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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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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 / Treatment
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* Other: Informational Intervention
* Other: Internet-Based Intervention
* Other: Quality-of-Life Assessment
* Other: Questionnaire Administration
* Behavioral: Telephone-Based Intervention


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm I (brochure)<br>Participants receive National Cancer Institute's Facing Forward brochure. | Other: Informational Intervention<br>* Receive brochure<br>Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Experimental: Arm II (EXCELS website)<br>Participants have untimed access to the EXCELS mobile web application. | Other: Internet-Based Intervention<br>* Have access to EXCELS<br>Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Experimental: Arm III (Healthcare coaching call)<br>Participants also receive 4 quarterly calls of 15-20 minutes each over 3 months. These calls focus on checking if patients have received preventive and cancer related follow-up care. | Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>Behavioral: Telephone-Based Intervention<br>* Receive quarterly calls<br>|
| Experimental: Arm IV (EXCELS website, health coaching calls)<br>Participants have access to EXCELS as in Arm II. Participants also receive 4 calls as in Arm III. | Other: Internet-Based Intervention<br>* Have access to EXCELS<br>Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>Behavioral: Telephone-Based Intervention<br>* Receive quarterly calls<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |