Advanced Cancer
Conditions
Brief 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.
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.
Interventions
BEHAVIORALcare management by oncology nurses
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.
Sponsors
American Cancer Society, Inc.
University of Pittsburgh
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Successful enrollment of 30 patient-caregiver pairs | Baseline to 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Enrolled-to-consent rate | Baseline to 3 months | Enrolled-to-consent rates will be tracked to assess feasibility |
| Intervention completion rate | Baseline to 3 months | Intervention completion rate among enrolled participants will be tracked to assess feasibility |
| Intervention fidelity | Baseline to 3 months | Percent of intervention components completed according to protocol will be tracked to assess feasibility |
| Consent-to-approach rate | Baseline to 3 months | Consent to approach rates will be tracked to assess feasibility |
| Missing data | Baseline to 3 months | Missing data rates will be tracked to assess feasibility |
| Acceptability | 3 months | 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: 1. \> 80% of patient and caregiver participants would recommend the intervention to other patients with advanced hematologic malignancies and their caregivers. 2. \> 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. 3. \> 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. 4. \> 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. |
| Outcome assessment rate | Baseline to 3 months | Outcome assessment rates among enrolled participants will be tracked to assess feasibility |
Countries
United States
Outcome results
None listed