RCT of ACP for Transplant

Cancer Patients Undergoing Stem Cell Transplantation (RCT of ACP for Transplant) Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03158467
• Other study ID #: UPCC 23417
• Status: Withdrawn
• Start date: May 15, 2017
• Est. completion date: November 15, 2019

Study information

• Verified date: May 2018
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 15, 2019
• Est. primary completion date: May 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer Patients Undergoing Stem Cell Transplantation (RCT of ACP for Transplant)

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of surveys completed		2 years