The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Mindfulness Interventions to Improve Health Activation, Coping, and Stress Among Childhood Cancer Survivors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06053268
Recruitment Status : Recruiting
First Posted : September 25, 2023
Last Update Posted : May 2, 2024
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital

Tracking Information
First Submitted Date  ICMJE September 7, 2023
First Posted Date  ICMJE September 25, 2023
Last Update Posted Date May 2, 2024
Estimated Study Start Date  ICMJE May 2024
Estimated Primary Completion Date March 1, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 21, 2023)
  • Intervention feasibility. [ Time Frame: 30 days (during intervention ]
    Headspace provides user metrics including date/time of meditation sessions, number of sessions completed, average duration of each session, and total meditation minutes overall.
  • Intervention acceptability [ Time Frame: up to 1 week post intervention] ]
    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).
  • Data collection feasibility. [ Time Frame: up to 1 week post intervention ]
    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
  • EMA data collection acceptability [ Time Frame: up to 1 week post intervention ]
    An adapted version of the TAAS was created to evaluate EMA assessment acceptability (7 items). Higher scores are indicative of greater acceptability
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 21, 2023)
  • Perceived Stress Scale [ Time Frame: Baseline and up to 1 week post intervention ]
    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.
  • 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 [ Time Frame: Baseline and up to 1 week post intervention ]
    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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mindfulness Interventions to Improve Health Activation, Coping, and Stress Among Childhood Cancer Survivors
Official Title  ICMJE Mindfulness Interventions to Improve Health Activation, Coping, and Stress Among Childhood Cancer Survivors
Brief Summary

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

  • Determine the feasibility and acceptability of completing the 30-day mobile mindfulness program
  • Evaluate the feasibility of digital health data collection procedures to detect autonomic nervous system (ANS) activation associated with stress (e.g., electrodermal activity, pulse rate variability, skin temperature) via wearable devices and self-reported ecological momentary assessments (EMA) among adult survivors of childhood cancer in the SJLIFE cohort
  • Generate preliminary data to estimate the effect size and power needed for an extramurally funded randomized controlled trials (RCT) examining the impact of daily mindfulness mediation on biomarkers of ANS activation, coping, health behaviors, and cardiometabolic outcomes in a cohort of survivors of childhood cancer.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Leukemia
  • Lymphoma
  • Childhood Cancer
Intervention  ICMJE Device: Headspace
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
Study Arms  ICMJE Experimental: Single-arm, within-subject pilot: EmbracePlus smartwatch
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.
Intervention: Device: Headspace
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 21, 2023)		 50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 1, 2025
Estimated Primary Completion Date March 1, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Research participant is at least 18 years old at enrollment
  • Research participant is followed by St. Jude Children's Research Hospital (SJCRH)
  • Research participant has a diagnosis history of leukemia or lymphoma
  • Research participant takes part in the St. Jude Lifetime Cohort Study (SJLIFE)
  • Research participant has elevated psychological stress scores of 6 or greater on most recent SJLIFE questionnaire
  • Participant can speak and read English

Exclusion Criteria:

  • Research participant currently engages in mindful stress-reduction practices >2x per week (e.g., tai chi, meditation)
  • Research participant takes psychiatric medications or medications that impact cardiac functioning, beta-blockers, alpha-blockers
  • Research participant wears a pacemaker
  • Research participant has a diagnosis of a congenital heart disease
  • Research participant has no access to a smartphone
  • Research participant has elevated pain interference scores (T≥70)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Rachel Webster, PhD 866-278-5833 referralinfo@stjude.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT06053268
Other Study ID Numbers  ICMJE MINDHACS
NCI-2023-09351 ( Other Identifier: NCI Clinical Trial Registration Program )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Time Frame: Data will be made available at the time of article publication.
Access Criteria: 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.
Current Responsible Party St. Jude Children's Research Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE St. Jude Children's Research Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rachel Webster, PhD St. Jude Children's Research Hospital
PRS Account St. Jude Children's Research Hospital
Verification Date May 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP