In Person and Mobile Health Coping Skills Training for Improving Symptom Management and Daily Steps in Hematopoietic Stem Cell Transplant Patients
Condition: Hematopoietic Neoplasms (Leukemia, Lymphoma, Multiple Myeloma)
MeSH terms: Multiple Myeloma; Hematologic Neoplasms
Study type: Interventional

Summary: 
      The purpose of the study is to assess the feasibility, acceptability, and efficacy of a novel
      mHealth behavioral intervention to enable HCT patients to effectively cope with symptoms to
      improve their ability to engage in physical activity that can improve physical disability.
      Our interdisciplinary team (psychiatry, hematology/oncology, occupational therapy) proposes a
      single arm pilot trial (N=20) to test a hybrid in-person and mHealth (video-conferencing,
      symptoms/activity monitoring, personalized feedback via text) HCT Coping Skills Training for
      Symptom Management and Daily Steps (CST Step-Up) intervention. CST Step-Up will provide
      patients with coping skills training and activity coaching sessions to enhance their ability
      to cope with symptoms that interfere with activity.
    

Detailed description: 
      Our group developed a mHealthpain coping skills training program for HCT patients and found
      in a small pilot trial (R21) that improved pain coping led to increased daily activity and
      reduced physical disability. However, fatigue and distress were also barriers to physical
      activity.

      We propose to assess the feasibility, acceptability, and outcome patterns suggesting efficacy
      of a novel mHealth behavioral intervention to enable HCT patients to effectively cope with
      symptoms to improve their ability to engage in physical activity that can improve physical
      disability.Our interdisciplinary team (psychiatry, hematology/oncology, occupational therapy)
      is conducting a single arm pilot trial (N=20) to test a hybrid in-person and mHealth
      (video-conferencing, symptoms/activity monitoring, personalized feedback via text) HCT Coping
      Skills Training for Symptom Management and Daily Steps (CST Step-Up) intervention. CST
      Step-Up will provide patients with coping skills training and activity coaching sessions to
      enhance their ability to cope with symptoms that interfere with activity.

      Aim 1:Use a single arm pilot trial (N=20) to examine the feasibility and acceptability of the
      CST Step-Up protocol. Feasibility will be assessed via (a) study accrual, (b) adherence to
      the study protocol (intervention and assessments), and (c) retention (% completing the
      study).

      H1:Feasibility will be determined by meeting targeted study accrual (20 patients 15 months),
      >80% adherence to the protocol, and <20% attrition. Acceptability will be demonstrated by 80%
      of participants reporting satisfaction with the intervention.

      Aim 2:Examine outcome patterns suggesting the efficacy of the CST Step-Up protocol for
      improving physical disability and other important outcomes.

      H2:Pre-and post-intervention differences will be examined with simple t-tests to evaluate
      patterns suggesting intervention efficacy on measures of physical disability (self-report,
      6-min walk test), pain, fatigue, distress, physical activity (daily steps), and self-efficacy
      for symptom management.

      Confirmed hypotheses would provide the first demonstration of the feasibility, acceptability,
      and positive impact of a hybrid in-person and mHealth coping skills training and activity
      coaching intervention that reduces physical disability by concurrently and synergistically
      decreasing symptom burden and increasing physical activity. This project has the potential to
      lead to future research (e.g., R01) that can redesign existing modes of behavioral
      intervention delivery, improve continuity and coordination of care, and ultimately enhance
      patient outcomes.
    

Intervention name(s): coping skills training
Intervention type(s): Behavioral
Intervention description(s): We aim to test a combined coping skills training and activity coaching protocol that: first, is feasible and acceptable, and second, improves physical disability, as well as pain, fatigue, distress, and physical activity in HCT patients. We propose a novel intervention protocol that uses a hybrid in-person and mHealth intervention delivery model.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care