests and Procedures Recommended on Their Survivorship Care Plan |
82; 78; 73 | — |
| SECONDARY Number of Participants Who Received Cancer-related Tests Consistent With Overuse |
22; 0; 1 | — |
| SECONDARY Patient-reported Outcomes: Preparing for Life as a (New) Survivor (PLANS) |
3.3; 3.2; 3.1; 7.7; 7.4; 7.4 | — |
| SECONDARY Patient-reported Outcomes: Assessment of Survivor Concerns (ASC) |
11.2; 11.2; 11.1 | — |
| SECONDARY Patient-reported Outcomes: Follow-up Care Use Among Survivors (FOCUS)-Information Needs Module |
3.7; 3.8; 3.9 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT03035773). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.