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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2017-01185 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| Pro2013003309 | |||
| 131318 | Other Identifier | Rutgers Cancer Institute of New Jersey | |
| R01CA176838 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| National Institutes of Health (NIH) | NIH |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (brochure) | Active Comparator | Participants receive National Cancer Institute's Facing Forward brochure. |
|
| Arm II (EXCELS website) | Experimental | Participants have untimed access to the EXCELS mobile web application. |
|
| Arm III (Healthcare coaching call) | Experimental | 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. |
|
| Arm IV (EXCELS website, health coaching calls) | Experimental | Participants have access to EXCELS as in Arm II. Participants also receive 4 calls as in Arm III. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Informational Intervention | Other | Receive brochure |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shawna Hudson | Rutgers Cancer Institute of New Jersey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903 | United States | ||
| Fox Chase Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30971205 | Derived | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jun 20, 2017 | Aug 9, 2022 |
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| Internet-Based Intervention |
| Other |
Have access to EXCELS |
|
| Quality-of-Life Assessment | Other | Ancillary studies |
|
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| Questionnaire Administration | Other | Ancillary studies |
|
| Telephone-Based Intervention | Behavioral | Receive quarterly calls |
|
| Philadelphia |
| Pennsylvania |
| 19111 |
| United States |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D011471 | Prostatic Neoplasms |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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