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

Not Applicable

Completed

• Conditions: Caregiver Distress
• Interventions: Behavioral: Stress Management and Metta-Meditation; Behavioral: Stress Management and CBT

• Registration Number: NCT03557515
• Lead Sponsor: University of Colorado, Denver

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.

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 Timeline

• Study First Submitted: 2018-05-22
• Study Start: 2018-06-12
• Study First Submitted QC: 2018-06-14
• Study First Posted: 2018-06-15
• Primary Completion: 2020-01-02
• Status Verified: 2021-05
• Study Completion: 2021-05-05
• Last Update Submitted: 2021-05-24
• Last Update Posted: 2021-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metta-Meditation Telephonic Sessions	Stress Management and Metta-Meditation	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.
CBT Telephonic Sessions	Stress Management and CBT	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.

Primary Outcome Measures

Name	Time	Method
Determine the acceptability of the P1-CaLL intervention using a Likert scale	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.
Assessing the feasibility of the P1-CaLL intervention by determining the percentage of recruitment and retention	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).

Secondary Outcome Measures

Name	Time	Method
PROMIS-Anxiety	Baseline to post-assessment (up to 9 weeks)	Measure between-subject changes in psychosocial variables in caregivers of phase 1 clinical trial participants.
Caregiver Burden (CRA)	Baseline to post-assessment (up to 9 weeks)	Measure between-subject changes in psychosocial variables in caregivers of phase 1 clinical trial participants.
PROMIS-Depression	Baseline to post-assessment (up to 9 weeks)	Measure between-subject changes in psychosocial variablesin caregivers of phase 1 clinical trial participants.
Positive Benefit Finding (Positive Aspects of Caregiving)	Baseline to post-assessment (up to 9 weeks)	Measure between-subject changes in psychosocial variables in caregivers of phase 1 clinical trial participants.
Compassion (Compassion Scale)	Baseline to post-assessment (up to 9 weeks)	Measure between-subject changes in psychosocial variables in caregivers of phase 1 clinical trial participants.
Dysfunctional Thoughts (ATD)	Baseline to post-assessment (up to 9 weeks)	Measure between-subject changes in psychosocial variables in caregivers of phase 1 clinical trial participants.
Depression Anxiety and Stress Scale (DASS)	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).
Self-Efficacy (CGI)	Baseline to post-assessment (up to 9 weeks)	Measure between-subject changes in psychosocial variables in caregivers of phase 1 clinical trial participants.

Trial Locations

Locations (1)

Universtiy of Colorado Denver; 🇺🇸 Denver, Colorado, United States