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Trial record 1 of 1 for:    NCT02465892
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Pillars4Life Trial (Pillars4Life)

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ClinicalTrials.gov Identifier: NCT02465892
Recruitment Status : Completed
First Posted : June 9, 2015
Last Update Posted : July 2, 2017
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date  ICMJE June 3, 2015
First Posted Date  ICMJE June 9, 2015
Last Update Posted Date July 2, 2017
Study Start Date  ICMJE May 2015
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2015)
Chronic pain [ Time Frame: 9 weeks ]
Subjects will report how much chronic pain they have and how they are coping with it.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2015)
  • Stress [ Time Frame: 9 weeks ]
    Subjects will report how much stress they are under they have and how they are coping with it.
  • Anxiety [ Time Frame: 9 weeks ]
    Subjects will report how much anxiety they have and how they are coping with it.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pillars4Life Trial
Official Title  ICMJE Pillars4Life Randomized Control Trial
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Supportive Care
Condition  ICMJE
  • Breast Cancer
  • Lung Cancer
  • Esophageal Cancer
  • Colon Cancer
  • Pancreatic Cancer
  • Liver Cancer
  • Renal Cancer
  • Bladder Cancer
  • Prostate Cancer
  • Ovarian Cancer
  • Cervical Cancer
  • Uterine Cancer
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Pillars4Life
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 6, 2016)
284
Original Estimated Enrollment  ICMJE
 (submitted: June 4, 2015)
180
Actual Study Completion Date  ICMJE October 2016
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02465892
Other Study ID Numbers  ICMJE Pro00061381
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator: Sophia K Smith, PhD, MSW Duke University School of Nursing
PRS Account Duke University
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP