Acute Myeloid LeukemiaNCT03806192
Feasibility of Partners in Care Program for Caregivers of Patients With Acute Myeloid Leukemia
A study testing Telephone-Based Intervention, Behavioral, Psychological or Informational Intervention and Questionnaire Administration in people with Acute Myeloid Leukemia, run by University of Washington at 1 site in United States.
Trial summary
This trial studies the feasibility of delivering the Partners in Care Program to caregivers of patients with acute myeloid leukemia. Psychological counseling interventions, such as the Partners in Care Program, may help to improve caregivers' psychosocial functioning, marital adjustment in the context of the cancer… Read more about this study
- Who is it for?
- Ages 18 to 82 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Telephone-Based Intervention, Behavioral, Psychological or Informational Intervention and Questionnaire Administration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2019to 30 Nov 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 18 to 82 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of AML within the recent 2 months
- Caregivers and patients need to write, read, and speak English as one of their languages of choice; and currently sharing a residence at least 50% of the time together
- Patient must have no other concurrent cancer diagnosis except for basal or squamous cell
- Caregiver must be able to sustain up to 60 minutes of interaction with patient educator
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Participants will be excluded if either the patient or the caregiver cannot write, read, and speak English as one of their languages of choice; are not currently sharing a residence at least 50% of the time together
- The patient cannot have another concurrent cancer diagnosis except for basal or squamous cell
- Caregiver cannot sustain up to 60 minutes of interaction with the patient educator
- Caregiver does not have access to a computer with 2-way video capability (i.e. ZOOM) or a cell phone
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: A Field Test of the Partners in Care Program
This trial studies the feasibility of delivering the Partners in Care Program to caregivers of patients with acute myeloid leukemia. Psychological counseling interventions, such as the Partners in Care Program, may help to improve caregivers' psychosocial functioning, marital adjustment in the context of the cancer, communication, and support skills to the patient.
Read the detailed description
OUTLINE: Participants are randomized to 1 of 2 groups.
GROUP A: Participants attend 5 psychoeducational counseling sessions over 30-60 minutes via telephone.
GROUP B: Participants attend 5 psychoeducational counseling sessions over 30-60 minutes via video teleconference.
After completion of study, participants are followed up at 4 months.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Telephone-Based Intervention, Behavioral, Psychological or Informational Intervention, Questionnaire Administration
- Keywords
- Caregiver
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone-Based InterventionBehavioural
Attend psychoeducational counseling sessions via telephone
Behavioral, Psychological or Informational InterventionOther
Attend psychoeducational counseling sessions via video teleconference
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Group A (psychoeducational counseling sessions via telephone) | Experimental | Participants attend 5 psychoeducational counseling sessions over 30-60 minutes via telephone. Receives: Behavioral: Telephone-Based Intervention; Other: Questionnaire Administration |
| Group B (psychoeducational counseling sessions in person) | Experimental | Participants attend 5 psychoeducational counseling sessions over 30-60 minutes via video teleconference. Receives: Other: Behavioral, Psychological or Informational Intervention; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of recruitment
Measured: Up to 1 year
Rate of enrollment
Measured: Up to 1 year
Rate of completion of 5-session intervention
Measured: Up to 1 year
Secondary outcomes (4)
Change in standardized measures of caregiver and patients' scores in each group on anxiety (State-Trait Anxiety Inventory [STAI])
Will assess the within-group changes using the one-sample t-test or the signed-rank test, as appropriate.
Measured: Baseline up to 4 months
Change in standardized measures of caregiver and patients' scores in each group on depressed mood (Center for Epidemiologic Studies Depression Scale [CES-D])
Will assess the within-group changes using the one-sample t-test or the signed-rank test, as appropriate.
Measured: Baseline up to 4 months
Change in standardized measures of caregiver and patients' scores in each group on Spouse Skills Checklist
Will assess the within-group changes using the one-sample t-test or the signed-rank test, as appropriate.
Measured: Baseline up to 4 months
Change in standardized measures of caregiver and patients' scores in each group on Cancer Self-efficacy (CASE)
Will assess the within-group changes using the one-sample t-test or the signed-rank test, as appropriate.
