An interventional study of Early palliative and supportive care in Leukemia, Lymphoma and Multiple Myeloma, sponsored by Alberta Health Services, Calgary. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-31.
Sponsored by Alberta Health Services, Calgary · Not applicable, Interventional, and Supportive care
Among 178 studies in Leukemia with a site in Canada — 16 open to participants now, 29 under way, 8 of them phase 3. Leukemia · Canada.
Among the 178 studies in Leukemia with a site in Canada, this one is the 60th largest by planned enrollment of the 157 interventional ones that give a count, is one of 8 that started in 2022, is one of 11 with no phase, reaches primary completion later than 7 of the 28 other live ones, and was the 163rd registered.
2,381 studies on the registry are indexed under Leukemia; 253 are open to participants now.
Browse Leukemia studies →16 of the 178 studies in Leukemia with a site in Canada are open now. Recruiting first, the newest first:
AstraZeneca · Sites in Canada, United States, Australia and 2 more countries
Novartis Pharmaceuticals · Sites in Canada, United States, Australia and 14 more countries
Kura Oncology, Inc. · Sites in Canada, United States, Australia and 14 more countries
AstraZeneca · Sites in Canada, United States, Australia and 10 more countries
University of British Columbia · Sites in Canada, United States
A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →
Of the 208 Leukemia studies recruiting now, 112 (54%) set no upper age limit and 74 (36%) stop at 75 or younger; 86 take children under 18; 24 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
178 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 59 · Phase 2 71 · Phase 3 47 · Phase 4 1
First in 1992; this study’s year is marked. 8 started in 2022.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 152 is above the median of 40 across 1,769 interventional studies indexed under Leukemia.
Median enrollment 87 across the 157 interventional studies, 355 across the 14 observational. Of the 142 that completed or were terminated, 55 (39%) have results posted.
This tab as a report to print or save as PDF → With an account.
81 of 178 have an industry lead sponsor. The 10 most frequent:
Alberta Health Services, Calgary is the lead sponsor of 10 studies on the registry; 4 are open to participants now.
Alberta Health Services, Calgary has 1 study filed under Leukemia — fewer than ten, so there is no comparison to draw.
6 of the studies in Leukemia with a site in Canada that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03836261Phase 3Acerta Pharma BVStudy of Acalabrutinib (ACP-196) in Combination With Venetoclax (ABT-199), With and Without Obinutuzumab (GA101) Versus Chemoimmunotherapy for Previously Untreated CLL | 2027-04-30 |
| NCT04256317Phase 3Taiho Oncology, Inc.A Multi-phase Study of ASTX030 (Azacitidine and Cedazuridine) in Myeloid Neoplasm Alone or in Combination With Venetoclax in AML (AZTOUND Study) | 2027-11-01 |
| NCT04541212Montreal Heart InstituteIdentification and Evaluation of Patients at Risk of Developing Cardiotoxicity After Receiving Chemotherapy for Breast Cancer, Lymphoma or Leukemia | 2027-04-30 |
| NCT03702309University Health Network, TorontoLiquid Biopsy Evaluation and Repository Development at Princess Margaret | 2027-07-06 |
| NCT02932280Memorial Sloan Kettering Cancer CenterSafety and Dose Finding Study of Neratinib in Children and Young Adults With Cancer That Has Returned or Not Responded to Treatment | 2027-10 |
Among the 178 studies in Leukemia with a site in Canada, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Research has shown that early palliative care in cancer care is associated with improved symptom management, better prognostic understanding, improved quality of life for patients and family caregivers, and even improved survival. Yet, in spite of the proven benefits of integration of palliative care in oncology, it has been well established that patients with hematologic malignancies and those undergoing cellular therapy (hematopoietic stem cell transplantation (HSCT) and chimeric antigen receptor (CAR) T-cell therapy) do not routinely receive palliative care. Most of the published research on the early integration of palliative care in oncology describes studies that have involved patients with solid tumours. To date, only one randomized trial examining the impact of integrated palliative care among patients undergoing HSCT has been published and there have been no studies examining the impact of integrated palliative care for patients undergoing CAR T-cell therapy. The American Society of Clinical Oncology recommends early palliative care for patients with advanced cancers or for those with high symptom burden. Patients with blood cancers experience high symptom burden and in the last 30 days of life, compared to patients with solid tumours, patients with blood cancers are more likely to die in hospital, have more intensive care unit admissions, have prolonged hospitalizations (>14 days), and pass away in an acute care facility. There is an urgent need to proactively address suffering throughout cellular therapy trajectories, even before treatment starts, so that patients and caregivers are not inevitably waiting for symptoms to arise before they can be addressed and to optimize quality of life for patients undergoing transplant as well as their family caregivers.
