Clinical trial NCT06575712: Coping Skills Training for Symptom Management and Daily Steps (Step Up)
Official title: Coping Skills Training for Symptom Management and Daily Steps (Step Up)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hematopoietic Stem Cell Transplant
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2024-08-28
Enrollment: 177
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* receipt of an autologous (auto) HCT 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in physical disability as measured by the Functional Assessment of Cancer Therapy (FACT)
timeFrame: Baseline, Post-Intervention (2-3 months after Baseline), 3-month Follow-Up, 6-Month Follow-Up
measure: Change in physical disability as measured by the Six-Minute Walk Test (6MWT)
timeFrame: Baseline, Post-Intervention (2-3 months after Baseline), 3-month Follow-Up, 6-Month Follow-Up
Secondary outcomes:
measure: Change in fatigue as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Adult Fatigue Profile 6-item Short Form
timeFrame: Baseline, Post-Intervention (2-3 months after Baseline), 3-month Follow-Up, 6-Month Follow-Up
measure: Change in pain as measured by the 4-item Brief Pain Inventory (BPI)
timeFrame: Baseline, Post-Intervention (2-3 months after Baseline), 3-month Follow-Up, 6-Month Follow-Up
measure: Change in psychological distress as measured by the Brief Symptom Inventory (BSI)
timeFrame: Baseline, Post-Intervention (2-3 months after Baseline), 3-month Follow-Up, 6-Month Follow-Up
measure: Change in activity as measured by daily step count
timeFrame: Baseline, Post-Intervention (2-3 months after Baseline), 3-month Follow-Up, 6-Month Follow-Up
measure: Change in self-efficacy for managing symptoms as measured by the PROMIS Self-Efficacy for Managing Symptoms 8-Item Short Form
timeFrame: Baseline, Post-Intervention (2-3 months after Baseline), 3-month Follow-Up, 6-Month Follow-Up
measure: Pre-Existing Physical Activity Behavior will be measured using the Stanford Leisure-Time Activity Categorical Item (L-Cat)
timeFrame: Baseline, Post-Intervention (2-3 months after Baseline), 3-month Follow-Up, 6-Month Follow-Up
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Cancer Institute
state: North Carolina
Study officials:
References: