Extended Cancer Education for Longer-Term Survivors in Primary Care for Patients With Stage I-II Breast or Prostate Cancer or Stage I-III Colorectal Cancer

Stage II Breast Cancer Clinical Trial

Official title:

Extended Cancer Education for Longer-Term Survivors (EXCELS) In Primary Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03233555
• Other study ID #: 131318
• Secondary ID: NCI-2017-01185Pr
• Status: Completed
• Phase: N/A
• Start date: September 3, 2013
• Est. completion date: July 31, 2022

Study information

• Verified date: August 2022
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study tests four different methods of educating patients about follow-up care (NCI facing forward, brochure, EXCELS website alone, EXCELS health coaching alone and EXCELS website & health coaching combination) after cancer treatment ends. While it is known that patients need information to guide follow-up it remains unknown how to best provide this in primary care.

Description:

PRIMARY OBJECTIVES:

I. Develop the EXCELS intervention to facilitate engaged self-management of cancer follow-up for cancer survivors.

II. Evaluate the efficacy of EXCELS intervention in a small randomized controlled trial.

III. Assess/refine intervention usability and acceptability for primary care patients.

OUTLINE:

PHASE I: EXCELS intervention is developed and assessed.

PHASE II: Participants are randomized into 1 of 4 arms.

ARM I: Participants receive National Cancer Institute's Facing Forward brochure.

ARM II: Participants have untimed access to the EXCELS mobile web application.

ARM III: Participants also receive 4 calls of 15-20 minutes each over 3 months focusing on assisting survivors with addressing challenges to receiving preventive service and health care.

ARM IV: Participants have access to EXCELS website as in Arm II. Participants also receive 4 health coaching calls as in Arm III.

Patients are followed up at 6 months, 12 months and 18 months post randomization.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 535
• Est. completion date: July 31, 2022
• Est. primary completion date: January 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

• Have been diagnosed with localized breast or prostate (stages 1-2) or colorectal cancer (stage 1-3)

• Have completed active treatment for their cancer diagnosis (excluding hormonal therapy)

• Have access to a phone for contact with health coach

• Be able to communicate in English; and be competent to consent

• Usability Testing and the randomized control trial (RCT): have access to a computer, a smartphone or an i-Pad/tablet equivalent with internet access

Exclusion Criteria:

• Patients who are required because of their disease to see primarily oncologists for follow-up will be excluded (i.e., those diagnosed with lymph node or distant metastasis, those with a new primary cancer)

Related Conditions & MeSH terms

• Breast Neoplasms
• Colorectal Neoplasms
• Prostatic Neoplasms
• Stage I Breast Cancer
• Stage I Colorectal Cancer AJCC v6 and v7
• Stage I Prostate Cancer
• Stage IA Breast Cancer
• Stage IB Breast Cancer
• Stage II Breast Cancer
• Stage II Colorectal Cancer AJCC v7
• Stage II Prostate Cancer
• Stage IIA Breast Cancer
• Stage IIA Colorectal Cancer AJCC v7
• Stage IIA Prostate Cancer
• Stage IIB Breast Cancer
• Stage IIB Colorectal Cancer AJCC v7
• Stage IIB Prostate Cancer
• Stage IIC Colorectal Cancer AJCC v7
• Stage III Colorectal Cancer AJCC v7
• Stage IIIA Colorectal Cancer AJCC v7
• Stage IIIB Colorectal Cancer AJCC v7
• Stage IIIC Colorectal Cancer AJCC v7

Intervention

Other:
• Informational Intervention
Receive brochure
• Internet-Based Intervention
Have access to EXCELS
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Behavioral:
• Telephone-Based Intervention
Receive quarterly calls

Locations

Country	Name	City	State
United States	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Use of preventive services	Preventative services will be measured using adherence to evidence based guideline care which will be computed as a percentage of the eligible guideline related services provided to each patient.	Up to 18 months