Psychological DistressNCT06858202
Structured Post-Operative Pain and Distress Treatment Intervention for Patients Undergoing Surgery for Intra-Abdominal Malignancies
A study testing Mindfulness Intervention and Non-mindfulness Intervention in people with Psychological Distress and Intra-abdominal Cancer, run by University of Utah at 1 site in United States.
Trial summary
The purpose of this study is to determine if different video based coping strategies can help patients undergoing surgery for cancer can improve patients pain and distress after surgery for their cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychological Distress, Intra-abdominal Cancer
- What is being tested?
- Mindfulness Intervention and Non-mindfulness Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2025to Sep 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
- English-speaking males or females 18 or older within the University of Utah Hospital system being treated for an intrabdominal malignancy.
- Patients undergoing surgical treatment of cancer within the abdominal cavity.
Who cannot join
- Altered mental status due to delirium or pharmacological sedation as determined by a clinical assessment conducted by a study staff.
- Non-English speaking.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Health
Salt Lake City, Utah, 84132
About this study
The purpose of this study is to determine if different video based coping strategies can help patients undergoing surgery for cancer can improve patients pain and distress after surgery for their cancer.
The main questions this study aims to answer are:
Read more
- Is it possible to use video-based coping strategies to help manage pain and distress after surgery?
- Is one type of coping strategy better than another?
Researchers will compare mindfulness-based coping strategies (e.g., guided meditation, expressive writing, etc.) with non-mindfulness coping strategies (e.g., support from social workers and the wellness center, health education, etc.) to understand how these can help in post-surgery recovery, pain management, and distress.
Participants will:
- Provide their full name, date of surgery, e-mail address, and phone number and agree to be contacted via email or text messaging.
- Fill out some questionnaires before surgery, which should take 10-15 minutes.
- Be assigned to one of three coping strategies.
- Review a video (about 15-20 minutes long) or links to online resources before surgery and respond to questions about pain and distress before and after viewing these materials.
- Review additional videos or links 2, 3, and 4 days after surgery and respond to questions about pain and distress before and after viewing these materials.
- Complete additional questionnaires 2 weeks, 3 months, and 6 months after surgery. These questionnaires will be sent by text or email and should take about 10-15 minutes to complete.
Read the detailed description
We propose to conduct a quality improvement project to determine the impact of different types of psychosocial support for patients undergoing surgery for intrabdominal malignancies.
This project will consist of a program evaluation/quality improvement study of existing pain and psychosocial management programs within the University of Utah Hospital System, which currently employs Study staff to provide mindfulness and non-mindfulness interventions for patients preparing for surgery and recovering from surgery. We wish to evaluate the differential impact of mindfulness interventions (e.g., guided meditation, expressive writing, etc.) and non-mindfulness interventions (. g., cognitive-behaviorally based psychoeducation, health education, grounding/earthing, and sham grounding/earthing, etc., support via social work and the wellness center, etc.) by randomly assigning patients to one of these approaches.
Objectives:
Aim 1 To assess the feasibility and acceptability of an application-based mindfulness or expressive writing intervention designed to address post-operative pain and distress, such as anxiety or depression, for patients undergoing surgery for intrabdominal malignancies.
Hypotheses: Greater than 50% of patients assigned to a mindfulness intervention, either guided meditation or expressive writing, will engage with at least one intervention, and over 30% of patients will engage with all four interventions.
Aim 2 To assess the differential effects of mindfulness vs. non-mindfulness therapeutic approaches on pain, distress, patient health engagement, and pain medication usage for patients preparing for/recovering from surgery for intraabdominal malignancies and identify the most sensitive instruments to detect this change in this population.
Hypotheses: Mindfulness-based therapeutic approaches, including guided meditation and expressive writing, will decrease pain, distress, and pain medicine usage and increase patient health engagement significantly more than standard non-mindfulness-based therapeutic approaches. We predict narcotic requirements during the post-operative period, and patient-reported pain scores will be the most sensitive.
- Conditions
- Psychological Distress, Intra-abdominal Cancer
- Being tested
- Mindfulness Intervention, Non-mindfulness Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness InterventionBehavioural
Guided meditation or guided expressive writing
Non-mindfulness InterventionBehavioural
Standard inpatient and outpatient resources available for Huntsman Cancer Institute patients through social work and the Wellness and Integrative Health Center. Participants will be encouraged to ask their providers for more information or if appropriate more consults to the appropriate resources if interested.
| Study group | Role | What they receive |
|---|---|---|
| Video-based Guided Mindfulness | Experimental | A 15-20-minute video based on previously tested and documented standards for guided meditation aimed at addressing pain and distress. Receives: Behavioral: Mindfulness Intervention |
| Video-based Guided Expressive Writing | Experimental | A 15-20-minute video based on expressive writing prompts aimed at addressing pain and distress. If the patient is assigned expressive writing, they will be offered a blank journal to use for the expressive writing interventions after randomization. Receives: Behavioral: Mindfulness Intervention |
| Non-Mindfulness Based Therapeutic Approaches | Active comparator | Standard inpatient and outpatient resources available for Huntsman Cancer Institute patients through social work and the Wellness and Integrative Health Center. Participants will be encouraged to ask their providers for more information or if appropriate more consults to the appropriate resources if interested. Receives: Behavioral: Non-mindfulness Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and acceptability of delivering video based mindfulness interventions
The frequency that patients start and complete at least one mindfulness intervention will be evaluated and compared to the other two cohorts. The frequency of engaging with and completing the interventions will be reported descriptively. The Chi2 for Fisher's will be used for exact test.
Measured: From enrollment to 6 months post-enrollment.
Secondary outcomes (10)
Participant-reported Global Impression of Change
Patient global impression for change will be assessed using the PCIG (Rampakakis, Ste-Marie, et al. 2015, Perrot and Lantéri-Minet 2019) questionnaire. The questionnaire includes two items in which patients rate the change in their activity limitations, symptoms, and emotions on a descriptive scale from "No Change" = 1 to "A great deal better" = 7 and a visual scale from "Much better" = 0 to "Much worse" = 10.
Measured: From enrollment to 6 months post-enrollment.
Participant-reported pain intensity
Change in pain symptoms will be assessed using the PROMIS Scale v2.0 Pain Intensity 3a questionnaire. This measure includes three items rating pain from "Had no pain" = 1 to "Very severe" = 5.
Measured: From enrollment to 6 months post-enrollment.
Participant-reported pain interference
Change in pain interference will be assessed using the PROMIS Scale v1.1 Pain Interference 4a questionnaire. This measure includes three items rating the scale in which pain interferes with daily life from "Not at all" = 1 to "Very much" = 5.
Measured: From enrollment to 6 months post-enrollment.
Participant-reported physical function
Change in physical will be assessed using the PROMIS Scale v2.0 Physical Function Short Form 6b questionnaire. This measure includes six items rating difficulty of daily tasks related to physical function from "Without any difficulty" = 1 to "Unable to do" = 5.
Measured: From enrollment to 6 months post-enrollment.
Participant-reported health engagement
Participant health engagement will be assessed using the PHE questionnaire (Graffigna et. al 2015). This measure includes nine items in which patients rate how they feel about and engage with their disease. This scale has been adapted for study use to be rated on a scale from "never" = 1 to "always" = 5.
Measured: From enrollment to 6 months post-enrollment.
Participant-reported depression
Change in emotional distress symptoms for depression will be assessed using the PROMIS Scale v1.0 Emotional Distress-Depression Short form 6a questionnaire. The questionnaire includes six items rating occurrence of different depression related emotions from "Never" = 1 to "Always" = 5.
Measured: From enrollment to 6 months post-enrollment.
Participant-reported anxiety
Change in emotional distress symptoms for anxiety will be assessed using the PROMIS Scale v1.0 Emotional Distress-Anxiety Short form 6a questionnaire. The questionnaire includes six items rating occurrence of different anxiety related emotions from "Never" = 1 to "Always" = 5.
Measured: From enrollment to 6 months post-enrollment.
Participant-reported social isolation
Change in levels of social isolation will be assessed using the PROMIS Scale v2.0 Social Isolation Short form 4a questionnaire. The questionnaire includes four items rating the occurrence of different feelings regarding social isolation from "Never" = 1 to "Always" = 5.
Measured: From enrollment to 6 months post-enrollment.
