Pillars4Life Trial (Pillars4Life)

June 29, 2017 updated by: Duke University

Pillars4Life Randomized Control Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

284

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard Care
Subjects in this group will continue receiving standard care from their provider team.
Experimental: Pillars4Life
Subjects in this group will complete the Pillars4Life online coping skills curriculum.
Behavioral: Pillars4Life
The Pillars4Life program will guide participants through activities that will help to identify stress and anxiety triggers, plan ways to cope with the stress of life and cancer, manage anxiety, deal with chronic pain, and balance competing priorities in life.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chronic pain
Time Frame: 9 weeks
Subjects will report how much chronic pain they have and how they are coping with it.
9 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stress
Time Frame: 9 weeks
Subjects will report how much stress they are under they have and how they are coping with it.
9 weeks
Anxiety
Time Frame: 9 weeks
Subjects will report how much anxiety they have and how they are coping with it.
9 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

Pfizer

Investigators

  • Principal Investigator: Sophia K Smith, PhD, MSW, Duke University School of Nursing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

June 3, 2015

First Submitted That Met QC Criteria

June 4, 2015

First Posted (Estimate)

June 9, 2015

Study Record Updates

Last Update Posted (Actual)

July 2, 2017

Last Update Submitted That Met QC Criteria

June 29, 2017

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00061381

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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