Trials / Completed
CompletedNCT03233555
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
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 535 (estimated)
- Sponsor
- Rutgers, The State University of New Jersey · Academic / Other
- Sex
- All
- Age
- 30 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- 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
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Informational Intervention | Receive brochure |
| OTHER | Internet-Based Intervention | Have access to EXCELS |
| OTHER | Quality-of-Life Assessment | Ancillary studies |
| OTHER | Questionnaire Administration | Ancillary studies |
| BEHAVIORAL | Telephone-Based Intervention | Receive quarterly calls |
Timeline
- Start date
- 2013-09-03
- Primary completion
- 2020-01-15
- Completion
- 2022-07-31
- First posted
- 2017-07-28
- Last updated
- 2022-08-29
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT03233555. Inclusion in this directory is not an endorsement.