Mindfulness and Cognitive Behavioral Therapy for Sleep in Cancer
Phase: NA
Conditions: Hematologic Malignancy
Sponsor: Duke University

 
 
 
 
 
 
 
 
 
 
 
Mindfulness and Cognitive Behavioral Therapy for Sleep in Cancer 
 
NCT04736056 
 
Document Date: May 10, 2023 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Purpose of the Study 
  
In this study, we will develop and pilot test the MBTI+ protocol for one-on-one, home-based delivery to 
hematologic cancer patients (i.e., acute myeloid leukemia, acute lymphoblastic leukemia, Non-Hodgkin’s 
lymphoma, multiple myeloma, myelodysplastic syndrome) reporting insomnia, fatigue, pain, and 
distress after any cycle of inpatient chemotherapy treatment.  
 
Study Phase I (months 0-6) will use patient (3 patient focus groups, approx. 4 patients in each focus 
group) and provider (1 provider focus groups, approx. 6 providers in focus groups) focus groups to adapt 
MBTI+ for individual treatment and improved symptom management. Intervention timing, scaling, and 
content will be further refined through iterative patient testing (months 6-12; N=5). The specific aims 
and hypotheses are: 
 
Aim 1: To develop and refine the MBTI+ protocol for individual, home-based delivery to hematologic 
cancer patients reporting insomnia, fatigue, pain, and distress following discharge from any cycle of 
inpatient chemotherapy treatment. Patient (3 patient focus groups, approx. 4 patients in each focus 
group) and provider (1 provider focus groups, approx. 6 providers in focus groups) focus groups, along 
with theory and expert opinion, will inform intervention adaptation. The MBTI+ protocol will be refined 
through an iterative patient testing process (N=5). Hypothesis: These activities will result in a 
manualized MBTI+ protocol including patient materials (i.e., study workbook, study folder) and a 
structured therapist manual (e.g., timing, scaling, content) that can be used to standardize the 
intervention. 
 
Study Phase II (months 12-36) will be a single-arm pilot (N=30). Patient-reported outcomes will be 
assessed at baseline, post-treatment, and 1-month follow-up. The specific aims and hypotheses are: 
 
Aim 2: To assess the feasibility, acceptability, and examine pre- to post-intervention outcomes of MBTI+ 
(N=30). Hypothesis 1: MBTI+ will be feasible (≥80% completed sessions; ≤20% attrition) and acceptable 
(80% of participants reporting intervention satisfaction on Client Satisfaction Questionnaire); Hypothesis 
2: Participants will evidence improvement in the primary outcome of insomnia symptoms; Hypothesis 3: 
Participants will evidence improvement in secondary outcomes: fatigue, pain, distress (i.e., anxiety, 
depression, hyperarousal), mindfulness, and self-efficacy for symptom management. 
  
Background & Significance 
 
Survival rates for hematologic cancer have increased with improved treatment. Unlike other cancers, 
treatment for hematologic malignancy often involves a rigorous 4 to 6-week hospitalization for 
induction chemotherapy. Patients who return home after undergoing this intensive inpatient treatment 
are left with significant sleep disturbance and persistent problems with fatigue, pain, and distress during 
the day. Rumination (i.e., anxiety and depressive symptoms, hyperarousal) about sleep problems can 
result in unhelpful responses that further exacerbate insomnia symptoms (e.g., napping/ extended time 
in bed, avoidance, medication use). As sleep quality worsens, cancer patients are more likely to have 
significant daytime fatigue, pain, and distress that interferes with valued work and family-related 
activities. Moreover, chronic insomnia puts cancer patients at elevated risk for disease progression. 

 
Treatment for insomnia in cancer is typically pharmacological, despite research suggesting 1) these 
interventions are suboptimal for cancer patients, and 2) that behavioral interventions for insomnia are 
efficacious and cost-effective. Although insomnia and persistent daytime fatigue, pain, and distress are 
experienced by many hematologic cancer patients after demanding inpatient treatment regimens, there 
is very little research on behavioral interventions for addressing these problems. Thus, there is a critical 
need for symptom management interventions that specifically target both nighttime sleep disturbance 
and daytime fatigue, pain and distress in hematologic cancer patients after discharge home from 
inpatient chemotherapy. 
 
Mindfulness-Based Therapy for Insomnia (MBTI) is a new treatment for insomnia. Delivered in a group 
setting, this intervention combines sleep restriction and stimulus control with mindfulness principles 
(e.g., non-striving, letting go, beginner’s mind) and exercises (e.g., body scan, sitting and walking 
meditations) to treat insomnia, reduce rumination, and promote positive responses to poor sleep (e.g., 
less time in bed, nurturing activities, less medication). MBTI could be particularly beneficial to 
hematologic cancer patients who are prone to experience both nighttime sleep disturbance and daytime 
fatigue, pain, and distress in the months following discharge from inpatient treatment. However, MBTI 
has only been tested in healthy outpatients with insomnia where it evidenced a large pre-post effect 
size on insomnia symptom severity. 
 
If MBTI is to meet the unique needs of hematologic cancer patients who have returned home after 
inpatient chemotherapy, it needs to be adapted in several ways. First, because hematologic cancer 
patients are immunosuppressed, MBTI needs to be adapted so it can be delivered in a one-to-one rather 
than group format. Second, because hematologic cancer patients often experience significant problems 
with fatigue, pain, and distress during the day, an adapted MBTI protocol needs to provide systematic 
training in skills for coping with these bothersome symptoms. An MBTI protocol that is specifically 
adapted to hematologic cancer could reduce the burden of insomnia and daytime symptoms (i.e., 
fatigue, pain, and distress) experienced by hematologic cancer patients in the months after they have 
completed inpatient chemotherapy treatment.   
 
The proposed, adapted MBTI+ intervention is designed to meet the unique symptom needs of 
hematologic cancer patients returning home after inpatient chemotherapy. This intervention aims to 
reduce both insomnia and symptoms of fatigue, pain, and distress. Insomnia is considered a 24-hour 
disorder, with daytime consequences of nighttime sleeplessness being cited as one of the most 
upsetting aspects of insomnia. The proposed MBTI+ intervention is innovative in that it integrates 
training in strategies to address sleep disturbance at night, with training in skills for managing daytime 
symptoms of daytime fatigue pain and distress. Although the proposed MBTI+ intervention could be 
beneficial and have implications for improving the health-related quality of life of hematologic cancer 
patients, to date, MBTI+ has not been adapted for, or tested with this understudied cancer population.  
 
We seek to provide researchers with a better understanding of the feasibility, acceptability, and 
preliminary efficacy of an adapted MBTI+ protocol for insomnia and daytime fatigue, pain, and distress 
in patients with hematologic cancer. Given the novel application to this population, it is essential to 
adapt the protocol to be minimally burdensome (e.g., remote treatment, flexible session scheduling, 

and well-received [i.e., high completed sessions, retention, and satisfaction]). If pre- to post-intervention 
reductions to insomnia symptoms are observed, this would provide support for a larger, more rigorous 
randomized efficacy trial. Findings could also encourage researchers to extend MBTI+ to other cancer 
and chronic illness populations reporting insomnia and daytime fatigue, pain, and distress. Finally, 
positive results could have implications for clinical practice. Patients with hematologic cancer returning 
home after inpatient chemotherapy might be screened for insomnia, fatigue, pain, and distress, and 
then offered timely intervention with our MBTI+ protocol. Delivery of this intervention may offset 
indirect costs associated with insomnia (i.e., physical and psychological comorbidities, health care use, 
decreased work performance). Future work could assess the cost-effectiveness of the MBTI+ 
intervention. 
 
Design & Procedures 
 
The proposed project will include two phases: 1) intervention adaptation (Phase I); and 2) assessing 
feasibility (i.e., ≥80% complete sessions; attrition ≤20%) and acceptability (i.e., 80% of participants 
reporting intervention satisfaction on the Client Satisfaction), and examining pre- to post-intervention 
outcomes in hematologic cancer patients (Phase II). 
 
Phase I: Focus Groups 
Study staff will conduct three focus groups comprised of 4 hematologic cancer patients, and one 
provider focus group comprised of 6 medical providers (e.g., hematology-oncologist, physician assistant 
etc.). Using a semi-structured format, participants will be asked to evaluate the MBTI+ protocol by 
reviewing session handouts outlining educational content and behavioral strategies to address 
symptoms of insomnia, fatigue, pain, and distress. After reviewing handouts, participants will be 
prompted with direct and open-ended questions such as “When you read this, what did you think 
about? What changes, if any, would you make?” Participants will also be asked about preferences for 
intervention structure (i.e., individual delivery, session length etc.) and delivery modality (i.e., in-person, 
telephone, or videoconference), and to describe potential barriers to attendance. Particular attention 
will be focused on adapting the intervention to be acceptable for hematologic cancer patients 
experiencing a high symptom burden. We expect qualitative data derived from focus groups to result in 
a manualized protocol including patient materials (i.e., study workbook, folder) and a therapist manual 
(e.g., timing, scaling, content) tailored to the unique needs of patients with hematologic cancer. Focus 
groups will range in length from 45-75 minutes. Patients will be compensated $30, while providers will 
be compensated with a $15 Starbucks gift card. Focus groups will be conducted at the Duke Cancer 
Institute (DCI) or the offices of the Pain Prevention and Treatment Research Program (approx. 1 mile 
from DCI). If necessary, focus groups may be conducted remotely via video-conferencing. All focus 
groups will be audio recorded and transcribed verbatim by F32-awardee, Hannah Fisher PhD, or other 
study personnel, for supervision and qualitative analysis. Focus group recordings will be stored on a 
secured drive behind the Duke firewall. These recordings will be destroyed upon study completion. 
Following the focus group, patients will complete an assessment of insomnia (Insomnia Severity Index), 
fatigue (Fatigue Symptom Inventory), pain (Brief Pain Inventory-Short Form), and distress (Hospital 
Anxiety and Depression Scale). Demographic and medical information will be completed via medical 
record review. 
 

Phase I: User Testing and Phase II: Single Arm Pilot 
Initial feasibility and acceptability of MBTI+ will be assessed with 5 hematologic cancer participants 
recruited for user testing. Participants will be asked to complete six, 60- to 75-minute intervention 
sessions with a study therapist. Interventions sessions will be done in-person or via a videoconferencing 
program (i.e., Zoom), depending on feedback given during focus groups. Participants will be asked to 
complete daily sleep diaries before each session, and at the beginning of each session participants will 
be asked several questions about any recent cancer treatments, use of sleep and/or pain medication, 
and coping skill use. The study sessions will be audio recorded by the therapist using the program Voice 
Recorder. A subset of these recordings will be reviewed by the study PI and research team to improve 
the intervention and ensure therapist fidelity to the intervention. Sessions recordings will be stored on a 
secured drive behind the Duke firewall. These recordings will be destroyed upon study completion. 
There are three assessments we will ask all participants to complete. They each take about 30-40 
minutes and include questions about the participant and their background, their cancer symptoms (e.g., 
insomnia, fatigue, pain), and their emotions (e.g., symptoms of depression, anxiety, hyperarousal). 
Participants will also be asked to give feedback on the sessions and intervention content; feedback will 
be used to make the intervention better for other patients who receive it in the future. The first survey 
is completed at the start of the study. The second survey is about 7 weeks later and the final survey is 
about 11 weeks after the start of the study. Study staff will be blinded to outcome assessments, as these 
will be completed online (i.e., via Redcap). Participants will receive $40 for completing each of the three 
study assessments. Total compensation may be up to $120. 
 
Selection of Subjects 
  
Eligibility criteria for patients included in Phase I and Phase II include: 
1) an initial or recurrent/relapse diagnosis of acute myeloid leukemia, acute lymphoblastic leukemia, 
Non-Hodgkin’s lymphoma, multiple myeloma, myelodysplastic syndrome 
2) within 8 weeks of discharge home after inpatient chemotherapy or CAR-T therapy 
3) score of 8 or greater on the Insomnia Severity Index (ISI);  
4) score of 5 or greater on the MD Anderson Symptom Inventory Scale for “worst” fatigue or pain or 
distress, and report that these symptoms interfered with at least two activities of living (i.e., general 
activity, mood, work) in the last week at 3 or greater on a 0=“Did not interfere” to 10=“Interfered 
completely” scale 
5) ability to speak and read English, and hearing and vision that allows for completion of sessions and 
assessments; 
6) age of 18 years or older.  
 
Exclusion criteria for patients included  Phase I and Phase II include: 
1) reported or suspected cognitive impairment subsequently informed by a Folstein Mini-Mental Status 
Examination of <25 
2) presence of a serious psychiatric (e.g., schizophrenia, suicidal intent) or medical condition (e.g., 
seizure disorder, narcolepsy) indicated by medical chart, treating oncologist or other medical provider 
that would contraindicate safe participation 
3) expected survival of 6 months or less. 
 

Eligibility criteria for providers included in Phase I include: 
1) Healthcare professional (e.g., oncologist, physician assistant, nurse) working within the Division of 
Hematological Malignancies and Cellular Therapy at Duke University Medical Center 
 
In order to assess eligibility, basic patient information will be gathered through the use of electronic 
medical record database information (i.e., DEDUCE and MaestroCare) under a Waiver of Consent and 
HIPAA authorization. This information will allow the study team to assess whether or not the patient 
meets study inclusion criteria (see above) and provide the study team with the patients’ name, 
provider's name, mailing address, phone number, and medical record number. 
 
Subject Recruitment and Compensation 
 
Recruitment will take place through the Duke Cancer Institute (DCI). Research and clinical care providers 
at the DCI are in support of recruitment for this study, including Thomas LeBlanc, MD, hematology-
oncologist, and Cheyenne Corbett, PhD, LMFT, Director of DCI Psychosocial Services and the Cancer 
Patient Support Program. Recruitment procedures will comply with HIPAA regulations.  
 
Provider recruitment will be facilitated by Thomas LeBlanc, MD, a hematology-oncologist and member 
of this study's mentoring committee. Dr. LeBlanc will invite his colleagues within the Division of 
Hematological Malignancies and Cellular Therapy to participate in the provider focus group. Interested 
providers will be contacted by F32-awardee and study coordinator, Hannah Fisher, PhD. Dr. Fisher will 
also deliver a brief presentation about the study to providers within the Division of Hematological 
Malignancies and Cellular Therapy to advertise the study. Time, format, and location for this 
presentation will be coordinated with Dr. LeBlanc. 
 
For patient recruitment, the proposed study will follow the same recruitment procedures used in 
numerous federally funded projects by our research team in the Duke Pain Prevention and Treatment 
Research Program (PPTRP). 
 
Under a HIPAA waiver, potentially eligible patients will be identified via electronic medical record 
review. Potential participants will be emailed directly and/or mailed a letter signed by their treating 
oncologist and study PI informing them about the study. The email or letter will state that a member of 
the study team may approach them in clinic at their next appointment; patients wishing not to be 
approached can call a number to opt out of the study. All study team members who are involved in 
recruitment (Dr. Fisher) have completed the required DOCR Recruitment and Engagement training. 
Confirmation of training completion has been attached to this application. Hematology-oncology 
providers will be recruited for the focus group directly through Dr. Thomas LeBlanc. Using a script that is 
compliant with IRB policies, a member of the study team will describe the study purpose, procedures, 
risks and benefits, and provide potential participants with an opportunity to ask questions, as well as 
assess participants’ eligibility. Informed consent will be documented by signature on forms approved by 
the IRB for eligible and interested participants. If a member of the study team is unable to make contact 
with the participant during a clinic appointment (e.g., due to time constraints, COVID-19 restrictions), 
the participant will be informed that a member of the study team would like to contact him/her by 
telephone. In these cases, the eligibility screening and informed consent procedures will occur remotely, 

via phone and/or videoconferencing. Eligible and interested participants who consent by phone will 
either: 1) complete an eConsent form via Redcap; or 2) be mailed two written consent forms (one for 
the participant and one to be returned to the research team via mail). This will be based on participant 
preference and convenience. 
 
For those who decline participation, information will immediately be deleted from our records including 
their address and telephone number. However, we will retain their name and MRN so that we do not 
contact a person who has already declined participation. This will allow us to respect the wishes of the 
patients who do not want to be involved. We will delete the patient’s name and MRN upon completion 
of enrollment. We will retain demographic information and basic medical information on patients who 
decline in order to see if we are systematically under including certain subgroups of the study 
population, which would limit our ability to generalize findings. This information will always be kept 
separate from direct identifiers. If a patient is not eligible or if he/she decides he/she is not/no longer 
interested in participating, the patient will be provided with psychosocial resources offered through DCI, 
if needed. Participants will be told they can discontinue participation at any time with no impact to their 
medical care. 
 
Additionally, Duke patients with hematologic cancer are able to contact the study staff if they are 
interested in participating in this study. 
 
Participants will be compensated $30 for participating in the focus group. Providers who participate in 
the focus group will be compensated with a $15 Starbucks giftcard. Participants recruited into user 
testing or the single-arm pilot will be compensated $40 for completing each of the three study 
assessments (i.e., baseline, post-intervention, 1-month follow-up) for a maximum compensation of 
$120.  
 
Demographic and Medical Variables Collected from Medical Record: These variables will be collected 
one time when a potential patient is identified for the study under a Waiver of HIPAA authorization. 
Demographic and medical variables will be collected from electronic medical records (via DEDUCE and 
Maestro Care) and include the patients’ MRN, name, sex, age, marital status, education, race, address, 
telephone number, cancer type, date of diagnosis, cancer stage, and cancer treatments received. As 
noted previously, for those who decline, identifying information will immediately be deleted from our 
records including their address and telephone number. However, we will retain their name and MRN so 
that we do not contact a person who has already declined participation. We will delete the patient’s 
name and MRN upon completion of enrollment. We will retain demographic information and basic 
medical information on patients who decline participation in order to see if we are systematically under 
including certain subgroups of the study population, which would limit our ability to generalize findings. 
This information will always be kept separate from direct identifiers. 
 
Self-Report Measures. Participants will complete online assessments of primary and secondary outcome 
measures at all time points (i.e., baseline, post-intervention, 1-month follow-up). These measures have 
been extensively tested in cancer populations and demonstrate good reliability and validity evidence. 
We specifically selected measures that are brief to reduce participant burden. Our preliminary data 
suggests these assessments take a total of 30 minutes to complete. 

 
Primary Outcome. Insomnia. Insomnia symptoms will be measured using the Insomnia Severity Index 
(ISI).33 The ISI consists of three items assessing difficulty falling asleep, staying asleep, and waking up 
too early in the past two weeks. The ISI uses a 5-point response scale, with options ranging from 0 (no 
difficulty) to 4 (very severe difficulty). The ISI also includes four items assessing 
satisfaction/dissatisfaction with sleep, how noticeably insomnia is impairing quality of life, distress 
regarding current sleep disturbance, and interference to daily functioning. The ISI has exhibited good 
reliability and validity in cancer populations and is recommended for studies targeting insomnia 
symptoms. 
 
Secondary Outcomes. Sleep. Sleep will be assessed using the 9-item Whole Week Self-Assessment of 
Sleep Survey (SASS). This is a retrospective version of the Consensus Sleep Diary from Carney et al. 
(2012) and includes questions that assess average bedtime, risetime ,and sleep quality across the past 
week (Dietch, Sethi, Slavish, & Taylor, 2019). Fatigue. Fatigue (i.e., severity and interference) will be 
assessed using the Fatigue Symptom Inventory (FSI), which was developed for and validated in cancer 
patients. The FSI consists of four items assessing fatigue (worst, least, average, and current fatigue) and 
seven items assessing fatigue interference in the past week. The FSI includes an 11-point response scale, 
with options ranging from 0 (no fatigue or no interference) to 10 (fatigue as bad as you can imagine or 
completely interferences). The FSI is often used in cancer populations and has evidenced excellent 
reliability and validity. Pain. Pain (i.e., severity and interference) will be measured using the Brief Pain 
Inventory-Short Form (BPI-SF). The BPI-SF consists of four items assessing pain (worst, least, average, 
and current pain) and seven items assessing pain interference in the past week. The BPI-SF includes an 
11-point response scale, with options ranging from 0 (no pain or no interference) to 10 (pain as bad as 
you can imagine or completely interferes). The BPI-SF has demonstrated good reliability and validity in 
prior studies investigating pain severity and interference in cancer patients. Distress. Anxiety and 
Depressive Symptoms. Anxiety and depressive symptoms will be measured using the 14-item Hospital 
Anxiety and Depression Scale (HADS). The HADS consists of two 7-item subscales assessing anxiety and 
depressive symptoms in the past week. Items are rated using an 4-point response scale. The HADS has 
demonstrated adequate reliability and validity in cancer populations. Hyperarousal. Hyperarousal will be 
measured using the 16-item Pre-Sleep Arousal Scale (PSAS), which assesses cognitive and somatic 
arousal before sleep in the past week. The PSAS uses a 5-point scale, with response items ranging from 1 
(not at all) to 5 (extremely). The PSAS has demonstrated good reliability and validity in studies targeting 
insomnia symptoms, and has been used in cancer populations. Mindfulness. Mindfulness skills (e.g., 
observing, describing, etc.) will be measured using the 39-item Kentucky Inventory of Mindfulness Skills 
(KIMS). Response options range from 1 (never/very rarely true) to 5 (very often/always true). The KIMS 
has adequate reliability and validity in cancer samples, and has been used in studies exploring 
mindfulness-based interventions for insomnia. Self-efficacy for symptom management. Self-efficacy for 
symptom management will be measured using the Self-Efficacy for Management Chronic Disease scale. 
This 6-item scale will assess participants’ confidence regarding management of symptoms, medication 
use, and doctor visits. Response options range from 1 (not at all confidence) to 10 (totally confident). An 
additional item will be added to assess self-efficacy for managing insomnia. This scale has been shown 
to have excellent validity and reliability in cancer populations. 
 

