Refining a Biobehavioral Intervention to Enhance Recovery Following Hematopoietic Stem Cell Transplantation
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Blood Cancer, Blood Cancer, Blood Cancer, Lymphoma, Lymphoma, Hematology, Leukemia |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 18 - 74 |
| Updated: | 2/10/2019 |
| Start Date: | March 2016 |
| End Date: | June 2, 2017 |
The goal of this project is to refine and evaluate the feasibility of a brief, behavioral
intervention to improve the 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 after HSCT. If the intervention is feasible and acceptable to patients, 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.
intervention to improve the 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 after HSCT. If the intervention is feasible and acceptable to patients, 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.
Details of the assessment strategy:
Patient-reported outcomes:
Participants will complete self-report measures prior to HSCT and 9 (mid-intervention) and 18
weeks (post-intervention) post-HSCT. The sleep disturbance, fatigue, and depression modules
of the NIH Patient Reported Outcomes Measurement Information System (PROMIS) will be the
primary outcomes. The investigators will compare performance with more established
instruments the investigation team has previously used: Insomnia Severity Index (ISI),
Fatigue Symptom Inventory (FSI), and the Inventory of Depression and Anxiety Symptoms (IDAS)
depression subscale.
Actigraphy:
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 at three time points: prior to HSCT and 9 (mid-intervention) and 18
weeks (post-intervention) post-HSCT. The following indices will be calculated: mesor (mean
activity level), amplitude (rhythm height), acrophase (time of day the rhythm peaks), and
R-squared (robustness of the rhythm). Participants will complete a concurrent nightly sleep
log, and traditional sleep parameters will be calculated from both the logs and actigraphy,
including total sleep time (TST), sleep onset latency (SOL), wake time after sleep onset
(WASO), and sleep efficiency (SE). For daytime activity, calibration thresholds will be used
to aggregate activity data into steps and minutes spent in sedentary, light, moderate, and
vigorous activity
Patient-reported outcomes:
Participants will complete self-report measures prior to HSCT and 9 (mid-intervention) and 18
weeks (post-intervention) post-HSCT. The sleep disturbance, fatigue, and depression modules
of the NIH Patient Reported Outcomes Measurement Information System (PROMIS) will be the
primary outcomes. The investigators will compare performance with more established
instruments the investigation team has previously used: Insomnia Severity Index (ISI),
Fatigue Symptom Inventory (FSI), and the Inventory of Depression and Anxiety Symptoms (IDAS)
depression subscale.
Actigraphy:
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 at three time points: prior to HSCT and 9 (mid-intervention) and 18
weeks (post-intervention) post-HSCT. The following indices will be calculated: mesor (mean
activity level), amplitude (rhythm height), acrophase (time of day the rhythm peaks), and
R-squared (robustness of the rhythm). Participants will complete a concurrent nightly sleep
log, and traditional sleep parameters will be calculated from both the logs and actigraphy,
including total sleep time (TST), sleep onset latency (SOL), wake time after sleep onset
(WASO), and sleep efficiency (SE). For daytime activity, calibration thresholds will be used
to aggregate activity data into steps and minutes spent in sedentary, light, moderate, and
vigorous activity
Inclusion Criteria:
- Adults 18 years of age or older 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) receiving standard conditioning regimens
- Allogeneic transplant recipients undergoing fully ablative transplants
- 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 receiving non-standard regimens
- Autologous transplant recipients with diagnoses other than multiple myeloma or
lymphoma
- Allogeneic transplant recipients receiving reduced intensity regimens
We found this trial at
1
site
600 Highland Ave.
Madison, Wisconsin 53792
Madison, Wisconsin 53792
(608) 263-6400
Principal Investigator: Erin Costanzo
Phone: 800-622-8922
University of Wisconsin Carbone Cancer Center UW Carbone Cancer Center holds the unique distinction of...
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