Clinical trial NCT03859765: In Person and mHealth Coping Skills Training for Symptom Management and Steps in Stem Cell Transplant Patients
Official title: Development and Pilot Testing of a Hybrid In Person and mHealth Coping Skills Training Intervention for Symptom Management and Daily Steps in Stem Cell Transplant Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stem Cell Transplant
Keywords: physical disability
pain
fatigue
distress
physical activity
coping
mHealth
cancer
symptom management
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2019-03-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hematopoietic stem cell transplant (HCT) is an aggressive treatment for life-threatening cancers. HCT improves survival, but most HCT patients experience significant physical disability, which is exacerbated by persistent symptoms. Pain, fatigue, and psychological distress are the most prevalent and debilitating symptoms. HCT patients experience a significant increase in disability as their pain, fatigue, and distress increase. This disability and symptom burden interferes with patients' ability to engage in recommended physical activity that can improve disability, symptoms, and other outcomes. Disability and symptoms also complicate an already challenging recovery course; HCT patients return home, often far from their medical team, are restricted from normal activities and socially isolated. These disability, symptom and activity challenges increase the risk for post-transplant complications and may compromise life expectancy. Teaching HCT patients to cope with symptoms and activity is critical to helping them increase activity and reduce disability. Cognitive behavioral coping skills training protocols can enhance HCT patients' ability to cope with symptoms (pain, fatigue, distress) that interfere with physical activity. However, the application of these protocols to HCT patients is limited by in person sessions, delivery of sessions in a medical center setting, and/or lack of tailoring to HCT patients' specific needs. Mobile health (mHealth) technologies can improve and extend intervention strategies to cope with symptoms and physical activity upon return home. Behavioral intervention strategies are needed to enable HCT patients to effectively cope with symptoms to improve their ability to engage in physical activity that can improve physical disability.

The investigators aim to develop and test a combined coping skills training and activity coaching protocol that: first, is feasible and acceptable, and second, improves physical disability, as well as pain, fatigue, distress, and physical activity in HCT patients. Specifically, the investigators will develop and test an in-person and mHealth HCT Coping Skills Training for Symptom Management and Daily Steps (HCT Symptoms and Steps) intervention protocol. To do this, the investigators will develop a mobile app, conduct focus groups, complete user testing, and conduct a small randomized controlled trial (RCT) to examine feasibility, acceptability, and outcome patterns suggesting intervention efficacy of the developed HCT Symptoms and Steps protocol. Following the development phase of the study (i.e., focus groups), the investigators will conduct user testing with 10 cancer patients who have undergone HCT; all 10 patients will receive the HCT Symptoms and Steps intervention. Next, the investigators will randomly assign 40 cancer participants who have undergone HCT and report pain, fatigue and stress to receive either HCT Symptoms and Steps or HCT Education. The investigators will test whether HCT Symptoms and Steps is feasible and acceptable to HCT patients, and improves physical disability, as well as other important outcomes. The investigators expect that HCT Symptoms and Steps will be feasible and acceptable to HCT patients and, compared to HCT Education, will be more likely to lead to improvements in physical disability, as well as pain, fatigue, distress, physical activity, and self-efficacy for symptom management.

The investigators' goal is to demonstrate the feasibility, acceptability, and positive impact of a hybrid in-person and mHealth coping skills training and activity coaching intervention that reduces physical disability by concurrently and synergistically decreasing symptom burden and increasing physical activity. This project has the potential to lead to future research that can redesign existing modes of behavioral intervention delivery, improve continuity and coordination of care, and ultimately enhance patient outcomes.


Eligibility criteria: Inclusion Criteria:

* Hematopoietic stem cell transplant due to oncological disease
* Clinical ratings of pain, fatigue and psychological distress
* Life expectancy of 12 or more months

Exclusion Criteria:

* Cognitive impairment
* Severe psychiatric condition
* Inability to converse in English

Primary outcomes:
measure: Feasibility as Measured by Number of Participants Accrued to the Study Within 16 Months
timeFrame: 16 months (additional year granted due to COVID-19).
measure: Number of Participants Who Adhere to at Least 80% of the Study Protocol
timeFrame: approximately 20-24 weeks
measure: Number of Participants Who do Not Complete the 3-month Post-treatment Follow-up Assessment
timeFrame: approximately 20-24 weeks
measure: Acceptability as Measured by the Client Satisfaction Questionnaire (CSQ) 8-item Version
timeFrame: post-treatment (approximately 7-12 weeks)
Secondary outcomes:
measure: Change in Physical Disability as Measured by the the Functional Assessment of Cancer Therapy (FACT)
timeFrame: pre-treatment (baseline), post-treatment (approximately 7-12 weeks)
measure: Change in Pain Severity
timeFrame: pre-treatment (baseline), post-treatment (approximately 7-12 weeks).
measure: Change in Fatigue
timeFrame: pre-treatment (baseline), post-treatment (approximately 7-12 weeks).
measure: Change in Physical Activity
timeFrame: pre-treatment (baseline), post-treatment (approximately 7-12 weeks).
measure: Change in Depression
timeFrame: pre-treatment (baseline), post-treatment (approximately 7-12 weeks)
measure: Change in Anxiety.
timeFrame: pre-treatment (baseline), post-treatment (approximately 7-12 weeks)
measure: Change in Self-Efficacy
timeFrame: pre-treatment (baseline), post-treatment (approximately 7-12 weeks)
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Cancer Institute
state: North Carolina
Study officials:
References: