Clinical trial NCT03960619: In Person and Mobile Health Coping Skills Training for Improving Symptom Management and Daily Steps in Hematopoietic Stem Cell Transplant Patients
Official title: In Person and Mobile Health Coping Skills Training for Improving Symptom Management and Daily Steps in Hematopoietic Stem Cell Transplant Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematopoietic Neoplasms (Leukemia, Lymphoma, Multiple Myeloma)
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2019-05-23
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the study is to assess the feasibility, acceptability, and efficacy of a novel mHealth behavioral intervention to enable HCT patients to effectively cope with symptoms to improve their ability to engage in physical activity that can improve physical disability. Our interdisciplinary team (psychiatry, hematology/oncology, occupational therapy) proposes a single arm pilot trial (N=20) to test a hybrid in-person and mHealth (video-conferencing, symptoms/activity monitoring, personalized feedback via text) HCT Coping Skills Training for Symptom Management and Daily Steps (CST Step-Up) intervention. CST Step-Up will provide patients with coping skills training and activity coaching sessions to enhance their ability to cope with symptoms that interfere with activity.

Detailed description: Our group developed a mHealthpain coping skills training program for HCT patients and found in a small pilot trial (R21) that improved pain coping led to increased daily activity and reduced physical disability. However, fatigue and distress were also barriers to physical activity.

We propose to assess the feasibility, acceptability, and outcome patterns suggesting efficacy of a novel mHealth behavioral intervention to enable HCT patients to effectively cope with symptoms to improve their ability to engage in physical activity that can improve physical disability.Our interdisciplinary team (psychiatry, hematology/oncology, occupational therapy) is conducting a single arm pilot trial (N=20) to test a hybrid in-person and mHealth (video-conferencing, symptoms/activity monitoring, personalized feedback via text) HCT Coping Skills Training for Symptom Management and Daily Steps (CST Step-Up) intervention. CST Step-Up will provide patients with coping skills training and activity coaching sessions to enhance their ability to cope with symptoms that interfere with activity.

Aim 1:Use a single arm pilot trial (N=20) to examine the feasibility and acceptability of the CST Step-Up protocol. Feasibility will be assessed via (a) study accrual, (b) adherence to the study protocol (intervention and assessments), and (c) retention (% completing the study).

H1:Feasibility will be determined by meeting targeted study accrual (20 patients 15 months), \>80% adherence to the protocol, and \<20% attrition. Acceptability will be demonstrated by 80% of participants reporting satisfaction with the intervention.

Aim 2:Examine outcome patterns suggesting the efficacy of the CST Step-Up protocol for improving physical disability and other important outcomes.

H2:Pre-and post-intervention differences will be examined with simple t-tests to evaluate patterns suggesting intervention efficacy on measures of physical disability (self-report, 6-min walk test), pain, fatigue, distress, physical activity (daily steps), and self-efficacy for symptom management.

Confirmed hypotheses would provide the first demonstration of 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 (e.g., R01) that can redesign existing modes of behavioral intervention delivery, improve continuity and coordination of care, and ultimately enhance patient outcomes.

Eligibility criteria: Inclusion Criteria:

* undergone hematopoietic stem cell transplant (HCT) due to an oncological disease (e.g., leukemia, lymphoma, multiple myeloma)
* being at least 18years old and
* life expectancy at least 12 months.

Exclusion Criteria:

* cognitive impairment (e.g., dementia) recorded in the chart or suspected by healthcare provider,
* presence of a severe psychiatric condition (i.e., psychotic disorder or episode) or a psychiatric condition (e.g., suicidal intent) that would contraindicate safe participation in the study as indicated by the medical chart, treating oncologist, or interactions with the medical/study staff, and
* inability to converse in English

Primary outcomes:
measure: Accrual as measured by number of participants recruited
timeFrame: 15 months
measure: Adherence as measured by completing all intervention sessions
timeFrame: 15 months
measure: Attrition as measured by 80% participants completing the study.
timeFrame: 15 months
measure: Acceptability as measured by 80% participants reporting satisfaction with CST program
timeFrame: 15 months
Secondary outcomes:
measure: Change in Physical Disability
timeFrame: assessments at baseline (pre - treatment) and post-intervention at 3-months..
measure: Change in Fatigue
timeFrame: assessments at baseline (pre-treatment) and post-intervention at 3-months.
measure: Change in Psychological Distress
timeFrame: assessments at baseline (pre-treatment) and post-intervention at 3-months.
measure: Change in Self-Efficacy for Symptom Management: PROMIS Self-Efficacy for Managing Symptoms Short Form
timeFrame: assessments at baseline (pre-treatment) and post-intervention at 3-months.
measure: Symptom Monitoring
timeFrame: post-intervention at 3-months.
measure: Physical Activity
timeFrame: post-intervention at 3-months.
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke university health system
state: North Carolina
Study officials:
affiliation: Duke University
name: Tamara J Somers, PhD
role: PRINCIPAL_INVESTIGATOR
References: