Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03676426
Other study ID # 829211
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 15, 2018
Est. completion date February 20, 2020

Study information

Verified date May 2020
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will compare a web-based advance directive to a standard advance directive.


Description:

Patients with GI and thoracic malignancies will be randomized to either a standard paper advance directive or the web advance directive (Ourcarewishes.org). Patients will be approached in the Cancer Center and provided the AD information to complete on their own. They will complete a survey at enrollment and a follow up survey administered by email. The primary endpoint will be proportion with new documentation in the EHR at 8 weeks. Second endpoints will include the change in satisfaction with end-of-life plans, AD acceptability, self-reported rates of completion, self-reported rate of sharing with their preferred surrogate decision-maker, proportion with new documentation of preferred decision-maker in the chart, and qualitative feedback. Patients in both groups will receive follow up reminder emails encouraging them to complete the advance directive.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date February 20, 2020
Est. primary completion date October 20, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria (any of the following)

- Pancreatic cancer, any stage except stage 0 (C25),

- NSCLC, stage IIIA or higher (C34),

- SCLC, any stage (C34),

- Colon cancer, stage IIIB or greater (C18),

- Rectal cancer, stage IIB or greater (C21),

- Esophageal cancer (adeno or squamous), any stage (C15),

- Stomach cancer, stage IIB or greater (C16),

- Gallbladder cancer, stage I or greater (C23),

- Cholangiocarcinoma, any stage (C22.1),

- HCC, any stage (no plan for transplant) (C22.0),

- Malignant carcinoid of GI tract, stage IV (C7A.019).

Exclusion criteria:

- Does not have an active patient portal (MyPennMedicine) account,

- Does not use email at least once per month,

- Has already completed a living will,

- Does not speak fluent English,

- Unwilling to be contacted by email,

- Determined to be too ill or inappropriate for participation by patient's oncologist.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Web platform for advance care planning/advance directive
Ourcarewishes (OCW) is a web-based platform to document advance care planning based at Penn. OCW contains more detailed content on preferences and values than a standard advance directive and allows electronic sharing with loved ones and transmission to the Penn EHR.
Standard advance directive
Patients receive a paper copy of an advance directive used by social workers at Penn Medicine and are encouraged to complete on their own.

Locations

Country Name City State
United States Ruth & Raymond Perelman Center for Advanced Medicine Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

References & Publications (2)

Halpern SD, Loewenstein G, Volpp KG, Cooney E, Vranas K, Quill CM, McKenzie MS, Harhay MO, Gabler NB, Silva T, Arnold R, Angus DC, Bryce C. Default options in advance directives influence how patients set goals for end-of-life care. Health Aff (Millwood). 2013 Feb;32(2):408-17. doi: 10.1377/hlthaff.2012.0895. — View Citation

Sudore RL, Landefeld CS, Barnes DE, Lindquist K, Williams BA, Brody R, Schillinger D. An advance directive redesigned to meet the literacy level of most adults: a randomized trial. Patient Educ Couns. 2007 Dec;69(1-3):165-95. Epub 2007 Oct 17. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary New documentation of advance care planning in the EHR any new advance directive or advance care planning note, excluding an advance directive that either 1) contains only information on the patient's preferred surrogate decision-makers, or 2) is blank except for personal identifying information. 8 weeks
Secondary Change in satisfaction with end-of-life plans Change in mean score on the satisfaction with end-of-life scale, adapted from doi: 10.1377/hlthaff.2012.0895, Canadian Healthcare Evaluation Project (CANHELP) questionnaire. This scale measures satisfaction with end-of-life planning on a 12-60 point scale (if all questions answered, 0 possible if "don't know/refusal" chosen for all 12 questions. Higher scores are considered better. Initial completed at enrollment, survey sent again at 15 days
Secondary Acceptability Mean score on an acceptability scale adapted from DOI: 10.1016/j.pec.2007.08.015. This is a scale that measures advance directive acceptability on a 5-50 point scale. Higher scores represent better outcomes. Survey sent at 15 days (reminders at 2 week intervals x 2, then phone call)
Secondary Self reporting sharing with surrogate Proportion reporting sharing with preferred surrogate Survey sent at 15 days (reminders 4, 6)Survey sent at 15 days (reminders at 2 week intervals x 2, then phone call)
Secondary Self reporting completion Proportion reporting completing some or all of the advance directive Survey sent at 15 days (reminders at 2 week intervals x 2, then phone call)
Secondary Qualitative feedback Comments on what patients liked, did not like, and would change about the advance directive Survey sent at 15 days (reminders at 2 week intervals x 2, then phone call)
Secondary Surrogate preferences Proportion of subjects with new information about their preferred surrogate decision-maker in the chart 8 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT04837950 - Changes in Pleural Cavity Volume and Surgical Exposure N/A
Completed NCT03121287 - Early Imaging Biomarkers in NSCLC
Completed NCT04553471 - Palliative Lattice Stereotactic Body Radiotherapy (SBRT) for Patients With Sarcoma, Thoracic, Abdominal, and Pelvic Cancers N/A
Recruiting NCT05053230 - A Study Evaluating the Integrative Medicine at Home (IM@HOME) Program in People With Cancer N/A
Completed NCT04570722 - Ipsilateral Peripheral Intravenous Access Procedures (The iPIVAP Study) N/A
Completed NCT05459311 - Investigating Radiation-Induced Injury to Airways and Pulmonary Vasculature in Lung Stereotactic Ablative Body Radiotherapy (SAbR)
Completed NCT01833637 - Electronic Patient Reported Symptom Assessment N/A
Completed NCT03658083 - Exploring Robotic-assisted Thoracic Surgery for Lung Cancer
Recruiting NCT05063396 - OFA in Thoracic Surgery N/A
Recruiting NCT03804307 - Short Course Radiation Therapy in Palliative Treatment of Thoracic Cancer N/A
Enrolling by invitation NCT05629065 - Pathways to Advance Targeted and Helpful Serious Illness Conversations (PATH-SIC) N/A
Recruiting NCT04749212 - Perioperative Troponin I and NT Pro-BNP in Lung Resection
Recruiting NCT05349552 - Safety and Efficacy of SBRT in the Treatment of Thoracic Malignant Tumors at Different Sites
Recruiting NCT05502263 - Interest of CPET to Predict Mortality and Complications of Lung Resection Candidates
Recruiting NCT05351268 - 3DPCT Combined With CT Guided RISI in the Treatment of Thoracic Malignant Tumors N/A
Recruiting NCT05549414 - Pivotal Study of Proton Radiotherapy Treatments Using Fixed Beam Chair-Based Delivery System N/A
Recruiting NCT06342284 - Patient-Generated Health Data Collection During Chemoradiotherapy for Lung Cancer
Recruiting NCT04799561 - Teleprehabilitation for Surgical Cancer Patients N/A
Completed NCT05143541 - Use of a New Stapling Device in General Thoracic Surgery
Active, not recruiting NCT04686500 - VisionRT-based Deep Inspiration Breath-hold (DIBH) Respiratory Motion Management Strategy, A Pilot Study for Thoracic and Abdominal Tumors N/A