PALS_CT will compare early palliative care to standard care for patients and their family caregivers undergoing HSCT or CAR T-cell therapy for blood cancers.
Problem: patients undergoing HSCT and CAR T-cell therapy experience high symptom burden (physical, psychological, spiritual), lack illness and prognostic understanding (which can adversely impact medical decision making). Research has found that patients with blood cancers experience poor end-of-life (EOL) quality indicators such as disease-directed therapy in the weeks before death, emergency room visits in the weeks before death, intensive care unit (ICU) admissions near the EOL, low rates of hospice use, and dying in hospital. Family caregivers (CGs) of patients undergoing HSCT and CAR T-cell therapy experience impaired QOL, physical and psychosocial concerns, and have expressed that their needs have not been adequately addressed by care teams. Palliative care, with its multidisciplinary approach and focus on improving QOL from a holistic perspective, can help reduce symptom burden and improve QOL, improve illness and prognostic understanding, and improve EOL care for patients undergoing HSCT and CAR T-cell therapy and their family CGs. This trial will assess the effectiveness of early PC in improving QOL for patients and their family CGs undergoing HSCT or CAR T-cell therapy for hematological malignancies.
Objectives The objectives for this study were developed after extensive review of the literature as well as were informed by preliminary data derived from an ongoing qualitative study that sought the perspectives of patients, family CGs, and clinicians regarding the integration of PC in HSCT.
Objective 1: To examine the impact of an outpatient PC intervention on patient-reported QOL for patients undergoing HSCT or CAR T-cell therapy Hypothesis: patients randomized to the PC intervention will report greater improvement in QOL at 1-month post-HSCT/CAR T-cell therapy and at 3 months post-HSCT/CAR T-cell therapy compared to patients receiving standard care.
Objective 2: To examine the impact of an outpatient PC intervention on symptoms at 2 weeks, 1 month, and 3 months post-HSCT/CAR T-cell therapy for patients undergoing HSCT/CAR T-cell therapy Hypothesis: patients randomized to the PC intervention will report a greater reduction in physical symptoms at 2 weeks, 1 month, and 3 months post-HSCT/CAR T-cell therapy compared to patients receiving standard care
Objective 3: To examine the impact of an outpatient PC intervention on family CG QOL at 1 month and 3 months post-HSCT/CAR T-cell therapy for CGs of patients undergoing HSCT/CAR T-cell therapy Hypothesis: family CGs of patients randomized to the PC intervention will report greater improvement in QOL compared to family CGs of patients receiving standard care
Objective 4: To examine the impact of an outpatient PC intervention on patient and family CG understanding of prognosis.
Hypothesis: patients and family CGs randomized to the PC intervention will report more accurate prognostic understanding compared to those receiving standard care
Exploratory objective 1: To evaluate whether an outpatient PC intervention is associated with overall survival at 1 and 5 years post-study enrolment.
Methods This is a prospective pragmatic randomized clinical trial to evaluate the effectiveness of an outpatient PC intervention integrated with standard care compared to standard care alone in 152 patients undergoing HSCT or CAR T-cell therapy. Randomization will be stratified by type of treatment: autologous transplant, allogeneic transplant, or CAR T-cell therapy. A pragmatic approach was selected given the desire to assess the effectiveness of integrating early PC in HSCT/CAR T-cell therapy. Previous studies have examined the efficacy of PC in oncology in patients with advanced cancer. This study will build the work of El-Jawahri et al. who studied the impact of inpatient PC on patients undergoing HSCT with the main difference being that participants will be recruited in the outpatient setting and the intervention will be delivered in the outpatient setting. Selected outcomes have been chosen as they are congruent with patient, family CG and clinician perspectives, based upon the qualitative study that was undertaken by the PI (R Booker) in 2020-2021.
Data Collection Participants will be emailed a secure link for the questionnaires. Data from questionnaires will be collected electronically using Research Electronic Data Capture (REDCap). Email reminders will be sent to participants to remind them to complete the surveys and if necessary, a research assistant will contact patients and family CGs to provide reminders to complete the surveys.
Following randomization, participants (patients and family CGs) will be asked to complete baseline questionnaires and demographic information (such as age, gender, diagnosis, urban/rural residence, religious affiliation, highest level of education, main CG (for patients), main source of support (for family CGs) will be collected via REDCap. The next evaluation will occur during the second week following HSCT or CAR T-cell therapy. For participants undergoing autologous HSCT or CAR T-cell therapy (and their family CGs), the second evaluation will occur on day +5 (with a 48-hour window). For participants undergoing allogeneic HSCT (and their family CGs), the second evaluation will occur on day +8 (with a 72-hour window). These time points were chosen based upon the study conducted by El-Jawahri et al. who indicated they selected the time points to coincide with the peak of severity in symptoms based upon the type of transplant being performed. All patients and family CGs will also complete questionnaires at 1 and 3 months post HSCT/CAR T-cell therapy. Data collection will be done remotely, with links to questionnaires sent via email completed via REDCap. As part of the consent process, participants will be asked if they would consider completing questionnaires at 6-12 months post-HSCT/CAR T-cell therapy. Patient participants will also be asked if they consent to the researchers accessing their medical charts until 5 years post-HSCT/CAR T-cell therapy in order to collect disease and treatment information.
Data Analysis Exclusive intention-to-treat (ITT) analysis may not be aligned with patient-centered outcomes and as such, this study will use both ITT and per protocol analyses. For any imbalances between the intervention and control groups, sensitivity analyses while be conducted and g-methods will be used to adjust for confounders that may vary over time. As per the revised CONSORT guidelines for reporting parallel-group randomized trials, the investigators will collect and report the reasons for participants lost to follow-up as well as the reasons why any participants' data were excluded from analysis.
Analysis Plan Primary Outcome To assess the primary outcome of the study, difference in QOL, as measured by the MQOL-E, between the intervention group and the standard care group will be compared. Because QOL will be assessed at multiple time points, area under the curve (AUC) will be used to calculate a summary score for each patient. Assessing multiple domains over time increases the possibility of Type I error. In particular, because it is expected that patient trajectories of QOL will be non-linear, AUC seems more appropriate than using specific time points as the latter may underestimate or overestimate treatment differences. Summary scores will be averaged across all patients in both the intervention and standard care arms and differences between the groups will be assessed using t-tests. The summary profiles for patients will be presented in graphical form for the MQOL and FACT-BMT.
Analysis Plan - Secondary Outcomes Family CG QOL will be analyzed using AUC and comparing the two groups using t-tests. For patient symptom burden, as measured by the ESAS, symptom scores will be tracked over time for each patient. An overall summary score for the ESAS will not be used given the diversity of symptoms assessed by the ESAS as well as the possibility that patients can add another symptom or concern to the tool. The latter would mean that there could be different symptoms being reported amongst participants, thereby making it difficult to compare groups. Patient and family CG prognostic understanding will be assessed using t-tests to compare the intervention group and standard care group at two time points, pre-HSCT/CAR T-cell therapy and at 3 months post-HSCT/CAR T-cell therapy.
Inclusion Criteria - Patients
Inclusion Criteria - Family Caregivers
Exclusion Criteria - Patients
Exclusion Criterion - Family Caregivers
* Inability to provide informed consent
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants randomized to the intervention arm will meet (either by phone or Zoom contingent upon participant preference) with a palliative care nurse practitioner or palliative care physician. During the first meeting, pre-transplant/CAR T-cell therapy, content will focus on the provision of information and education, including: a description of palliative and supportive care, symptom management, advance care planning, prognostic and illness understanding and treatment expectations, and coping strategies. All subsequent visits will include, at minimum, these topics. All meetings will be audio-recorded using a handheld audio-recorder; the record feature of Zoom will not be utilized. Participants in the intervention arm will meet with a member of the study team (palliative care nurse practitioner or palliative care physician) one to two times weekly, or more frequently if requested by the patient and/or family caregiver, until 3 months post-transplant/CAR T-cell therapy.
