Biobehavioral Intervention to Enhance Hematopoietic Stem Cell Transplant Recovery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-22

Study Completion Date

2018-10-26

Brief Summary

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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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Detailed Description

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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.

Conditions

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Hodgkin Lymphoma Non-Hodgkin Lymphoma Plasma Cell Myeloma Lymphoid Leukemia Myeloid Leukemia Myelodysplastic Syndromes Multiple Myeloma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Behavioral intervention

Participants will learn behavioral techniques to improve sleep and increase daytime activity with the goal of alleviating insomnia, fatigue, and depression. The intervention will be delivered in three 45-60 minute face-to-face sessions at approximately 3-4, 8, and 12 weeks post-HSCT with brief telephone coaching calls scheduled between sessions. Participants will be encouraged to use the behavioral strategies from hospital discharge through 18 weeks post-HSCT. Participants will be asked to complete a daily checklist indicating which intervention strategies they used. Participants will also receive standard medical care following HSCT.

Group Type EXPERIMENTAL

Behavioral techniques

Intervention Type 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.

Usual care

Participants will receive standard medical care following HSCT.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Behavioral techniques

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No