Pillars4Life Trial

Not Applicable

Completed

• Conditions: Bladder Cancer; Breast Cancer; Renal Cancer; Prostate Cancer; Ovarian Cancer; Cervical Cancer; Lung Cancer; Esophageal Cancer; Colon Cancer; Pancreatic Cancer
• Interventions: Behavioral: Pillars4Life

• Registration Number: NCT02465892
• Lead Sponsor: Duke University

Brief Summary

This study aims to explore whether cancer patients can benefit from completing the Pillars4Life online coping program. This randomized control trial will have half its subject completing the program and the other half receiving standard care in order to measure whether the program is beneficial in dealing with stress, anxiety, and particularly chronic pain that often accompany a cancer diagnosis.

Detailed Description

Subjects will complete three online surveys as part of the study. Each subject who completes the first survey will be randomized to either the control group who receive standard care from their care team or to complete the 9-week Pillars4Life curriculum. Subjects completing the Pillars4Life program will select a course day/time that works for them from those offered. Each week the program will send an email approximately 15 minutes before class time with a link. Subjects will click the link to go to the "classroom," where they will enter their name and phone number. The program will call the number provided and the subject will listen to the audio over the phone, while watching the guide and activities in the virtual classroom on their computer. Each class will last about an hour.

All subjects will complete two additional surveys, at approximately 9 weeks and 18 weeks after enrolling in the study.

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-06-03
• Study First Submitted QC: 2015-06-04
• Study First Posted: 2015-06-09
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Status Verified: 2016-12
• Last Update Submitted: 2017-06-29
• Last Update Posted: 2017-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 284

Inclusion Criteria

• Current pain level ≥3 and at least one prior score ≥3 on a 0-10 scale as reported in EPIC;
• Age ≥18 years
• Diagnosed with Breast, GI, GU, GYN, or Thoracic cancer
• Actively receiving care at the Duke Cancer Center, Durham Regional Hospital, or Duke Raleigh Hospital
• Able/willing to have an online interaction with the Pillars4Life online CORE program curriculum
• Life expectancy ≥6 months
• Providing informed consent
• Able to read/write English.

Exclusion Criteria

• none

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pillars4Life	Pillars4Life	Subjects in this group will complete the Pillars4Life online coping skills curriculum.

Primary Outcome Measures

Name	Time	Method
Chronic pain	9 weeks	Subjects will report how much chronic pain they have and how they are coping with it.

Secondary Outcome Measures

Name	Time	Method
Anxiety	9 weeks	Subjects will report how much anxiety they have and how they are coping with it.
Stress	9 weeks	Subjects will report how much stress they are under they have and how they are coping with it.

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States