In Person and mHealth Coping Skills Training for Symptom Management and Steps in Stem Cell Transplant Patients

Stem Cell Transplant Clinical Trial

— Symptoms-Steps  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03859765
• Other study ID #: Pro00100321
• Status: Completed
• Phase: N/A
• Start date: July 23, 2019
• Est. completion date: December 20, 2021

Study information

• Verified date: September 2022
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 20, 2021
• Est. primary completion date: December 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stem Cell Transplant

Intervention

Behavioral:
• HCT Symptoms and Steps
HCT Symptoms and Steps will provide patients with cognitive behavioral coping skills training and activity coaching sessions to enhance their ability to manage symptoms that interfere with activity.

Locations

Country	Name	City	State
United States	Duke Cancer Institute	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility as Measured by Number of Participants Accrued to the Study Within 16 Months	Feasibility will be shown by meeting targeted study accrual (N=40) in the 16-month study period.	16 months (additional year granted due to COVID-19).
Primary	Number of Participants Who Adhere to at Least 80% of the Study Protocol	A measure of feasibility.	approximately 20-24 weeks
Primary	Number of Participants Who do Not Complete the 3-month Post-treatment Follow-up Assessment	A measure of feasibility.	approximately 20-24 weeks
Primary	Acceptability as Measured by the Client Satisfaction Questionnaire (CSQ) 8-item Version	This questionnaire contains 8 items rated from 1=low acceptability to 4=high acceptability; scores are created by utilizing the Likert Scale to sum CSQ answers resulting in a score range from 8 to 32. The intervention is considered acceptable if the mean value for acceptability across all participants is above 80% of max acceptability score (i.e., 25.6).	post-treatment (approximately 7-12 weeks)
Secondary	Change in Physical Disability as Measured by the the Functional Assessment of Cancer Therapy (FACT)	Physical Disability will be assessed using the Functional Assessment of Cancer Therapy 7-item physical well-being scale. Each item is scored 0=not at all to 4=very much as the statement applies to the past 7 days. The full range of the scale is 0 to 28, with a higher score indicating a better outcome.	pre-treatment (baseline), post-treatment (approximately 7-12 weeks)
Secondary	Change in Pain Severity	Pain severity will be assessed with the Brief Pain Inventory (BPI). Patients will rate their "pain right now", "worst", "least" and "average" pain in the last week from 0=no pain to 10=worst pain imaginable. An average of the responses to these items is used to create a single pain severity score.	pre-treatment (baseline), post-treatment (approximately 7-12 weeks).
Secondary	Change in Fatigue	Fatigue will be assessed using the Patient Reported Outcomes Measurement Information System (PROMIS) seven-item Fatigue Scale. For each item, the statement applies to the past 7 days: "never" (1), "rarely" (2), "sometimes" (3), "often" (4), or "always" (5). The summed score is then converted to a T-Score (0-100), where a higher T-Score indicates worse fatigue. 50 indicates the population mean with a standard deviation of 10. 50 and below is considered below average, 50-60 is mild, and 60 or greater is moderate/severe.	pre-treatment (baseline), post-treatment (approximately 7-12 weeks).
Secondary	Change in Physical Activity	Physical Activity will be assessed via step count with a wireless activity tracker (e.g., Fitbit). A distinct value pre and post treatment are reported, no averages were taken across multiple days.	pre-treatment (baseline), post-treatment (approximately 7-12 weeks).
Secondary	Change in Depression	Depression will be assessed using the Hospital Anxiety and Depression Scale (HADS). Each question rated 0-3, totaling 21 points.Total score of 0-7 = normal, 8-10 = borderline abnormal, 11-21 = abnormal.	pre-treatment (baseline), post-treatment (approximately 7-12 weeks)
Secondary	Change in Anxiety.	Anxiety will be assessed using the Hospital Anxiety and Depression Scale (HADS). Each question rated 0-3, totaling 21 points.Total score of 0-7 = normal, 8-10 = borderline abnormal, 11-21 = abnormal.	pre-treatment (baseline), post-treatment (approximately 7-12 weeks)
Secondary	Change in Self-Efficacy	Change in self-efficacy as measured by the Self-Efficacy for Symptom Management scale: 1=not at all confident to 10=totally confident.	pre-treatment (baseline), post-treatment (approximately 7-12 weeks)