RCT of ACP for Transplant

NCT03158467 | Withdrawn DMC

• 1 other identifier: UPCC 23417
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Number of surveys completed

  2 years

Study Arms (2)

Phase 1

Other: Surveys

Phase 2

Other: Surveys

Interventions

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.

Phase 1; Phase 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Cancer Patients Undergoing Stem Cell Transplantation

You may qualify if:

• 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
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Pallavi Kumar, MD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2017
• First Posted: May 18, 2017
• Study Start: May 15, 2017
• Primary Completion: May 15, 2019
• Study Completion: November 15, 2019
• Last Updated: September 20, 2018

Record last verified: 2018-05