Clinical trial NCT02955043: Biobehavioral Intervention to Enhance Hematopoietic Stem Cell Transplant Recovery
Official title: A Pilot Trial of a Biobehavioral Intervention to Enhance Hematopoietic Stem Cell Transplant Recovery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hodgkin Lymphoma
Non-Hodgkin Lymphoma
Plasma Cell Myeloma
Lymphoid Leukemia
Myeloid Leukemia
Myelodysplastic Syndromes
Multiple Myeloma
Keywords: Hematopoietic Stem Cell Transplantation (HSCT)
Fatigue
Insomnia
Depression
Behavioral Intervention
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: National Institutes of Health (NIH)
First posted: 2016-11-04
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Ability to recruit patients
timeFrame: At the time eligible patients are approached to explain study, up to 40 minutes
measure: Ability to recruit patients
timeFrame: At the time eligible patients are approached to explain study, up to 20 minutes
measure: Ability to retain participants
timeFrame: 18 weeks post-transplant
measure: Ability to collect complete data from participants
timeFrame: 18 weeks post-transplant
measure: Participant willingness to be randomized and acceptability of the usual care condition
timeFrame: 4 weeks post-transplant
measure: Participant willingness to be randomized and acceptability of the usual care condition
timeFrame: 18 weeks post-transplant
measure: Satisfaction with and acceptability of the behavioral techniques
timeFrame: 18 weeks post-transplant
measure: Satisfaction with and acceptability of the behavioral techniques
timeFrame: 18 weeks post-transplant
measure: Satisfaction with and acceptability of the behavioral techniques
timeFrame: 12 weeks post-transplant
measure: Acceptability of the assessment strategy
timeFrame: 18 weeks post-transplant
measure: Acceptability of the assessment strategy
timeFrame: 18 weeks post-transplant
measure: Validity of the assessment strategy
timeFrame: 18 weeks post-transplant
Secondary outcomes:
measure: NIH Patient Reported Outcomes Measurement Information System (PROMIS) Sleep disturbance
timeFrame: Pre-transplant, 9 weeks (mid-intervention) and 18 weeks (post-intervention) post-transplant
measure: NIH Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue
timeFrame: Pre-transplant, 9 weeks (mid-intervention) and 18 weeks (post-intervention) post-transplant
measure: NIH Patient Reported Outcomes Measurement Information System (PROMIS) Depression
timeFrame: Pre-transplant, 9 weeks (mid-intervention) and 18 weeks (post-intervention) post-transplant
measure: Actigraphy indices
timeFrame: Pre-transplant, 9 weeks (mid-intervention) and 18 weeks (post-intervention) post-transplant
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, MD
role: PRINCIPAL_INVESTIGATOR
References: