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In Person and Mobile Health Coping Skills Training for Improving Symptom Management and Daily Steps in Hematopoietic Stem Cell Transplant Patients (CST Step Up)

Primary Purpose

Hematopoietic Neoplasms (Leukemia, Lymphoma, Multiple Myeloma)

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
coping skills training
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hematopoietic Neoplasms (Leukemia, Lymphoma, Multiple Myeloma)

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Duke university health system

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

in-person & mHealth coping skills training

Arm Description

hybrid in-person and mHealth coping skills training and activity coaching intervention is to reduce physical disability and decrease pain, fatigue and stress while enhancing patients' abilities to cope with symptoms that interfere with activity.

Outcomes

Primary Outcome Measures

Accrual as measured by number of participants recruited
Accrual will be indicated by meeting the recruitment goal
Adherence as measured by completing all intervention sessions
Adherence will be indicated by the proportion successfully completing intervention sessions
Attrition as measured by 80% participants completing the study.
Attrition will be indicated by 80% of consented participants completing the study protocol.
Acceptability as measured by 80% participants reporting satisfaction with CST program
Acceptability will be indicated by 80% of patients reporting satisfaction with CST Step-Up on the CSQ.

Secondary Outcome Measures

Change in Physical Disability
Functional Assessment of Cancer Therapy 7-item physical well-being scale will be used to assess physical disability.
Change in Fatigue
Fatigue will be measured with the PROMIS Adult Fatigue Short Form.
Change in Psychological Distress
Psychological Distress will be measured with the Brief Symptom Inventory
Change in Self-Efficacy for Symptom Management: PROMIS Self-Efficacy for Managing Symptoms Short Form
Self-Efficacy for Symptom Management will be measured with the PROMIS Self-Efficacy for Managing Symptoms Short Form
Symptom Monitoring
Symptom Monitoring will involve participants using the study phone to provide (text) daily average ratings of Pain, fatigue, and distress on a 0=none to 10=worst imaginable scale. Symptom data will inform personalized feedback via text from the therapist to the CST Step-Up participant.
Physical Activity
Physical Activity will be measured by asking participants to monitor daily activity as assessed by step count with a wireless activity tracker (e.g., Fitbit) that syncs with assigned study phone.

Full Information

First Posted
May 21, 2019
Last Updated
June 12, 2023
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT03960619
Brief Title
In Person and Mobile Health Coping Skills Training for Improving Symptom Management and Daily Steps in Hematopoietic Stem Cell Transplant Patients
Acronym
CST Step Up
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
July 16, 2019 (Actual)
Primary Completion Date
November 22, 2019 (Actual)
Study Completion Date
November 22, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematopoietic Neoplasms (Leukemia, Lymphoma, Multiple Myeloma)

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
in-person & mHealth coping skills training
Arm Type
Experimental
Arm Description
hybrid in-person and mHealth coping skills training and activity coaching intervention is to reduce physical disability and decrease pain, fatigue and stress while enhancing patients' abilities to cope with symptoms that interfere with activity.
Intervention Type
Behavioral
Intervention Name(s)
coping skills training
Intervention Description
We aim to 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. We propose a novel intervention protocol that uses a hybrid in-person and mHealth intervention delivery model.
Primary Outcome Measure Information:
Title
Accrual as measured by number of participants recruited
Description
Accrual will be indicated by meeting the recruitment goal
Time Frame
15 months
Title
Adherence as measured by completing all intervention sessions
Description
Adherence will be indicated by the proportion successfully completing intervention sessions
Time Frame
15 months
Title
Attrition as measured by 80% participants completing the study.
Description
Attrition will be indicated by 80% of consented participants completing the study protocol.
Time Frame
15 months
Title
Acceptability as measured by 80% participants reporting satisfaction with CST program
Description
Acceptability will be indicated by 80% of patients reporting satisfaction with CST Step-Up on the CSQ.
Time Frame
15 months
Secondary Outcome Measure Information:
Title
Change in Physical Disability
Description
Functional Assessment of Cancer Therapy 7-item physical well-being scale will be used to assess physical disability.
Time Frame
assessments at baseline (pre - treatment) and post-intervention at 3-months..
Title
Change in Fatigue
Description
Fatigue will be measured with the PROMIS Adult Fatigue Short Form.
Time Frame
assessments at baseline (pre-treatment) and post-intervention at 3-months.
Title
Change in Psychological Distress
Description
Psychological Distress will be measured with the Brief Symptom Inventory
Time Frame
assessments at baseline (pre-treatment) and post-intervention at 3-months.
Title
Change in Self-Efficacy for Symptom Management: PROMIS Self-Efficacy for Managing Symptoms Short Form
Description
Self-Efficacy for Symptom Management will be measured with the PROMIS Self-Efficacy for Managing Symptoms Short Form
Time Frame
assessments at baseline (pre-treatment) and post-intervention at 3-months.
Title
Symptom Monitoring
Description
Symptom Monitoring will involve participants using the study phone to provide (text) daily average ratings of Pain, fatigue, and distress on a 0=none to 10=worst imaginable scale. Symptom data will inform personalized feedback via text from the therapist to the CST Step-Up participant.
Time Frame
post-intervention at 3-months.
Title
Physical Activity
Description
Physical Activity will be measured by asking participants to monitor daily activity as assessed by step count with a wireless activity tracker (e.g., Fitbit) that syncs with assigned study phone.
Time Frame
post-intervention at 3-months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tamara J Somers, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke university health system
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27707
Country
United States

12. IPD Sharing Statement

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In Person and Mobile Health Coping Skills Training for Improving Symptom Management and Daily Steps in Hematopoietic Stem Cell Transplant Patients

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