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
4 other identifiers
interventional
535
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2013
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 3, 2013
CompletedFirst Submitted
Initial submission to the registry
July 19, 2017
CompletedFirst Posted
Study publicly available on registry
July 28, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2022
CompletedAugust 29, 2022
August 1, 2022
6.4 years
July 19, 2017
August 23, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Up to 18 months
Study Arms (4)
Arm I (brochure)
ACTIVE COMPARATORParticipants receive National Cancer Institute's Facing Forward brochure.
Arm II (EXCELS website)
EXPERIMENTALParticipants have untimed access to the EXCELS mobile web application.
Arm III (Healthcare coaching call)
EXPERIMENTALParticipants 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 IV (EXCELS website, health coaching calls)
EXPERIMENTALParticipants have access to EXCELS as in Arm II. Participants also receive 4 calls as in Arm III.
Interventions
Have access to EXCELS
Ancillary studies
Ancillary studies
Receive quarterly calls
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rutgers, The State University of New Jerseylead
- National Cancer Institute (NCI)collaborator
- National Institutes of Health (NIH)collaborator
Study Sites (2)
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Related Publications (1)
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.
PMID: 30971205DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shawna Hudson
Rutgers Cancer Institute of New Jersey
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 19, 2017
First Posted
July 28, 2017
Study Start
September 3, 2013
Primary Completion
January 15, 2020
Study Completion
July 31, 2022
Last Updated
August 29, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share