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Trial record 42 of 166 for:    colon cancer AND Colorectal Neoplasms | ( 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

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.


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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

Resource links provided by the National Library of Medicine


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




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.



Information from the National Library of Medicine

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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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03233555


Locations
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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
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Principal Investigator: Shawna Hudson Rutgers Cancer Institute of New Jersey

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Breast Neoplasms
Prostatic Neoplasms
Colorectal Neoplasms
Neoplasms by Site
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Colonic Diseases
Breast Diseases
Skin Diseases
Genital Diseases, Male
Prostatic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases