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

July 14, 2026 updated by: Duke University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
177

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Recruiting
        • Duke Cancer Institute
        • Contact:
          • Sarah A Kelleher, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Step Up
A hybrid in-person and mHealth (mobile health) coping skills training and activity coaching intervention.
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.
Other: Usual Care Plus (UC+)
Usual medical care plus videos delivering educational content via an app.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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)
Time Frame: Baseline, Post-Intervention (2-3 months after Baseline), 3-month Follow-Up, 6-Month Follow-Up
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in fatigue as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Adult Fatigue Profile 6-item Short Form
Time Frame: Baseline, Post-Intervention (2-3 months after Baseline), 3-month Follow-Up, 6-Month Follow-Up
Fatigue will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Adult Fatigue Profile 6-item Short Form. The PROMIS F-SF consists of seven items that measure both the experience of fatigue and the interference of fatigue on daily activities over the past week. Response options are on a 5-point Likert scale, ranging from 1 = never to 5 = always. One item, "How often did you have enough energy to exercise strenuously," is reverse scored. The total score is used in the analysis and is obtained by summing keyed scores of all items. Scores can range from 7 to 35, with higher scores indicating greater fatigue.
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)
Time Frame: Baseline, Post-Intervention (2-3 months after Baseline), 3-month Follow-Up, 6-Month Follow-Up
The BSI-18 will be condensed to include 12 items. Responses are rated on a 5-point scale where 0=not at all and 4=extremely. The total score ranges from 0 to 48, where higher scores indicate greater distress.
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
Time Frame: Baseline, Post-Intervention (2-3 months after Baseline), 3-month Follow-Up, 6-Month Follow-Up
The PROMIS Self-Efficacy for Managing Symptoms 8-Item Short Form inquires about participants' level of confidence in their ability to manage symptoms. Responses are on a 5-point Likert scale where 1=I am not at all confident to 5=I am very confident. The total summed score ranges from 8 to 40, where higher scores reflect more self-efficacy.
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)
Time Frame: Baseline, Post-Intervention (2-3 months after Baseline), 3-month Follow-Up, 6-Month Follow-Up
The BPI is a scale used to rate pain severity and interference over the last 7 days. Pain severity is rated on a scale from 0=no pain to 10=worst pain imaginable in response to "average pain", "worst pain", "least pain", and "pain right now". An average of the responses to these four items is used to create a single pain severity score where higher scores indicate greater pain. Pain interference is rated on a scale from 0=does not interfere to 10=completely interferes in response to how much pain has interfered with different areas of life.
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
Time Frame: Baseline, Post-Intervention (2-3 months after Baseline), 3-month Follow-Up, 6-Month Follow-Up
Step count will be measured by a Garmin Vivosmart 5 activity tracker that has a 6+ day battery life, syncs wirelessly and automatically to computers and smartphones, and resets at midnight. Garmins automatically sync daily with the study app.
Baseline, Post-Intervention (2-3 months after Baseline), 3-month Follow-Up, 6-Month Follow-Up
Pre-Existing Physical Activity Behavior will be measured using the Stanford Leisure-Time Activity Categorical Item (L-Cat)
Time Frame: Baseline, Post-Intervention (2-3 months after Baseline), 3-month Follow-Up, 6-Month Follow-Up
Participants identify which category best describes their level of activity during leisure time in the last month. Categories range from 0 "inactive" to 5 "very active."
Baseline, Post-Intervention (2-3 months after Baseline), 3-month Follow-Up, 6-Month Follow-Up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Duke University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institutes of Health (NIH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 21, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 15, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 28, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00116334

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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