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Completed

NCT Number: NCT02465892

Pillars4Life Trial

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.

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Key information

Conditions

Breast Cancer Adnexal Diseases Anxiety Disorders Bladder Cancer Breast Diseases Breast Neoplasms Cervical Cancer Chronic Pain Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Esophageal Cancer Esophageal Diseases Esophageal Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Gonadal Disorders Head and Neck Neoplasms Intestinal Diseases Intestinal Neoplasms Kidney Diseases Kidney Neoplasms Liver Cancer Liver Diseases Liver Neoplasms Lung Cancer Lung Diseases Lung Neoplasms Male Urogenital Diseases Mental Disorders Neoplasms Neoplasms by Site Neurologic Manifestations Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Pain Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Pathological Conditions, Signs and Symptoms Prostate Cancer Prostatic Diseases Prostatic Neoplasms Renal Cancer Respiratory Tract Diseases Respiratory Tract Neoplasms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases Thoracic Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Uterine Cancer Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pillars4Life

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.

Primary outcomes

  1. Chronic pain

    Time frame: 9 weeks

    Subjects will report how much chronic pain they have and how they are coping with it.

Secondary outcomes

  1. Stress

    Time frame: 9 weeks

    Subjects will report how much stress they are under they have and how they are coping with it.

  2. Anxiety

    Time frame: 9 weeks

    Subjects will report how much anxiety they have and how they are coping with it.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Pfizer

Registry information

Official study title

Pillars4Life Randomized Control Trial

Acronym: Pillars4Life

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 9, 2015
Registry last updated
Jul 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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