Treatment Feasibility and Acceptability. Feasibility. Feasibility will be assessed by session attendance 
(≥80%) and attrition (≤ 20%). Acceptability. Satisfaction will be measured post-intervention using the 
Client Satisfaction Questionnaire 8-item version. The scale includes eight items assessing the 
participant’s level of satisfaction with treatment, with response options ranging from 1 (quite 
dissatisfied) to 4 (very satisfied). Acceptability will be demonstrated by 80% of participants reporting 
intervention satisfaction on the Client Satisfaction Questionnaire. Engagement in the intervention will 
be assessed at the beginning of sessions 3 and 6, and post-intervention follow-up. The participant will be 
asked about his or her coping skills practice and completion of homework assignments from the 
previous time point. These data will be recorded by the study therapist in RedCap. 
 
Demographics and Medical Information: At baseline, participants will report their education, household 
income, employment status, and history of comorbidities (e.g., hypertension, heart disease). At each 
assessment, participants will also be asked about their cancer treatments in the last 7 days 
(chemotherapy, radiation, surgery, hormone therapy, vaccine, pill anti-cancer drug) and how many days 
in the last 7 they have taken any type of pain and/or sleep medication.  
 
Risk/Benefit Assessment 
 
Risks: 
In the proposed study, the risks to participants are minimal and primarily include psychological distress 
and breach of confidentiality. Participants will be asked about their thoughts and feelings about their 
cancer; thus, it is possible that they may experience distress. The psychological risk associated with 
answering questions and participating in the intervention is expected to be minimal. Although some 
participants may find certain questions or topics to be upsetting, heightened awareness of existing 
psychosocial and practical needs may be the first step in resolving these concerns. The recruitment 
letter clearly acknowledges the voluntary nature of participation and patients will have the ability to 
decline further contact from study personnel (i.e., to opt out). Participants will be fully informed about 
the study during the informed consent process and instructed to decline to answer any question or to 
discuss any issues they find troubling. If a participant reports significant distress during study 
participation, Dr. Somers (licensed clinical psychologists) will be consulted. If the participant requires 
additional treatment, appropriate referrals will be made. The study team has extensive experience 
conducting psychosocial intervention trials with cancer patients and have not encountered significant 
psychological distress caused by study participation. Moreover, cancer patients and their family 
caregivers often report benefits from participating in psychosocial research. Thus, the risk of 
psychological distress is modest and the safeguards should be adequate. Breach of confidentiality is 
another possible risk. This is clearly stated in the consent form. All efforts will be made to maintain 
confidentiality. Participants’ data and research records will be carefully stored. All study personnel will 
be required to complete courses and ongoing training in protecting participant confidentiality. 
 
The adapted MBTI intervention involves sleep consolidation and reconditioning exercises. Although 
unexpected, it is possible that these sleep strategies may result in increased daytime sleepiness, and 
some problems with mood and/or slowed thinking during treatment; however, these effects are 
primarily restricted to the early stages of treatment, when behavioral therapies are introduced, and 
improve over time, typically resolving by the end of treatment. 

 
If patients are not interested in study participation but are interested in supportive services, they will be 
given information on the extensive, free resources available to them through the Duke Cancer Patient 
Support Program. These resources range from psychotherapy to financial and legal services. These 
resources will also be described to those who enroll in the study, regardless of their assigned study 
condition. 
 
