Biobehavioral Intervention to Enhance Hematopoietic Stem Cell Transplant Recovery

Multiple Myeloma Clinical Trial

Official title:

A Pilot Trial of a Biobehavioral Intervention to Enhance Hematopoietic Stem Cell Transplant Recovery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02955043
• Other study ID #: UW16057
• Secondary ID: P30CA014520NCI-2
• Status: Completed
• Phase: N/A
• Start date: December 22, 2016
• Est. completion date: October 26, 2018

Study information

• Verified date: September 2019
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: October 26, 2018
• Est. primary completion date: October 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of Wisconsin Carbone Cancer Center	Madison	Wisconsin

Sponsors (3)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ability to recruit patients	Ability to recruit patients will be evaluated by tracking percent of eligible patients who provide informed consent to the study.	At the time eligible patients are approached to explain study, up to 40 minutes
Primary	Ability to recruit patients	Ability to recruit patients will be evaluated by examining reasons for non-participation.	At the time eligible patients are approached to explain study, up to 20 minutes
Primary	Ability to retain participants	Ability to retain participants will be will be evaluated by tracking retention rates through the 18-week study period.	18 weeks post-transplant
Primary	Ability to collect complete data from participants	Ability to collect complete data from participants will be evaluated by examining rates of completion of study assessments.	18 weeks post-transplant
Primary	Participant willingness to be randomized and acceptability of the usual care condition	Participant willingness to be randomized will be evaluated by examining attrition between enrollment and the first intervention session.	4 weeks post-transplant
Primary	Participant willingness to be randomized and acceptability of the usual care condition	Participant willingness to be randomized and acceptability of the usual care condition will be evaluated by examining responses to a semi-structured interview of usual care participants at 18 weeks post-transplant.	18 weeks post-transplant
Primary	Satisfaction with and acceptability of the behavioral techniques	Satisfaction with and acceptability of the behavioral techniques will be evaluated by examining participants' responses to a semi-structured interview at 18 weeks post-transplant.	18 weeks post-transplant
Primary	Satisfaction with and acceptability of the behavioral techniques	Satisfaction with and acceptability of the behavioral techniques will be evaluated by examining scores on the Client Satisfaction Questionnaire (CSQ-8) at 18 weeks post-transplant.	18 weeks post-transplant
Primary	Satisfaction with and acceptability of the behavioral techniques	To examine intervention uptake, participants will complete daily checklist to indicate which intervention strategies they tried between the initial and final intervention sessions.	12 weeks post-transplant
Primary	Acceptability of the assessment strategy	Acceptability of the assessment strategy will be evaluated by examining participant responses to a semi-structured interview at 18 weeks post-transplant.	18 weeks post-transplant
Primary	Acceptability of the assessment strategy	Acceptability of the assessment strategy will be evaluated by examining rates of completion of study assessments.	18 weeks post-transplant
Primary	Validity of the assessment strategy	To address validity, the ability to predict PROMIS measures with the legacy measures the investigators have previously used successfully with this patient population will be assessed. Strong prediction will imply that the PROMIS measures are a statistically valid approach to quantifying the effects of the intervention.	18 weeks post-transplant
Secondary	NIH Patient Reported Outcomes Measurement Information System (PROMIS) Sleep disturbance	A preliminary test of the efficacy of the intervention will be conducted to determine estimates of variance and effect sizes for determination of power and sample size for a larger trial.	Pre-transplant, 9 weeks (mid-intervention) and 18 weeks (post-intervention) post-transplant
Secondary	NIH Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue	A preliminary test of the efficacy of the intervention will be conducted to determine estimates of variance and effect sizes for determination of power and sample size for a larger trial.	Pre-transplant, 9 weeks (mid-intervention) and 18 weeks (post-intervention) post-transplant
Secondary	NIH Patient Reported Outcomes Measurement Information System (PROMIS) Depression	A preliminary test of the efficacy of the intervention will be conducted to determine estimates of variance and effect sizes for determination of power and sample size for a larger trial.	Pre-transplant, 9 weeks (mid-intervention) and 18 weeks (post-intervention) post-transplant
Secondary	Actigraphy indices	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. A traditional cosinor approach will be applied to yield the following indices: mesor (mean activity level), amplitude (rhythm height), acrophase (time of day the rhythm peaks), and R-squared (goodness-of-fit or robustness of the rhythm). The indices will also be compared to determine the effects of the intervention on rest-activity patterns.	Pre-transplant, 9 weeks (mid-intervention) and 18 weeks (post-intervention) post-transplant

External Links

•   UW Carbone Cancer Center Home Page