Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study seeks to decrease distress in the lives of the caregivers who are helping cancer patients who have entered a phase 1 clinical trial.
This study seeks to decrease distress in the lives of the caregivers who are helping cancer patients who have entered a phase 1 clinical trial. The P1-CaLL study uses a psychosocial intervention aimed at decreasing distress through the utilization of adaptive coping strategies (e.g., meditation, emotion-focused coping) and cognitive behavioral techniques. Caregivers will receive 4 weeks of stress-management sessions (over the phone). Then, they will be randomized to receive 4 more weekly sessions of either Cognitive Behavioral Therapy or Metta-Meditation (over the phone). Participants will receive tasks to complete each week.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBT Telephonic Sessions | Experimental | All participants will receive four stress management sessions. Then, the participant is randomly assigned to receive 4 weekly additional CBT telephonic sessions. Participants will be given weekly assignments to practice the skills learned in the sessions. Sessions will last 45 minutes to 1 hour. Optional grief and loss telephonic session will be offered. |
|
| Metta-Meditation Telephonic Sessions | Experimental | All participants will receive four stress management sessions. Then, the participant is randomly assigned to receive 4 weekly additional Metta-meditation sessions. Participants will be given weekly assignments to practice the skills learned in the sessions. Sessions will last 45 minutes to 1 hour. Optional grief and loss telephonic session will be offered. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stress Management and CBT | Behavioral | Stress Management will focus on:
Cognitive Behavioral Therapy will focus on:
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessing the feasibility of the P1-CaLL intervention by determining the percentage of recruitment and retention | Fifty percent of those approached decide to enroll (recruitment), and fifty percent of those enrolled complete all sessions (retention). | Baseline to end of study period (up to one year) |
| Determine the acceptability of the P1-CaLL intervention using a Likert scale | Quantitatively measure the acceptability of the P1-CaLL intervention (at least fifty percent of those that complete the intervention rate it) as average or above average on a Likert Scale of Acceptability. | Baseline to end of study period (up to one year) |
| Measure | Description | Time Frame |
|---|---|---|
| Depression Anxiety and Stress Scale (DASS) | The between-subject change in symptoms of distress as measured by response on the Depression Anxiety and Stress Scale (DASS) from baseline (week one) to post-assessment (week nine). | Baseline to post-assessment (up to 9 weeks) |
| PROMIS-Depression |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kristin Kilbourn, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universtiy of Colorado Denver | Denver | Colorado | 80045 | United States |
Not provided
| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Stress Management and Metta-Meditation | Behavioral | Stress Management will focus on:
Metta-Meditation will focus on:
|
|
Measure between-subject changes in psychosocial variablesin caregivers of phase 1 clinical trial participants. |
| Baseline to post-assessment (up to 9 weeks) |
| PROMIS-Anxiety | Measure between-subject changes in psychosocial variables in caregivers of phase 1 clinical trial participants. | Baseline to post-assessment (up to 9 weeks) |
| Caregiver Burden (CRA) | Measure between-subject changes in psychosocial variables in caregivers of phase 1 clinical trial participants. | Baseline to post-assessment (up to 9 weeks) |
| Positive Benefit Finding (Positive Aspects of Caregiving) | Measure between-subject changes in psychosocial variables in caregivers of phase 1 clinical trial participants. | Baseline to post-assessment (up to 9 weeks) |
| Self-Efficacy (CGI) | Measure between-subject changes in psychosocial variables in caregivers of phase 1 clinical trial participants. | Baseline to post-assessment (up to 9 weeks) |
| Compassion (Compassion Scale) | Measure between-subject changes in psychosocial variables in caregivers of phase 1 clinical trial participants. | Baseline to post-assessment (up to 9 weeks) |
| Dysfunctional Thoughts (ATD) | Measure between-subject changes in psychosocial variables in caregivers of phase 1 clinical trial participants. | Baseline to post-assessment (up to 9 weeks) |