Biobehavioral Intervention to Enhance Hematopoietic Stem Cell Transplant Recovery

NCT02955043 | Completed DMC

• 8 other identifiers: UW16057P30CA014520NCI-2016-015082016-0914K07CA1369664UL1TR000427-10A538900SMPH/PSYCHIATRY/PSYCHIATRY
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (12)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (4)

• NIH Patient Reported Outcomes Measurement Information System (PROMIS) Sleep disturbance

  Pre-transplant, 9 weeks (mid-intervention) and 18 weeks (post-intervention) post-transplant

• NIH Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue

  Pre-transplant, 9 weeks (mid-intervention) and 18 weeks (post-intervention) post-transplant

• NIH Patient Reported Outcomes Measurement Information System (PROMIS) Depression

  Pre-transplant, 9 weeks (mid-intervention) and 18 weeks (post-intervention) post-transplant

• Actigraphy indices

  Pre-transplant, 9 weeks (mid-intervention) and 18 weeks (post-intervention) post-transplant

Study Arms (2)

Behavioral intervention

EXPERIMENTAL

Participants will learn behavioral techniques to improve sleep and increase daytime activity with the goal of alleviating insomnia, fatigue, and depression. The intervention will be delivered in three 45-60 minute face-to-face sessions at approximately 3-4, 8, and 12 weeks post-HSCT with brief telephone coaching calls scheduled between sessions. Participants will be encouraged to use the behavioral strategies from hospital discharge through 18 weeks post-HSCT. Participants will be asked to complete a daily checklist indicating which intervention strategies they used. Participants will also receive standard medical care following HSCT.

Behavioral: Behavioral techniques

Usual care

NO INTERVENTION

Participants will receive standard medical care following HSCT.

Interventions

Behavioral techniques BEHAVIORAL

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.

Behavioral 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 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Cancer Institute (NCI): collaborator
• National Institutes of Health (NIH): 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; Lymphoma, Non-Hodgkin; Multiple Myeloma; Leukemia, Lymphoid; Leukemia, Myeloid; 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; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders; Leukemia; 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, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 31, 2016
• First Posted: November 4, 2016
• Study Start: December 22, 2016
• Primary Completion: October 26, 2018
• Study Completion: October 26, 2018
• Last Updated: November 15, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)