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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Caregiver Distress

Intervention / Treatment
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* Behavioral: Stress Management and CBT
* Behavioral: Stress Management and Metta-Meditation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Has a cognitive or psychiatric condition prohibiting participation. Current enrollment in another psychosocial intervention trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBT Telephonic Sessions<br>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<br>* Stress Management will focus on: Mind-Body Connection Coping Skills Communication Social Support Cognitive Behavioral Therapy will focus on: Intro to CBT-Tracking Automatic Thoughts Identifying Distorted Thoughts Challenging Distorted Thoughts Core Beliefs/Relapse Prevention<br>|
| Experimental: Metta-Meditation Telephonic Sessions<br>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<br>* Stress Management will focus on: Mind-Body Connection Coping Skills Communication Social Support Metta-Meditation will focus on: Intro to Meditation vis Mindfulness of the Breath and Body-Noticing Critical Self Talk Intro to Brief Loving-Kindness Meditation and Self-Care Continuing with Additional Metta-Based Exercises to Cultivate Compassion for Oneself and Others and Mitigating Self-Criticism Review/Plan for Future<br>|

What is the study measuring?
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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 | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Baseline to post-assessment (up to 9 weeks) | 
| PROMIS-Depression | Measure between-subject changes in psychosocial variablesin caregivers of phase 1 clinical trial participants. | 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. | 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. | Baseline to post-assessment (up to 9 weeks) | 
| Positive Benefit Finding (Positive Aspects of Caregiving) | 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) | 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) | 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) | Measure between-subject changes in psychosocial variables in caregivers of phase 1 clinical trial participants. | Baseline to post-assessment (up to 9 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Cognitive Behavioral Therapy, Coping, Meditation, Anxiety