Participant-reported quality of life
Participant quality of life will be assessed using the World Health Organization Quality of Life questionnaire. This questionnaire consists of two items that assess how patients feel about their quality of life on a scale from "Very poor" and "Very dissatisfied" =1 to "Very good" and "Very satisfied" = 5.
Measured: From enrollment to 6 months post-enrollment.
Participant use of pain medicine
Patient narcotic consumption in the post-operative period will be collected via chart abstraction. Use of pain medicine will be compared with intervention acceptability and frequency of use at the end of the study, which may help guide future studies.
Measured: From enrollment to 6 months post-enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start20 Feb 2025
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Psychological DistressStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erin Ward, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06858202
- Sponsor's protocol ID
- HCI166993
- Status last verified
- Mar 2026
- First submitted
- 21 Feb 2025
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang R, Li L, Xu J, Ding ZT, Qiao J, Redding SR, Xianyu YY, Ouyang YQ. Effects of Structured Expressive Writing on Quality of Life and Perceived Self-Care Self-Efficacy of Breast Cancer Patients Undergoing Chemotherapy in Central China: A Randomized Controlled Trial. Healthcare (Basel). 2022 Sep 14;10(9):1762. doi: 10.3390/healthcare10091762.
PubMed 36141374Day MA, Ward LC, Ehde DM, Thorn BE, Burns J, Barnier A, Mattingley JB, Jensen MP. A Pilot Randomized Controlled Trial Comparing Mindfulness Meditation, Cognitive Therapy, and Mindfulness-Based Cognitive Therapy for Chronic Low Back Pain. Pain Med. 2019 Nov 1;20(11):2134-2148. doi: 10.1093/pm/pny273.
PubMed 30605517Rouleau CR, Garland SN, Carlson LE. The impact of mindfulness-based interventions on symptom burden, positive psychological outcomes, and biomarkers in cancer patients. Cancer Manag Res. 2015 Jun 1;7:121-31. doi: 10.2147/CMAR.S64165. eCollection 2015.
PubMed 26064068Hanley AW, Gililland J, Erickson J, Pelt C, Peters C, Rojas J, Garland EL. Brief preoperative mind-body therapies for total joint arthroplasty patients: a randomized controlled trial. Pain. 2021 Jun 1;162(6):1749-1757. doi: 10.1097/j.pain.0000000000002195.
PubMed 33449510Garland EL, Baker AK, Larsen P, Riquino MR, Priddy SE, Thomas E, Hanley AW, Galbraith P, Wanner N, Nakamura Y. Randomized Controlled Trial of Brief Mindfulness Training and Hypnotic Suggestion for Acute Pain Relief in the Hospital Setting. J Gen Intern Med. 2017 Oct;32(10):1106-1113. doi: 10.1007/s11606-017-4116-9. Epub 2017 Jul 12.
PubMed 28702870Zgierska AE, Burzinski CA, Cox J, Kloke J, Stegner A, Cook DB, Singles J, Mirgain S, Coe CL, Backonja M. Mindfulness Meditation and Cognitive Behavioral Therapy Intervention Reduces Pain Severity and Sensitivity in Opioid-Treated Chronic Low Back Pain: Pilot Findings from a Randomized Controlled Trial. Pain Med. 2016 Oct;17(10):1865-1881. doi: 10.1093/pm/pnw006. Epub 2016 Mar 10.
PubMed 26968850Teresi JA, Yu X, Stewart AL, Hays RD. Guidelines for Designing and Evaluating Feasibility Pilot Studies. Med Care. 2022 Jan 1;60(1):95-103. doi: 10.1097/MLR.0000000000001664.
PubMed 34812790Billingham SA, Whitehead AL, Julious SA. An audit of sample sizes for pilot and feasibility trials being undertaken in the United Kingdom registered in the United Kingdom Clinical Research Network database. BMC Med Res Methodol. 2013 Aug 20;13:104. doi: 10.1186/1471-2288-13-104.
PubMed 23961782Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016 Jun;25(3):1057-73. doi: 10.1177/0962280215588241. Epub 2015 Jun 19.