The risks to providers are minimal and primarily include psychological distress and breach of 
confidentiality. Providers will be asked to evaluate the MBTI+ protocol by reviewing session handouts 
outlining educational content and behavioral strategies to address cancer symptoms (e.g., insomnia, 
fatigue, pain, and distress). Providers will also be asked about preferences for intervention structure 
(i.e., individual delivery, session length etc.) and delivery modality (i.e., in-person, telephone, or 
videoconference), and to describe potential barriers to attendance. These questions are unlikely to 
cause psychological distress, however, providers will be reminded that they can decline to answer any 
question or to discuss any issues they find troubling. Breach of confidentiality is another possible risk. 
This is clearly stated in the consent form. All efforts will be made to maintain confidentiality. 
Participants’ data and research records will be carefully stored. All study personnel will be required to 
complete courses and ongoing training in protecting participant confidentiality. 
 
Benefits:  
There are numerous potential benefits of the proposed research. Providers and hematologic cancer 
patients who participate in the focus group may learn about skills that can help reduce nighttime sleep 
disturbances and daytime symptoms of fatigue, pain, and psychological stress. Participants who 
participate in user testing or the single-arm pilot will receive a mindfulness and cognitive-behavioral 
intervention at no cost. As demonstrated in prior mindfulness and behavioral symptom management 
studies, the proposed intervention may lead to improvements in patients' nighttime sleep and daytime 
symptoms of fatigue, pain, and distress. Furthermore, information learned from this study may benefit 
other patients with cancer in the future. Lessons learned will provide a foundation for subsequent 
larger, methodologically rigorous, randomized efficacy trials of adapted MBTI. This research program 
could also serve an heuristic purpose in encouraging researchers to extend adapted MBTI to other 
cancer and chronic illness populations reporting insomnia and daytime fatigue, pain, and distress. Future 
work might examine the effects of adapted MBTI on neuroendocrine and immune markers that are 
linked to sleep and have implications for cancer progression 
 
Data Analysis & Statistical Considerations 
 
Sample size and statistical power: Part 1 of Phase I will include three focus groups comprised of 4 
patients and one provider focus group comprised of 6 medical providers. User testing (Part 2, Phase I) 
will involve 5 patients. This sample size is based on our prior work using focus groups in the hematology-
oncology setting.27 Research suggests that 2-3 focus groups are sufficient to reveal 80% of themes.70 If 
the intervention content is not significantly altered during user testing, these participants will be 
combined with those from Phase II for an intent-to-treat sample of 35 participants. 
 
Analytic Plan 

Aim 1: Focus groups with hematologic cancer patients and their providers will be transcribed verbatim 
and analyzed using Atlas.ti. An initial coding scheme will be developed based on a review of literature, 
our research goals, and prior work, as well as themes that emerged during focus groups. The codes will 
be applied to the transcripts in Atlas.ti. Two independent individuals, including Dr. Fisher, will code each 
transcript to ensure similar understanding of the codes and consistency in judgement.72 As part of the 
training plan, Dr. Fisher will complete several workshops on analyzing qualitative data. Additionally, the 
study sponsors and the mentoring team have extensive experience with qualitative analyses, and access 
to a shared resource of qualitative experts to assist with these analyses and any challenges that may 
arise. 
 
Aim 2: Feasibility (i.e., ≥80% of sessions completed; attrition ≤ 20%) and acceptability (i.e., 80% of 
participants reporting intervention satisfaction on the Client Satisfaction Questionnaire, participant 
completion of homework assignments) data will be examined using descriptive statistics (mean, median, 
standard deviation, percent etc.). Paired sample t-tests will be run to quantify the degree of change over 
time for all primary and secondary outcomes. Effect sizes will be computed using Cohen’s d. 
Unconditional latent growth models will be used to assess main time effects across baseline, post-
treatment, and 1-month follow-up. Time will be coded as the number of months since the baseline 
assessment. Determination of linear versus quadratic change will be made by comparing the relative fit 
of the two models using the Bayesian Information Criterion, as recommended. Control variables and 
their interactions with time will be included in the conditional models. Analyses will be conducted on an 
intent-to-treat basis to make use of all available data (N=35).  
 
Data & Safety Monitoring 
 
The proposed study carries minimal risk. The protocol does not use an investigational drug, procedure, 
or device. Data obtained from participants will include information from medical chart review, patient 
and provider focus groups, and self-report inventories. The study team considers the management of 
participant information and data as a key priority. Best practices for confidentiality and data 
management will be observed.