Recruiting

Step Up

Sponsor:

Duke University

Code:

NCT06575712

Conditions

Hematopoietic Stem Cell Transplant

CAR-T Cell Therapy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Step Up

Usual Care Plus (UC+)

Study Details

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.

Conditions

Hematopoietic Stem Cell Transplant

CAR-T Cell Therapy

Study ID

NCT06575712

Start date

Apr 21, 2025

Status verified date

Jul, 2026

Completion date

Aug 31, 2028

Anticipated

Primary completion date

Aug 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

177 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Step Up

Step Up participants will complete 7 sessions over 7-14 weeks (45 min/session). Of the 7 sessions, participants will complete 3 in-person in the hospital/outpatient clinic (1 coping skills training for symptom management \[45 min\] and 2 activity coaching \[45 min\]) followed by 4 via videoconferencing (coping skills training for symptom management and activity coaching \[45 min each\]) once the patient has been discharged home from the outpatient clinic.

other: Usual Care Plus (UC+)

Usual Care Plus (UC+) participants will complete all assessments at time intervals corresponding to Step Up, and otherwise continue to receive their usual medical care plus 7 videos delivering educational content (1 video/week for 7 weeks; 5-10 minutes/video) via a study app (free download), but not the Step Up protocol.

Interventions

Step Up

A hybrid in-person and mHealth (mobile health) coping skills training and activity coaching intervention.

Usual Care Plus (UC+)

Usual medical care plus videos delivering educational content via an app.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Allison Diachina

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

Sarah Kelleher, PhD

sarah.kelleher@duke.edu

Locations

Duke Cancer Institute

Recruiting

Durham, North Carolina, United States, 27705

More Information

Sponsor

Duke University

Last update posted

Jul 15, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-07-15.