Pillars4Life Trial

NCT ID: NCT02465892

Last Updated: 2017-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 284 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2016-10-31

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.

Conditions

Breast Cancer; Lung Cancer; Esophageal Cancer; Colon Cancer; Pancreatic Cancer; Liver Cancer; Renal Cancer; Bladder Cancer; Prostate Cancer; Ovarian Cancer; Cervical Cancer; Uterine Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE

Study Groups

Standard Care

Subjects in this group will continue receiving standard care from their provider team.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Pillars4Life

Subjects in this group will complete the Pillars4Life online coping skills curriculum.

Group Type: EXPERIMENTAL

Pillars4Life

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sophia K Smith, PhD, MSW

Role: PRINCIPAL_INVESTIGATOR

Duke University School of Nursing

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00061381

Identifier Type: -

Identifier Source: org_study_id