NCT02465892

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
284

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started May 2015

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 3, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 9, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

July 2, 2017

Status Verified

December 1, 2016

Enrollment Period

1.4 years

First QC Date

June 3, 2015

Last Update Submit

June 29, 2017

Conditions

Breast CancerLung CancerEsophageal CancerColon CancerPancreatic CancerLiver CancerRenal CancerBladder CancerProstate CancerOvarian CancerCervical CancerUterine Cancer

Keywords

cancerstresschronic painanxietycopingbalanceonline coursepsychosocialsupporttools

Outcome Measures

Primary Outcomes (1)

  • Chronic pain

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

    9 weeks

Secondary Outcomes (2)

  • Stress

    9 weeks

  • Anxiety

    9 weeks

Study Arms (2)

Standard Care

NO INTERVENTION

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

Pillars4Life

EXPERIMENTAL

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

Behavioral: Pillars4Life

Interventions

Pillars4LifeBEHAVIORAL

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.

Pillars4Life

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsLung NeoplasmsEsophageal NeoplasmsColonic NeoplasmsPancreatic NeoplasmsLiver NeoplasmsKidney NeoplasmsUrinary Bladder NeoplasmsProstatic NeoplasmsOvarian NeoplasmsUterine Cervical NeoplasmsUterine NeoplasmsNeoplasmsChronic PainAnxiety Disorders

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesGastrointestinal NeoplasmsDigestive System NeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesColorectal NeoplasmsIntestinal NeoplasmsColonic DiseasesIntestinal DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System DiseasesLiver DiseasesUrologic NeoplasmsUrogenital NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesUrinary Bladder DiseasesGenital Neoplasms, MaleGenital Diseases, MaleGenital DiseasesProstatic DiseasesOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleGenital Neoplasms, FemaleGonadal DisordersUterine Cervical DiseasesUterine DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Sophia K Smith, PhD, MSW

    Duke University School of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2015

First Posted

June 9, 2015

Study Start

May 1, 2015

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

July 2, 2017

Record last verified: 2016-12

Locations

US(1)