Pillars4Life Trial

Breast Cancer Clinical Trial

— Pillars4Life  

Official title:

Pillars4Life Randomized Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02465892
• Other study ID #: Pro00061381
• Status: Completed
• Phase: N/A
• First received: June 3, 2015
• Last updated: June 29, 2017
• Start date: May 2015
• Est. completion date: October 2016

Study information

• Verified date: December 2016
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 284
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Bladder Cancer
• Breast Cancer
• Carcinoma, Renal Cell
• Cervical Cancer
• Colon Cancer
• Esophageal Cancer
• Esophageal Neoplasms
• Kidney Neoplasms
• Liver Cancer
• Liver Neoplasms
• Lung Cancer
• Ovarian Cancer
• Pancreatic Cancer
• Pancreatic Neoplasms
• Prostate Cancer
• Renal Cancer
• Urinary Bladder Neoplasms
• Uterine Cancer
• Uterine Cervical Neoplasms
• Uterine Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chronic pain	Subjects will report how much chronic pain they have and how they are coping with it.	9 weeks
Secondary	Stress	Subjects will report how much stress they are under they have and how they are coping with it.	9 weeks
Secondary	Anxiety	Subjects will report how much anxiety they have and how they are coping with it.	9 weeks