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

NCT06575712 | Recruiting

• 1 other identifier: Pro00116334
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Change in physical disability as measured by the Functional Assessment of Cancer Therapy (FACT)

  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.

  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)

  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.

  Baseline, Post-Intervention (2-3 months after Baseline), 3-month Follow-Up, 6-Month Follow-Up

Secondary Outcomes (6)

• Change in fatigue as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Adult Fatigue Profile 6-item Short Form

  Baseline, Post-Intervention (2-3 months after Baseline), 3-month Follow-Up, 6-Month Follow-Up

• Change in pain as measured by the 4-item Brief Pain Inventory (BPI)

  Baseline, Post-Intervention (2-3 months after Baseline), 3-month Follow-Up, 6-Month Follow-Up

• Change in psychological distress as measured by the Brief Symptom Inventory (BSI)

  Baseline, Post-Intervention (2-3 months after Baseline), 3-month Follow-Up, 6-Month Follow-Up

• Change in activity as measured by daily step count

  Baseline, Post-Intervention (2-3 months after Baseline), 3-month Follow-Up, 6-Month Follow-Up

• Change in self-efficacy for managing symptoms as measured by the PROMIS Self-Efficacy for Managing Symptoms 8-Item Short Form

  Baseline, Post-Intervention (2-3 months after Baseline), 3-month Follow-Up, 6-Month Follow-Up

Study Arms (2)

Step Up

EXPERIMENTAL

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.

Behavioral: Step Up

Usual Care Plus (UC+)

OTHER

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.

Other: Usual Care Plus (UC+)

Interventions

Step Up BEHAVIORAL

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

Step Up

Usual Care Plus (UC+) OTHER

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

Usual Care Plus (UC+)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Duke Cancer Institute

Durham, North Carolina, 27705, United States

RECRUITING

Central Study Contacts

Allison Diachina

CONTACT

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

Sarah Kelleher, PhD

CONTACT

sarah.kelleher@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2024
• First Posted: August 28, 2024
• Study Start: April 21, 2025
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)