Clinical trial NCT03233555: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: National Institutes of Health (NIH)
First posted: 2017-07-28
Enrollment: 535
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_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.

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)

Primary outcomes:
measure: Use of preventive services
timeFrame: Up to 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
Study officials:
affiliation: Rutgers Cancer Institute of New Jersey
name: Shawna Hudson
role: PRINCIPAL_INVESTIGATOR
References:
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.