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

Not Applicable

Completed

• Conditions: Stage I Breast Cancer; Stage I Prostate Cancer; Stage IA Breast Cancer; Stage IB Breast Cancer; Stage II Colorectal Cancer AJCC v7; Stage II Prostate Cancer; Stage IIC Colorectal Cancer AJCC v7; Stage I Colorectal Cancer AJCC v6 and v7; Stage IIA Breast Cancer; Stage IIB Colorectal Cancer AJCC v7
• Interventions: Other: Internet-Based Intervention; Other: Informational Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Behavioral: Telephone-Based Intervention

• Registration Number: NCT03233555
• Lead Sponsor: Rutgers, The State University of New Jersey

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.

Study Timeline

• Study Start: 2013-09-03
• Study First Submitted: 2017-07-19
• Study First Submitted QC: 2017-07-25
• Study First Posted: 2017-07-28
• Primary Completion: 2020-01-15
• Study Completion: 2022-07-31
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-23
• Last Update Posted: 2022-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 535

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I (brochure)	Quality-of-Life Assessment	Participants receive National Cancer Institute's Facing Forward brochure.
Arm IV (EXCELS website, health coaching calls)	Quality-of-Life Assessment	Participants have access to EXCELS as in Arm II. Participants also receive 4 calls as in Arm III.
Arm II (EXCELS website)	Internet-Based Intervention	Participants have untimed access to the EXCELS mobile web application.
Arm II (EXCELS website)	Quality-of-Life Assessment	Participants have untimed access to the EXCELS mobile web application.
Arm IV (EXCELS website, health coaching calls)	Telephone-Based Intervention	Participants have access to EXCELS as in Arm II. Participants also receive 4 calls as in Arm III.
Arm III (Healthcare coaching call)	Telephone-Based Intervention	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.
Arm I (brochure)	Informational Intervention	Participants receive National Cancer Institute's Facing Forward brochure.
Arm IV (EXCELS website, health coaching calls)	Questionnaire Administration	Participants have access to EXCELS as in Arm II. Participants also receive 4 calls as in Arm III.
Arm IV (EXCELS website, health coaching calls)	Internet-Based Intervention	Participants have access to EXCELS as in Arm II. Participants also receive 4 calls as in Arm III.
Arm I (brochure)	Questionnaire Administration	Participants receive National Cancer Institute's Facing Forward brochure.
Arm II (EXCELS website)	Questionnaire Administration	Participants have untimed access to the EXCELS mobile web application.
Arm III (Healthcare coaching call)	Quality-of-Life Assessment	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.
Arm III (Healthcare coaching call)	Questionnaire Administration	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.

Primary Outcome Measures

Name	Time	Method
Use of preventive services	Up to 18 months	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.

Trial Locations

Locations (2)

Rutgers Cancer Institute of New Jersey; 🇺🇸 New Brunswick, New Jersey, United States

Fox Chase Cancer Center; 🇺🇸 Philadelphia, Pennsylvania, United States