Stage I Breast CancerNCT03233555
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
A study testing Informational Intervention, Internet-Based Intervention and Quality-of-Life Assessment in people with Stage I Breast Cancer and Stage I Colorectal Cancer AJCC v6 and v7, run by Rutgers, The State University of New Jersey at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Stage I Breast Cancer, Stage I Colorectal Cancer AJCC v6 and v7, Stage I Prostate Cancer
- What is being tested?
- Informational Intervention, Internet-Based Intervention and Quality-of-Life Assessment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 535 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Sep 2013to 31 Jul 2022
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
About this study
Official title: Extended Cancer Education for Longer-Term Survivors (EXCELS) In Primary Care
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- 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
- Being tested
- Informational Intervention, Internet-Based Intervention, Quality-of-Life Assessment, Questionnaire Administration, Telephone-Based Intervention
- Medical subject headings
- Breast Neoplasms, Prostatic Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Informational InterventionOther
Receive brochure
Internet-Based InterventionOther
Have access to EXCELS
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
Telephone-Based InterventionBehavioural
Receive quarterly calls
| Study group | Role | What they receive |
|---|---|---|
| Arm I (brochure) | Active comparator | Participants receive National Cancer Institute's Facing Forward brochure. Receives: Other: Informational Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
| Arm II (EXCELS website) | Experimental | Participants have untimed access to the EXCELS mobile web application. Receives: Other: Internet-Based Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
| 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. Receives: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Behavioral: Telephone-Based Intervention |
| 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. Receives: Other: Internet-Based Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Behavioral: Telephone-Based Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2017
- Study start3 Sep 2013
- Primary completion15 Jan 2020
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stage I Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 535 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Shawna Hudson, Principal investigator, Rutgers Cancer Institute of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03233555
- Sponsor's protocol ID
- 131318
- Other IDs
- NCI-2017-01185, Pro2013003309, 131318, R01CA176838
- Status last verified
- Aug 2022
- First submitted
- 19 Jul 2017
- Last updated
- 29 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 30971205