Clinical trial NCT03557515: Reducing Distress in Phase 1 Trial Caregivers: The P1-CaLL Study
Official title: Reducing Distress in Phase 1 Trial Caregivers: The P1-CaLL Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caregiver Distress
Keywords: Depression
Cognitive Behavioral Therapy
Coping
Meditation
Anxiety
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2018-06-15
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

1. Informal caregiver of a patient screening for a phase 1 clinical trial
2. 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.
3. Provision to sign and date the consent form.
4. Completes the Patient Health Questionnaire (PHQ-4) screener with a total score of \>3.
5. Stated willingness to comply with all study procedures and be available for the duration of the study.
6. Age \>18
7. Has consistent access to a telephone
8. Able to read and understand English

Exclusion Criteria:

1. Has a cognitive or psychiatric condition prohibiting participation.
2. Current enrollment in another psychosocial intervention trial.

Primary outcomes:
measure: Assessing the feasibility of the P1-CaLL intervention by determining the percentage of recruitment and retention
timeFrame: Baseline to end of study period (up to one year)
measure: Determine the acceptability of the P1-CaLL intervention using a Likert scale
timeFrame: Baseline to end of study period (up to one year)
Secondary outcomes:
measure: Depression Anxiety and Stress Scale (DASS)
timeFrame: Baseline to post-assessment (up to 9 weeks)
measure: PROMIS-Depression
timeFrame: Baseline to post-assessment (up to 9 weeks)
measure: PROMIS-Anxiety
timeFrame: Baseline to post-assessment (up to 9 weeks)
measure: Caregiver Burden (CRA)
timeFrame: Baseline to post-assessment (up to 9 weeks)
measure: Positive Benefit Finding (Positive Aspects of Caregiving)
timeFrame: Baseline to post-assessment (up to 9 weeks)
measure: Self-Efficacy (CGI)
timeFrame: Baseline to post-assessment (up to 9 weeks)
measure: Compassion (Compassion Scale)
timeFrame: Baseline to post-assessment (up to 9 weeks)
measure: Dysfunctional Thoughts (ATD)
timeFrame: Baseline to post-assessment (up to 9 weeks)
Other outcomes:
Locations:
city: Denver
country: United States
facility: Universtiy of Colorado Denver
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Kristin Kilbourn, MD
role: PRINCIPAL_INVESTIGATOR
References: