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

University of Colorado, Denver25 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Caregiver Distress

Interventions

Stress Management and CBTBEHAVIORAL

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

Stress Management and Metta-MeditationBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Universtiy of Colorado Denver

Denver, Colorado, United States

Outcomes

Primary Outcomes

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).

Time frame: 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.

Time frame: Baseline to end of study period (up to one year)

Secondary Outcomes

Depression Anxiety and Stress Scale (DASS)

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).

Time frame: Baseline to post-assessment (up to 9 weeks)

PROMIS-Depression

Measure between-subject changes in psychosocial variablesin caregivers of phase 1 clinical trial participants.

Time frame: Baseline to post-assessment (up to 9 weeks)

PROMIS-Anxiety

Measure between-subject changes in psychosocial variables in caregivers of phase 1 clinical trial participants.

Time frame: Baseline to post-assessment (up to 9 weeks)

Caregiver Burden (CRA)

Measure between-subject changes in psychosocial variables in caregivers of phase 1 clinical trial participants.

Time frame: Baseline to post-assessment (up to 9 weeks)

Data from ClinicalTrials.gov

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