CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 378 enrolled
Drug / intervention
Care Plan Only +2 morebehavioral
Likely dose
Not stated in record
Key inclusion· 6
  • Age 21 years or older
  • Diagnosed with breast, colorectal, or prostate cancer (stages I-III)
  • Treated with intent to cure
  • No evidence of disease
Key exclusion· 5
  • Younger than 21 years of age
  • In situ (Stage 0) or metastatic (Stage IV) disease
  • Not treated with curative intent
  • Cancer care not primarily managed within participating clinics or those institutions not primarily responsible for survivorship care

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03035773
NCT03035773N/ACompleted

Simplifying Survivorship Care Planning; Comparing the Efficacy and Patient-Centeredness of Three Care Delivery Models

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins·interventional·Posted Jan 30, 2017·Updated Jun 27, 2024

In Brief

A clinical study evaluating Care Plan Only, Care Plan During a Visit, and 1 other intervention for Cancer. Completed, enrolled 378 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCancer
CountriesUnited States

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 30, 2017
Enrollment StartOct 1, 2015
Primary CompletionDec 1, 2020
Study CompletionMar 31, 2021
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 9.4 years ago

Interventions

Care Plan Onlybehavioral

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.

Care Plan During a Visitbehavioral

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.

Care Plan During a Visit with an Additional Visitbehavioral

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.