Refining a Biobehavioral Intervention to Enhance Recovery Following Hematopoietic Stem Cell Transplantation
Condition: Hodgkin's Lymphoma; Leukemia; Lymphoid Leukemia; Multiple Myeloma; Myeloid Leukemia; Non-hodgkin's Lymphoma; Myelodysplastic Syndrome
MeSH terms: Lymphoma; Leukemia; Multiple Myeloma; Leukemia, Lymphoid; Myelodysplastic Syndromes
Study type: Interventional

Summary: 
      The goal of this project is to refine and evaluate the feasibility of a brief, behavioral
      intervention to improve the recovery following hematopoietic stem cell transplantation
      (HSCT). Cancer patients who were treated with HSCT will learn behavioral techniques to
      improve sleep and increase daytime activity with the goal of alleviating insomnia, fatigue,
      and depression after HSCT. If the intervention is feasible and acceptable to patients, a
      future study will test the effects in a larger trial, with the long-term goal of improving
      the care and quality of life of cancer survivors recovering from HSCT.
    

Detailed description: 
      Details of the assessment strategy:

      Patient-reported outcomes:

      Participants will complete self-report measures prior to HSCT and 9 (mid-intervention) and 18
      weeks (post-intervention) post-HSCT. The sleep disturbance, fatigue, and depression modules
      of the NIH Patient Reported Outcomes Measurement Information System (PROMIS) will be the
      primary outcomes. The investigators will compare performance with more established
      instruments the investigation team has previously used: Insomnia Severity Index (ISI),
      Fatigue Symptom Inventory (FSI), and the Inventory of Depression and Anxiety Symptoms (IDAS)
      depression subscale.

      Actigraphy:

      The Actiwatch-2 (Philips Respironics), a wrist-worn actigraphy device, will be used to
      objectively quantify circadian rest-activity patterns over a continuous 7-day period using
      1-minute sampling epochs at three time points: prior to HSCT and 9 (mid-intervention) and 18
      weeks (post-intervention) post-HSCT. The following indices will be calculated: mesor (mean
      activity level), amplitude (rhythm height), acrophase (time of day the rhythm peaks), and
      R-squared (robustness of the rhythm). Participants will complete a concurrent nightly sleep
      log, and traditional sleep parameters will be calculated from both the logs and actigraphy,
      including total sleep time (TST), sleep onset latency (SOL), wake time after sleep onset
      (WASO), and sleep efficiency (SE). For daytime activity, calibration thresholds will be used
      to aggregate activity data into steps and minutes spent in sedentary, light, moderate, and
      vigorous activity
    

Intervention name(s): Behavioral techniques
Intervention type(s): Behavioral
Intervention description(s): Learning behavioral techniques designed to improve nighttime sleep quality and daytime activity for approximately 45-60 minutes on three occasions.
Device: Actiwatch-2 (Philips Respironics)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Hematopoietic Stem Cell Transplantation; Fatigue; Insomnia; Depression; Behavioral Intervention