RCT of ACP for Transplant | NCT03158467

Studies
RCT of ACP for Transplant

NCT03158467

Sponsor

Abramson Cancer Center at Penn Medicine

Status

Withdrawn

Last Update Posted

Sep 20, 2018Actual

Enrollment

0Actual

Phase

Not provided

Conditions

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

Interventions

Surveys

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2018

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Did not enroll

Expanded Access Info

Start Date

May 15, 2017Actual

Primary Completion Date

May 15, 2019Estimated

Completion Date

Nov 15, 2019Estimated

First Submitted Date

May 16, 2017

First Submission Date that Met QC Criteria

May 16, 2017

First Posted Date

May 18, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 18, 2018

Last Update Posted Date

Sep 20, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Phase 1			Other: Surveys
Phase 2			Other: Surveys

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Surveys	Other	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.

Measure	Description	Time Frame
Number of surveys completed		2 years

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Cancer Patients Undergoing Stem Cell Transplantation

Sampling Method

Probability Sample

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms