Hodgkin LymphomaNCT02955043
Biobehavioral Intervention to Enhance Hematopoietic Stem Cell Transplant Recovery
A study testing Behavioral techniques in people with Hodgkin Lymphoma and Non-Hodgkin Lymphoma, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Plasma Cell Myeloma
- 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
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Dec 2016to 26 Oct 2018
- 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 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792
About this study
Official title: A Pilot Trial of a Biobehavioral Intervention to Enhance Hematopoietic Stem Cell Transplant Recovery
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.
Read the detailed description
Hematologic cancer patients undergoing hematopoietic stem cell transplantation (HSCT) frequently experience physical and psychological sequelae that impair their quality of life and undermine recovery. Findings from the investigators' laboratory and others indicate that insomnia, fatigue, and depression are among the most persistent, distressing, and debilitating quality-of-life concerns after HSCT. These symptoms co-occur as a "cluster" among cancer patients. Modifying sleep and circadian rest-activity patterns has been suggested to be a particularly promising intervention strategy for alleviating this symptom cluster. The proposed project will therefore evaluate the feasibility and acceptability of a biobehavioral intervention to alleviate insomnia, fatigue, and depression by optimizing sleep and rest-activity patterns during the first 4 months following HSCT. Evidence-based behavioral strategies to enhance the quality of nighttime sleep and increase engagement in non-sedentary daytime activity will be combined to optimize 24-hour rest-activity patterns. These non-pharmacologic approaches can be taught in a few brief sessions and will be delivered in an individual format tailored to each patient.
The investigators have already refined the intervention based on preliminary feasibility testing in a small sample of HSCT recipients and are now conducting a pilot RCT to compare the refined intervention with usual care among adults recovering from HSCT. Semi-structured interviews will determine participant satisfaction with and acceptability of the intervention. Proposed outcome assessments will also be piloted, including patient-reported fatigue, depression, and insomnia measures and actigraphy assessments. The primary goal is to evaluate the feasibility and acceptability of the intervention. The exploratory goal is to conduct a preliminary test of the efficacy of the intervention to determine estimates of variance and effect sizes for determination of power and sample size for a larger trial.
- Conditions
- Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Plasma Cell Myeloma, Lymphoid Leukemia, Myeloid Leukemia, Myelodysplastic Syndromes
- Being tested
- Behavioral techniques
- Keywords
- Hematopoietic Stem Cell Transplantation (HSCT), Fatigue, Insomnia, Depression, Behavioral Intervention
- Medical subject headings
- Hodgkin Disease, Lymphoma, Non-Hodgkin, Multiple Myeloma, Leukemia, Lymphoid, Leukemia, Myeloid, Myelodysplastic Syndromes, Fatigue, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral techniquesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Behavioral techniques |
| Usual care | No intervention | Participants will receive standard medical care following HSCT. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to recruit patients
Ability to recruit patients will be evaluated by tracking percent of eligible patients who provide informed consent to the study.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 18 weeks post-transplant
Secondary outcomes (4)
NIH Patient Reported Outcomes Measurement Information System (PROMIS) Sleep disturbance
A preliminary test of the efficacy of the intervention will be conducted to determine estimates of variance and effect sizes for determination of power and sample size for a larger trial.
Measured: Pre-transplant, 9 weeks (mid-intervention) and 18 weeks (post-intervention) post-transplant
NIH Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue
A preliminary test of the efficacy of the intervention will be conducted to determine estimates of variance and effect sizes for determination of power and sample size for a larger trial.
Measured: Pre-transplant, 9 weeks (mid-intervention) and 18 weeks (post-intervention) post-transplant
NIH Patient Reported Outcomes Measurement Information System (PROMIS) Depression
A preliminary test of the efficacy of the intervention will be conducted to determine estimates of variance and effect sizes for determination of power and sample size for a larger trial.
Measured: Pre-transplant, 9 weeks (mid-intervention) and 18 weeks (post-intervention) post-transplant
Actigraphy indices
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. A traditional cosinor approach will be applied to yield the following indices: mesor (mean activity level), amplitude (rhythm height), acrophase (time of day the rhythm peaks), and R-squared (goodness-of-fit or robustness of the rhythm). The indices will also be compared to determine the effects of the intervention on rest-activity patterns.
Measured: Pre-transplant, 9 weeks (mid-intervention) and 18 weeks (post-intervention) post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2016 (estimated)
- Study start22 Dec 2016
- Primary completion26 Oct 2018
- Study completion26 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Erin Costanzo, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02955043
- Sponsor's protocol ID
- UW16057
- Other IDs
- P30CA014520, NCI-2016-01508, 2016-0914, K07CA136966, 4UL1TR000427-10, A538900, SMPH/PSYCHIATRY/PSYCHIATRY
- Status last verified
- Sep 2019
- First submitted
- 31 Oct 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
- A Pilot Trial of a Biobehavioral Intervention to Enhance Hematopoietic Stem Cell Transplant Recovery
- ClinicalTrials.gov ID
- NCT02955043
- Acronym / sponsor ID
- UW16057
- Conditions
- Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Plasma Cell Myeloma, Lymphoid Leukemia, Myeloid Leukemia, Myelodysplastic Syndromes
- Keywords
- Hematopoietic Stem Cell Transplantation (HSCT), Fatigue, Insomnia, Depression, Behavioral Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institutes of Health (NIH)
- Study start
- 22 Dec 2016 (actual)
- Primary completion
- 26 Oct 2018 (actual)
- Study completion
- 26 Oct 2018 (actual)
- First posted
- 4 Nov 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 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.
Detailed description
Hematologic cancer patients undergoing hematopoietic stem cell transplantation (HSCT) frequently experience physical and psychological sequelae that impair their quality of life and undermine recovery. Findings from the investigators' laboratory and others indicate that insomnia, fatigue, and depression are among the most persistent, distressing, and debilitating quality-of-life concerns after HSCT. These symptoms co-occur as a "cluster" among cancer patients. Modifying sleep and circadian rest-activity patterns has been suggested to be a particularly promising intervention strategy for alleviating this symptom cluster. The proposed project will therefore evaluate the feasibility and acceptability of a biobehavioral intervention to alleviate insomnia, fatigue, and depression by optimizing sleep and rest-activity patterns during the first 4 months following HSCT. Evidence-based behavioral strategies to enhance the quality of nighttime sleep and increase engagement in non-sedentary daytime activity will be combined to optimize 24-hour rest-activity patterns. These non-pharmacologic approaches can be taught in a few brief sessions and will be delivered in an individual format tailored to each patient.
The investigators have already refined the intervention based on preliminary feasibility testing in a small sample of HSCT recipients and are now conducting a pilot RCT to compare the refined intervention with usual care among adults recovering from HSCT. Semi-structured interviews will determine participant satisfaction with and acceptability of the intervention. Proposed outcome assessments will also be piloted, including patient-reported fatigue, depression, and insomnia measures and actigraphy assessments. The primary goal is to evaluate the feasibility and acceptability of the intervention. The exploratory goal is to conduct a preliminary test of the efficacy of the intervention to determine estimates of variance and effect sizes for determination of power and sample size for a larger trial.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral intervention | Experimental | Behavioral: Behavioral techniquesParticipants 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. |
| Usual care | No intervention | –Participants will receive standard medical care following 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 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
Key exclusion criteria (2 listed)
- 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.
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 techniquesImprove 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. | Behavioural | Behavioral intervention |
Primary outcome
Ability to recruit patients
Time frame: At the time eligible patients are approached to explain study, up to 40 minutes
Ability to recruit patients will be evaluated by tracking percent of eligible patients who provide informed consent to the study.
Ability to recruit patients
Time frame: At the time eligible patients are approached to explain study, up to 20 minutes
Ability to recruit patients will be evaluated by examining reasons for non-participation.
Ability to retain participants
Time frame: 18 weeks post-transplant
Ability to retain participants will be will be evaluated by tracking retention rates through the 18-week study period.
Ability to collect complete data from participants
Time frame: 18 weeks post-transplant
Ability to collect complete data from participants will be evaluated by examining rates of completion of study assessments.
Participant willingness to be randomized and acceptability of the usual care condition
Time frame: 4 weeks post-transplant
Participant willingness to be randomized will be evaluated by examining attrition between enrollment and the first intervention session.
Participant willingness to be randomized and acceptability of the usual care condition
Time frame: 18 weeks post-transplant
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.
Satisfaction with and acceptability of the behavioral techniques
Time frame: 18 weeks post-transplant
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.
Satisfaction with and acceptability of the behavioral techniques
Time frame: 18 weeks post-transplant
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.
Satisfaction with and acceptability of the behavioral techniques
Time frame: 12 weeks post-transplant
To examine intervention uptake, participants will complete daily checklist to indicate which intervention strategies they tried between the initial and final intervention sessions.
Acceptability of the assessment strategy
Time frame: 18 weeks post-transplant
Acceptability of the assessment strategy will be evaluated by examining participant responses to a semi-structured interview at 18 weeks post-transplant.
Acceptability of the assessment strategy
Time frame: 18 weeks post-transplant
Acceptability of the assessment strategy will be evaluated by examining rates of completion of study assessments.
Validity of the assessment strategy
Time frame: 18 weeks post-transplant
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.
4 secondary outcomes
NIH Patient Reported Outcomes Measurement Information System (PROMIS) Sleep disturbance
Time frame: Pre-transplant, 9 weeks (mid-intervention) and 18 weeks (post-intervention) post-transplant
NIH Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue
Time frame: Pre-transplant, 9 weeks (mid-intervention) and 18 weeks (post-intervention) post-transplant
NIH Patient Reported Outcomes Measurement Information System (PROMIS) Depression
Time frame: Pre-transplant, 9 weeks (mid-intervention) and 18 weeks (post-intervention) post-transplant
Actigraphy indices
Time frame: Pre-transplant, 9 weeks (mid-intervention) and 18 weeks (post-intervention) post-transplant
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
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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, MD 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 Lymphoma and Non-Hodgkin Lymphoma, 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 2 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 patients (time frame: At the time eligible patients are approached to explain study, up to 40 minutes). The study lists 12 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.