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

Completed · Not applicable

Conditions studied: Caregiver Distress

In brief

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.

Key facts

Study ID

NCT03557515

Run by

University of Colorado, Denver

People needed

25

Starts

2018-06-12

Expected to finish

2021-05-05

Last updated by the study team

2021-05-26

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Informal caregiver of a patient screening for a phase 1 clinical trial
• 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.
• Provision to sign and date the consent form.
• Completes the Patient Health Questionnaire (PHQ-4) screener with a total score of >3.
• Stated willingness to comply with all study procedures and be available for the duration of the study.
• Age >18
• Has consistent access to a telephone
• Able to read and understand English

You may not qualify if…

• Has a cognitive or psychiatric condition prohibiting participation.
• Current enrollment in another psychosocial intervention trial.

Where it is running

• Universtiy of Colorado Denver — Denver, Colorado, United States

Full record on ClinicalTrials.gov

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