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

• ClinicalTrials.gov Identifier: NCT03233555
• Recruitment Status: Recruiting
• First Posted: July 28, 2017
• Last Update Posted: August 26, 2019
• Sponsor: Rutgers, The State University of New Jersey
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Rutgers, The State University of New Jersey

Study Description

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.

Condition or disease	Intervention/treatment	Phase
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	Other: Informational Intervention; Other: Internet-Based Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Behavioral: Telephone-Based Intervention	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 535 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Extended Cancer Education for Longer-Term Survivors (EXCELS) In Primary Care
• Actual Study Start Date: September 3, 2013
• Estimated Primary Completion Date: July 31, 2022
• Estimated Study Completion Date: July 31, 2022

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Arm I (brochure); Participants receive National Cancer Institute's Facing Forward brochure.	Other: Informational Intervention; Receive brochure; Other: Quality-of-Life Assessment; Ancillary studies; Other Name: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies
Experimental: Arm II (EXCELS website); Participants have untimed access to the EXCELS mobile web application.	Other: Internet-Based Intervention; Have access to EXCELS; Other: Quality-of-Life Assessment; Ancillary studies; Other Name: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies
Experimental: Arm III (Healthcare coaching call); 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; Ancillary studies; Other Name: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Behavioral: Telephone-Based Intervention; Receive quarterly calls
Experimental: Arm IV (EXCELS website, health coaching calls); Participants have access to EXCELS as in Arm II. Participants also receive 4 calls as in Arm III.	Other: Internet-Based Intervention; Have access to EXCELS; Other: Quality-of-Life Assessment; Ancillary studies; Other Name: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Behavioral: Telephone-Based Intervention; Receive quarterly calls

Outcome Measures

Primary Outcome Measures :

1. Use of preventive services [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 30 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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)

Contacts and Locations

Locations

United States, New Jersey

Rutgers Cancer Institute of New Jersey; Recruiting

New Brunswick, New Jersey, United States, 08903

Contact: Shawna V. Hudson 848-932-0218 hudsonsh@rwjms.rutgers.edu

Principal Investigator: Shawna V. Hudson

United States, Pennsylvania

Fox Chase Cancer Center; Active, not recruiting

Philadelphia, Pennsylvania, United States, 19111

Sponsors and Collaborators

Rutgers, The State University of New Jersey

National Cancer Institute (NCI)

Investigators

• Principal Investigator: Shawna Hudson; Rutgers Cancer Institute of New Jersey

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Davis SN, O'Malley DM, Bator A, Ohman-Strickland P, Clemow L, Ferrante JM, Crabtree BF, Miller SM, Findley P, Hudson SV. Rationale and design of extended cancer education for longer term survivors (EXCELS): a randomized control trial of 'high touch' vs. 'high tech' cancer survivorship self-management tools in primary care. BMC Cancer. 2019 Apr 11;19(1):340. doi: 10.1186/s12885-019-5531-6.

• Responsible Party: Rutgers, The State University of New Jersey
• ClinicalTrials.gov Identifier: NCT03233555 History of Changes
• Other Study ID Numbers: 131318; NCI-2017-01185 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ); Pro2013003309; 131318 ( Other Identifier: Rutgers Cancer Institute of New Jersey ); P30CA072720 ( U.S. NIH Grant/Contract ); R01CA176838 ( U.S. NIH Grant/Contract )
• First Posted: July 28, 2017
• Last Update Posted: August 26, 2019
• Last Verified: August 2019

Additional relevant MeSH terms:

Breast Neoplasms; Prostatic Neoplasms; Colorectal Neoplasms; Neoplasms by Site; Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Colonic Diseases; Rectal Diseases; Breast Diseases; Skin Diseases; Genital Diseases, Male; Prostatic Diseases; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases