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

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Caregiver Distress

Treatments: Behavioral: Stress Management and Metta-Meditation; Behavioral: Stress Management and CBT

Study type: Interventional

Funder types: Other

Identifiers

NCT03557515

17-0514.cc

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

CBT Telephonic Sessions

Experimental group

Description:

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.

Treatment:

Behavioral: Stress Management and CBT

Metta-Meditation Telephonic Sessions

Experimental group

Description:

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.

Treatment:

Behavioral: Stress Management and Metta-Meditation