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Completed

NCT Number: NCT03859765

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke Cancer Institute

Durham, North Carolina, 27701, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HCT Symptoms and Steps

Behavioral

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.

Primary outcomes

  1. Feasibility as Measured by Number of Participants Accrued to the Study Within 16 Months

    Time frame: 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.

  2. Number of Participants Who Adhere to at Least 80% of the Study Protocol

    Time frame: approximately 20-24 weeks

    A measure of feasibility.

  3. Number of Participants Who do Not Complete the 3-month Post-treatment Follow-up Assessment

    Time frame: approximately 20-24 weeks

    A measure of feasibility.

  4. Acceptability as Measured by the Client Satisfaction Questionnaire (CSQ) 8-item Version

    Time frame: 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).

Secondary outcomes

  1. Change in Physical Disability as Measured by the the Functional Assessment of Cancer Therapy (FACT)

    Time frame: 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.

  2. Change in Pain Severity

    Time frame: 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.

  3. Change in Fatigue

    Time frame: 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.

  4. Change in Physical Activity

    Time frame: 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.

  5. Change in Depression

    Time frame: 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.

  6. Change in Anxiety.

    Time frame: 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.

  7. Change in Self-Efficacy

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study 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

Acronym: Symptoms-Steps

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 1, 2019
Registry last updated
Mar 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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