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

NCT03557515 | Completed DMC

• 1 other identifier: 17-0514.cc
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Caregiver Distress

Keywords

Depression; Cognitive Behavioral Therapy; Coping; Meditation; Anxiety

Outcome Measures

Primary Outcomes (2)

• Assessing the feasibility of the P1-CaLL intervention by determining the percentage of recruitment and retention

  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

  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 Outcomes (8)

• Depression Anxiety and Stress Scale (DASS)

  Baseline to post-assessment (up to 9 weeks)

• PROMIS-Depression

  Baseline to post-assessment (up to 9 weeks)

• PROMIS-Anxiety

  Baseline to post-assessment (up to 9 weeks)

• Caregiver Burden (CRA)

  Baseline to post-assessment (up to 9 weeks)

• Positive Benefit Finding (Positive Aspects of Caregiving)

  Baseline to post-assessment (up to 9 weeks)

Study Arms (2)

CBT Telephonic Sessions

EXPERIMENTAL

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

Metta-Meditation Telephonic Sessions

EXPERIMENTAL

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

Interventions

Stress Management and CBT 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

CBT Telephonic Sessions

Stress Management and Metta-Meditation 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

Metta-Meditation Telephonic Sessions

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informal caregiver of a patient screening for a phase 1 clinical trial
• 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.
• Provision to sign and date the consent form.
• Completes the Patient Health Questionnaire (PHQ-4) screener with a total score of \>3.
• Stated willingness to comply with all study procedures and be available for the duration of the study.
• Age \>18
• Has consistent access to a telephone
• Able to read and understand English

You may not qualify if:

• Has a cognitive or psychiatric condition prohibiting participation.
• Current enrollment in another psychosocial intervention trial.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Universtiy of Colorado Denver

Denver, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Kristin Kilbourn, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2018
• First Posted: June 15, 2018
• Study Start: June 12, 2018
• Primary Completion: January 2, 2020
• Study Completion: May 5, 2021
• Last Updated: May 26, 2021

Record last verified: 2021-05

Locations

US (1)