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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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03233555
Enrollment
535
Registered
2017-07-28
Start date
2013-09-03
Completion date
2022-07-31
Last updated
2022-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stage IA Breast Cancer, Stage IB Breast Cancer, Stage I Breast Cancer, Stage I Colorectal Cancer AJCC v6 and v7, 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 II Breast Cancer, Stage IIC Colorectal Cancer AJCC v7, Stage II Colorectal Cancer AJCC v7, Stage IIIA Colorectal Cancer AJCC v7, Stage IIIB Colorectal Cancer AJCC v7, Stage IIIC Colorectal Cancer AJCC v7, Stage III Colorectal Cancer AJCC v7, Stage II Prostate Cancer, Stage I Prostate Cancer

Brief 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.

Detailed 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.

Interventions

OTHERInternet-Based Intervention

Have access to EXCELS

OTHERQuality-of-Life Assessment

Ancillary studies

OTHERQuestionnaire Administration

Ancillary studies

OTHERInformational Intervention

Receive brochure

BEHAVIORALTelephone-Based Intervention

Receive quarterly calls

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Use of preventive servicesUp to 18 monthsPreventative 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026