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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03557515
Other study ID # 17-0514.cc
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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)
See also
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