Advanced Cancer Clinical Trial
Official title:
SHARE - Supportive Care Management for Patients With Hematologic Cancers by Registered Nurses
Verified date | April 2020 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | March 19, 2020 |
Est. primary completion date | March 19, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility |
Participants will be (1) patients with advanced hematologic malignancies receiving care at
a participating clinic; (2) their caregivers; (3) participating clinicians. Patient: Inclusion Criteria: - 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. Exclusion criteria: - 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 Inclusion Criteria: - adults (= 21 years old) - family member or friend of an eligible patient Exclusion criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pittsburgh | American Cancer Society, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Successful enrollment of 30 patient-caregiver pairs | Baseline to 3 months | ||
Secondary | Consent-to-approach rate | Consent to approach rates will be tracked to assess feasibility | Baseline to 3 months | |
Secondary | Enrolled-to-consent rate | Enrolled-to-consent rates will be tracked to assess feasibility | Baseline to 3 months | |
Secondary | Intervention completion rate | Intervention completion rate among enrolled participants will be tracked to assess feasibility | Baseline to 3 months | |
Secondary | Intervention fidelity | Percent of intervention components completed according to protocol will be tracked to assess feasibility | Baseline to 3 months | |
Secondary | Outcome assessment rate | Outcome assessment rates among enrolled participants will be tracked to assess feasibility | Baseline to 3 months | |
Secondary | Missing data | Missing data rates will be tracked to assess feasibility | Baseline to 3 months | |
Secondary | 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. |
3 months |
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