Coping Skills Training for Symptom Management and Daily Steps (Step Up)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorDuke University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
receipt of an autologous (auto) HCT or CAR-T cell therapy due to a hematologic malignancy, such as a diagnosis of leukemia, lymphoma, multiple myeloma
age >18
self-reported fatigue, pain, and psychological distress (confirmed at recruitment) - minimum two of three symptoms reported at >3 on 0-10 scale
life expectancy > 12 months
Disqualifiers
cognitive impairment (e.g., dementia) recorded in the chart or suspected by provider
metastases to the brain
presence of a severe psychiatric condition (e.g., psychotic disorder) that would contraindicate safe participation as indicated by the medical chart, treating oncologist, or interactions with the medical/study staff
inability to converse in English
Trial design
Design model
Parallel
Treatments tested in this trial
Step Up
BehavioralA hybrid in-person and mHealth (mobile health) coping skills training and activity coaching intervention.
Usual Care Plus (UC+)
Other interventionUsual medical care plus videos delivering educational content via an app.
Treatment groups
177 Participants
are divided into 2 treatment groupsGroup A: Step UpExperimental treatment 1 intervention
Group B: Usual Care Plus (UC+)Other 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, Post-Intervention (2-3 months after Baseline), 3-month Follow-Up, 6-Month Follow-Up2
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.
Time frame
Baseline, Post-Intervention (2-3 months after Baseline), 3-month Follow-Up, 6-Month Follow-UpSecondary outcomes
1
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.
Time frame
Baseline, Post-Intervention (2-3 months after Baseline), 3-month Follow-Up, 6-Month Follow-Up2
Change in pain as measured by the 4-item Brief Pain Inventory (BPI)
The BPI is a scale used to rate pain severity and interference over the last 7 days. Pain severity is rated on a scale from 0=no pain to 10=worst pain imaginable in response to "average pain", "worst pain", "least pain", and "pain right now". An average of the responses to these four items is used to create a single pain severity score where higher scores indicate greater pain. Pain interference is rated on a scale from 0=does not interfere to 10=completely interferes in response to how much pain has interfered with different areas of life.
Time frame
Baseline, Post-Intervention (2-3 months after Baseline), 3-month Follow-Up, 6-Month Follow-Up3
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.
Time frame
Baseline, Post-Intervention (2-3 months after Baseline), 3-month Follow-Up, 6-Month Follow-Up4
Change in activity as measured by daily step count
Step count will be measured by a Garmin Vivosmart 5 activity tracker that has a 6+ day battery life, syncs wirelessly and automatically to computers and smartphones, and resets at midnight. Garmins automatically sync daily with the study app.
Time frame
Baseline, Post-Intervention (2-3 months after Baseline), 3-month Follow-Up, 6-Month Follow-UpSponsors and contacts
Click on the lead sponsor to view all of their trials.
Duke University
Lead sponsor
National Institutes of Health (NIH)
Collaborator
Source ClinicalTrials.gov