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?

This trial tests a program called Step Up, designed to help individuals who have undergone a bone marrow transplant manage symptoms like pain, fatigue, and stress. The goal is to determine if this program can improve participants' well-being and activity levels, potentially enhancing overall physical function. Participants will either follow the Step Up program or receive usual care with additional educational videos. Ideal candidates are those who have had a bone marrow transplant due to blood cancer and experience at least two symptoms, such as fatigue, pain, or stress. As an unphased trial, this study provides a unique opportunity for participants to contribute to innovative research that could improve post-transplant care.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this coping skills training is safe for bone marrow transplant patients?

Research has shown that the Step Up program is safe and well-liked by participants. In past studies, over 80% of patients reported satisfaction with the program, indicating that most find it helpful and easy to follow. The program teaches coping skills to manage symptoms like pain and tiredness. It includes both in-person and video sessions and has been shown to improve physical activity.

No major side effects or problems have been reported. Instead, patients appear to manage their symptoms better and become more active. This makes the program promising for those undergoing bone marrow transplants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Step Up" coping skills training because it offers a novel approach to helping bone marrow transplant patients manage symptoms and increase activity levels. Unlike standard care, which typically focuses on medical management, Step Up integrates personalized coping skills training and activity coaching through both in-person and video sessions. This method not only addresses the physical aspects of recovery but also empowers patients with practical tools to handle the emotional and psychological challenges post-transplant. This comprehensive approach aims to improve overall recovery outcomes and enhance quality of life for patients.

What evidence suggests that the Step Up intervention is effective for coping with symptoms in bone marrow transplant patients?

This trial will compare the "Step Up" program with "Usual Care Plus (UC+)" for bone marrow transplant patients. Studies have shown that exercise and stress management during bone marrow transplants can enhance patients' quality of life. Research indicates that learning coping strategies can boost resilience and mental health after hospital discharge. A small trial found that training in pain management skills helped patients manage symptoms more effectively. Other studies suggest these methods can also reduce depression and anxiety. Overall, these findings support the idea that learning coping skills and staying active can positively impact both physical and mental health for transplant patients. ^{5 6 7 8 9}

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

My doctor expects me to live more than 12 months.

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

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10341539/

The Prospective Effects of Coping Strategies on Mental ... This study examines the prospective effects of coping strategies during hospitalization on resilience and on various mental-health dimensions at five months ...

2. astctjournal.org astctjournal.org/article/S1083-8791(14)00325-5/fulltext

Exercise and Stress Management Training Prior to ... Studies show that engaging patients in exercise and/or stress management techniques during hematopoietic cell transplantation (HCT) improves quality of life ...

3. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncr.33191

Enhanced coping and self‐efficacy in caregivers of stem cell ... A brief multimodal psychosocial intervention improves quality of life and reduces depression and anxiety symptoms for caregivers of patients ...

4. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/65/NCT03859765/Prot_SAP_000.pdf

In Person and mHealth Coping Skills Training for Symptom ... Our group developed a mHealth pain coping skills training program for HCT patients and found in a small pilot trial (R21) that improved pain coping led to ...

5. bmchealthservres.biomedcentral.com bmchealthservres.biomedcentral.com/articles/10.1186/s12913-018-3483-1

a self-directed coping skills intervention for patients and ... This two-phase qualitative descriptive study seeks to understand the perceptions of HSCT patients, CGs, individually, and in dyads, and clinicians about Coping ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03960619

In Person and Mobile Health Coping Skills Training for ... Acceptability will be indicated by 80% of patients reporting satisfaction with CST Step-Up on the CSQ. 15 months. Secondary Outcome Measures ...

7. trialx.com trialx.com/clinical-trials/listings/309788/coping-skills-training-for-symptom-management-and-daily-steps-step-up/

Coping Skills Training for Symptom Management and Daily ... Our R21 results show Step Up is feasible, acceptable to patients, and demonstrates a strong signal for intervention benefits, including improvements in physical ...

8. pattern.health pattern.health/portfolio/step-up/

Step Up (Symptom Management for Stem Cell Transplant ... Cognitive behavioral coping skills training protocols can enhance HCT patients' ability to cope with symptoms (pain, fatigue, distress) that interfere with ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10247893/

Hybrid-Delivered Cognitive Behavioral Symptom ... CBT-based coping skills training has been shown to improve symptom self-efficacy and, in turn, improve adherence to activity recommendations and ...