CancerHemeNCT05294991
Wellness App for Sleep Disturbance in Hematological Cancer Patients
A study testing Wellness app intervention #1 and Wellness app intervention #2 in people with Cancer and Sleep Disturbance, run by The University of Texas Health Science Center at San Antonio at 3 sites in United States.
Trial summary
In a randomized controlled trial (RCT), the investigators will recruit participants to an 8-week "app-based wellness" intervention, followed by a 12-week follow-up period. The investigators will recruit a total of 276 self-declared Chronic Hematological Cancer (CHC) patients who (representative of age, race/ethnicity… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Sleep Disturbance, Anxiety
- What is being tested?
- Wellness app intervention #1 and Wellness app intervention #2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 3 sitesUnited States
- Study dates
- 20 Feb 2023to 20 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-declared diagnosis of hematological cancer on stable maintenance management* by treating physician (i.e., on stable medical therapy) or observation (i.e., no changes in disease targeted medications for the past two weeks)
- Not currently participating in a therapeutic pharmacologic clinical trial
- Not planning to receive an allogenic stem cell transplantation during the study time frame (i.e., 20 weeks)
- Score of >5 on PSQI (Pittsburgh Sleep Quality Index)
- Own a mobile smartphone (iPhone with iOS 14 or later or an Android 6 or later) with an active data or WiFi connection
- Willing to download two mobile apps
Show all 11Show fewer
- Able to read/understand English
- ≥18 years of age
- Willing to be randomized
- Willing to drive to a nearby lab for blood draws 3x during the study over the course of 20 weeks (8-week intervention period followed by 12-week follow-up period)
- Taking sleep medications and/or over-the-counter sleep drugs/supplements (if any) on fewer than 3 nights per week and one of the following: 1) willing to maintain the same intake without change throughout the study time frame (i.e., 20 weeks) or 2) willing to discontinue if intake is prescribed "as needed" (PRN) by a physician throughout the study time frame (i.e., 20 weeks)
Who cannot join
- Self-report meditation practice or meditative movement practice (i.e., yoga, tai chi, qi gong) of ≥60 min/week in past 2 months
- Reside outside of the United States of America
- Any planned change to a new pharmacologic therapy (i.e., new drug) for the treatment of their cancer diagnosis (excluding dose changes)
- Diagnosed with a sleep disorder except insomnia (≥2 positive categories on Berlin Questionnaire)
- Taking prescribed sleep medications and/or over-the-counter drugs/supplements (including drugs like NyQuil, Benadryl, and other antihistamine-based drugs) on ≥3 nights per week
- Any other diagnosed and uncontrolled medical or psychiatric condition
- Has a pacemaker
- Shift work schedule
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Arizona State University
Phoenix, Arizona, 85004
Mays Cancer Center at The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27101
About this study
Official title: Consumer-Based Meditation App, Calm, for Treatment of Sleep Disturbance in Hematological Cancer Patients
In a randomized controlled trial (RCT), the investigators will recruit participants to an 8-week "app-based wellness" intervention, followed by a 12-week follow-up period. The investigators will recruit a total of 276 self-declared Chronic Hematological Cancer (CHC) patients who (representative of age, race/ethnicity, and gender) will be on stable CHC pharmacologic therapy (if any), self-identify as sleep disturbed (>5 on Pittsburgh Sleep Quality Index), do not have a sleep disorder diagnosis, do not take sleep medication/supplements >3 times per week, and are not currently practicing regular meditation.
Aim 1: Test the efficacy of two app-based wellness programs (10 minutes per day) on the primary outcome of self reported sleep disturbance (Insomnia Severity Index (primary) and PROMIS Sleep Disturbance (secondary)) and secondary sleep outcomes including sleep impairment (PROMIS Sleep Impairment Scale) and sleep efficiency measured via sleep diaries and actigraphy.
Read more
Aim 2: Test the efficacy of two app-based wellness programs (10 minutes per day) on inflammatory markers (i.e., TNF-a, IL-6, IL-8, CRP), fatigue, and emotional distress (i.e., anxiety, depressive symptoms measured with PROMIS®).
Aim 3: Explore the sustained effects (i.e., 20 weeks from baseline) of two app-based wellness programs (10 minutes per day) in CHC patients.
Read the detailed description
Background:
Hematological cancers account for 11% of all cancer diagnoses in the US. Chronic hematological cancer (CHC) patients are characterized by long term and high symptom burden. Up to 65% of CHC patients report chronic sleep disturbances (e.g., difficulty falling asleep, difficulty staying asleep, nonrestorative sleep, insomnia) that are highly correlated with poorer cognitive and physical functioning, increases in fatigue and emotional distress, and heightened levels of specific inflammatory markers (TNF-a, IL-6, IL-8, CRP) that negatively impact quality of life. Sleep interventions have been tested in solid tumor patients, but no research has examined sleep interventions specifically for CHC patients. Medications are commonly prescribed but often come with side effects and risk for long-term dependence. Cognitive behavioral therapy for insomnia (CBT-I) is the most studied and first line of therapy for treating sleep disturbances in cancer patients, but CBT-I is time-consuming, resource-intensive, and not easily accessible for all cancer patients. There is a need for long-term, accessible, non-pharmacologic interventions targeting sleep in CHC patients.
RCTs have shown meditation and mindfulness-based interventions lead to improvements in sleep disturbance among breast cancer patients, but this research has not been extended to CHCs. Meditation has potential as a non-pharmacologic strategy to reduce sleep disturbance in CHC patients without the time and expertise limitations of CBT-I and side effect risks from medication. In person meditation, however, is still inaccessible long term due to potential fatigue, pain, transportation, and scheduling difficulties.
Smartphone apps have attracted considerable interest from cancer patients as an easily accessible and empowering way to self-manage health. Existing research using apps has focused on short term psychological measures (e.g., distress, cancer-related distress, anxiety, etc.) or cancer-specific biological changes as outcomes and not sleep disturbance, in solid tumor survivors with minimal residual disease (e.g., breast cancer post-treatment), or those with short survival (e.g., metastatic solid tumor patients). The unique, long-lasting disease course of CHC patients and high chronic symptom burden warrants distinct interventions from resolved solid tumor patients. CHC patients with sleep disturbance have no options for easily accessible and evidence-based treatments for sleep disturbances. The investigators propose to test the effects of two app-based wellness programs (10 minutes per day) on sleep disturbance in CHC patients.
Study Timeline:
This study is expected to last 5 years with enrollment beginning in January 2023. The investigators aim to enroll 276 CHC patients.
Objectives:
Objective #1: Test the efficacy of two app-based wellness programs (10 minutes per day) on the primary outcome of self-reported sleep disturbance (Insomnia Severity Index (primary) and PROMIS Sleep Disturbance (secondary) and additional secondary sleep outcomes including sleep impairment (PROMIS Sleep Impairment Scale) and sleep efficiency measured via sleep diaries and actigraphy.
Objective #2: Test the efficacy of two app-based wellness programs (10 minutes per day) on inflammatory markers (i.e., TNF-a, IL-6, IL-8, CRP), fatigue, and emotional distress (i.e., anxiety, depressive symptoms measured with PROMIS®).
Objective #3: Explore the sustained effects (i.e., 20 weeks from baseline) of two app-based wellness programs (10 minutes per day) on in CHC patients.
Recruitment:
The investigators aim to recruit 276 CHC patients nationally.
Study Procedures:
All study procedures are remote and have been approved by an institutional review board. Interested patients will complete an online eligibility survey via RedCap. Eligible participants will be sent an email notifying them of their eligibility, asked to review a video-based overview of the study. If interested in participating, participants will be invited to electronically sign the informed consent via RedCap.
Once the consent is signed, participants will receive information on how to provide a blood sample at a local lab, how to choose a size for their sleep device, and sign up for a 30-minute virtual visit with a research assistant. Once participants receive their sleep device in the mail, they will meet with a research assistant via video conference to review the study procedures and activate their sleep device. After the video conference, participants will be sent an online link to complete the baseline survey. Then, for 7 days (baseline week), participants will be asked to wear a sleep device continuously and complete an online sleep diary each morning upon waking. At the end of the baseline week, participants will receive compensation and will then be randomized to download one of two wellness apps.
During the 8-week intervention period, participants will be asked to wear the sleep device continuously and complete an online sleep diary each morning. They will also be asked to engage with their assigned wellness app each day for at least 10 minutes (70 minutes per week). At the end of each week, they will complete a brief survey to assess changes in treatment, and provide assessments of psychosocial wellbeing. At the end of the 8-week intervention period, participants will be emailed an online survey and be asked to complete a second blood draw, and compensation will be provided. At this time, participants will no longer be required to wear the sleep device, complete sleep diaries, or use their wellness app.
Participants then wait until the beginning of study week 20 to begin the follow-up period. At Week 20, for a period of 7 days, participants will be asked to wear the sleep device continuously and complete an online sleep diary each morning. They will also be asked to complete an online survey and provide a third blood sample. At the end of the follow-up week, participants will return their sleep device and receive their earned compensation.
- Conditions
- Cancer, Sleep Disturbance, Anxiety, Depression, Inflammation, Fatigue
- Being tested
- Wellness app intervention #1, Wellness app intervention #2
- Medical subject headings
- Neoplasms, Parasomnias, Anxiety Disorders, Depression, Inflammation, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wellness app intervention #1Behavioural
This is the active intervention group.
Wellness app intervention #2Behavioural
This is the active comparator/control group.
| Study group | Role | What they receive |
|---|---|---|
| Wellness app intervention #1 | Experimental | Participants assigned to this group will be asked to engage with the app a minimum of 10 minutes per day (70 minutes per week), at any time of day they choose for at 8-week period. There is a recommended program to follow for the 8-week period, but participants are also welcome to engage with other features and content within the app. Receives: Behavioral: Wellness app intervention #1 |
| Wellness app intervention #2 | Active comparator | Participants assigned to this group will be asked to engage with the app a minimum of 10 minutes per day (70 minutes per week), at any time of day they choose for at 8-week period. There is a recommended program to follow for the 8-week period, but participants are also welcome to engage with other features and content within the app. Receives: Behavioral: Wellness app intervention #2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Disturbance (subjective)
Sleep disturbance will be measured with the Insomnia Severity Index (ISI). Total scores range from 0 to 28 with scores 8 to 14, and ≥15 indicating subclinical and moderate-to-severe insomnia symptom severity, respectively.
Measured: Changes in sleep disturbance will be measured at baseline, week 2, week 4, week 6, week 8, and week 20. Total scores range from 0 to 28 with scores 8 to 14, and ≥15 indicating subclinical and moderate-to-severe insomnia symptom severity, respectively.
Sleep Disturbance (subjective)
Sleep disturbance will be measured with the Patient Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form 8b. This form consists of 8 items in a 1-5 Likert scale. The measure generates a total summed score, which is then converted to a standardized t-score.
Measured: Changes in sleep disturbance will be measured at baseline, week 8, and week 20. This form consists of 8 items in a 1-5 Likert scale. The measure generates a total summed score, which is then converted to a standardized t-score.
Sleep Disturbance (subjective)
Sleep disturbance will be measured with the Patient Reported Outcomes Measurement Information System (PROMIS) Sleep-Related Impairment. This form consists of 8 items in a 1-5 Likert scale. The measure generates a total summed score, which is then converted to a standardized t-score.
Measured: Changes in sleep disturbance will be measured at baseline, week 8, and week 20. This form consists of 8 items in a 1-5 Likert scale. The measure generates a total summed score, which is then converted to a standardized t-score.
Sleep disturbance (subjective)
Sleep disturbance will be measured with an investigator-developed weekly sleep diary
Measured: Changes in sleep disturbance will be measured weekly throughout the 8-week intervention period and once again during the week 20 follow-up period.
Sleep disturbance (objective)
Sleep disturbance will be measured with wrist actigraphy
Measured: Changes in sleep disturbance will be measured weekly throughout the 8-week intervention period and once again during the week 20 follow-up period.
Secondary outcomes (4)
Inflammation
Inflammation will be measured with blood serum cytokines (C-reactive protein, TNF-a, IL-6, IL-8)
Measured: Changes in inflammation will be measured at baseline, week 8, and week 20.
Fatigue (subjective)
Fatigue will be measured with the Patient Reported Outcomes Measurement Information System (PROMIS) Adult Cancer Fatigue Short Form 7a. This form consists of 7 items in a 1-5 Likert scale. The measure generates a total summed score, which is then converted to a standardized t-score.
Measured: Changes in fatigue will be measured at baseline, week 8, and week 20.
Anxiety (subjective)
Fatigue will be measured with the Patient Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Anxiety Short Form 7a. This form consists of 7 items in a 1-5 Likert scale. The measure generates a total summed score, which is then converted to a standardized t-score.
Measured: Changes in anxiety will be measured at baseline, week 8, and week 20.
Depression (subjective)
Fatigue will be measured with the Patient Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Depression Short Form 8a. This form consists of 8 items in a 1-5 Likert scale. The measure generates a total summed score, which is then converted to a standardized t-score.
Measured: Changes in fatigue will be measured at baseline, week 8, and week 20.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start20 Feb 2023
- Primary completion20 Dec 2026 (estimated)
- Study completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 276 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Arizona State University, Laboratory Corporation of America, Wake Forest University Health Sciences, Calm.com, Inc., National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jennifer Huberty, PhD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05294991
- Sponsor's protocol ID
- CTMS# 22-0116
- Other IDs
- R01CA262041
- Acronym
- Heme
- Status last verified
- Aug 2026
- First submitted
- 15 Mar 2022
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huberty J, Bhuiyan N, Eckert R, Larkey L, Petrov M, Todd M, Mesa R. Insomnia as an Unmet Need in Patients With Chronic Hematological Cancer: Protocol for a Randomized Controlled Trial Evaluating a Consumer-Based Meditation App for Treatment of Sleep Disturbance. JMIR Res Protoc. 2022 Jul 1;11(7):e39007. doi: 10.2196/39007.
PubMed 35776489
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consumer-Based Meditation App, Calm, for Treatment of Sleep Disturbance in Hematological Cancer Patients
- ClinicalTrials.gov ID
- NCT05294991
- Acronym / sponsor ID
- Heme / CTMS# 22-0116
- Conditions
- Cancer, Sleep Disturbance, Anxiety, Depression, Inflammation, Fatigue
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 276 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- Arizona State University, Laboratory Corporation of America, Wake Forest University Health Sciences, Calm.com, Inc., National Cancer Institute (NCI)
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 24 Mar 2022 (actual)
- 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.
In a randomized controlled trial (RCT), the investigators will recruit participants to an 8-week "app-based wellness" intervention, followed by a 12-week follow-up period. The investigators will recruit a total of 276 self-declared Chronic Hematological Cancer (CHC) patients who (representative of age, race/ethnicity, and gender) will be on stable CHC pharmacologic therapy (if any), self-identify as sleep disturbed (>5 on Pittsburgh Sleep Quality Index), do not have a sleep disorder diagnosis, do not take sleep medication/supplements >3 times per week, and are not currently practicing regular meditation.
Aim 1: Test the efficacy of two app-based wellness programs (10 minutes per day) on the primary outcome of self reported sleep disturbance (Insomnia Severity Index (primary) and PROMIS Sleep Disturbance (secondary)) and secondary sleep outcomes including sleep impairment (PROMIS Sleep Impairment Scale) and sleep efficiency measured via sleep diaries and actigraphy.
Aim 2: Test the efficacy of two app-based wellness programs (10 minutes per day) on inflammatory markers (i.e., TNF-a, IL-6, IL-8, CRP), fatigue, and emotional distress (i.e., anxiety, depressive symptoms measured with PROMIS®).
Aim 3: Explore the sustained effects (i.e., 20 weeks from baseline) of two app-based wellness programs (10 minutes per day) in CHC patients.
Detailed description
Background:
Hematological cancers account for 11% of all cancer diagnoses in the US. Chronic hematological cancer (CHC) patients are characterized by long term and high symptom burden. Up to 65% of CHC patients report chronic sleep disturbances (e.g., difficulty falling asleep, difficulty staying asleep, nonrestorative sleep, insomnia) that are highly correlated with poorer cognitive and physical functioning, increases in fatigue and emotional distress, and heightened levels of specific inflammatory markers (TNF-a, IL-6, IL-8, CRP) that negatively impact quality of life. Sleep interventions have been tested in solid tumor patients, but no research has examined sleep interventions specifically for CHC patients. Medications are commonly prescribed but often come with side effects and risk for long-term dependence. Cognitive behavioral therapy for insomnia (CBT-I) is the most studied and first line of therapy for treating sleep disturbances in cancer patients, but CBT-I is time-consuming, resource-intensive, and not easily accessible for all cancer patients. There is a need for long-term, accessible, non-pharmacologic interventions targeting sleep in CHC patients.
RCTs have shown meditation and mindfulness-based interventions lead to improvements in sleep disturbance among breast cancer patients, but this research has not been extended to CHCs. Meditation has potential as a non-pharmacologic strategy to reduce sleep disturbance in CHC patients without the time and expertise limitations of CBT-I and side effect risks from medication. In person meditation, however, is still inaccessible long term due to potential fatigue, pain, transportation, and scheduling difficulties.
Smartphone apps have attracted considerable interest from cancer patients as an easily accessible and empowering way to self-manage health. Existing research using apps has focused on short term psychological measures (e.g., distress, cancer-related distress, anxiety, etc.) or cancer-specific biological changes as outcomes and not sleep disturbance, in solid tumor survivors with minimal residual disease (e.g., breast cancer post-treatment), or those with short survival (e.g., metastatic solid tumor patients). The unique, long-lasting disease course of CHC patients and high chronic symptom burden warrants distinct interventions from resolved solid tumor patients. CHC patients with sleep disturbance have no options for easily accessible and evidence-based treatments for sleep disturbances. The investigators propose to test the effects of two app-based wellness programs (10 minutes per day) on sleep disturbance in CHC patients.
Study Timeline:
This study is expected to last 5 years with enrollment beginning in January 2023. The investigators aim to enroll 276 CHC patients.
Objectives:
Objective #1: Test the efficacy of two app-based wellness programs (10 minutes per day) on the primary outcome of self-reported sleep disturbance (Insomnia Severity Index (primary) and PROMIS Sleep Disturbance (secondary) and additional secondary sleep outcomes including sleep impairment (PROMIS Sleep Impairment Scale) and sleep efficiency measured via sleep diaries and actigraphy.
Objective #2: Test the efficacy of two app-based wellness programs (10 minutes per day) on inflammatory markers (i.e., TNF-a, IL-6, IL-8, CRP), fatigue, and emotional distress (i.e., anxiety, depressive symptoms measured with PROMIS®).
Objective #3: Explore the sustained effects (i.e., 20 weeks from baseline) of two app-based wellness programs (10 minutes per day) on in CHC patients.
Recruitment:
The investigators aim to recruit 276 CHC patients nationally.
Study Procedures:
All study procedures are remote and have been approved by an institutional review board. Interested patients will complete an online eligibility survey via RedCap. Eligible participants will be sent an email notifying them of their eligibility, asked to review a video-based overview of the study. If interested in participating, participants will be invited to electronically sign the informed consent via RedCap.
Once the consent is signed, participants will receive information on how to provide a blood sample at a local lab, how to choose a size for their sleep device, and sign up for a 30-minute virtual visit with a research assistant. Once participants receive their sleep device in the mail, they will meet with a research assistant via video conference to review the study procedures and activate their sleep device. After the video conference, participants will be sent an online link to complete the baseline survey. Then, for 7 days (baseline week), participants will be asked to wear a sleep device continuously and complete an online sleep diary each morning upon waking. At the end of the baseline week, participants will receive compensation and will then be randomized to download one of two wellness apps.
During the 8-week intervention period, participants will be asked to wear the sleep device continuously and complete an online sleep diary each morning. They will also be asked to engage with their assigned wellness app each day for at least 10 minutes (70 minutes per week). At the end of each week, they will complete a brief survey to assess changes in treatment, and provide assessments of psychosocial wellbeing. At the end of the 8-week intervention period, participants will be emailed an online survey and be asked to complete a second blood draw, and compensation will be provided. At this time, participants will no longer be required to wear the sleep device, complete sleep diaries, or use their wellness app.
Participants then wait until the beginning of study week 20 to begin the follow-up period. At Week 20, for a period of 7 days, participants will be asked to wear the sleep device continuously and complete an online sleep diary each morning. They will also be asked to complete an online survey and provide a third blood sample. At the end of the follow-up week, participants will return their sleep device and receive their earned compensation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wellness app intervention #1 | Experimental | Behavioral: Wellness app intervention #1Participants assigned to this group will be asked to engage with the app a minimum of 10 minutes per day (70 minutes per week), at any time of day they choose for at 8-week period. There is a recommended program to follow for the 8-week period, but participants are also welcome to engage with other features and content within the app. |
| Wellness app intervention #2 | Active comparator | Behavioral: Wellness app intervention #2Participants assigned to this group will be asked to engage with the app a minimum of 10 minutes per day (70 minutes per week), at any time of day they choose for at 8-week period. There is a recommended program to follow for the 8-week period, but participants are also welcome to engage with other features and content within the app. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Self-declared diagnosis of hematological cancer on stable maintenance management* by treating physician (i.e., on stable medical therapy) or observation (i.e., no changes in disease targeted medications for the past two weeks)
- Not currently participating in a therapeutic pharmacologic clinical trial
- Not planning to receive an allogenic stem cell transplantation during the study time frame (i.e., 20 weeks)
- Score of >5 on PSQI (Pittsburgh Sleep Quality Index)
- Own a mobile smartphone (iPhone with iOS 14 or later or an Android 6 or later) with an active data or WiFi connection
Key exclusion criteria (8 listed)
- Self-report meditation practice or meditative movement practice (i.e., yoga, tai chi, qi gong) of ≥60 min/week in past 2 months
- Reside outside of the United States of America
- Any planned change to a new pharmacologic therapy (i.e., new drug) for the treatment of their cancer diagnosis (excluding dose changes)
- Diagnosed with a sleep disorder except insomnia (≥2 positive categories on Berlin Questionnaire)
- Taking prescribed sleep medications and/or over-the-counter drugs/supplements (including drugs like NyQuil, Benadryl, and other antihistamine-based drugs) on ≥3 nights per week
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 |
|---|---|---|
| Wellness app intervention #1This is the active intervention group. | Behavioural | Wellness app intervention #1 |
| Wellness app intervention #2This is the active comparator/control group. | Behavioural | Wellness app intervention #2 |
Primary outcome
Sleep Disturbance (subjective)
Time frame: Changes in sleep disturbance will be measured at baseline, week 2, week 4, week 6, week 8, and week 20. Total scores range from 0 to 28 with scores 8 to 14, and ≥15 indicating subclinical and moderate-to-severe insomnia symptom severity, respectively.
