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

NCT03557515 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2021-05-26

No results posted yet for this study

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.

Conditions

  • Caregiver Distress

Interventions

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

Sponsors & Collaborators

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Kristin Kilbourn, MD · University of Colorado, Denver

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-12
Primary Completion
2020-01-02
Completion
2021-05-05

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03557515 on ClinicalTrials.gov