RCT of ACP for Transplant

September 18, 2018 updated by: Abramson Cancer Center of the University of Pennsylvania

A Pilot Randomized Control Trial of Advance Care Planning and Triggered Palliative Care for Cancer Patients Undergoing Stem Cell Transplantation (RCT of ACP for Transplant)

We aim to examine the effect of an online advance directive on decisional conflict and quality of life in patients undergoing stem cell transplant. We also aim to assess the effect of palliative care at the time of a sentinel event on quality of life.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Cancer Patients Undergoing Stem Cell Transplantation

Description

Inclusion Criteria:

The inclusion criteria for Phase I (primary objective) are as follows:

  • Age ≥ 18 years
  • Hematologic malignancy diagnosis including any subset of myeloma, lymphoma, leukemia, or myelodysplastic syndrome
  • Currently scheduled for autologous or allogeneic transplant at the Hospital of the University of Pennsylvania

The inclusion criteria for Phase II (secondary objective) are as follows:

  • Age ≥ 18 years
  • Hematologic malignancy diagnosis including any subset of lymphoma, leukemia, or myelodysplastic syndrome
  • Received an autologous or allogeneic stem cell transplant at the Hospital of the University of Pennsylvania and experienced a sentinel event of either 1) disease relapse,2) severe (Grade III or IV) graft-versus-host disease, or 3) unplanned hospital admission with length of stay greater than 72 hours.

Exclusion Criteria:

The exclusion criteria for Phase I include:

  • Inability to read and write English
  • Not serving as the primary decision maker for their health-related decisions
  • Having a non-hematologic malignancy reason for undergoing transplantation (e.g. aplastic anemia)

The exclusion criteria for Phase II include:

  • Not completing participation in Phase I of the study
  • Myeloma diagnosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Phase 1
Other: Surveys
Instruments will be administered via the online RedCAP platform. The survey instruments will include a Decision Conflict Scale (DCS), the McGill Quality of Life (MQoL), the Human Connection (THC), and a general demographics questionnaire. Patients will have the opportunity to complete the instruments via a research iPad while in clinic or via a survey link emailed to their private email account.
Phase 2
Other: Surveys
Instruments will be administered via the online RedCAP platform. The survey instruments will include a Decision Conflict Scale (DCS), the McGill Quality of Life (MQoL), the Human Connection (THC), and a general demographics questionnaire. Patients will have the opportunity to complete the instruments via a research iPad while in clinic or via a survey link emailed to their private email account.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of surveys completed
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abramson Cancer Center of the University of Pennsylvania

Investigators

  • Principal Investigator: Pallavi Kumar, MD, Abramson Cancer Center of the University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2017

Primary Completion (Anticipated)

May 15, 2019

Study Completion (Anticipated)

November 15, 2019

Study Registration Dates

First Submitted

May 16, 2017

First Submitted That Met QC Criteria

May 16, 2017

First Posted (Actual)

May 18, 2017

Study Record Updates

Last Update Posted (Actual)

September 20, 2018

Last Update Submitted That Met QC Criteria

September 18, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • UPCC 23417

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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