Hematopoietic Neoplasms (Leukemia, Lymphoma, Multiple Myeloma)CST Step UpNCT03960619
In Person and Mobile Health Coping Skills Training for Improving Symptom Management and Daily Steps in Hematopoietic Stem Cell Transplant Patients
A study testing coping skills training in people with Hematopoietic Neoplasms (Leukemia, Lymphoma, Multiple Myeloma), run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hematopoietic Neoplasms (Leukemia, Lymphoma, Multiple Myeloma)
- What is being tested?
- coping skills training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2019to 22 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke university health system
Durham, North Carolina, 27707
About this study
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.
Read the 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.
- Being tested
- coping skills training
- Medical subject headings
- Hematologic Neoplasms, Leukemia, Lymphoma, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coping skills trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| in-person & mHealth coping skills training | Experimental | 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. Receives: Behavioral: coping skills training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accrual as measured by number of participants recruited
Accrual will be indicated by meeting the recruitment goal
Measured: 15 months
Adherence as measured by completing all intervention sessions
Adherence will be indicated by the proportion successfully completing intervention sessions
Measured: 15 months
Attrition as measured by 80% participants completing the study.
Attrition will be indicated by 80% of consented participants completing the study protocol.
Measured: 15 months
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.
Measured: 15 months
Secondary outcomes (6)
Change in Physical Disability
Functional Assessment of Cancer Therapy 7-item physical well-being scale will be used to assess physical disability.
Measured: assessments at baseline (pre - treatment) and post-intervention at 3-months..
Change in Fatigue
Fatigue will be measured with the PROMIS Adult Fatigue Short Form.
Measured: assessments at baseline (pre-treatment) and post-intervention at 3-months.
Change in Psychological Distress
Psychological Distress will be measured with the Brief Symptom Inventory
Measured: assessments at baseline (pre-treatment) and post-intervention at 3-months.
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
Measured: assessments at baseline (pre-treatment) and post-intervention at 3-months.
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.
Measured: post-intervention at 3-months.
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.
Measured: post-intervention at 3-months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2019
- Study start16 Jul 2019
- Primary completion22 Nov 2019
- Study completion22 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic Neoplasms (Leukemia, Lymphoma, Multiple Myeloma)Studies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tamara J Somers, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03960619
- Sponsor's protocol ID
- Pro00100451
- Acronym
- CST Step Up
- Status last verified
- Jun 2023
- First submitted
- 21 May 2019
- Last updated
- 13 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Person and Mobile Health Coping Skills Training for Improving Symptom Management and Daily Steps in Hematopoietic Stem Cell Transplant Patients
- ClinicalTrials.gov ID
- NCT03960619
- Acronym / sponsor ID
- CST Step Up / Pro00100451
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 16 Jul 2019 (actual)
- Primary completion
- 22 Nov 2019 (actual)
- Study completion
- 22 Nov 2019 (actual)
- First posted
- 23 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| in-person & mHealth coping skills training | Experimental | Behavioral: coping skills traininghybrid 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| coping skills trainingWe 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. | Behavioural | in-person & mHealth coping skills training |
Primary outcome
Accrual as measured by number of participants recruited
Time frame: 15 months
Accrual will be indicated by meeting the recruitment goal
Adherence as measured by completing all intervention sessions
Time frame: 15 months
Adherence will be indicated by the proportion successfully completing intervention sessions
Attrition as measured by 80% participants completing the study.
Time frame: 15 months
Attrition will be indicated by 80% of consented participants completing the study protocol.
Acceptability as measured by 80% participants reporting satisfaction with CST program
Time frame: 15 months
Acceptability will be indicated by 80% of patients reporting satisfaction with CST Step-Up on the CSQ.
6 secondary outcomes
Change in Physical Disability
Time frame: assessments at baseline (pre - treatment) and post-intervention at 3-months..
Change in Fatigue
Time frame: assessments at baseline (pre-treatment) and post-intervention at 3-months.
Change in Psychological Distress
Time frame: assessments at baseline (pre-treatment) and post-intervention at 3-months.
Change in Self-Efficacy for Symptom Management: PROMIS Self-Efficacy for Managing Symptoms Short Form
Time frame: assessments at baseline (pre-treatment) and post-intervention at 3-months.
Symptom Monitoring
Time frame: post-intervention at 3-months.
Physical Activity
Time frame: post-intervention at 3-months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tamara J Somers, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing coping skills training in people with Hematopoietic Neoplasms (Leukemia, Lymphoma, Multiple Myeloma), run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accrual as measured by number of participants recruited (time frame: 15 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2023.