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

NCT ID: NCT03557515

Last Updated: 2021-05-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-12
• Study Completion Date: 2021-05-05

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Stress Management and CBT

Intervention Type: BEHAVIORAL

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

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.

Group Type: EXPERIMENTAL

Stress Management and Metta-Meditation

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: 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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kristin Kilbourn, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

Universtiy of Colorado Denver

Denver, Colorado, United States

Countries

United States

Other Identifiers

17-0514.cc

Identifier Type: -

Identifier Source: org_study_id