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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

Primary Purpose

Stage I Breast Cancer, Stage I Colorectal Cancer AJCC v6 and v7, Stage I Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Informational Intervention
Internet-Based Intervention
Quality-of-Life Assessment
Questionnaire Administration
Telephone-Based Intervention
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stage I Breast Cancer

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Rutgers Cancer Institute of New Jersey
  • Fox Chase Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Arm I (brochure)

Arm II (EXCELS website)

Arm III (Healthcare coaching call)

Arm IV (EXCELS website, health coaching calls)

Arm Description

Participants receive National Cancer Institute's Facing Forward brochure.

Participants have untimed access to the EXCELS mobile web application.

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.

Participants have access to EXCELS as in Arm II. Participants also receive 4 calls as in Arm III.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 19, 2017
Last Updated
August 23, 2022
Sponsor
Rutgers, The State University of New Jersey
Collaborators
National Cancer Institute (NCI), National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT03233555
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
September 3, 2013 (Actual)
Primary Completion Date
January 15, 2020 (Actual)
Study Completion Date
July 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rutgers, The State University of New Jersey
Collaborators
National Cancer Institute (NCI), National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
535 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm I (brochure)
Arm Type
Active Comparator
Arm Description
Participants receive National Cancer Institute's Facing Forward brochure.
Arm Title
Arm II (EXCELS website)
Arm Type
Experimental
Arm Description
Participants have untimed access to the EXCELS mobile web application.
Arm Title
Arm III (Healthcare coaching call)
Arm Type
Experimental
Arm Description
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 Title
Arm IV (EXCELS website, health coaching calls)
Arm Type
Experimental
Arm Description
Participants have access to EXCELS as in Arm II. Participants also receive 4 calls as in Arm III.
Intervention Type
Other
Intervention Name(s)
Informational Intervention
Intervention Description
Receive brochure
Intervention Type
Other
Intervention Name(s)
Internet-Based Intervention
Intervention Description
Have access to EXCELS
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Behavioral
Intervention Name(s)
Telephone-Based Intervention
Intervention Description
Receive quarterly calls
Primary Outcome Measure Information:
Title
Use of preventive services
Description
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.
Time Frame
Up to 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shawna Hudson
Organizational Affiliation
Rutgers Cancer Institute of New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rutgers Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30971205
Citation
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.
Results Reference
derived

Learn more about this trial

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

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