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

Rutgers The State University of New Jersey

Status

Completed

Conditions

Stage IIIA Colorectal Cancer AJCC v7

Stage II Colorectal Cancer AJCC v7

Stage IIC Colorectal Cancer AJCC v7

Stage IIIB Colorectal Cancer AJCC v7

Stage IIB Breast Cancer

Stage IIA Breast Cancer

Stage I Colorectal Cancer AJCC v6 and v7

Stage I Breast Cancer

Stage I Prostate Cancer

Stage IIB Prostate Cancer

Stage III Colorectal Cancer AJCC v7

Stage IB Breast Cancer

Stage II Prostate Cancer

Stage IIA Colorectal Cancer AJCC v7

Stage II Breast Cancer

Stage IA Breast Cancer

Stage IIA Prostate Cancer

Stage IIIC Colorectal Cancer AJCC v7

Stage IIB Colorectal Cancer AJCC v7

Treatments

Behavioral: Telephone-Based Intervention

Other: Questionnaire Administration

Other: Internet-Based Intervention

Other: Informational Intervention

Other: Quality-of-Life Assessment

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT03233555

Pro2013003309

NCI-2017-01185 (Registry Identifier)

R01CA176838 (U.S. NIH Grant/Contract)

131318 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

535 estimated patients

Sex

All

Ages

30+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

535 participants in 4 patient groups

Arm I (brochure)

Active Comparator group

Description:

Participants receive National Cancer Institute's Facing Forward brochure.

Treatment:

Other: Informational Intervention

Other: Quality-of-Life Assessment

Other: Questionnaire Administration

Arm II (EXCELS website)

Experimental group

Description:

Participants have untimed access to the EXCELS mobile web application.

Treatment:

Other: Quality-of-Life Assessment

Other: Internet-Based Intervention

Other: Questionnaire Administration

Arm III (Healthcare coaching call)

Experimental group

Description:

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.

Treatment:

Other: Quality-of-Life Assessment

Behavioral: Telephone-Based Intervention

Other: Questionnaire Administration

Arm IV (EXCELS website, health coaching calls)

Experimental group

Description:

Participants have access to EXCELS as in Arm II. Participants also receive 4 calls as in Arm III.

Treatment:

Other: Quality-of-Life Assessment

Behavioral: Telephone-Based Intervention

Other: Internet-Based Intervention