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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Colorado, Denver

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 12, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 2, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 5, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 22, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 15, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 26, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 24, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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