NCT03557515

Reducing Distress in Phase 1 Trial Caregivers: The P1-CaLL Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

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.

Conditions

• Caregiver Distress

Interventions

Type	Name	Description
BEHAVIORAL	Stress Management and CBT	Stress Management will focus on: 1. Mind-Body Connection 2. Coping Skills 3. Communication 4. Social Support Cognitive Behavioral Therapy will focus on: 1. Intro to CBT-Tracking Automatic Thoughts 2. Identifying Distorted Thoughts 3. Challenging Distorted Thoughts 4. Core Beliefs/Relapse Prevention
BEHAVIORAL	Stress Management and Metta-Meditation	Stress Management will focus on: 1. Mind-Body Connection 2. Coping Skills 3. Communication 4. Social Support Metta-Meditation will focus on: 1. Intro to Meditation vis Mindfulness of the Breath and Body-Noticing Critical Self Talk 2. Intro to Brief Loving-Kindness Meditation and Self-Care 3. Continuing with Additional Metta-Based Exercises to Cultivate Compassion for Oneself and Others and Mitigating Self-Criticism 4. Review/Plan for Future

Timeline

• Start date: 2018-06-12
• Primary completion: 2020-01-02
• Completion: 2021-05-05
• First posted: 2018-06-15
• Last updated: 2021-05-26

Locations

1 site across 1 country: United States