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Trial record 69 of 127 for:    colon cancer AND Rectal | ( Map: New Jersey, United States )

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

Tracking Information
First Submitted Date  ICMJE July 19, 2017
First Posted Date  ICMJE July 28, 2017
Last Update Posted Date August 26, 2019
Actual Study Start Date  ICMJE September 3, 2013
Estimated Primary Completion Date July 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History Complete list of historical versions of study NCT03233555 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • 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  ICMJE
  • 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  ICMJE
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 25, 2017)
535
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2022
Estimated Primary Completion Date July 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03233555
Other Study ID Numbers  ICMJE 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 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rutgers, The State University of New Jersey
Study Sponsor  ICMJE Rutgers, The State University of New Jersey
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Shawna Hudson Rutgers Cancer Institute of New Jersey
PRS Account Rutgers, The State University of New Jersey
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP