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

Duke University

Status: Enrolling

Conditions: Hematopoietic Stem Cell Transplant

Treatments: Behavioral: Step Up; Other: Usual Care Plus (UC+)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06575712

Pro00116334

Details and patient eligibility

About

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.

Enrollment: 177 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• receipt of an autologous (auto) HCT 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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177 participants in 2 patient groups

Step Up

Experimental group

Description:

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.

Treatment:

Behavioral: Step Up

Usual Care Plus (UC+)

Other group

Description:

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.

Treatment:

Other: Usual Care Plus (UC+)