Caregivers of adult phase 1 oncology trial patients experience high levels of distress and face barriers to in-person supportive care. The Phase 1 Caregiver LifeLine (P1CaLL) pilot study assessed the feasibility, acceptability, and general impact of an individual telephone-based cognitive behavioral stress-management (CBSM) intervention for caregivers of phase I oncology trial patients.

The pilot study involved 4 weekly adapted CBSM sessions followed by participant randomization to 4 weekly cognitive behavioral therapy sessions or metta-meditation sessions. A mixed-methods design used quantitative data from 23 caregivers and qualitative data from 5 caregivers to examine the feasibility and acceptability outcomes. Feasibility was determined using recruitment, retention, and assessment completion rates. Acceptability was assessed with self-reported satisfaction with program content and participation barriers. Baseline to post-intervention changes in caregiver distress and other psychosocial outcomes were assessed for the 8-session intervention.

The enrollment rate was 45.3%, which demonstrated limited feasibility based on an a priori criterion enrollment rate of 50%. Participants completed an average of 4.9 sessions, with 9/25 (36%) completing all sessions and an 84% assessment completion rate. Intervention acceptability was high, and participants found the sessions helpful in managing stress related to the phase 1 oncology trial patient experience. Participants showed reductions in worry and isolation and stress.

The P1CaLL study demonstrated adequate acceptability and limited feasibility and provided data on the general impact of the intervention on caregiver distress and other psychosocial outcomes. Caregivers of phase 1 oncology trial patients would benefit from supportive care services; a telephone-based intervention may have more utilization and thus make a larger impact.

Under COVID-19 lockdown, mostly all organizations in non-productive sphere had to implement distant work forms. The personnel obligatory and rapidly switched to unknown work conditions and faced new stressors: COVID-19 fears, unstable internet connections, tensed communications, permanent noise, work hours extension. In order to cope with increased daily stress, the new version of self-regulation training program (Leonova, Kuznetsova, 2019) was implemented in distant format in order to train people: to evaluate the impact of distant work stressors; to measure stress manifestations during work hours; to choose self-regulation skills, effective for distant stress reduction.

In order to verify the distant training program, the empirical study was conducted, targeted to estimate effectiveness of self-regulation means during COVID-19 pandemic period.

The program included progressive relaxation exercises as means for anxiety reduction and negative emotions control, and autogenic exercises for achievement an optimal for different work situations mental state. The empirical data were obtained by diagnostic methods for self-assessment of the main distant stress manifestations: anxiety and high fatigue (Spielberger, 1994, Leonova, 2012).

The program verification was conducted in employees of municipal administration offices (n = 214). The empirical data revealed high effectiveness of relaxation and autogenic means in decrease of anxiety (t=8,64; p<0,001) and fatigue (t=9,18; p<0,001).

The first variant of distant program could be recommended for stress-management under pandemic lockdown. At the same time, advanced evaluating procedures are necessary to measure the coping effect of such programs, and to prove stress-reduction capacities of specialized distant training modules.