Reducing Distress in Phase 1 Trial Caregivers: The P1-CaLL Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Caregiver Distress
- Sponsor
- University of Colorado, Denver
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Determine the acceptability of the P1-CaLL intervention using a Likert scale
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Informal caregiver of a patient screening for a phase 1 clinical trial
- •Self-identifies as a caregiver as consistent with the National Study Of Caregiving (NSOC) definition13- individuals who help a patient with self-care, mobility, or household activities (the latter, for health or functioning related reasons) and are either related to the patient (paid or and non-paid) or are unrelated non-paid helpers.
- •Provision to sign and date the consent form.
- •Completes the Patient Health Questionnaire (PHQ-4) screener with a total score of \>
- •Stated willingness to comply with all study procedures and be available for the duration of the study.
- •Has consistent access to a telephone
- •Able to read and understand English
Exclusion Criteria
- •Has a cognitive or psychiatric condition prohibiting participation.
- •Current enrollment in another psychosocial intervention trial.
Outcomes
Primary Outcomes
Determine the acceptability of the P1-CaLL intervention using a Likert scale
Time Frame: Baseline to end of study period (up to one year)
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.
Assessing the feasibility of the P1-CaLL intervention by determining the percentage of recruitment and retention
Time Frame: Baseline to end of study period (up to one year)
Fifty percent of those approached decide to enroll (recruitment), and fifty percent of those enrolled complete all sessions (retention).
Secondary Outcomes
- PROMIS-Anxiety(Baseline to post-assessment (up to 9 weeks))
- Caregiver Burden (CRA)(Baseline to post-assessment (up to 9 weeks))
- PROMIS-Depression(Baseline to post-assessment (up to 9 weeks))
- Positive Benefit Finding (Positive Aspects of Caregiving)(Baseline to post-assessment (up to 9 weeks))
- Compassion (Compassion Scale)(Baseline to post-assessment (up to 9 weeks))
- Dysfunctional Thoughts (ATD)(Baseline to post-assessment (up to 9 weeks))
- Depression Anxiety and Stress Scale (DASS)(Baseline to post-assessment (up to 9 weeks))
- Self-Efficacy (CGI)(Baseline to post-assessment (up to 9 weeks))