Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-09351 | Other Identifier | NCI Clinical Trial Registration Program |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will explore feasibility and acceptability of using a daily mobile mindfulness app to cope with stress. In addition, feasibility of digital health data collection procedures including wrist-worn devices and ecological momentary assessments will be examined.
PRIMARY OBJECTIVES
Prior to engaging in the intervention participants will complete baseline assessments of stress and coping. Participants will then engage in a daily mindfulness practice via the Headspace mobile application. The basic application program includes daily 10-minute sessions in guided mindfulness meditation that include mindful breathing, body awareness, emotion and thought recognition, and attentional control. During the first and fourth week of the intervention, participants will complete EMAs assessing mood, current activity, and intervention engagement. Participants will also wear a wrist-worn device to assess biomarkers of stress. At the completion of the intervention participants will complete follow-up assessments related to intervention and data collection procedures feasibility and acceptability as well as coping behaviors and stress.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-arm, within-subject pilot: EmbracePlus smartwatch | Experimental | Prior to engaging in the intervention participants will complete baseline assessments of stress and coping. Participants will then engage in a daily mindfulness practice via the Headspace mobile application. The basic application program includes daily 10-minute sessions in guided mindfulness meditation that include mindful breathing, body awareness, emotion and thought recognition, and attentional control. During the first and fourth week of the intervention, participants will complete EMAs assessing mood, current activity, and intervention engagement. Participants will also wear a wrist-worn device to assess biomarkers of stress. At the completion of the intervention participants will complete follow-up assessments related to intervention and data collection procedures feasibility and acceptability as well as coping behaviors and stress. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Headspace | Device | The intervention will be delivered via the Headspace mobile application. The basic application program includes daily 10-minute sessions in guided mindfulness meditation that include mindful breathing, body awareness, emotion and thought recognition, and attentional control |
| Measure | Description | Time Frame |
|---|---|---|
| Intervention feasibility. | Headspace provides user metrics including date/time of meditation sessions, number of sessions completed, average duration of each session, and total meditation minutes overall. | 30 days (during intervention |
| Intervention acceptability | Treatment Acceptability and Adherence Scale- Participants will rate on a 0 ("Strongly disagree") to 7 ("Strongly agree") scale regarding their perceptions of acceptability of the mindfulness intervention (10 items). | up to 1 week post intervention] |
| Data collection feasibility. | Wearable Technology. EmbracePlus includes on-wrist detection, and this data will be used to evaluate how long and for how many days participants wear the device. EMA. Completion of EMA data will be calculated based on the number of assessments completed | up to 1 week post intervention |
| EMA data collection acceptability | An adapted version of the TAAS was created to evaluate EMA assessment acceptability (7 items). Higher scores are indicative of greater acceptability | up to 1 week post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Perceived Stress Scale | This measure is a 10-item, widely used and validated assessment of stress and efficacy of managing stress. The Participants are asked to respond to each question on a 5-point Likert scale ranging from 0 (never) to 4 (very often), indicating how often they have felt or thought a certain way within the past month. Scores range from 0 to 40. | Baseline and up to 1 week post intervention |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Rachel Webster, PhD | St. Jude Children's Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | United States |
Not provided
| Label | URL |
|---|---|
| St. Jude Children's Research Hospital | View source |
| Clinical Trials Open at St. Jude | View source |
Not provided
Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.
Data will be made available at the time of article publication.
Data will be provided to researchers following a formal request with the following information: full name of requestor, affiliation, data set requested, and timing of when data is needed. As an informational point, the lead statistician and study principal investigator will be informed that primary results datasets have been requested.
Not provided
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 9, 2026 | Apr 29, 2026 | 12 | ||
| May 21, 2026 |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Brief Cope inventory is a 28-item, validated assessment measure of positive and negative coping strategies across 14 domains. Participants respond on a 4 point Likert scale how often they have engaged in a particular coping strategy | Digital biomarkers of ANS activation. EmbracePlus (Empatica, Milano, Italy) is a smartwatch engineered to collect physiological biomarkers associated with ANS activation including electrodermal activity (EDA), pulse rate variability, inter-beat interval, respiratory rate, skin temperature, blood volume pulse- each used to develop a stress experience composite score | Baseline and up to 1 week post intervention |
| Jun 17, 2026 |
| 13 |
| Jun 25, 2026 |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |