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Pillars4Life Trial


2015-05


2016-10


2016-10


284

Study Overview

Pillars4Life 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.

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 Ȭlassroom," 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.

  • Breast Cancer
  • Lung Cancer
  • Esophageal Cancer
  • Colon Cancer
  • Pancreatic Cancer
  • Liver Cancer
  • Renal Cancer
  • Bladder Cancer
  • Prostate Cancer
  • Ovarian Cancer
  • Cervical Cancer
  • Uterine Cancer
  • BEHAVIORAL: Pillars4Life
  • Pro00061381

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 Registration Dates Results Reporting Dates Study Record Updates

2015-06-03  

N/A  

2017-06-29  

2015-06-04  

N/A  

2017-07-02  

2015-06-09  

N/A  

2016-12  

Study Plan

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

Design Details

Primary Purpose:
Supportive Care


Allocation:
Randomized


Interventional Model:
Parallel


Masking:
N/A


Arms and Interventions

Participant Group/ArmIntervention/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 l
Primary Outcome MeasuresMeasure DescriptionTime Frame
Chronic painSubjects will report how much chronic pain they have and how they are coping with it.9 weeks
Secondary Outcome MeasuresMeasure DescriptionTime Frame
StressSubjects will report how much stress they are under they have and how they are coping with it.9 weeks
AnxietySubjects will report how much anxiety they have and how they are coping with it.9 weeks

Contacts and Locations

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

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    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

Collaborators and Investigators

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

  • Pfizer

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

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available