Pillars4Life Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pillars4Life Randomized Control Trial

Conditions
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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 / Treatment
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* Behavioral: Pillars4Life


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Care<br>Subjects in this group will continue receiving standard care from their provider team. | |
| Experimental: Pillars4Life<br>Subjects in this group will complete the Pillars4Life online coping skills curriculum. | Behavioral: Pillars4Life<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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support, cancer, stress, chronic pain, anxiety, coping, balance, online course, psychosocial, tools