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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-03629 | Registry Identifier | NCI / CTRP | |
| 10048 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium |
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Terminated due to insufficient funding
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (psychoeducational counseling sessions via telephone) | Experimental | Participants attend 5 psychoeducational counseling sessions over 30-60 minutes via telephone. |
|
| Group B (psychoeducational counseling sessions in person) | Experimental | Participants attend 5 psychoeducational counseling sessions over 30-60 minutes via video teleconference. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telephone-Based Intervention | Behavioral | Attend psychoeducational counseling sessions via telephone |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of recruitment | Up to 1 year | |
| Rate of enrollment | Up to 1 year | |
| Rate of completion of 5-session intervention | Up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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]) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frances Lewis | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
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Site intermediary and referring MD
| Behavioral, Psychological or Informational Intervention | Other | Attend psychoeducational counseling sessions via video teleconference |
|
| Questionnaire Administration | Other | Ancillary studies |
|
Will assess the within-group changes using the one-sample t-test or the signed-rank test, as appropriate. |
| 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. | 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. | Baseline up to 4 months |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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