Reducing Distress in Phase 1 Trial Caregivers: The P1-CaLL Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: CBT Telephonic Sessions 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. |
Behavioral: Stress Management and CBT
Stress Management will focus on:
Mind-Body Connection
Coping Skills
Communication
Social Support
Cognitive Behavioral Therapy will focus on:
Intro to CBT-Tracking Automatic Thoughts
Identifying Distorted Thoughts
Challenging Distorted Thoughts
Core Beliefs/Relapse Prevention
|
| Experimental: Metta-Meditation Telephonic Sessions 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. |
Behavioral: Stress Management and Metta-Meditation
Stress Management will focus on:
Mind-Body Connection
Coping Skills
Communication
Social Support
Metta-Meditation will focus on:
Intro to Meditation vis Mindfulness of the Breath and Body-Noticing Critical Self Talk
Intro to Brief Loving-Kindness Meditation and Self-Care
Continuing with Additional Metta-Based Exercises to Cultivate Compassion for Oneself and Others and Mitigating Self-Criticism
Review/Plan for Future
|
Outcome Measures
Primary Outcome Measures
- Assessing the feasibility of the P1-CaLL intervention by determining the percentage of recruitment and retention [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).
- Determine the acceptability of the P1-CaLL intervention using a Likert scale [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.
Secondary Outcome Measures
- Depression Anxiety and Stress Scale (DASS) [Baseline to post-assessment (up to 9 weeks)]
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).
- PROMIS-Depression [Baseline to post-assessment (up to 9 weeks)]
Measure between-subject changes in psychosocial variablesin caregivers of phase 1 clinical trial participants.
- PROMIS-Anxiety [Baseline to post-assessment (up to 9 weeks)]
Measure between-subject changes in psychosocial variables in caregivers of phase 1 clinical trial participants.
- Caregiver Burden (CRA) [Baseline to post-assessment (up to 9 weeks)]
Measure between-subject changes in psychosocial variables in caregivers of phase 1 clinical trial participants.
- Positive Benefit Finding (Positive Aspects of Caregiving) [Baseline to post-assessment (up to 9 weeks)]
Measure between-subject changes in psychosocial variables in caregivers of phase 1 clinical trial participants.
- Self-Efficacy (CGI) [Baseline to post-assessment (up to 9 weeks)]
Measure between-subject changes in psychosocial variables in caregivers of phase 1 clinical trial participants.
- Compassion (Compassion Scale) [Baseline to post-assessment (up to 9 weeks)]
Measure between-subject changes in psychosocial variables in caregivers of phase 1 clinical trial participants.
- Dysfunctional Thoughts (ATD) [Baseline to post-assessment (up to 9 weeks)]
Measure between-subject changes in psychosocial variables in caregivers of phase 1 clinical trial participants.
Eligibility Criteria
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 >3.
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Stated willingness to comply with all study procedures and be available for the duration of the study.
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Age >18
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Universtiy of Colorado Denver | Denver | Colorado | United States | 80045 |
Sponsors and Collaborators
- University of Colorado, Denver
Investigators
- Principal Investigator: Kristin Kilbourn, MD, University of Colorado, Denver
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 17-0514.cc