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

• ClinicalTrials.gov Identifier: NCT03557515
• Recruitment Status: Completed
• First Posted: June 15, 2018
• Last Update Posted: May 26, 2021
• Sponsor: University of Colorado, Denver
• Information provided by (Responsible Party): University of Colorado, Denver

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Caregiver Distress	Behavioral: Stress Management and CBT; Behavioral: Stress Management and Metta-Meditation	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 25 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Reducing Distress in Phase 1 Trial Caregivers: The P1-CaLL Study
• Actual Study Start Date: June 12, 2018
• Actual Primary Completion Date: January 2, 2020
• Actual Study Completion Date: May 5, 2021

Arms and Interventions

Arm	Intervention/treatment
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: 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
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: 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

Outcome Measures

Primary Outcome Measures :

1. 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).
2. 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.

Secondary Outcome Measures :

1. 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).
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
8. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 99 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

United States, Colorado

Universtiy of Colorado Denver

Denver, Colorado, United States, 80045

Sponsors and Collaborators

University of Colorado, Denver

Investigators

• Principal Investigator: Kristin Kilbourn, MD; University of Colorado, Denver

More Information

• Responsible Party: University of Colorado, Denver
• ClinicalTrials.gov Identifier: NCT03557515
• Other Study ID Numbers: 17-0514.cc
• First Posted: June 15, 2018
• Last Update Posted: May 26, 2021
• Last Verified: May 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Colorado, Denver:

Depression; Cognitive Behavioral Therapy; Coping; Meditation; Anxiety