Other: Early palliative and supportive care
Standard care will involve the usual care that patients undergoing HSCT/CAR T-cell therapy would be expected to receive, including palliative care consultation as needed or upon request. Palliative care interventions beyond what are provided in the study will be tracked in both the intervention and the standard care arms.
The intervention itself will be predominantly the provision of education and information. It is possible that patients in the intervention arm may receive treatment recommendations to help manage symptoms.
Patient quality of life
The primary outcome of the study, QOL, will be assessed using the McGill Quality of Life Questionnaire - Expanded (MQOL-E) summary score of QOL monthly for a period of three months. The MQOL-E consists of 21 items with possible scores of 0 to 10 for each item. The higher the score, the better the QOL. The trajectories of QOL will be evaluated rather than looking at change in scores as it is anticipated that there will be significant fluctuation in QOL scores over time. The Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT) will also be used to measure QOL. The FACT-BMT is more specific to BMT and may capture issues that are unique to BMT. The FACT-BMT consists of 47 items; a 5-point Likert-type scale is used for item. The total score ranges from 0-196 and higher scores indicate better QOL.
Time frame: 3 months
Patient symptom burden
The Edmonton Symptom Assessment System (ESAS) is a validated scale that assesses symptom burden in patients with cancer. While several iterations of the ESAS are available, this study will use the ESAS-revised (ESAS-r) which includes 10 items scored using a numeric rating scale, where 0=no symptom and 10=worst symptom. The ESAS assesses physical symptoms (pain, fatigue, nausea, drowsiness, dyspnea, loss of appetite), emotional symptoms (anxiety and depression), and well-being. Individual patient scores will be tracked over time to assess the trajectory of symptom burden.
Time frame: 3 months
Patient and family caregiver prognostic understanding
The Perception of Treatment and Prognosis Questionnaire (PTPQ) is 10 item self-report questionnaire that assesses patients' beliefs about the likelihood of cure, the importance and helpfulness of knowing about prognosis, the primary goal of cancer treatment, the preferences for information about treatment, and the satisfaction with quality of information provided regarding prognosis and treatment. Items on the questionnaire are scored individually with statements about the degree to which the patient agrees with each item. Patients and CGs will complete the PTPQ pre-HSCT/CAR T-cell therapy and at 3 months post HSCT/CAR T-cell therapy.
Time frame: 3 months
Family caregiver quality of life
The Quality of Life in Life-Threatening Illness - Family carer version 2 (QOLLTI-F v2) will be used to assess CG QOL. The QOLLTI-Fv2 is a 17-item questionnaire that includes seven subscales that assess the following domains: environment, patient condition, the CG's own state, quality of care, relationships, and financial worries. In addition, there is a single item that pertains to overall QOL. Items on the QOLLTI-Fv2 are ranked from 0-10 (total possible score ranges from 0-170), where higher scores are associated with better QOL. Caregivers in both the intervention and standard care arms will complete the QOLLTI-Fv2 pre-HSCT/CAR T-cell therapy, and at 2-weeks, 1-month, and 3-months post-HSCT/CAR T-cell therapy.
Time frame: 3 months
1 year overall survival
Patient survival at 1 year post-study enrolment
Time frame: 1 year
5 year overall survival
Patient survival at 5 years post-study enrolment
Time frame: 5 years
Plan to share: No
Started Apr 2022 (actual). Primary completion is estimated for Apr 2025, 36 months after the start.
Of 103 non-industry interventional studies with no phase under Leukemia, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 128. This study's planned 36 months is close to that.
Counting every sponsor, half of 110 studies reached it within 38 months; a quarter within 22 and three quarters within 75.
How these figures are worked out, and which studies are left out of them.
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Alberta Health Services, Calgary