Advanced CancerNCT02992171
Primary Palliative Care for Patients With Advanced Hematologic Malignancies
A study testing care management by oncology nurses in people with Advanced Cancer, run by University of Pittsburgh at 1 site in United States.
Trial summary
This study seeks to develop and pilot-test an oncology nurse-led care management intervention to meet the primary palliative care needs of patients with advanced hematologic malignancies. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- care management by oncology nurses
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 2 May 2017to 19 Mar 2020
- Phase
- Interventional
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults (≥ 21 years old)
- Refractory or Recurrent hematologic cancer: lymphoma, leukemia, myeloma, amyloidosis (secondary manifestation myeloma \& AL Amyloidosis), and CML (CML can only be accelerated or blast phase)
- planning to receive ongoing care from a participating oncologist and willing to be seen at least monthly.
- adults (≥ 21 years old)
- family member or friend of an eligible patient
Who cannot join
- chronic myeloid leukemia (CML) OTHER THAN accelerated or blast phase
- unable to read and respond to questions in English
- lacks decision-making capacity, as determined by the patient's oncologist
- unable to complete baseline interview
- Caregiver
- unable to read and respond to questions in English
- unable to complete the baseline interview (patients will be asked to select as caregiver the person who is most likely to accompany them to visits or help with their care should they need it)
- Eligible clinicians will be oncology nurses and oncologists practicing at participating clinics.
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
About this study
Official title: SHARE - Supportive Care Management for Patients With Hematologic Cancers by Registered Nurses
This study seeks to develop and pilot-test an oncology nurse-led care management intervention to meet the primary palliative care needs of patients with advanced hematologic malignancies.
Read the detailed description
Study investigators will develop and pilot-test an oncology nurse-led care management intervention to meet the primary palliative care needs of patients with advanced hematologic malignancies.
Aim 1 is a case series to develop and refine the intervention. During this time, we will develop initial interventionist training materials, study protocols, and a web-based outcomes database; train 2 hematology-oncology nurses; enroll 10 patients with advanced hematologic malignancies and their informal caregivers to receive intervention visits; conduct debriefing interviews; iteratively refine the intervention based on nurse, oncologist, patient, and caregiver feedback; and prepare the protocol for Aim 2. Aim 2 is a pilot study to assess the feasibility and acceptability of administering the intervention and assessing outcomes. We will recruit 30 patients and their informal caregivers to receive the intervention developed in Aim 1 and collect measures of quality of life, symptom burden, anxiety and depressive symptoms, caregiver burden, and healthcare utilization at baseline and monthly for up to three months. Trial outcomes will include: rates of enrollment, study completion, and outcome completion; intervention fidelity; and self-reported measures of study burdensomeness and effectiveness among patients, caregivers, and clinicians.
- Conditions
- Advanced Cancer
- Being tested
- care management by oncology nurses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
care management by oncology nursesBehavioural
The intervention employs a care management approach to facilitate provision of primary palliative care within existing oncology clinic structures. The intervention is deployed through a series of nurse-led encounters occurring before or after regularly-scheduled oncology clinic visits.
| Study group | Role | What they receive |
|---|---|---|
| care management by oncology nurses | Experimental | The intervention employs a care management approach to facilitate provision of primary palliative care within existing oncology clinic structures. The intervention is deployed through a series of nurse-led encounters occurring before or after regularly-scheduled oncology clinic visits. Receives: Behavioral: care management by oncology nurses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful enrollment of 30 patient-caregiver pairs
Measured: Baseline to 3 months
Secondary outcomes (7)
Consent-to-approach rate
Consent to approach rates will be tracked to assess feasibility
Measured: Baseline to 3 months
Enrolled-to-consent rate
Enrolled-to-consent rates will be tracked to assess feasibility
Measured: Baseline to 3 months
Intervention completion rate
Intervention completion rate among enrolled participants will be tracked to assess feasibility
Measured: Baseline to 3 months
Intervention fidelity
Percent of intervention components completed according to protocol will be tracked to assess feasibility
Measured: Baseline to 3 months
Outcome assessment rate
Outcome assessment rates among enrolled participants will be tracked to assess feasibility
Measured: Baseline to 3 months
Missing data
Missing data rates will be tracked to assess feasibility
Measured: Baseline to 3 months
Acceptability
We will assess acceptability based on patient, caregiver, and clinician responses to closed-end survey questions. Definitions of adequate acceptability based on these surveys include:
- > 80% of patient and caregiver participants would recommend the intervention to other patients with advanced hematologic malignancies and their caregivers.
- > 80% of patient and caregiver participants agree or strongly agree that intervention visits have been helpful for (a) improving pain or other symptoms, (b) helping with illness understanding, (c) helping with coping, and (d) helping with planning for the future.
- > 80% of oncologist participants disagree or strongly disagree that (a) working with intervention nurses has been burdensome or (b) the intervention has been disruptive to clinic workflow.
- > 80% of oncologist and nurse participants agree or strongly agree that the intervention (a) has helped me to take better care of my patients and (b) has improved the quality of care.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2016 (estimated)
- Study start2 May 2017
- Primary completion19 Mar 2020
- Study completion19 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Principal investigator, Yael Schenker, MD, MAS, University of Pittsburgh
- Investigators
- Yael Schenker, MD, MAS, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02992171
- Sponsor's protocol ID
- PRO16100199
- Other IDs
- 130225-PEP-16-205-01-PCSM
- Status last verified
- Apr 2020
- First submitted
- 7 Dec 2016
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share study data with investigators at Duke University. They will have access to de-identified research data, specifically audio recordings and debriefing interviews, for purposes of quality assurance and/or data analysis.
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SHARE - Supportive Care Management for Patients With Hematologic Cancers by Registered Nurses
- ClinicalTrials.gov ID
- NCT02992171
- Acronym / sponsor ID
- PRO16100199
- Conditions
- Advanced Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- 2 May 2017 (actual)
- Primary completion
- 19 Mar 2020 (actual)
- Study completion
- 19 Mar 2020 (actual)
- First posted
- 14 Dec 2016 (estimated)
- 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.
This study seeks to develop and pilot-test an oncology nurse-led care management intervention to meet the primary palliative care needs of patients with advanced hematologic malignancies.
Detailed description
Study investigators will develop and pilot-test an oncology nurse-led care management intervention to meet the primary palliative care needs of patients with advanced hematologic malignancies.
Aim 1 is a case series to develop and refine the intervention. During this time, we will develop initial interventionist training materials, study protocols, and a web-based outcomes database; train 2 hematology-oncology nurses; enroll 10 patients with advanced hematologic malignancies and their informal caregivers to receive intervention visits; conduct debriefing interviews; iteratively refine the intervention based on nurse, oncologist, patient, and caregiver feedback; and prepare the protocol for Aim 2. Aim 2 is a pilot study to assess the feasibility and acceptability of administering the intervention and assessing outcomes. We will recruit 30 patients and their informal caregivers to receive the intervention developed in Aim 1 and collect measures of quality of life, symptom burden, anxiety and depressive symptoms, caregiver burden, and healthcare utilization at baseline and monthly for up to three months. Trial outcomes will include: rates of enrollment, study completion, and outcome completion; intervention fidelity; and self-reported measures of study burdensomeness and effectiveness among patients, caregivers, and clinicians.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| care management by oncology nurses | Experimental | Behavioral: care management by oncology nursesThe intervention employs a care management approach to facilitate provision of primary palliative care within existing oncology clinic structures. The intervention is deployed through a series of nurse-led encounters occurring before or after regularly-scheduled oncology clinic visits. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- adults (≥ 21 years old)
- Refractory or Recurrent hematologic cancer: lymphoma, leukemia, myeloma, amyloidosis (secondary manifestation myeloma \& AL Amyloidosis), and CML (CML can only be accelerated or blast phase)
- planning to receive ongoing care from a participating oncologist and willing to be seen at least monthly.
- adults (≥ 21 years old)
- family member or friend of an eligible patient
Key exclusion criteria (8 listed)
- chronic myeloid leukemia (CML) OTHER THAN accelerated or blast phase
- unable to read and respond to questions in English
- lacks decision-making capacity, as determined by the patient's oncologist
- unable to complete baseline interview
- Caregiver
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 |
|---|---|---|
| care management by oncology nursesThe intervention employs a care management approach to facilitate provision of primary palliative care within existing oncology clinic structures. The intervention is deployed through a series of nurse-led encounters occurring before or after regularly-scheduled oncology clinic visits. | Behavioural | care management by oncology nurses |
Primary outcome
Successful enrollment of 30 patient-caregiver pairs
Time frame: Baseline to 3 months
7 secondary outcomes
Consent-to-approach rate
Time frame: Baseline to 3 months
Enrolled-to-consent rate
Time frame: Baseline to 3 months
Intervention completion rate
Time frame: Baseline to 3 months
Intervention fidelity
Time frame: Baseline to 3 months
Outcome assessment rate
Time frame: Baseline to 3 months
Missing data
Time frame: Baseline to 3 months
Acceptability
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
- Individual participant dataSharing planned: Yes. We will share study data with investigators at Duke University. They will have access to de-identified research data, specifically audio recordings and debriefing interviews, for purposes of quality assurance and/or data analysis.
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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.
Yael Schenker, MD, MAS principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing care management by oncology nurses in people with Advanced Cancer, run by University of Pittsburgh at 1 site in United States.
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 5 inclusion and 8 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: finished, as of the sponsor's last update on 24 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Successful enrollment of 30 patient-caregiver pairs (time frame: Baseline to 3 months). 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 24 Apr 2020.