Caregiver Distress Clinical Trial
Official title:
Reducing Distress in Phase 1 Trial Caregivers: The P1-CaLL Study
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 |
Verified date | May 2021 |
Source | University of Colorado, Denver |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | Universtiy of Colorado Denver | Denver | Colorado |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Denver |
United States,
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) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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