Clincosm LogoSign in Get a demo

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

Sponsor
Rutgers, The State University of New Jersey (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03233555
Collaborator
National Cancer Institute (NCI) (NIH), National Institutes of Health (NIH) (NIH)
535
Enrollment
2
Locations
4
Arms
106.9
Anticipated Duration (Months)
267.5
Patients Per Site
2.5
Patients Per Site Per Month

Study Details

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
  • Other: Informational Intervention
  • Other: Internet-Based Intervention
  • Other: Quality-of-Life Assessment
  • Other: Questionnaire Administration
  • Behavioral: Telephone-Based Intervention
 N/A

Detailed Description

PRIMARY OBJECTIVES:

  1. Develop the EXCELS intervention to facilitate engaged self-management of cancer follow-up for cancer survivors.

  2. Evaluate the efficacy of EXCELS intervention in a small randomized controlled trial.

  3. 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
Anticipated 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 :
Sep 3, 2013
Actual Primary Completion Date :
Jan 15, 2020
Anticipated Study Completion Date :
Jul 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 [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

    Criteria

    Ages Eligible for Study:
    30 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Site City State Country Postal Code
    1 Rutgers Cancer Institute of New Jersey New Brunswick New Jersey United States 08903
    2 Fox Chase Cancer Center Philadelphia Pennsylvania United States 19111

    Sponsors and Collaborators

    • Rutgers, The State University of New Jersey
    • National Cancer Institute (NCI)
    • National Institutes of Health (NIH)

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rutgers, The State University of New Jersey
    ClinicalTrials.gov Identifier:
    NCT03233555
    Other Study ID Numbers:
    • 131318
    • NCI-2017-01185
    • Pro2013003309
    • 131318
    • R01CA176838
    First Posted:
    Jul 28, 2017
    Last Update Posted:
    Jan 31, 2022
    Last Verified:
    Jan 1, 2022
    Additional relevant MeSH terms:
    Breast Neoplasms
    Prostatic Neoplasms
    Colorectal Neoplasms

    Study Results

    No Results Posted as of Jan 31, 2022