RecruitingNot Applicable

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

United States177 participantsStarted 2025-04-21

Plain-language 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.

Who can participate

Age range18 Years – 99 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 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

What they're measuring

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

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

Trial details

NCT IDNCT06575712

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-08-31

Contact for this trial

Allison Diachina

919-416-3421 allison.diachina@duke.edu

View on ClinicalTrials.gov More Hematopoietic Stem Cell Transplant trials

Plain-language summary

Who can participate

Age range18 Years – 99 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

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