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Completed

NCT Number: NCT03557515

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

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.

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Key information

Conditions

Caregiver Distress Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universtiy of Colorado Denver

Denver, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Stress Management and CBT

Behavioral

Stress Management will focus on:

  • Mind-Body Connection
  • Coping Skills
  • Communication
  • Social Support

Cognitive Behavioral Therapy will focus on:

  • Intro to CBT-Tracking Automatic Thoughts
  • Identifying Distorted Thoughts
  • Challenging Distorted Thoughts
  • Core Beliefs/Relapse Prevention

Stress Management and Metta-Meditation

Behavioral

Stress Management will focus on:

  • Mind-Body Connection
  • Coping Skills
  • Communication
  • Social Support

Metta-Meditation will focus on:

  • Intro to Meditation vis Mindfulness of the Breath and Body-Noticing Critical Self Talk
  • Intro to Brief Loving-Kindness Meditation and Self-Care
  • Continuing with Additional Metta-Based Exercises to Cultivate Compassion for Oneself and Others and Mitigating Self-Criticism
  • Review/Plan for Future

Primary outcomes

  1. Assessing the feasibility of the P1-CaLL intervention by determining the percentage of recruitment and retention

    Time frame: 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).

  2. Determine the acceptability of the P1-CaLL intervention using a Likert scale

    Time frame: 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 outcomes

  1. Depression Anxiety and Stress Scale (DASS)

    Time frame: 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).

  2. PROMIS-Depression

    Time frame: Baseline to post-assessment (up to 9 weeks)

    Measure between-subject changes in psychosocial variablesin caregivers of phase 1 clinical trial participants.

  3. PROMIS-Anxiety

    Time frame: Baseline to post-assessment (up to 9 weeks)

    Measure between-subject changes in psychosocial variables in caregivers of phase 1 clinical trial participants.

  4. Caregiver Burden (CRA)

    Time frame: Baseline to post-assessment (up to 9 weeks)

    Measure between-subject changes in psychosocial variables in caregivers of phase 1 clinical trial participants.

  5. Positive Benefit Finding (Positive Aspects of Caregiving)

    Time frame: Baseline to post-assessment (up to 9 weeks)

    Measure between-subject changes in psychosocial variables in caregivers of phase 1 clinical trial participants.

  6. Self-Efficacy (CGI)

    Time frame: Baseline to post-assessment (up to 9 weeks)

    Measure between-subject changes in psychosocial variables in caregivers of phase 1 clinical trial participants.

  7. Compassion (Compassion Scale)

    Time frame: Baseline to post-assessment (up to 9 weeks)

    Measure between-subject changes in psychosocial variables in caregivers of phase 1 clinical trial participants.

  8. Dysfunctional Thoughts (ATD)

    Time frame: Baseline to post-assessment (up to 9 weeks)

    Measure between-subject changes in psychosocial variables in caregivers of phase 1 clinical trial participants.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Jun 15, 2018
Registry last updated
May 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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