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Remotely-Delivered Cognitive Behavioral Stress Management Effects on Cancer-Accelerated Aging in Older, Distressed Breast Cancer Survivors

US · IL NIH RePORTER grant open #nih-1R01CA296071-01A1

Summary

This study protocol investigates the effects of remotely-delivered Cognitive Behavioral Stress Management (R-CBSM) on cancer-accelerated aging in older, distressed breast cancer survivors.

What they want

The study will enroll 192 breast cancer survivors (BCS) who completed initial treatment 3-12 months prior, are on adjuvant endocrine therapy (AET), distressed, mid-older aged (>50yrs), post-menopausal, and diagnosed with Stage I-III HR+, Her2neu- breast cancer. Participants will undergo a run-in period for screening, followed by baseline assessments including REDCAP questionnaires, saliva collection for cortisol, Empatica wristband for heart rate variability (HRV), and an in-person blood draw. Participants will be block randomized to either Remotely-delivered Cognitive Behavioral Stress Management (R-CBSM) + Survivorship Care Planning (SCP) (n=96) or SCP-only control (n=96). The R-CBSM+SCP group will receive 10 weekly group R-CBSM sessions via ZOOM and access to a website with educational materials. Weekly changes in intervention processes (stress, mood, perceived stress management skills, emotion regulation) will be monitored via ecological momentary assessment (EMA) to mobile phones or paper diaries. Follow-up assessments at 6 and 12 months will include RedCap questionnaires, saliva (cortisol), wristbands (HRV), and blood (immune measures). Physical and mental health (depression, quality of life) will be assessed at 0, 6, 12, and 24 months through questionnaires/interviews (remote or in-person) and blood draws, totaling 4 visits (T1: 0m, T2: 6m, T3:12m, T4: 24m) plus remote intercurrent monitoring.
Deliverables
  • Data on psychological adaptation
  • Data on neuroimmune regulation
  • Data on immune cell senescence
  • Data on depression and quality of life
  • Monitoring of intervention process changes
Technical requirements
  • REDCap for baseline and follow-up assessments
  • Empatica wristband for heart rate variability (HRV) collection
  • ZOOM for remotely-delivered Cognitive Behavioral Stress Management (R-CBSM) sessions
  • Website for stress management educational materials
  • Mobile phones for ecological momentary assessment (EMA) or paper diaries

How they evaluate

  • Intermediary improvements in psychological adaptation
  • Intermediary improvements in neuroimmune regulation
  • Longer-term immune cell senescence
  • Mental health outcomes (depression, quality of life)
  • Correlation of intervention process changes with regulatory variables
Remotely-Delivered Cognitive Behavioral St…
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