Caregiver Distress
Conditions
Keywords
Depression, Cognitive Behavioral Therapy, Coping, Meditation, Anxiety
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.
Interventions
BEHAVIORALStress Management and CBT
Stress Management will focus on: 1. Mind-Body Connection 2. Coping Skills 3. Communication 4. Social Support Cognitive Behavioral Therapy will focus on: 1. Intro to CBT-Tracking Automatic Thoughts 2. Identifying Distorted Thoughts 3. Challenging Distorted Thoughts 4. Core Beliefs/Relapse Prevention
BEHAVIORALStress Management and Metta-Meditation
Stress Management will focus on: 1. Mind-Body Connection 2. Coping Skills 3. Communication 4. Social Support Metta-Meditation will focus on: 1. Intro to Meditation vis Mindfulness of the Breath and Body-Noticing Critical Self Talk 2. Intro to Brief Loving-Kindness Meditation and Self-Care 3. Continuing with Additional Metta-Based Exercises to Cultivate Compassion for Oneself and Others and Mitigating Self-Criticism 4. Review/Plan for Future
Sponsors
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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). |
| 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. |
| 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. |
| PROMIS-Depression | Baseline to post-assessment (up to 9 weeks) | Measure between-subject changes in psychosocial variablesin caregivers of phase 1 clinical trial participants. |
Countries
United States
Outcome results
None listed