Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01CA258311 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Pennsylvania | OTHER |
| National Cancer Institute (NCI) | NIH |
| University of Missouri-Columbia | OTHER |
Not provided
Not provided
Not provided
Not provided
This study is a randomized clinical trial of a problem-solving therapy intervention for family caregivers of individuals with cancer receiving outpatient palliative care.
This study is a randomized clinical trial of a problem-solving therapy intervention for family caregivers of individuals with cancer receiving outpatient palliative care. Study participants will be randomized to receive either a three-session problem-solving therapy intervention in addition to usual care or three sessions of attention-matched control in addition to usual care.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Attention Control | Placebo Comparator | Family caregivers in the attention control study arm will receive three sessions of attention-matched control in addition to the services and support provided as part of usual outpatient palliative care. Attention-matched control will consist of three "friendly visits" with a trained research staff person. |
|
| Problem Solving Therapy Intervention | Experimental | Family caregivers in the intervention study arm will participate in three problem-solving therapy sessions with a trained interventionist in addition to receiving the services and support provided as part of usual outpatient palliative care. |
|
| In-Depth Interviews for non-FCG Stakeholders | Other | Each year of the project, the investigators will recruit 6 key stakeholders to participate in individual interviews focused on potential barriers and facilitators to adoption of the PST intervention into clinical practice for a total of 30 unique stakeholders who will be interviewed over the duration of this 5-year study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Problem-Solving Therapy | Behavioral | Over an approximately 3-week period, family caregivers randomized to the intervention study arm will learn and apply a problem-solving approach based on the ADAPT model, which encourages participants to follow five steps when solving caregiving problems: 1) focus on adopting a positive attitude to problem solving, 2) define the problem and set goals, 3) generate a list of alternative solutions to the problem, 4) predict consequences of the alternative solutions, and 5) try implementing the most promising solution from among the list of alternatives. The intervention will be delivered by a trained interventionist over the course of three structured sessions via telephone or videoconferencing technology, depending on the FCG's preference. Session content will be summarized in an intervention manual, which we will provide to all intervention participants. Sessions will last approximately 45-60 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in anxiety as measured by the PROMIS Short Form v1.0 - Anxiety 8a | Family caregivers indicate the frequency with which they experience eight different symptoms of anxiety (8 items); higher scores reflect higher anxiety severity. | At the time of enrollment, Week 4, and 30-day follow-up |
| Change in symptoms of depression as measured by the PROMIS Short Form v1.0 - Depression 8a | Family caregivers indicate the frequency with which they experience eight different symptoms of depression (8 items); higher scores reflect higher depression severity | At the time of enrollment, Week 4, and 30-day follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Change in positive aspects of caregiving as measured by Positive Aspects of Caregiving Scale - Short Form (S-PAC; 7 items) |
|
Not provided
Inclusion Criteria for Family Caregivers (FCGs)
Inclusion Criteria for Non-Family Caregiver Stakeholders
Exclusion Criteria for Family Caregivers (FCGs)
Exclusion Criteria for Non-Family Caregiver Stakeholders
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Karla Washington, Ph.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Missouri | Columbia | Missouri | 65211 | United States | ||
| Washington University School of Medicine |
Not provided
| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Apr 3, 2023 | May 6, 2026 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
Not provided
Not provided
The randomized portion of the trial will enroll 540 family caregivers. An additional portion of the trial will enroll 30 key stakeholders to participate in individual interviews focused on potential barriers and facilitators to adoption of the problem-solving therapy (PST) intervention into clinical practice.
Not provided
Not provided
Not provided
|
| Attention-matched Control | Other | Over an approximately 3-week period, family caregivers randomized to the attention control study arm will participate in informal conversations ("friendly visits") with a trained member of the research team. |
|
| In-depth interviews | Other | The 30 key stakeholders interviews will discuss how the PST intervention fits into existing clinical practice and institutional values, what might incentivize adoption of the PST intervention, and how the intervention compares to alternative existing or proposed programs. |
|
| At the time of enrollment, Week 4, and 30-day follow-up |
| St Louis |
| Missouri |
| 63110 |
| United States |
| University of Pennslyvania | Philadelphia | Pennsylvania | 19104 | United States |