Refining a Biobehavioral Intervention to Enhance Recovery Following Hematopoietic Stem Cell Transplantation

Not Applicable

Completed

• Conditions: Non-hodgkin's Lymphoma; Hodgkin's Lymphoma; Multiple Myeloma; Leukemia; Lymphoid Leukemia; Myeloid Leukemia; Myelodysplastic Syndrome
• Interventions: Behavioral: Behavioral techniques

• Registration Number: NCT02719821
• Lead Sponsor: University of Wisconsin, Madison

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

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-03-16
• Study First Submitted QC: 2016-03-24
• Study First Posted: 2016-03-25
• Primary Completion: 2017-06-02
• Study Completion: 2017-06-02
• Status Verified: 2019-02
• Last Update Submitted: 2019-11-14
• Last Update Posted: 2019-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Behavioral techniques	Individuals treated with HSCT will learn behavioral techniques to improve sleep and increase daytime activity with the goal of alleviating insomnia, fatigue, and depression. Study investigators will conduct semi-structured interviews after each session to determine participant satisfaction with and acceptability of the behavioral strategies, timing, delivery mode, assessment strategy, and time commitment. Participants will be asked to complete a daily checklist indicating which intervention strategies they used daily. Participants will be asked to complete self-report assessments, to wear a wrist-worn actigraphy device, and to complete a sleep log at three time points: prior to HSCT and approximately 9 and 18 weeks post-HSCT.

Primary Outcome Measures

Name	Time	Method
Intervention fidelity	18 weeks	A selection of audio recorded intervention sessions will be evaluated using a fidelity checklist.
Validity of the assessment strategy	18 weeks	To address validity, the investigators will assess the ability of PROMIS measures to predict legacy measures the investigators have previously used successfully with this patient population (ISI, FSI, IDAS).
Acceptability of the assessment strategy	18 weeks	Acceptability will be assessed by examining the aforementioned semi-structured interview data and rates of completion of self-report measures and actigraphy.; We will examine rates of completion of the following self-report measures: NIH Patient Reported Outcomes Measurement Information System (PROMIS) sleep disturbance, fatigue, and depression modules; Insomnia Severity Index (ISI); Fatigue Symptom Inventory (FSI); Inventory of Depression and Anxiety Symptoms (IDAS) depression subscale; We will examine rates of completion of sufficient actigraphy data for calculating the following indices: Mesor (mean activity level); Amplitude (rhythm height); Acrophase (time of day the rhythm peaks); R-squared (robustness of the rhythm); total sleep time (TST); sleep onset latency (SOL); wake time after sleep onset (WASO); sleep efficiency (SE)
Ability to recruit, retain, and collect complete data from all participants	18 weeks	Recruitment rate, reasons for non-participation, and attrition will be tracked at Retention rates and those contributing complete data will be tracked at milestones throughout the study period.
Intervention uptake and adherence	18 weeks	Participants will be asked to complete a daily checklist to indicate which intervention strategies they attempted each day.
Participant satisfaction and acceptability	18 weeks	Study investigators will conduct semi-structured interviews approximately one week after each session to determine participant satisfaction with and acceptability of the behavioral strategies, timing, delivery mode, assessment strategy, and time commitment; the interviews will be audio recorded. Participants will be asked about barriers to participation and problems encountered as well as areas of satisfaction with each of the aforementioned elements. Recordings will be reviewed to generate a list of barriers and facilitators of participation.

Trial Locations

Locations (1)

University of Wisconsin Carbone Cancer Center; 🇺🇸 Madison, Wisconsin, United States