- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02465892
Pillars4Life Trial (Pillars4Life)
Pillars4Life Randomized Control Trial
Study Overview
Status
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke University Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
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Experimental: Pillars4Life
Subjects in this group will complete the Pillars4Life online coping skills curriculum.
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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.
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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.
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9 weeks
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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
Sponsor
Collaborators
Investigators
- Principal Investigator: Sophia K Smith, PhD, MSW, Duke University School of Nursing
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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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