Pillars4Life Trial

Sponsor

Duke University (Other)

Overall Status

Completed

CT.gov ID

NCT02465892

Collaborator

Pfizer (Industry)

284

Enrollment

Location

Arms

17.1

Duration (Months)

16.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
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	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

284 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Primary Purpose:

Supportive Care

Official Title:

Pillars4Life Randomized Control Trial

Study Start Date :

May 1, 2015

Actual Primary Completion Date :

Oct 1, 2016

Actual Study Completion Date :

Oct 1, 2016

Arms and Interventions

Arm	Intervention/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 life.

Arm

Intervention/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 life.

Outcome Measures

Primary Outcome Measures

Chronic pain [9 weeks]
Subjects will report how much chronic pain they have and how they are coping with it.

Secondary Outcome Measures

Stress [9 weeks]
Subjects will report how much stress they are under they have and how they are coping with it.
Anxiety [9 weeks]
Subjects will report how much anxiety they have and how they are coping with it.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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.