Cancer Patients Undergoing Stem Cell Transplantation (RCT of ACP for Transplant)NCT03158467
RCT of ACP for Transplant
An observational study of Cancer Patients Undergoing Stem Cell Transplantation (RCT of ACP for Transplant), run by Abramson Cancer Center at Penn Medicine.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Patients Undergoing Stem Cell Transplantation (RCT of ACP for Transplant)
- What is being tested?
- Surveys
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2017to 15 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cancer Patients Undergoing Stem Cell Transplantation
Who may be able to join
- 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.
Who cannot join
- 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
About this study
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)
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.
- Being tested
- Surveys
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveysOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 | Not described Receives: Other: Surveys | |
| Phase 2 | Not described Receives: Other: Surveys |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of surveys completed
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2017
- Study start15 May 2017
- Primary completion15 May 2019 (estimated)
- Study completion15 Nov 2019 (estimated)
Why it stopped: Did not enroll
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer Patients Undergoing Stem Cell Transplantation (RCT of ACP for Transplant)Studies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pallavi Kumar, MD, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03158467
- Sponsor's protocol ID
- UPCC 23417
- Status last verified
- May 2018
- First submitted
- 16 May 2017
- Last updated
- 20 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03158467
- Acronym / sponsor ID
- UPCC 23417
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Did not enroll
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- 15 May 2017 (actual)
- Primary completion
- 15 May 2019 (estimated)
- Study completion
- 15 Nov 2019 (estimated)
- First posted
- 18 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1 | – | Other: Surveys |
| Phase 2 | – | Other: Surveys |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cancer Patients Undergoing Stem Cell Transplantation
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurveysInstruments 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. | Other | Phase 1, Phase 2 |
Primary outcome
Number of surveys completed
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pallavi Kumar, MD principal investigator
Abramson Cancer Center at Penn Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer Patients Undergoing Stem Cell Transplantation (RCT of ACP for Transplant), run by Abramson Cancer Center at Penn Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of surveys completed (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2018.