Coping Skills Training for Bone Marrow Transplant

Overseen By Allison Diachina

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Cognitive impairment, Brain metastases, Severe psychiatric condition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 7-14 weeks

177 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for adults over 18 who have had an autologous bone marrow transplant due to blood cancers like leukemia, lymphoma, or multiple myeloma. They must be experiencing at least two of the following symptoms: fatigue, pain, and psychological distress rated above 3 on a scale of 0-10. Participants should also expect to live more than a year.

Inclusion Criteria

I experience significant fatigue, pain, or distress, scoring above 3 in at least two.

My doctor expects me to live more than 12 months.

I have had a stem cell transplant for blood cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a hybrid in-person and mHealth coping skills training and activity coaching intervention over 7-14 weeks

7-14 weeks

3 in-person visits, 4 virtual visits

Follow-up

Participants are monitored for changes in physical disability, self-efficacy, psychological distress, fatigue, pain, and activity levels

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Step Up

Trial Overview The 'Step Up' program combines in-person and mobile health coaching to help patients manage symptoms such as pain, fatigue, and stress after their bone marrow transplant. The goal is to improve their physical activity levels which can reduce disability from these symptoms.

How Is the Trial Designed?

Group I: Usual Care Plus (UC+) Experimental Treatment 1 Intervention

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 II: Step Up Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+