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

NCT02719821 | Completed DMC

• 7 other identifiers: UW15080P30CA014520NCI-2016-002382015-12614UL1TR000427-10A538900SMPH\PSYCHIATRY\PSYCHIATRY
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (6)

• Ability to recruit, retain, and collect complete data from all participants

  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.

  18 weeks

• Intervention uptake and adherence

  Participants will be asked to complete a daily checklist to indicate which intervention strategies they attempted each day.

  18 weeks

• Intervention fidelity

  A selection of audio recorded intervention sessions will be evaluated using a fidelity checklist.

  18 weeks

• Participant satisfaction and acceptability

  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.

  18 weeks

• Acceptability of the assessment strategy

  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)

  18 weeks

• Validity of the assessment strategy

  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).

  18 weeks

Study Arms (1)

Intervention

EXPERIMENTAL

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.

Behavioral: Behavioral techniques

Interventions

Behavioral techniques BEHAVIORAL

Learning behavioral techniques designed to improve nighttime sleep quality and daytime activity for approximately 45-60 minutes on three occasions. Device: Actiwatch-2 (Philips Respironics)

Intervention

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 53792, United States

Location

Related Links

• UW Carbone Cancer Center Home Page

MeSH Terms

Conditions

Hodgkin Disease; Leukemia; Leukemia, Lymphoid; Multiple Myeloma; Leukemia, Myeloid; Lymphoma, Non-Hodgkin; Myelodysplastic Syndromes; Fatigue; Sleep Initiation and Maintenance Disorders; Depression

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Hematologic Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Bone Marrow Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Erin Costanzo

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2016
• First Posted: March 25, 2016
• Study Start: March 1, 2016
• Primary Completion: June 2, 2017
• Study Completion: June 2, 2017
• Last Updated: November 15, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)