Breast CancerPillars4LifeNCT02465892
Pillars4Life Trial
A study testing Pillars4Life in people with Breast Cancer and Lung Cancer, run by Duke University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Lung Cancer, Esophageal Cancer
- What is being tested?
- Pillars4Life
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 284 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Pillars4Life Randomized Control 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.
Read the 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
- Being tested
- Pillars4Life
- Keywords
- cancer, stress, chronic pain, anxiety, coping, balance, online course, psychosocial, support, tools
- Medical subject headings
- Breast Neoplasms, Lung Neoplasms, Esophageal Neoplasms, Colonic Neoplasms, Pancreatic Neoplasms, Liver Neoplasms, Kidney Neoplasms, Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pillars4LifeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Pillars4Life |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic pain
Subjects will report how much chronic pain they have and how they are coping with it.
Measured: 9 weeks
Secondary outcomes (2)
Stress
Subjects will report how much stress they are under they have and how they are coping with it.
Measured: 9 weeks
Anxiety
Subjects will report how much anxiety they have and how they are coping with it.
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2015 (estimated)
- Study startMay 2015
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 284 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Sophia K Smith, PhD, MSW, Principal investigator, Duke University School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02465892
- Sponsor's protocol ID
- Pro00061381
- Acronym
- Pillars4Life
- Status last verified
- Dec 2016
- First submitted
- 3 Jun 2015
- Last updated
- 2 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pillars4Life Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02465892
- Acronym / sponsor ID
- Pillars4Life / Pro00061381
- Conditions
- Breast Cancer, Lung Cancer, Esophageal Cancer, Colon Cancer, Pancreatic Cancer, Liver Cancer
- Keywords
- cancer, stress, chronic pain, anxiety, coping, balance, online course, psychosocial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 284 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- May 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 9 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care | No intervention | –Subjects in this group will continue receiving standard care from their provider team. |
| Pillars4Life | Experimental | Behavioral: Pillars4LifeSubjects in this group will complete the Pillars4Life online coping skills curriculum. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pillars4LifeThe 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. | Behavioural | Pillars4Life |
Primary outcome
Chronic pain
Time frame: 9 weeks
Subjects will report how much chronic pain they have and how they are coping with it.
2 secondary outcomes
Stress
Time frame: 9 weeks
Anxiety
Time frame: 9 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophia K Smith, PhD, MSW principal investigator
Duke University School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pillars4Life in people with Breast Cancer and Lung Cancer, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic pain (time frame: 9 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.