Clinical trial NCT02719821: Refining a Biobehavioral Intervention to Enhance Recovery Following Hematopoietic Stem Cell Transplantation
Official title: Refining a Biobehavioral Intervention to Enhance Recovery Following Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hodgkin's Lymphoma
Leukemia
Lymphoid Leukemia
Multiple Myeloma
Myeloid Leukemia
Non-hodgkin's Lymphoma
Myelodysplastic Syndrome
Keywords: Hematopoietic Stem Cell Transplantation
Fatigue
Insomnia
Depression
Behavioral Intervention
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-03-25
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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

Eligibility criteria: 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

Primary outcomes:
measure: Ability to recruit, retain, and collect complete data from all participants
timeFrame: 18 weeks
measure: Intervention uptake and adherence
timeFrame: 18 weeks
measure: Intervention fidelity
timeFrame: 18 weeks
measure: Participant satisfaction and acceptability
timeFrame: 18 weeks
measure: Acceptability of the assessment strategy
timeFrame: 18 weeks
measure: Validity of the assessment strategy
timeFrame: 18 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Carbone Cancer Center
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Erin Costanzo
role: PRINCIPAL_INVESTIGATOR
References: