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

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT06575712
Status
Recruiting
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Conditions

  • CAR-T Cell Therapy
  • Hematopoietic Stem Cell Transplant

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Step Up — BEHAVIORAL
    A hybrid in-person and mHealth (mobile health) coping skills training and activity coaching intervention.
  • Usual Care Plus (UC+) — OTHER
    Usual medical care plus videos delivering educational content via an app.

Study Details

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.

Key Dates

Start date
Apr 21, 2025
Status verified
Apr 2026
Primary completion
Aug 31, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
177 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

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.

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke Cancer InstituteDurhamNorth Carolina27705
Sarah A Kelleher, PhD

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By research site
Duke Cancer Institute· Durham, NC

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