Hodgkin's LymphomaNCT02719821
Refining a Biobehavioral Intervention to Enhance Recovery Following Hematopoietic Stem Cell Transplantation
A study testing Behavioral techniques in people with Hodgkin's Lymphoma and Leukemia, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Hodgkin's Lymphoma, Leukemia, Lymphoid Leukemia
- What is being tested?
- Behavioral techniques
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to 2 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792
About this study
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.
Read the 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
- Conditions
- Hodgkin's Lymphoma, Leukemia, Lymphoid Leukemia, Multiple Myeloma, Myeloid Leukemia, Non-hodgkin's Lymphoma
- Being tested
- Behavioral techniques
- Keywords
- Hematopoietic Stem Cell Transplantation, Fatigue, Insomnia, Depression, Behavioral Intervention
- Medical subject headings
- Hodgkin Disease, Leukemia, Leukemia, Lymphoid, Multiple Myeloma, Leukemia, Myeloid, Lymphoma, Non-Hodgkin, Myelodysplastic Syndromes, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral techniquesBehavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Behavioral techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 weeks
Intervention uptake and adherence
Participants will be asked to complete a daily checklist to indicate which intervention strategies they attempted each day.
Measured: 18 weeks
Intervention fidelity
A selection of audio recorded intervention sessions will be evaluated using a fidelity checklist.
Measured: 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.
Measured: 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)
Measured: 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).
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2016 (estimated)
- Study startMar 2016
- Primary completion2 Jun 2017
- Study completion2 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin's LymphomaStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Erin Costanzo, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02719821
- Sponsor's protocol ID
- UW15080
- Other IDs
- P30CA014520, NCI-2016-00238, 2015-1261, 4UL1TR000427-10, A538900, SMPH\PSYCHIATRY\PSYCHIATRY
- Status last verified
- Feb 2019
- First submitted
- 16 Mar 2016
- Last updated
- 15 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Refining a Biobehavioral Intervention to Enhance Recovery Following Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT02719821
- Acronym / sponsor ID
- UW15080
- Conditions
- Hodgkin's Lymphoma, Leukemia, Lymphoid Leukemia, Multiple Myeloma, Myeloid Leukemia, Non-hodgkin's Lymphoma
- Keywords
- Hematopoietic Stem Cell Transplantation, Fatigue, Insomnia, Depression, Behavioral Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2016
- Primary completion
- 2 Jun 2017 (actual)
- Study completion
- 2 Jun 2017 (actual)
- First posted
- 25 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Behavioral techniquesIndividuals 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. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral techniquesLearning behavioral techniques designed to improve nighttime sleep quality and daytime activity for approximately 45-60 minutes on three occasions. Device: Actiwatch-2 (Philips Respironics) | Behavioural | Intervention |
Primary outcome
Ability to recruit, retain, and collect complete data from all participants
Time frame: 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
Time frame: 18 weeks
Participants will be asked to complete a daily checklist to indicate which intervention strategies they attempted each day.
Intervention fidelity
Time frame: 18 weeks
A selection of audio recorded intervention sessions will be evaluated using a fidelity checklist.
Participant satisfaction and acceptability
Time frame: 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.
Acceptability of the assessment strategy
Time frame: 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)
Validity of the assessment strategy
Time frame: 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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2019.
- UW Carbone Cancer Center Home PageLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Hodgkin's Lymphoma
RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Not yet recruitingPhase 2
Obesity Treatment With Phentermine-Topiramate ER in AYA Surviving Leukemia and Lymphoma
Acute Lymphoblastic Leukemia in Remission, Hodgkin Lymphoma in Remission
Active, not recruitingPhase 2
A Study of Anakinra to Prevent or Treat Severe Side Effects for Patients Receiving CAR-T Cell Therapy
B Cell ALL, B-Cell Lymphoma
Active, not recruitingPhase 1
A Rollover Study of CC-122
Non-Hodgkin Lymphoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erin Costanzo principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral techniques in people with Hodgkin's Lymphoma and Leukemia, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability to recruit, retain, and collect complete data from all participants (time frame: 18 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2019.