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

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ClinicalTrials.gov Identifier: NCT03859765
Recruitment Status : Recruiting
First Posted : March 1, 2019
Last Update Posted : January 25, 2021
Sponsor:
Information provided by (Responsible Party):
Duke University

Brief 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.


Condition or disease Intervention/treatment Phase
Stem Cell Transplant Behavioral: HCT Symptoms and Steps Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 10, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care

Arm Intervention/treatment
Experimental: HCT Symptoms and Steps
HCT Symptoms and Steps participants will complete in-person (3) and video-conferencing (4) coping skills training and activity coaching sessions teaching cognitive behavioral coping skills to manage pain, fatigue, and distress and increase activity. Participants will be given a wireless activity tracker and a smartphone for accessing the study mobile app.
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.

No Intervention: HCT Education
HCT Education participants will receive 1 brief in clinic session prior to discharge home providing education related to symptom management and physical activity, and a wireless activity tracker. HCT Education participants will also receive 6 brief phone calls upon return home.



Primary Outcome Measures :
  1. Feasibility as measured by study accrual by meeting recruitment goal [ Time Frame: approximately 20-24 weeks ]
    Feasibility will be shown by meeting targeted study accrual (N=50) in the 12-month study period.

  2. Feasibility as measured by adherence to the study protocol by number of intervention sessions and assessments completed by the participant [ Time Frame: approximately 20-24 weeks ]
    Feasibility will be shown by adherence to at least 80% of the study protocol.

  3. Feasibility as measured by study attrition which will be assessed by patients who do not complete the 3-month post-treatment follow-up assessment. [ Time Frame: approximately 20-24 weeks ]
    Feasibility will be shown by no more than 20% study attrition.

  4. Acceptability as measured by the Client Satisfaction Questionnaire (CSQ) 10-item version [ Time Frame: post-treatment (approximately 7-12 weeks) ]
    Acceptability will be indicated by at least 80% of the participants reporting satisfaction with the HCT Symptoms and Steps protocol (mean score of 7) on the CSQ.


Secondary Outcome Measures :
  1. Change in Physical Disability [ Time Frame: pre-treatment (baseline), post-treatment (approximately 7-12 weeks), 3-months post-treatment (approximately 20-24 weeks) ]
    Physical Disability will be assessed using the Functional Assessment of Cancer Therapy 7-item physical well-being scale.

  2. Change in Physical Disability [ Time Frame: pre-treatment (baseline), post-treatment (approximately 7-12 weeks), 3-months post-treatment (approximately 20-24 weeks) ]
    Physical Disability will be assessed using the 6-Minute Walk Test, a laboratory-based assessment of patients' functional capacity.

  3. Change in Pain Severity [ Time Frame: pre-treatment (baseline), post-treatment (approximately 7-12 weeks), 3-months post-treatment (approximately 20-24 weeks) ]
    Pain Severity will be assessed using the Brief Pain Inventory (BPI).

  4. Change in Fatigue [ Time Frame: pre-treatment (baseline), post-treatment (approximately 7-12 weeks), 3-months post-treatment (approximately 20-24 weeks) ]
    Fatigue will be assessed using the Patient Reported Outcomes Measurement Information System (PROMIS) four-item Fatigue Scale.

  5. Change in Psychological Distress [ Time Frame: pre-treatment (baseline), post-treatment (approximately 7-12 weeks), 3-months post-treatment (approximately 20-24 weeks) ]
    Psychological Distress will be assessed using the Brief Symptom Inventory (BSI).

  6. Change in Physical Activity [ Time Frame: pre-treatment (baseline), post-treatment (approximately 7-12 weeks), 3-months post-treatment (approximately 20-24 weeks) ]
    Physical Activity will be assessed via step count with a wireless activity tracker (e.g., Fitbit).

  7. Change in Self-Efficacy for Symptom Management [ Time Frame: pre-treatment (baseline), post-treatment (approximately 7-12 weeks), 3-months post-treatment (approximately 20-24 weeks) ]
    Self-Efficacy for Symptom Management will be assessed using the Patient Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy for Managing Symptoms Short Form.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03859765


Contacts
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Contact: Sarah A. Kelleher, PhD 919-416-3405 sarah.kelleher@duke.edu

Locations
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United States, North Carolina
Duke Cancer Institute Recruiting
Durham, North Carolina, United States, 27701
Contact: Sarah Kelleher, PhD         
Sponsors and Collaborators
Duke University
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03859765    
Other Study ID Numbers: Pro00100321
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: January 25, 2021
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Duke University:
physical disability
pain
fatigue
distress
physical activity
coping
mHealth
cancer
symptom management