Coping Skills Training for Symptom Management and Daily Steps (Step Up)

This study is testing a program called "Step Up" to help people who have had a hematopoietic stem cell transplant (HCT) or CAR-T cell therapy. Step Up combines in-person and mobile app-based training to teach coping skills and provide activity coaching. The goal is to help you manage symptoms like fatigue, pain, and stress, which can make it hard to be physically active. Researchers want to see if Step Up can improve your physical ability compared to receiving usual medical care plus educational videos (Usual Care Plus). You might be able to join if you are over 18, have had an HCT or CAR-T cell therapy for blood cancer, and are experiencing at least two of these symptoms: fatigue, pain, or psychological distress. The study will look at changes in your physical ability over about six months. The current status of this study is unclear, and it plans to enroll 177 participants.

Study design
This study is an interventional trial comparing the Step Up program to Usual Care Plus. It plans to enroll 177 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for about six months after the intervention, with assessments at baseline, 2-3 months, 3 months, and 6 months.

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NCT06575712

Coping Skills Training for Symptom Management and Daily Steps (Step Up)

Recruiting
NAAges 18–99InterventionalSupportive care
Duke University
~177 participants
Updated 2026-07-15 on ClinicalTrials.gov
What's tested:Step UpUsual Care Plus (UC+)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in physical disability as measured by the Functional Assessment of Cancer Therapy (FACT)
Measured over Baseline, Post-Intervention (2-3 months after Baseline), 3-month Follow-Up, 6-Month Follow-Up
+1 more outcome measured
Hematopoietic Stem Cell Transplant
CAR-T Cell Therapy
1 sites across 1 states
North Carolina1

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Eligibility criteria

Inclusion

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

Exclusion

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
  • Change in physical disability as measured by the Functional Assessment of Cancer Therapy (FACT)Baseline, Post-Intervention (2-3 months after Baseline), 3-month Follow-Up, 6-Month Follow-Up

    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.

  • Change in physical disability as measured by the Six-Minute Walk Test (6MWT)Baseline, Post-Intervention (2-3 months after Baseline), 3-month Follow-Up, 6-Month Follow-Up

    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.