Coping Skills Training for Symptom Management and Daily Steps (HCT Step Up)
NCT Number: NCT06575712
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hematopoietic Stem Cell Transplant
Interventions: BEHAVIORAL: Step Up|OTHER: Usual Care Plus (UC+)
Sponsor: Duke University
Collaborators: National Institutes of Health (NIH)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 177
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2025-02-01
Completion Date: 2027-08-05

Summary:
The aim of this study is to test the efficacy of a hybrid in-person and mHealth coping skills training and activity coaching intervention (Step Up), to enable HCT patients to effectively cope with symptoms (pain, fatigue, and stress) to improve their ability to engage in physical activity that can improve physical disability.

Primary Outcome Measures: Change in physical disability as measured by the Functional Assessment of Cancer Therapy (FACT), The FACT is widely used in oncology research and includes four subscales assessing physical, functional, social/family, and emotional well-being. The 7-item physical subscale will be used in this study to assess physical disability. Each item is rated on a 5-point Likert scale (0 to 4). The total score is the sum of all items and thus ranges from 0 to 28, where higher scores indicate better physical well-being., Baseline, Post-Intervention (2-3 months after Baseline), 3-month Follow-Up, 6-Month Follow-Up|Change in physical disability as measured by the Six-Minute Walk Test (6MWT), A self-paced timed walk test, the 6MWT is sensitive to change following medical treatments and has shown moderate correlations with physical disability. It measures the distance a patient walks in 6 minutes., Baseline, Post-Intervention (2-3 months after Baseline), 3-month Follow-Up, 6-Month Follow-Up
Secondary Outcome Measures: Change in fatigue as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Adult Fatigue Profile 6-item Short Form, Fatigue will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Adult Fatigue Profile 6-item Short Form. The PROMIS F-SF consists of seven items that measure both the experience of fatigue and the interference of fatigue on daily activities over the past week. Response options are on a 5-point Likert scale, ranging from 1 = never to 5 = always. One item, "How often did you have enough energy to exercise strenuously," is reverse scored. The total score is used in the analysis and is obtained by summing keyed scores of all items. Scores can range from 7 to 35, with higher scores indicating greater fatigue., Baseline, Post-Intervention (2-3 months after Baseline), 3-month Follow-Up, 6-Month Follow-Up|Change in pain as measured by the 4-item Brief Pain Inventory (BPI), The BPI is a scale used to rate pain from 0=no pain to 10=worst pain imaginable in response to "average pain", "worst pain", "least pain", and "pain right now" over the last 7 days. An average of the responses to these four items is used to create a single pain severity score where higher scores indicate greater pain., Baseline, Post-Intervention (2-3 months after Baseline), 3-month Follow-Up, 6-Month Follow-Up|Change in psychological distress as measured by the Brief Symptom Inventory (BSI), The BSI-18 will be condensed to include 12 items. Responses are rated on a 5-point scale where 0=not at all and 4=extremely. The total score ranges from 0 to 48, where higher scores indicate greater distress., Baseline, Post-Intervention (2-3 months after Baseline), 3-month Follow-Up, 6-Month Follow-Up|Change in activity as measured by daily step count, Step count will be measured by a Fitbit versa 2 activity tracker that has a 6+ day battery life, syncs wirelessly and automatically to computers and smartphones, and resets at midnight. Fitbits automatically sync daily with the study app., Baseline, Post-Intervention (2-3 months after Baseline), 3-month Follow-Up, 6-Month Follow-Up|Change in self-efficacy for managing symptoms as measured by the PROMIS Self-Efficacy for Managing Symptoms 8-Item Short Form, The PROMIS Self-Efficacy for Managing Symptoms 8-Item Short Form inquires about participants' level of confidence in their ability to manage symptoms. Responses are on a 5-point Likert scale where 1=I am not at all confident to 5=I am very confident. The total summed score ranges from 8 to 40, where higher scores reflect more self-efficacy., Baseline, Post-Intervention (2-3 months after Baseline), 3-month Follow-Up, 6-Month Follow-Up