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

NCT ID: NCT06575712

Last Updated: 2025-07-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 177 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-21
• Study Completion Date: 2028-08-31

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.

Detailed Description

The objective of this R01 project is to use novel mobile health (mHealth) behavioral intervention approaches to enable patients who have undergone hematopoietic stem cell transplant (HCT) and Car T cell therapy to effectively cope with their symptoms to improve their ability to engage in physical activity that can improve physical disability. In a NCI R21 study, we developed a hybrid in-person and mHealth Coping Skills Training for Symptom Management and Daily Steps (Step Up) intervention protocol, including mobile app. Step Up provides HCT and CAR T patients with cognitive behavioral coping skills training and occupational therapy (OT)-led activity coaching sessions to enhance their ability to cope with symptoms - fatigue, pain, distress - that interfere with physical activity. Step Up has been developed by experts in symptom management, members of the HCT medical team, and with extensive input from HCT patients. Our R21 results show Step Up is feasible, acceptable to patients, and demonstrates a strong signal for intervention benefits, including improvements in physical disability, symptoms, and activity (daily steps). This R01 project uses a randomized controlled trial (RCT) to test the efficacy of Step Up compared to Usual Care Plus (UC+). Step Up includes a mobile app and activity trackers (Garmins) to capture daily symptom, activity, and biometric data allowing the study team to provide real-time personalized feedback. Our central hypothesis is Step Up will lead to improvements in physical disability (primary outcome), as well as secondary outcomes of symptom severity, physical activity, and digital biomarkers reflective of symptom burden following HCT. A RCT (N=177) will be used to pursue three specific aims: 1) Test the efficacy of Step Up for improving physical disability, as well as symptom severity, physical activity, and self-efficacy for symptom management compared to UC+; 2) Examine the relationship between symptoms and activity; and 3) Test the efficacy of Step Up for improving digital biomarkers reflective of symptom burden (heart rate, activity, sleep time) measured via Garmins. The proposed work is innovative and impactful for HCT and CAR T patients as it addresses interfering symptoms, integrates evidence-based coping skills training with OT sessions to increase activity while decreasing symptoms that interfere with activity, and uses mHealth technology for personalized real-time feedback to patients. Positive results would provide the first demonstration of efficacy of a hybrid-delivered cognitive behavioral coping skills training and activity coaching intervention that reduces physical disability by concurrently and synergistically decreasing symptom burden and increasing activity. The proposed research has the potential to produce significant public health benefit by redesigning existing modes of behavioral intervention delivery, improving continuity and coordination of care, and ultimately enhancing patient outcomes.

Conditions

CAR-T Cell Therapy; Hematopoietic Stem Cell Transplant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Step Up

Intervention Type: BEHAVIORAL

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

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.

Group Type: OTHER

Usual Care Plus (UC+)

Intervention Type: OTHER

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

Interventions

Step Up

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

Intervention Type: BEHAVIORAL

Usual Care Plus (UC+)

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Duke Cancer Institute

Durham, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Allison Diachina

Role: CONTACT

allison.diachina@duke.edu

919-416-3421

Sarah Kelleher, PhD

Role: CONTACT

sarah.kelleher@duke.edu

Facility Contacts

Sarah A Kelleher, PhD

Role: primary

Other Identifiers

Pro00116334

Identifier Type: -

Identifier Source: org_study_id