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Completed

NCT Number: NCT02955043

Biobehavioral Intervention to Enhance Hematopoietic Stem Cell Transplant Recovery

The goal of this project is to conduct a pilot randomized clinical trial (RCT) to evaluate the feasibility of a brief, behavioral intervention to improve recovery following hematopoietic stem cell transplantation (HSCT). Cancer patients who were treated with HSCT will learn behavioral techniques to improve sleep and increase daytime activity with the goal of alleviating insomnia, fatigue, and depression. If the intervention demonstrates evidence of feasibility and acceptability, a future study will test the effects in a larger trial, with the long-term goal of improving the care and quality of life of cancer survivors recovering from HSCT.

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Key information

Conditions

Hodgkin Lymphoma Behavior Behavioral Symptoms Blood Protein Disorders Bone Marrow Diseases Cardiovascular Diseases Depression Dyssomnias Fatigue Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Leukemia, Myeloid Lymphatic Diseases Lymphoid Leukemia Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Mental Disorders Multiple Myeloma Myelodysplastic Syndromes Myeloid Leukemia Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Nervous System Diseases Non-Hodgkin Lymphoma Paraproteinemias Pathological Conditions, Signs and Symptoms Plasma Cell Myeloma Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Vascular Diseases

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 53792, United States

About this study

Hematologic cancer patients undergoing hematopoietic stem cell transplantation (HSCT) frequently experience physical and psychological sequelae that impair their quality of life and undermine recovery. Findings from the investigators' laboratory and others indicate that insomnia, fatigue, and depression are among the most persistent, distressing, and debilitating quality-of-life concerns after HSCT. These symptoms co-occur as a "cluster" among cancer patients. Modifying sleep and circadian rest-activity patterns has been suggested to be a particularly promising intervention strategy for alleviating this symptom cluster. The proposed project will therefore evaluate the feasibility and acceptability of a biobehavioral intervention to alleviate insomnia, fatigue, and depression by optimizing sleep and rest-activity patterns during the first 4 months following HSCT. Evidence-based behavioral strategies to enhance the quality of nighttime sleep and increase engagement in non-sedentary daytime activity will be combined to optimize 24-hour rest-activity patterns. These non-pharmacologic approaches can be taught in a few brief sessions and will be delivered in an individual format tailored to each patient.

The investigators have already refined the intervention based on preliminary feasibility testing in a small sample of HSCT recipients and are now conducting a pilot RCT to compare the refined intervention with usual care among adults recovering from HSCT. Semi-structured interviews will determine participant satisfaction with and acceptability of the intervention. Proposed outcome assessments will also be piloted, including patient-reported fatigue, depression, and insomnia measures and actigraphy assessments. The primary goal is to evaluate the feasibility and acceptability of the intervention. The exploratory goal is to conduct a preliminary test of the efficacy of the intervention to determine estimates of variance and effect sizes for determination of power and sample size for a larger trial.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults undergoing hematopoietic stem cell transplantation (HSCT) at the University of Wisconsin Carbone Cancer Center (UWCCC)
  • Autologous transplant recipients with multiple myeloma or lymphoma (both Hodgkin's and Non-Hodgkin's types)
  • Allogeneic transplant recipients hospitalized for at least 10 days will also be eligible to participate
  • Participants who develop treatment complications or disease recurrence after being enrolled in the study may continue to participate if they are able to do so

Exclusion criteria

  • Autologous transplant recipients with diagnoses other than multiple myeloma or lymphoma
  • Allogeneic transplant recipients hospitalized for less than 10 days (a small proportion of allogeneic transplant recipients at UWCCC) will be excluded.

Treatment and study plan

Behavioral techniques

Behavioral

Improve nighttime sleep: Participants will receive a modified form of cognitive-behavioral therapy for insomnia with a primary focus on stimulus control, a set of techniques to strengthen the association between bed and sleep and weaken its association with stimulating behaviors.

Increase daytime activity: Participants will receive instruction in activity management strategies including prioritizing activities, planning activities during peak energy, activity pacing, and alternating between rest and activity. Participants will be provided with a basic step-count pedometer to enhance ability to self-monitor activity and increase motivation for activity.

The intervention will be adapted to individual needs based on assessments of sleep and activity patterns.

Primary outcomes

  1. Ability to recruit patients

    Time frame: At the time eligible patients are approached to explain study, up to 40 minutes

    Ability to recruit patients will be evaluated by tracking percent of eligible patients who provide informed consent to the study.

