NCT03859765: Symptoms-Steps

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

Completed NA Results posted Last updated 22 March 2024

What this trial tests

NA trial testing HCT Symptoms and Steps in Stem Cell Transplant in 40 participants. Completed in 20 December 2021.

Timeline

23 July 2019

Primary endpoint
20 December 2021

20 December 2021

Quick facts

Lead sponsor	Duke University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	23 July 2019
Primary completion	20 December 2021
Estimated completion	20 December 2021
Sites	1 location across United States

Drugs / interventions tested

• HCT Symptoms and Steps

Conditions studied

• Stem Cell Transplant — all drugs for Stem Cell Transplant →

Sponsor

Duke University

Who can join

18 and older, any sex, with Stem Cell Transplant. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Feasibility as Measured by Number of Participants Accrued to the Study Within 16 Months Primary · 16 months (additional year granted due to COVID-19).

Feasibility will be shown by meeting targeted study accrual (N=40) in the 16-month study period.

Group	Value	95% CI
Screening	28
Screening	51
Screening	4
Screening	40

Number of Participants Who Adhere to at Least 80% of the Study Protocol Primary · approximately 20-24 weeks

A measure of feasibility.

Group	Value	95% CI
HCT Symptoms and Steps	17
HCT Education	18

Number of Participants Who do Not Complete the 3-month Post-treatment Follow-up Assessment Primary · approximately 20-24 weeks

A measure of feasibility.

Group	Value	95% CI
HCT Symptoms and Steps	3
HCT Education	2

Acceptability as Measured by the Client Satisfaction Questionnaire (CSQ) 8-item Version Primary · post-treatment (approximately 7-12 weeks)

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).

Group	Value	95% CI
HCT Symptoms and Steps	27.89	± 3.46

Change in Physical Disability as Measured by the the Functional Assessment of Cancer Therapy (FACT) Secondary · pre-treatment (baseline), post-treatment (approximately 7-12 weeks)

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.

Group	Value	95% CI
HCT Symptoms and Steps	4.78	± 4.91
HCT Education	6.94	± 6.66

Change in Pain Severity Secondary · pre-treatment (baseline), post-treatment (approximately 7-12 weeks).

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.

Group	Value	95% CI
HCT Symptoms and Steps	-.79	± 2.19
HCT Education	.02	± 1.54

Change in Fatigue Secondary · pre-treatment (baseline), post-treatment (approximately 7-12 weeks).

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.

Group	Value	95% CI
HCT Symptoms and Steps	-2.62	± 6.98
HCT Education	-4.72	± 8.73

Change in Physical Activity Secondary · pre-treatment (baseline), post-treatment (approximately 7-12 weeks).

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.

Group	Value	95% CI
HCT Symptoms and Steps	1686.35	± 3894.57
HCT Education	1001.50	± 2471.15

Change in Depression Secondary · pre-treatment (baseline), post-treatment (approximately 7-12 weeks)

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.

Group	Value	95% CI
HCT Symptoms and Steps	-1.28	± 2.49
HCT Education	-2.72	± 5.26

Change in Anxiety. Secondary · pre-treatment (baseline), post-treatment (approximately 7-12 weeks)

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.

Group	Value	95% CI
HCT Symptoms and Steps	-1.28	± 1.96
HCT Education	-1.22	± 2.37

Change in Self-Efficacy Secondary · pre-treatment (baseline), post-treatment (approximately 7-12 weeks)

Change in self-efficacy as measured by the Self-Efficacy for Symptom Management scale: 1=not at all confident to 10=totally confident.

Group	Value	95% CI
HCT Symptoms and Steps	-.98	± 2.47
HCT Education	.85	± 1.52

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Hybrid-delivered cognitive behavioral symptom management and activity coaching intervention for patients undergoing hematopoietic stem cell transplant: Findings from intervention development and a pilot randomized trial.
   Kelleher SA, Fisher HM, Hyland K, Miller SN, et al · · 2023 · cited 6× · PMID 36476318 · DOI 10.1080/07347332.2022.2152519