Pillars4Life Trial (Pillars4Life)
Primary Purpose
Breast Cancer, Lung Cancer, Esophageal Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pillars4Life
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring cancer, stress, chronic pain, anxiety, coping, balance, online course, psychosocial, support, tools
Eligibility Criteria
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
Sites / Locations
- Duke University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard Care
Pillars4Life
Arm Description
Subjects in this group will continue receiving standard care from their provider team.
Subjects in this group will complete the Pillars4Life online coping skills curriculum.
Outcomes
Primary Outcome Measures
Chronic pain
Subjects will report how much chronic pain they have and how they are coping with it.
Secondary Outcome Measures
Stress
Subjects will report how much stress they are under they have and how they are coping with it.
Anxiety
Subjects will report how much anxiety they have and how they are coping with it.
Full Information
NCT ID
NCT02465892
First Posted
June 3, 2015
Last Updated
June 29, 2017
Sponsor
Duke University
Collaborators
Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT02465892
Brief Title
Pillars4Life Trial
Acronym
Pillars4Life
Official Title
Pillars4Life Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of 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
Keywords
cancer, stress, chronic pain, anxiety, coping, balance, online course, psychosocial, support, tools
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Allocation
Randomized
Enrollment
284 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
Subjects in this group will continue receiving standard care from their provider team.
Arm Title
Pillars4Life
Arm Type
Experimental
Arm Description
Subjects in this group will complete the Pillars4Life online coping skills curriculum.
Intervention Type
Behavioral
Intervention Name(s)
Pillars4Life
Intervention Description
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.
Primary Outcome Measure Information:
Title
Chronic pain
Description
Subjects will report how much chronic pain they have and how they are coping with it.
Time Frame
9 weeks
Secondary Outcome Measure Information:
Title
Stress
Description
Subjects will report how much stress they are under they have and how they are coping with it.
Time Frame
9 weeks
Title
Anxiety
Description
Subjects will report how much anxiety they have and how they are coping with it.
Time Frame
9 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sophia K Smith, PhD, MSW
Organizational Affiliation
Duke University School of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
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Pillars4Life Trial
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