Caregiver AnxietyNCT07420101
Easing Scan Anxiety in Pediatric Oncology Caregivers Through Meditation-based Programs
A study testing Mindful Module Caregiver Packet in people with Caregiver Anxiety and Caregiver Anxiety Related to Cancer Imaging, run by Kimberley Roche at 1 site in United States.
Trial summary
"Scanxiety" is a term coined to describe anxiety related to imaging during cancer treatment and has not been robustly studied in pediatric oncology caregivers. Mindfulness-based Stress Reduction (MBSR) is a meditation-based program that offers a non-pharmacologic approach to managing stress. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caregiver Anxiety, Caregiver Anxiety Related to Cancer Imaging, Pediatric Oncology
- What is being tested?
- Mindful Module Caregiver Packet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2026to 1 Feb 2027
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to understand spoken English and be able to read written English
- 18 years of age or older
- Able to understand and willing to sign informed consent document
- Have access to a smart phone or tablet device that is able to receive texts
- Is a caregiver of any age oncology patient (including patients above 18 years of age)
- Caregiver of a patient that is scheduled for a routine scan (CT's, MRI's, PET scans) within the upcoming 3 months
- If assigned to the Phase 2 intervention group, willing and able to eat a raisin (a box of which will be mailed to home address)
Who cannot join
- Oncology patient is of adult age and caring for self
- Medically-diagnosed cognitive delay in caregiver (by self-disclosure in eligibility questionnaire)
- Upcoming scan is due to concern for relapse/disease recurrence and is urgent
- Upcoming scan is part of initial oncology work-up
- Any non-routine surveillance scan
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
Kimberley Roche, APRN, (860) 545-8343, KRoche01@connecticutchildrens.org
Adam Barselau, M.S., 8605459630, Abarselau@connecticutchildrens.org
About this study
Official title: A Mindfulness Approach to Scanxiety
"Scanxiety" is a term coined to describe anxiety related to imaging during cancer treatment and has not been robustly studied in pediatric oncology caregivers. Mindfulness-based Stress Reduction (MBSR) is a meditation-based program that offers a non-pharmacologic approach to managing stress. The main purposes of this study are two-fold: 1). to determine if scanxiety exists in the caregivers of pediatric oncology patients and 2.) if scanxiety is found, does the implementation of a mindfulness program help to improve caregiver anxiety related to imaging.
Read the detailed description
"Scanxiety" is a term coined to describe anxiety related to imaging during cancer treatment. It is multifactorial and includes anxiety leading up to the scan as well as the waiting period after imaging and prior to results, as well as worry about possible changes in treatment. It has been documented in adult oncology literature and is associated with lower quality of life. Past adult studies show an inverse relationship with time since diagnosis and scanxiety, the further out from diagnosis, the lower level of scanxiety. Scanxiety is higher in those with lower education levels and higher baseline anxiety. Though scanxiety has been sparsely acknowledged in pediatric oncology literature, anxiety has been documented in parents of pediatric patients receiving MRI's for various diagnoses. Although caregivers of pediatric oncology patients experience high levels of distress, to date there are no studies that have measured the presence of scanxiety specifically in caregivers of pediatric oncology patients. Therefore, there are no intervention studies attempting to ameliorate anxiety related to imaging in the caregivers of pediatric oncology patients.
Mindfulness-based Stress Reduction (MBSR) is a meditation-based program that offers a non-pharmacologic approach to managing stress. Its effects of reducing stress and other stress-related outcomes including anxiety is documented in various populations including police officers, prison inmates, university students, adolescents with cardiac diagnoses, and healthcare professionals. It has also been used to decrease stress in oncology patients and the partners of adult oncology patients. MBSR sessions can be provided in person but are also effective in an online training format. Although it has been well-studied in a variety of populations, the effectiveness of MBSR has yet to be evaluated in the caregivers of pediatric oncology patients. In particular, this study aims to fill the scientific gap in exploring if MSBR may reduce scanxiety in this population.
- Being tested
- Mindful Module Caregiver Packet
- Keywords
- Scanxiety, caregiver anxiety, caregiver support, meditation, mindfulness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindful Module Caregiver PacketOther
If Scanxiety was identified, patient's caregiver will receive the Mindful Module Caregiver Packet. The intervention group will receive the daily module on Days 1-7; Day 7 being the day before scan. At the end of the module (Day 7), they will be directed to two surveys (STAI and Feasibility of the Program).
| Study group | Role | What they receive |
|---|---|---|
| Phase 1: Scanxiety Assessment | No intervention | To see if patient caregiver reports scanxiety (2-5 on the Anxiety Likert Scale). Scanxiety Assessment to determine if patients are eligible to enroll in the study. Phase 1 : Two Weeks Prior to Scan, Enrolled Patients will complete * Demographics Form * Questions About Treatment Form * Likert-style anxiety scale These instruments will determine if patients have "Scanxiety" and can participate in Phase 2 of the study. |
| Phase 2: Intervention Group | Experimental | Phase 2 participants will be randomized to either the intervention group or the control group using a random number generator sequence.
Two weeks before the scan, those assigned to the Intervention Group will be mailed a Mindful Module Caregiver Packet (Days 2-7) to complete a week before their upcoming scan. On day one they will be sent the STAI Survey via REDCAp to complete along with Mindful Module 1. Each day there will a new module sent to their email. Days 2-7 participants will be sent a daily module. At the end of the module Day 7, the day before the scan, they will be directed to 2 surveys (STAI, Feasibility and Acceptability of the Program to complete before their scan).
Control Group: Patient caregivers will not receive the Mindful Modules Caregiver Packet and will not get the sent the daily mindfulness modules. Will complete above surveys at above timelines as stated in Intervention Group. Receives: Other: Mindful Module Caregiver Packet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Likert-Style Anxiety Scale
Used to determine if the caregivers of pediatric oncology patients experience scanxiety. This one-item instrument scale ranges from 1 (not anxious at all) to 5 (extremely anxious). The goal of this instrument is to grossly establish if Scanxiety is present in caregivers. If caregivers answer between 2 (A little anxious)-5 (Extremely anxious) it demonstrates levels of anxiety.
Measured: Caregivers will complete this 2 weeks before the scan.
State-Trait Anxiety Inventory (STAI)
Used to determine if the caregivers of pediatric oncology patients experience scanxiety. This 40-item self-reported survey measures anxiety. These 40 questions are divided into two 20-quesiton sections (one for "state" anxiety, and one for "trait" anxiety). Higher scores demonstrate high levels of anxiety. the scores range from 20-80 [very high anxiety (> 65), high anxiety (56-65), moderate anxiety (46-55), low anxiety (36-45) and very low anxiety (< or = 35).
Measured: If anxiety is demonstrated in caregivers, they will move into Phase 2 of this study either in the Intervention Arm or the Control Arm. The State-Trait Anxiety Inventory (STAI) will be administered on Timepoint Day 1 and again on Timepoint Day 7.
Feasibility of the Program
This questionnaire measures the ease of completion of the mindfulness modules, the perceived appeal of the mindfulness program, participant interest, likelihood of recommending the program to others, and participation in other mindfulness-based activities (e.g., yoga or meditation) outside of the study in a YES or NO response format.
Measured: Will be administered to caregivers in the Intervention Arm Only on Day 7.
Acceptability of Intervention Measure (AIM)
To evaluate the study's ability to generate interest in similar programs and its perceived applicability. This 4-question scale has values ranging from 1 (Completely disagree), 2 Disagree, 3 Neither agree nor disagree, 4 Agree, and 5 Completely agree).
Measured: Will be administered to both Intervention and Control Arm on both Day 1 and Day 7.
Intervention Appropriateness Measure (IAM)
To evaluate the study's ability to generate interest in similar programs its, perceived applicability and the likelihood of recommendation to other oncology families. This 4-question scale has values ranging from 1 (Completely disagree), 2 Disagree, 3 Neither agree nor disagree, 4 Agree, and 5 Completely agree).
Measured: Timeframe: Will be administered on both intervention and Control Arm on both Day 1 and Day 7.
Feasibility of Intervention Measure (FIM)
To evaluate the study's ability to generate interest in its ease of completion. This 4-question scale has values ranging from 1 (Completely disagree), 2 Disagree, 3 Neither agree nor disagree, 4 Agree, and 5 Completely agree).
Measured: Will be administered on both intervention and Control Arm on both Day 1 and Day 7.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start1 Feb 2026
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Caregiver AnxietyStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase 1: To determine if scanxiety occurs in the caregivers of pediatric oncology patients relative to imaging studies at Connecticut Children's. Phase 2: To test whether a MBSR-influenced online intervention program decreases caregiver scanxiety.
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kimberley Roche
- Sponsor type
- University, hospital or other
- Collaborators
- Connecticut Children's Medical Center, UConn Health
- Responsible party
- Sponsor-investigator, Kimberley Roche, Connecticut Children's Medical Center
- Investigators
- Kimberley Roche, MSN, PPCNP-BC, APRN, Principal investigator, Connecticut Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07420101
- Sponsor's protocol ID
- 24-135
- Status last verified
- Feb 2026
- First submitted
- 30 Jan 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yu J, Han M, Miao F, Hua D. Using mindfulness-based stress reduction to relieve loneliness, anxiety, and depression in cancer patients: A systematic review and meta-analysis. Medicine (Baltimore). 2023 Sep 15;102(37):e34917. doi: 10.1097/MD.0000000000034917.
PubMed 37713902Worthen M, Cash E. Stress Management. 2023 Aug 14. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK513300/
PubMed 30020672Wexler TM, Schellinger J. Mindfulness-Based Stress Reduction for Nurses: An Integrative Review. J Holist Nurs. 2023 Mar;41(1):40-59. doi: 10.1177/08980101221079472. Epub 2022 Feb 25.
PubMed 35213264Wang Y, Kou J, Han B. Effect of online modified mindfulness-based stress reduction training on the resilience of nursing interns in China. Nurs Open. 2023 Aug;10(8):5493-5499. doi: 10.1002/nop2.1788. Epub 2023 Apr 25.
PubMed 37186462Voss A, Bogdanski M, Langohr B, Albrecht R, Sandbothe M. Mindfulness-Based Student Training Leads to a Reduction in Physiological Evaluated Stress. Front Psychol. 2020 May 14;11:645. doi: 10.3389/fpsyg.2020.00645. eCollection 2020.
PubMed 32477199van den Hurk DG, Schellekens MP, Molema J, Speckens AE, van der Drift MA. Mindfulness-Based Stress Reduction for lung cancer patients and their partners: Results of a mixed methods pilot study. Palliat Med. 2015 Jul;29(7):652-60. doi: 10.1177/0269216315572720. Epub 2015 Feb 20.
PubMed 25701663Vadvilavicius T, Varnagiryte E, Jarasiunaite-Fedosejeva G, Gustainiene L. The Effectiveness of Mindfulness-Based Interventions for Police Officers' Stress Reduction: a Systematic Review. J Police Crim Psychol. 2023;38(1):223-239. doi: 10.1007/s11896-022-09570-2. Epub 2023 Jan 30.
PubMed 36741275Spielberger, C. D., Gorsuch, R. L., Lushene, R., Vagg, P. R., & Jacobs, G. A. (1983). Manual for the State-Trait Anxiety Inventory. Palo Alto, CA: Consulting Psychologists Press.
Scarponi D, Sarti P, Rivi V, Colliva C, Marconi E, Pession A, Blom JMC. Emotional, Behavioral, and Physical Health Consequences in Caregivers of Children with Cancer: A Network Analysis Differentiation in Mothers' and Fathers' Reactivity. Cancers (Basel). 2023 Jul 4;15(13):3496. doi: 10.3390/cancers15133496.
PubMed 37444606Morel B, Andersson F, Samalbide M, Binninger G, Carpentier E, Sirinelli D, Cottier JP. Impact on child and parent anxiety level of a teddy bear-scale mock magnetic resonance scanner. Pediatr Radiol. 2020 Jan;50(1):116-120. doi: 10.1007/s00247-019-04514-1. Epub 2019 Sep 9.
PubMed 31501961Lamothe M, Rondeau E, Duval M, McDuff P, Pastore YD, Sultan S. Changes in hair cortisol and self-reported stress measures following mindfulness-based stress reduction (MBSR): A proof-of-concept study in pediatric hematology-oncology professionals. Complement Ther Clin Pract. 2020 Nov;41:101249. doi: 10.1016/j.ctcp.2020.101249. Epub 2020 Oct 23.
PubMed 33120117Kriakous SA, Elliott KA, Lamers C, Owen R. The Effectiveness of Mindfulness-Based Stress Reduction on the Psychological Functioning of Healthcare Professionals: a Systematic Review. Mindfulness (N Y). 2021;12(1):1-28. doi: 10.1007/s12671-020-01500-9. Epub 2020 Sep 24.
PubMed 32989406Freedenberg VA, Hinds PS, Friedmann E. Mindfulness-Based Stress Reduction and Group Support Decrease Stress in Adolescents with Cardiac Diagnoses: A Randomized Two-Group Study. Pediatr Cardiol. 2017 Oct;38(7):1415-1425. doi: 10.1007/s00246-017-1679-5. Epub 2017 Jul 12.
PubMed 28702717Derry-Vick HM, Heathcote LC, Glesby N, Stribling J, Luebke M, Epstein AS, Prigerson HG. Scanxiety among Adults with Cancer: A Scoping Review to Guide Research and Interventions. Cancers (Basel). 2023 Feb 22;15(5):1381. doi: 10.3390/cancers15051381.
PubMed 36900174Bui KT, Liang R, Kiely BE, Brown C, Dhillon HM, Blinman P. Scanxiety: a scoping review about scan-associated anxiety. BMJ Open. 2021 May 26;11(5):e043215. doi: 10.1136/bmjopen-2020-043215.
PubMed 34039571
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mindfulness Approach to Scanxiety
- ClinicalTrials.gov ID
- NCT07420101
- Acronym / sponsor ID
- 24-135
- Keywords
- Scanxiety, caregiver anxiety, caregiver support, meditation, mindfulness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Kimberley RocheUniversity, hospital or other
- Collaborators
- Connecticut Children's Medical Center, UConn Health
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 19 Feb 2026 (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.
"Scanxiety" is a term coined to describe anxiety related to imaging during cancer treatment and has not been robustly studied in pediatric oncology caregivers. Mindfulness-based Stress Reduction (MBSR) is a meditation-based program that offers a non-pharmacologic approach to managing stress. The main purposes of this study are two-fold: 1). to determine if scanxiety exists in the caregivers of pediatric oncology patients and 2.) if scanxiety is found, does the implementation of a mindfulness program help to improve caregiver anxiety related to imaging.
Detailed description
"Scanxiety" is a term coined to describe anxiety related to imaging during cancer treatment. It is multifactorial and includes anxiety leading up to the scan as well as the waiting period after imaging and prior to results, as well as worry about possible changes in treatment. It has been documented in adult oncology literature and is associated with lower quality of life. Past adult studies show an inverse relationship with time since diagnosis and scanxiety, the further out from diagnosis, the lower level of scanxiety. Scanxiety is higher in those with lower education levels and higher baseline anxiety. Though scanxiety has been sparsely acknowledged in pediatric oncology literature, anxiety has been documented in parents of pediatric patients receiving MRI's for various diagnoses. Although caregivers of pediatric oncology patients experience high levels of distress, to date there are no studies that have measured the presence of scanxiety specifically in caregivers of pediatric oncology patients. Therefore, there are no intervention studies attempting to ameliorate anxiety related to imaging in the caregivers of pediatric oncology patients.
Mindfulness-based Stress Reduction (MBSR) is a meditation-based program that offers a non-pharmacologic approach to managing stress. Its effects of reducing stress and other stress-related outcomes including anxiety is documented in various populations including police officers, prison inmates, university students, adolescents with cardiac diagnoses, and healthcare professionals. It has also been used to decrease stress in oncology patients and the partners of adult oncology patients. MBSR sessions can be provided in person but are also effective in an online training format. Although it has been well-studied in a variety of populations, the effectiveness of MBSR has yet to be evaluated in the caregivers of pediatric oncology patients. In particular, this study aims to fill the scientific gap in exploring if MSBR may reduce scanxiety in this population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phase 1: To determine if scanxiety occurs in the caregivers of pediatric oncology patients relative to imaging studies at Connecticut Children's. Phase 2: To test whether a MBSR-influenced online intervention program decreases caregiver scanxiety.
| Arm | Type | Receives |
|---|---|---|
| Phase 1: Scanxiety Assessment | No intervention | –To see if patient caregiver reports scanxiety (2-5 on the Anxiety Likert Scale). Scanxiety Assessment to determine if patients are eligible to enroll in the study. Phase 1 : Two Weeks Prior to Scan, Enrolled Patients will complete * Demographics Form * Questions About Treatment Form * Likert-style anxiety scale These instruments will determine if patients have "Scanxiety" and can participate in Phase 2 of the study. |
| Phase 2: Intervention Group | Experimental | Other: Mindful Module Caregiver PacketPhase 2 participants will be randomized to either the intervention group or the control group using a random number generator sequence. Two weeks before the scan, those assigned to the Intervention Group will be mailed a Mindful Module Caregiver Packet (Days 2-7) to complete a week before their upcoming scan. On day one they will be sent the STAI Survey via REDCAp to complete along with Mindful Module 1. Each day there will a new module sent to their email. Days 2-7 participants will be sent a daily module. At the end of the module Day 7, the day before the scan, they will be directed to 2 surveys (STAI, Feasibility and Acceptability of the Program to complete before their scan). Control Group: Patient caregivers will not receive the Mindful Modules Caregiver Packet and will not get the sent the daily mindfulness modules. Will complete above surveys at above timelines as stated in Intervention Group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Able to understand spoken English and be able to read written English
- 18 years of age or older
- Able to understand and willing to sign informed consent document
- Have access to a smart phone or tablet device that is able to receive texts
- Is a caregiver of any age oncology patient (including patients above 18 years of age)
Key exclusion criteria (5 listed)
- Oncology patient is of adult age and caring for self
- Medically-diagnosed cognitive delay in caregiver (by self-disclosure in eligibility questionnaire)
- Upcoming scan is due to concern for relapse/disease recurrence and is urgent
- Upcoming scan is part of initial oncology work-up
- Any non-routine surveillance scan
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 |
|---|---|---|
| Mindful Module Caregiver PacketIf Scanxiety was identified, patient's caregiver will receive the Mindful Module Caregiver Packet. The intervention group will receive the daily module on Days 1-7; Day 7 being the day before scan. At the end of the module (Day 7), they will be directed to two surveys (STAI and Feasibility of the Program). | Other | Phase 2: Intervention Group |
Primary outcome
Likert-Style Anxiety Scale
Time frame: Caregivers will complete this 2 weeks before the scan.
Used to determine if the caregivers of pediatric oncology patients experience scanxiety. This one-item instrument scale ranges from 1 (not anxious at all) to 5 (extremely anxious). The goal of this instrument is to grossly establish if Scanxiety is present in caregivers. If caregivers answer between 2 (A little anxious)-5 (Extremely anxious) it demonstrates levels of anxiety.
State-Trait Anxiety Inventory (STAI)
Time frame: If anxiety is demonstrated in caregivers, they will move into Phase 2 of this study either in the Intervention Arm or the Control Arm. The State-Trait Anxiety Inventory (STAI) will be administered on Timepoint Day 1 and again on Timepoint Day 7.
Used to determine if the caregivers of pediatric oncology patients experience scanxiety. This 40-item self-reported survey measures anxiety. These 40 questions are divided into two 20-quesiton sections (one for "state" anxiety, and one for "trait" anxiety). Higher scores demonstrate high levels of anxiety. the scores range from 20-80 [very high anxiety (> 65), high anxiety (56-65), moderate anxiety (46-55), low anxiety (36-45) and very low anxiety (< or = 35).
Feasibility of the Program
Time frame: Will be administered to caregivers in the Intervention Arm Only on Day 7.
This questionnaire measures the ease of completion of the mindfulness modules, the perceived appeal of the mindfulness program, participant interest, likelihood of recommending the program to others, and participation in other mindfulness-based activities (e.g., yoga or meditation) outside of the study in a YES or NO response format.
Acceptability of Intervention Measure (AIM)
Time frame: Will be administered to both Intervention and Control Arm on both Day 1 and Day 7.
To evaluate the study's ability to generate interest in similar programs and its perceived applicability. This 4-question scale has values ranging from 1 (Completely disagree), 2 Disagree, 3 Neither agree nor disagree, 4 Agree, and 5 Completely agree).
Intervention Appropriateness Measure (IAM)
Time frame: Timeframe: Will be administered on both intervention and Control Arm on both Day 1 and Day 7.
To evaluate the study's ability to generate interest in similar programs its, perceived applicability and the likelihood of recommendation to other oncology families. This 4-question scale has values ranging from 1 (Completely disagree), 2 Disagree, 3 Neither agree nor disagree, 4 Agree, and 5 Completely agree).
Feasibility of Intervention Measure (FIM)
Time frame: Will be administered on both intervention and Control Arm on both Day 1 and Day 7.
To evaluate the study's ability to generate interest in its ease of completion. This 4-question scale has values ranging from 1 (Completely disagree), 2 Disagree, 3 Neither agree nor disagree, 4 Agree, and 5 Completely agree).
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 19 Mar 2026.
- Background: PubMed 37713902Yu J, Han M, Miao F, Hua D. Using mindfulness-based stress reduction to relieve loneliness, anxiety, and depression in cancer patients: A systematic review and meta-analysis. Medicine (Baltimore). 2023 Sep 15;102(37):e34917. doi: 10.1097/MD.0000000000034917.
- Background: PubMed 30020672Worthen M, Cash E. Stress Management. 2023 Aug 14. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK513300/
- Background: PubMed 35213264Wexler TM, Schellinger J. Mindfulness-Based Stress Reduction for Nurses: An Integrative Review. J Holist Nurs. 2023 Mar;41(1):40-59. doi: 10.1177/08980101221079472. Epub 2022 Feb 25.
- Background: PubMed 37186462Wang Y, Kou J, Han B. Effect of online modified mindfulness-based stress reduction training on the resilience of nursing interns in China. Nurs Open. 2023 Aug;10(8):5493-5499. doi: 10.1002/nop2.1788. Epub 2023 Apr 25.
- Background: PubMed 32477199Voss A, Bogdanski M, Langohr B, Albrecht R, Sandbothe M. Mindfulness-Based Student Training Leads to a Reduction in Physiological Evaluated Stress. Front Psychol. 2020 May 14;11:645. doi: 10.3389/fpsyg.2020.00645. eCollection 2020.
- Background: PubMed 25701663van den Hurk DG, Schellekens MP, Molema J, Speckens AE, van der Drift MA. Mindfulness-Based Stress Reduction for lung cancer patients and their partners: Results of a mixed methods pilot study. Palliat Med. 2015 Jul;29(7):652-60. doi: 10.1177/0269216315572720. Epub 2015 Feb 20.
- Background: PubMed 36741275Vadvilavicius T, Varnagiryte E, Jarasiunaite-Fedosejeva G, Gustainiene L. The Effectiveness of Mindfulness-Based Interventions for Police Officers' Stress Reduction: a Systematic Review. J Police Crim Psychol. 2023;38(1):223-239. doi: 10.1007/s11896-022-09570-2. Epub 2023 Jan 30.
- BackgroundSpielberger, C. D., Gorsuch, R. L., Lushene, R., Vagg, P. R., & Jacobs, G. A. (1983). Manual for the State-Trait Anxiety Inventory. Palo Alto, CA: Consulting Psychologists Press.
- Background: PubMed 37444606Scarponi D, Sarti P, Rivi V, Colliva C, Marconi E, Pession A, Blom JMC. Emotional, Behavioral, and Physical Health Consequences in Caregivers of Children with Cancer: A Network Analysis Differentiation in Mothers' and Fathers' Reactivity. Cancers (Basel). 2023 Jul 4;15(13):3496. doi: 10.3390/cancers15133496.
- Background: PubMed 31501961Morel B, Andersson F, Samalbide M, Binninger G, Carpentier E, Sirinelli D, Cottier JP. Impact on child and parent anxiety level of a teddy bear-scale mock magnetic resonance scanner. Pediatr Radiol. 2020 Jan;50(1):116-120. doi: 10.1007/s00247-019-04514-1. Epub 2019 Sep 9.
- Background: PubMed 33120117Lamothe M, Rondeau E, Duval M, McDuff P, Pastore YD, Sultan S. Changes in hair cortisol and self-reported stress measures following mindfulness-based stress reduction (MBSR): A proof-of-concept study in pediatric hematology-oncology professionals. Complement Ther Clin Pract. 2020 Nov;41:101249. doi: 10.1016/j.ctcp.2020.101249. Epub 2020 Oct 23.
- Background: PubMed 32989406Kriakous SA, Elliott KA, Lamers C, Owen R. The Effectiveness of Mindfulness-Based Stress Reduction on the Psychological Functioning of Healthcare Professionals: a Systematic Review. Mindfulness (N Y). 2021;12(1):1-28. doi: 10.1007/s12671-020-01500-9. Epub 2020 Sep 24.
- Individual participant dataSharing planned: No
Related trials for Caregiver Anxiety
Recruiting
Comprehensive Assessment of Rehabilitation Experience Using the SAFE Scale
Caregiver Anxiety, Acquired Brain Injury
Not yet recruiting
Health-Related Social Needs Food Boxes Delivery Program
Food Insecurity
Not yet recruitingObservational study
Caregiver and Child Anxiety, Relationships, and Daily Emotions ("CARE Study")
Anxiety
Recruiting
A Study of an Anxiety Intervention for Latino/Latina/Hispanic Older Adults With Cancer and Their Caregivers
Cancer Patients, Care Givers
Not yet recruitingPhase 2
Peer Support for Family Caregivers of Older Adults Living With Dementia
Caregiver Burden, Caregiver Burnout
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.
Kimberley Roche, MSN, PPCNP-BC, APRN principal investigator
Connecticut Children's Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindful Module Caregiver Packet in people with Caregiver Anxiety and Caregiver Anxiety Related to Cancer Imaging, run by Kimberley Roche 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 7 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 19 Mar 2026. 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?
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?
Contact Kimberley Roche, MSN, PPCNP-BC, APRN (860-545-9671, KRoche01@connecticutchildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Likert-Style Anxiety Scale (time frame: Caregivers will complete this 2 weeks before the scan.). The study lists 6 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 NCT07420101, which also lists 17 linked publications.
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 19 Mar 2026.