Multiple Myeloma Clinical Trial
Official title:
Refining a Biobehavioral Intervention to Enhance Recovery Following Hematopoietic Stem Cell Transplantation
Verified date | February 2019 |
Source | University of Wisconsin, Madison |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 17 |
Est. completion date | June 2, 2017 |
Est. primary completion date | June 2, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 74 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Wisconsin Carbone Cancer Center | Madison | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
University of Wisconsin, Madison | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | Intervention uptake and adherence | Participants will be asked to complete a daily checklist to indicate which intervention strategies they attempted each day. | 18 weeks | |
Primary | Intervention fidelity | A selection of audio recorded intervention sessions will be evaluated using a fidelity checklist. | 18 weeks | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 |
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