Sleep disturbance will be measured with the Insomnia Severity Index (ISI). Total scores range from 0 to 28 with scores 8 to 14, and ≥15 indicating subclinical and moderate-to-severe insomnia symptom severity, respectively.
Sleep Disturbance (subjective)
Time frame: Changes in sleep disturbance will be measured at baseline, week 8, and week 20. This form consists of 8 items in a 1-5 Likert scale. The measure generates a total summed score, which is then converted to a standardized t-score.
Sleep disturbance will be measured with the Patient Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form 8b. This form consists of 8 items in a 1-5 Likert scale. The measure generates a total summed score, which is then converted to a standardized t-score.
Sleep Disturbance (subjective)
Time frame: Changes in sleep disturbance will be measured at baseline, week 8, and week 20. This form consists of 8 items in a 1-5 Likert scale. The measure generates a total summed score, which is then converted to a standardized t-score.
Sleep disturbance will be measured with the Patient Reported Outcomes Measurement Information System (PROMIS) Sleep-Related Impairment. This form consists of 8 items in a 1-5 Likert scale. The measure generates a total summed score, which is then converted to a standardized t-score.
Sleep disturbance (subjective)
Time frame: Changes in sleep disturbance will be measured weekly throughout the 8-week intervention period and once again during the week 20 follow-up period.
Sleep disturbance will be measured with an investigator-developed weekly sleep diary
Sleep disturbance (objective)
Time frame: Changes in sleep disturbance will be measured weekly throughout the 8-week intervention period and once again during the week 20 follow-up period.
Sleep disturbance will be measured with wrist actigraphy
4 secondary outcomes
Inflammation
Time frame: Changes in inflammation will be measured at baseline, week 8, and week 20.
Fatigue (subjective)
Time frame: Changes in fatigue will be measured at baseline, week 8, and week 20.
Anxiety (subjective)
Time frame: Changes in anxiety will be measured at baseline, week 8, and week 20.
Depression (subjective)
Time frame: Changes in fatigue will be measured at baseline, week 8, and week 20.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Derived from this study: PubMed 35776489Huberty J, Bhuiyan N, Eckert R, Larkey L, Petrov M, Todd M, Mesa R. Insomnia as an Unmet Need in Patients With Chronic Hematological Cancer: Protocol for a Randomized Controlled Trial Evaluating a Consumer-Based Meditation App for Treatment of Sleep Disturbance. JMIR Res Protoc. 2022 Jul 1;11(7):e39007. doi: 10.2196/39007.
- 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.
Jennifer Huberty, PhD principal investigator
The University of Texas Health Science Center at San Antonio
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wellness app intervention #1 and Wellness app intervention #2 in people with Cancer and Sleep Disturbance, run by The University of Texas Health Science Center at San Antonio at 3 sites 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 11 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Sleep Disturbance (subjective) (time frame: Changes in sleep disturbance will be measured at baseline, week 2, week 4, week 6, week 8, and week 20. Total scores range from 0 to 28 with scores 8 to 14, and ≥15 indicating subclinical and moderate-to-severe insomnia symptom severity, respectively.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05294991, which also lists 1 linked publication.
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 5 Aug 2026.