Biobehavioral Intervention to Enhance Hematopoietic Stem Cell Transplant Recovery
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Blood Cancer, Blood Cancer, Blood Cancer, Lymphoma, Lymphoma, Hematology, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 18 - 74 |
| Updated: | 10/5/2018 |
| Start Date: | October 2016 |
| End Date: | July 2022 |
A Pilot Trial of a 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.
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.
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.
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.
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.
We found this trial at
1
site
600 Highland Ave.
Madison, Wisconsin 53792
Madison, Wisconsin 53792
(608) 263-6400
Principal Investigator: Erin Costanzo, PhD
Phone: 800-622-8922
University of Wisconsin Carbone Cancer Center UW Carbone Cancer Center holds the unique distinction of...
Click here to add this to my saved trials
