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

May 24, 2021 updated by: University of Colorado, Denver
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80045
        • Universtiy of Colorado Denver

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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:

  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
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:

  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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline to end of study period (up to one year)
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.
Baseline to end of study period (up to one year)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression Anxiety and Stress Scale (DASS)
Time Frame: 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).
Baseline to post-assessment (up to 9 weeks)
PROMIS-Depression
Time Frame: Baseline to post-assessment (up to 9 weeks)
Measure between-subject changes in psychosocial variablesin caregivers of phase 1 clinical trial participants.
Baseline to post-assessment (up to 9 weeks)
PROMIS-Anxiety
Time Frame: Baseline to post-assessment (up to 9 weeks)
Measure between-subject changes in psychosocial variables in caregivers of phase 1 clinical trial participants.
Baseline to post-assessment (up to 9 weeks)
Caregiver Burden (CRA)
Time Frame: Baseline to post-assessment (up to 9 weeks)
Measure between-subject changes in psychosocial variables in caregivers of phase 1 clinical trial participants.
Baseline to post-assessment (up to 9 weeks)
Positive Benefit Finding (Positive Aspects of Caregiving)
Time Frame: Baseline to post-assessment (up to 9 weeks)
Measure between-subject changes in psychosocial variables in caregivers of phase 1 clinical trial participants.
Baseline to post-assessment (up to 9 weeks)
Self-Efficacy (CGI)
Time Frame: Baseline to post-assessment (up to 9 weeks)
Measure between-subject changes in psychosocial variables in caregivers of phase 1 clinical trial participants.
Baseline to post-assessment (up to 9 weeks)
Compassion (Compassion Scale)
Time Frame: Baseline to post-assessment (up to 9 weeks)
Measure between-subject changes in psychosocial variables in caregivers of phase 1 clinical trial participants.
Baseline to post-assessment (up to 9 weeks)
Dysfunctional Thoughts (ATD)
Time Frame: Baseline to post-assessment (up to 9 weeks)
Measure between-subject changes in psychosocial variables in caregivers of phase 1 clinical trial participants.
Baseline to post-assessment (up to 9 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Investigators

  • Principal Investigator: Kristin Kilbourn, MD, University of Colorado, Denver

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 12, 2018

Primary Completion (ACTUAL)

January 2, 2020

Study Completion (ACTUAL)

May 5, 2021

Study Registration Dates

First Submitted

May 22, 2018

First Submitted That Met QC Criteria

June 14, 2018

First Posted (ACTUAL)

June 15, 2018

Study Record Updates

Last Update Posted (ACTUAL)

May 26, 2021

Last Update Submitted That Met QC Criteria

May 24, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 17-0514.cc

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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