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

Caregiver Distress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03557515
• Other study ID #: 17-0514.cc
• Status: Completed
• Phase: N/A
• Start date: June 12, 2018
• Est. completion date: May 5, 2021

Study information

• Verified date: May 2021
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: May 5, 2021
• Est. primary completion date: January 2, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Caregiver Distress

Intervention

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
• 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

Locations

Country	Name	City	State
United States	Universtiy of Colorado Denver	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	PROMIS-Depression	Measure between-subject changes in psychosocial variablesin caregivers of phase 1 clinical trial participants.	Baseline to post-assessment (up to 9 weeks)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)