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: September 24, 2020
• Sponsor: Rutgers, The State University of New Jersey
• Collaborators: National Cancer Institute (NCI); National Institutes of Health (NIH)
• Information provided by (Responsible Party): Rutgers, The State University of New Jersey

Tracking Information

• First Submitted Date: July 19, 2017
• First Posted Date: July 28, 2017
• Last Update Posted Date: September 24, 2020
• Actual Study Start Date: September 3, 2013
• Estimated Primary Completion Date: July 31, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 25, 2017)

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.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• Official Title: Extended Cancer Education for Longer-Term Survivors (EXCELS) In Primary Care
• 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care

Condition

• 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

• Other: Informational Intervention
  Receive brochure
• 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

Study Arms

• Active Comparator: Arm I (brochure)
  Participants receive National Cancer Institute's Facing Forward brochure.
  Interventions:

  • Other: Informational Intervention
  • Other: Quality-of-Life Assessment
  • Other: Questionnaire Administration
• Experimental: Arm II (EXCELS website)
  Participants have untimed access to the EXCELS mobile web application.
  Interventions:

  • Other: Internet-Based Intervention
  • Other: Quality-of-Life Assessment
  • Other: Questionnaire Administration
• 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.
  Interventions:

  • Other: Quality-of-Life Assessment
  • Other: Questionnaire Administration
  • Behavioral: Telephone-Based Intervention
• 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.
  Interventions:

  • Other: Internet-Based Intervention
  • Other: Quality-of-Life Assessment
  • Other: Questionnaire Administration
  • Behavioral: Telephone-Based Intervention

• Publications *: 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.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: July 25, 2017): 535
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 31, 2022
• Estimated Primary Completion Date: July 31, 2022 (Final data collection date for primary outcome measure)

Eligibility 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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 30 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03233555
• 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 ); R01CA176838 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Rutgers, The State University of New Jersey
• Study Sponsor: Rutgers, The State University of New Jersey

Collaborators

• National Cancer Institute (NCI)
• National Institutes of Health (NIH)

Investigators

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

• PRS Account: Rutgers, The State University of New Jersey
• Verification Date: September 2020