  2. Ability to recruit patients

    Time frame: At the time eligible patients are approached to explain study, up to 20 minutes

    Ability to recruit patients will be evaluated by examining reasons for non-participation.

  3. Ability to retain participants

    Time frame: 18 weeks post-transplant

    Ability to retain participants will be will be evaluated by tracking retention rates through the 18-week study period.

  4. Ability to collect complete data from participants

    Time frame: 18 weeks post-transplant

    Ability to collect complete data from participants will be evaluated by examining rates of completion of study assessments.

  5. Participant willingness to be randomized and acceptability of the usual care condition

    Time frame: 4 weeks post-transplant

    Participant willingness to be randomized will be evaluated by examining attrition between enrollment and the first intervention session.

  6. Participant willingness to be randomized and acceptability of the usual care condition

    Time frame: 18 weeks post-transplant

    Participant willingness to be randomized and acceptability of the usual care condition will be evaluated by examining responses to a semi-structured interview of usual care participants at 18 weeks post-transplant.

  7. Satisfaction with and acceptability of the behavioral techniques

    Time frame: 18 weeks post-transplant

    Satisfaction with and acceptability of the behavioral techniques will be evaluated by examining participants' responses to a semi-structured interview at 18 weeks post-transplant.

  8. Satisfaction with and acceptability of the behavioral techniques

    Time frame: 18 weeks post-transplant

    Satisfaction with and acceptability of the behavioral techniques will be evaluated by examining scores on the Client Satisfaction Questionnaire (CSQ-8) at 18 weeks post-transplant.

  9. Satisfaction with and acceptability of the behavioral techniques

    Time frame: 12 weeks post-transplant

    To examine intervention uptake, participants will complete daily checklist to indicate which intervention strategies they tried between the initial and final intervention sessions.

  10. Acceptability of the assessment strategy

    Time frame: 18 weeks post-transplant

    Acceptability of the assessment strategy will be evaluated by examining participant responses to a semi-structured interview at 18 weeks post-transplant.

  11. Acceptability of the assessment strategy

    Time frame: 18 weeks post-transplant

    Acceptability of the assessment strategy will be evaluated by examining rates of completion of study assessments.

  12. Validity of the assessment strategy

    Time frame: 18 weeks post-transplant

    To address validity, the ability to predict PROMIS measures with the legacy measures the investigators have previously used successfully with this patient population will be assessed. Strong prediction will imply that the PROMIS measures are a statistically valid approach to quantifying the effects of the intervention.

Secondary outcomes

  1. NIH Patient Reported Outcomes Measurement Information System (PROMIS) Sleep disturbance

    Time frame: Pre-transplant, 9 weeks (mid-intervention) and 18 weeks (post-intervention) post-transplant

    A preliminary test of the efficacy of the intervention will be conducted to determine estimates of variance and effect sizes for determination of power and sample size for a larger trial.

  2. NIH Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue

    Time frame: Pre-transplant, 9 weeks (mid-intervention) and 18 weeks (post-intervention) post-transplant

    A preliminary test of the efficacy of the intervention will be conducted to determine estimates of variance and effect sizes for determination of power and sample size for a larger trial.

  3. NIH Patient Reported Outcomes Measurement Information System (PROMIS) Depression

    Time frame: Pre-transplant, 9 weeks (mid-intervention) and 18 weeks (post-intervention) post-transplant

    A preliminary test of the efficacy of the intervention will be conducted to determine estimates of variance and effect sizes for determination of power and sample size for a larger trial.

  4. Actigraphy indices

    Time frame: Pre-transplant, 9 weeks (mid-intervention) and 18 weeks (post-intervention) post-transplant

    The Actiwatch-2 (Philips Respironics), a wrist-worn actigraphy device, will be used to objectively quantify circadian rest-activity patterns over a continuous 7-day period using 1-minute sampling epochs. A traditional cosinor approach will be applied to yield the following indices: mesor (mean activity level), amplitude (rhythm height), acrophase (time of day the rhythm peaks), and R-squared (goodness-of-fit or robustness of the rhythm). The indices will also be compared to determine the effects of the intervention on rest-activity patterns.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)

Registry information

Official study title

A Pilot Trial of a Biobehavioral Intervention to Enhance Hematopoietic Stem Cell Transplant Recovery

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Nov 4, 2016
Registry last updated
Nov 15, 2019

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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