Measured: Baseline up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start16 Mar 2019
- Primary completion30 Nov 2020
- Study completion30 Nov 2020
Why it stopped: Terminated due to insufficient funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frances Lewis, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03806192
- Sponsor's protocol ID
- RG1003619
- Other IDs
- NCI-2018-03629, 10048
- Status last verified
- Dec 2020
- First submitted
- 14 Jan 2019
- Last updated
- 23 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Field Test of the Partners in Care Program
- ClinicalTrials.gov ID
- NCT03806192
- Acronym / sponsor ID
- RG1003619
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Caregiver
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to insufficient funding
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 16 Mar 2019 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 16 Jan 2019 (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.
This trial studies the feasibility of delivering the Partners in Care Program to caregivers of patients with acute myeloid leukemia. Psychological counseling interventions, such as the Partners in Care Program, may help to improve caregivers' psychosocial functioning, marital adjustment in the context of the cancer, communication, and support skills to the patient.
Detailed description
OUTLINE: Participants are randomized to 1 of 2 groups.
GROUP A: Participants attend 5 psychoeducational counseling sessions over 30-60 minutes via telephone.
GROUP B: Participants attend 5 psychoeducational counseling sessions over 30-60 minutes via video teleconference.
After completion of study, participants are followed up at 4 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (psychoeducational counseling sessions via telephone) | Experimental | Behavioral: Telephone-Based Intervention, Other: Questionnaire AdministrationParticipants attend 5 psychoeducational counseling sessions over 30-60 minutes via telephone. |
| Group B (psychoeducational counseling sessions in person) | Experimental | Other: Behavioral, Psychological or Informational Intervention, Other: Questionnaire AdministrationParticipants attend 5 psychoeducational counseling sessions over 30-60 minutes via video teleconference. |
Who may qualify
- Ages
- 18 to 82 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of AML within the recent 2 months
- Caregivers and patients need to write, read, and speak English as one of their languages of choice; and currently sharing a residence at least 50% of the time together
- Patient must have no other concurrent cancer diagnosis except for basal or squamous cell
- Caregiver must be able to sustain up to 60 minutes of interaction with patient educator
- Ability to understand and the willingness to sign a written informed consent document
Key exclusion criteria (4 listed)
- Participants will be excluded if either the patient or the caregiver cannot write, read, and speak English as one of their languages of choice; are not currently sharing a residence at least 50% of the time together
- The patient cannot have another concurrent cancer diagnosis except for basal or squamous cell
- Caregiver cannot sustain up to 60 minutes of interaction with the patient educator
- Caregiver does not have access to a computer with 2-way video capability (i.e. ZOOM) or a cell phone
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 |
|---|---|---|
| Telephone-Based InterventionAttend psychoeducational counseling sessions via telephone | Behavioural | Group A (psychoeducational counseling sessions via telephone) |
| Behavioral, Psychological or Informational InterventionAttend psychoeducational counseling sessions via video teleconference | Other | Group B (psychoeducational counseling sessions in person) |
| Questionnaire AdministrationAncillary studies | Other | Group A (psychoeducational counseling sessions via telephone), Group B (psychoeducational counseling sessions in person) |
Primary outcome
Rate of recruitment
Time frame: Up to 1 year
Rate of enrollment
Time frame: Up to 1 year
Rate of completion of 5-session intervention
Time frame: Up to 1 year
4 secondary outcomes
Change in standardized measures of caregiver and patients' scores in each group on anxiety (State-Trait Anxiety Inventory [STAI])
Time frame: Baseline up to 4 months
Change in standardized measures of caregiver and patients' scores in each group on depressed mood (Center for Epidemiologic Studies Depression Scale [CES-D])
Time frame: Baseline up to 4 months
Change in standardized measures of caregiver and patients' scores in each group on Spouse Skills Checklist
Time frame: Baseline up to 4 months
Change in standardized measures of caregiver and patients' scores in each group on Cancer Self-efficacy (CASE)
Time frame: Baseline up to 4 months
Results and safety
The study was stopped early (reason given: Terminated due to insufficient funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2021.
- Individual participant dataSharing planned: No
Related trials for Acute Myeloid Leukemia
RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingPhase 1/2
Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
Acute Biphenotypic Leukemia, Acute Myeloid Leukemia
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome
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.
Frances Lewis principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone-Based Intervention, Behavioral, Psychological or Informational Intervention and Questionnaire Administration in people with Acute Myeloid Leukemia, run by University of Washington 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 4 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: stopped early, as of the sponsor's last update on 23 Jun 2021. 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 was stopped early (reason given: Terminated due to insufficient funding). Results are not available in the source record.
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?
Rate of recruitment (time frame: Up to 1 year). The study lists 3 primary outcomes in all. 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 23 Jun 2021.