PubMed 26092476Rampakakis E, Ste-Marie PA, Sampalis JS, Karellis A, Shir Y, Fitzcharles MA. Real-life assessment of the validity of patient global impression of change in fibromyalgia. RMD Open. 2015 Sep 14;1(1):e000146. doi: 10.1136/rmdopen-2015-000146. eCollection 2015.
PubMed 26535150Perrot S, Lanteri-Minet M. Patients' Global Impression of Change in the management of peripheral neuropathic pain: Clinical relevance and correlations in daily practice. Eur J Pain. 2019 Jul;23(6):1117-1128. doi: 10.1002/ejp.1378. Epub 2019 Mar 18.
PubMed 30793414Hanley AW, Garland EL. Clarity of mind: Structural equation modeling of associations between dispositional mindfulness, self-concept clarity and psychological well-being. Pers Individ Dif. 2017 Feb 1;106:334-339. doi: 10.1016/j.paid.2016.10.028. Epub 2016 Nov 9. No abstract available.
PubMed 28584390Hanley AW, Garland EL. Dispositional Mindfulness Co-varies with Self-Reported Positive Reappraisal. Pers Individ Dif. 2014 Aug 1;66:146-152. doi: 10.1016/j.paid.2014.03.014.
PubMed 24904191Milbury K, Spelman A, Wood C, Matin SF, Tannir N, Jonasch E, Pisters L, Wei Q, Cohen L. Randomized controlled trial of expressive writing for patients with renal cell carcinoma. J Clin Oncol. 2014 Mar 1;32(7):663-70. doi: 10.1200/JCO.2013.50.3532. Epub 2014 Jan 27.
PubMed 24470003Carlson LE, Tamagawa R, Stephen J, Drysdale E, Zhong L, Speca M. Randomized-controlled trial of mindfulness-based cancer recovery versus supportive expressive group therapy among distressed breast cancer survivors (MINDSET): long-term follow-up results. Psychooncology. 2016 Jul;25(7):750-9. doi: 10.1002/pon.4150. Epub 2016 May 18.
PubMed 27193737
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structured Post-Operative Pain and Distress Treatment Intervention for Patients Undergoing Surgery for Intra-Abdominal Malignancies
- ClinicalTrials.gov ID
- NCT06858202
- Acronym / sponsor ID
- HCI166993
- Conditions
- Psychological Distress, Intra-abdominal Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 95 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 20 Feb 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 5 Mar 2025 (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.
The purpose of this study is to determine if different video based coping strategies can help patients undergoing surgery for cancer can improve patients pain and distress after surgery for their cancer.
The main questions this study aims to answer are:
- Is it possible to use video-based coping strategies to help manage pain and distress after surgery?
- Is one type of coping strategy better than another?
Researchers will compare mindfulness-based coping strategies (e.g., guided meditation, expressive writing, etc.) with non-mindfulness coping strategies (e.g., support from social workers and the wellness center, health education, etc.) to understand how these can help in post-surgery recovery, pain management, and distress.
Participants will:
- Provide their full name, date of surgery, e-mail address, and phone number and agree to be contacted via email or text messaging.
- Fill out some questionnaires before surgery, which should take 10-15 minutes.
- Be assigned to one of three coping strategies.
- Review a video (about 15-20 minutes long) or links to online resources before surgery and respond to questions about pain and distress before and after viewing these materials.
- Review additional videos or links 2, 3, and 4 days after surgery and respond to questions about pain and distress before and after viewing these materials.
- Complete additional questionnaires 2 weeks, 3 months, and 6 months after surgery. These questionnaires will be sent by text or email and should take about 10-15 minutes to complete.
Detailed description
We propose to conduct a quality improvement project to determine the impact of different types of psychosocial support for patients undergoing surgery for intrabdominal malignancies.
This project will consist of a program evaluation/quality improvement study of existing pain and psychosocial management programs within the University of Utah Hospital System, which currently employs Study staff to provide mindfulness and non-mindfulness interventions for patients preparing for surgery and recovering from surgery. We wish to evaluate the differential impact of mindfulness interventions (e.g., guided meditation, expressive writing, etc.) and non-mindfulness interventions (. g., cognitive-behaviorally based psychoeducation, health education, grounding/earthing, and sham grounding/earthing, etc., support via social work and the wellness center, etc.) by randomly assigning patients to one of these approaches.
Objectives:
Aim 1 To assess the feasibility and acceptability of an application-based mindfulness or expressive writing intervention designed to address post-operative pain and distress, such as anxiety or depression, for patients undergoing surgery for intrabdominal malignancies.
Hypotheses: Greater than 50% of patients assigned to a mindfulness intervention, either guided meditation or expressive writing, will engage with at least one intervention, and over 30% of patients will engage with all four interventions.
Aim 2 To assess the differential effects of mindfulness vs. non-mindfulness therapeutic approaches on pain, distress, patient health engagement, and pain medication usage for patients preparing for/recovering from surgery for intraabdominal malignancies and identify the most sensitive instruments to detect this change in this population.
Hypotheses: Mindfulness-based therapeutic approaches, including guided meditation and expressive writing, will decrease pain, distress, and pain medicine usage and increase patient health engagement significantly more than standard non-mindfulness-based therapeutic approaches. We predict narcotic requirements during the post-operative period, and patient-reported pain scores will be the most sensitive.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Video-based Guided Mindfulness | Experimental | Behavioral: Mindfulness InterventionA 15-20-minute video based on previously tested and documented standards for guided meditation aimed at addressing pain and distress. |
| Video-based Guided Expressive Writing | Experimental | Behavioral: Mindfulness InterventionA 15-20-minute video based on expressive writing prompts aimed at addressing pain and distress. If the patient is assigned expressive writing, they will be offered a blank journal to use for the expressive writing interventions after randomization. |
| Non-Mindfulness Based Therapeutic Approaches | Active comparator | Behavioral: Non-mindfulness InterventionStandard inpatient and outpatient resources available for Huntsman Cancer Institute patients through social work and the Wellness and Integrative Health Center. Participants will be encouraged to ask their providers for more information or if appropriate more consults to the appropriate resources if interested. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- English-speaking males or females 18 or older within the University of Utah Hospital system being treated for an intrabdominal malignancy.
- Patients undergoing surgical treatment of cancer within the abdominal cavity.
Key exclusion criteria (2 listed)
- Altered mental status due to delirium or pharmacological sedation as determined by a clinical assessment conducted by a study staff.
- Non-English speaking.
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 |
|---|---|---|
| Mindfulness InterventionGuided meditation or guided expressive writing | Behavioural | Video-based Guided Expressive Writing, Video-based Guided Mindfulness |
| Non-mindfulness InterventionStandard inpatient and outpatient resources available for Huntsman Cancer Institute patients through social work and the Wellness and Integrative Health Center. Participants will be encouraged to ask their providers for more information or if appropriate more consults to the appropriate resources if interested. | Behavioural | Non-Mindfulness Based Therapeutic Approaches |
Primary outcome
Feasibility and acceptability of delivering video based mindfulness interventions
Time frame: From enrollment to 6 months post-enrollment.
The frequency that patients start and complete at least one mindfulness intervention will be evaluated and compared to the other two cohorts. The frequency of engaging with and completing the interventions will be reported descriptively. The Chi2 for Fisher's will be used for exact test.
10 secondary outcomes
Participant-reported Global Impression of Change
Time frame: From enrollment to 6 months post-enrollment.
Participant-reported pain intensity
Time frame: From enrollment to 6 months post-enrollment.
Participant-reported pain interference
Time frame: From enrollment to 6 months post-enrollment.
Participant-reported physical function
Time frame: From enrollment to 6 months post-enrollment.
Participant-reported health engagement
Time frame: From enrollment to 6 months post-enrollment.
Participant-reported depression
Time frame: From enrollment to 6 months post-enrollment.
Participant-reported anxiety
Time frame: From enrollment to 6 months post-enrollment.
Participant-reported social isolation
Time frame: From enrollment to 6 months post-enrollment.
Participant-reported quality of life
Time frame: From enrollment to 6 months post-enrollment.
Participant use of pain medicine
Time frame: From enrollment to 6 months post-enrollment.
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 7 Apr 2026.
- Background: PubMed 36141374Wang R, Li L, Xu J, Ding ZT, Qiao J, Redding SR, Xianyu YY, Ouyang YQ. Effects of Structured Expressive Writing on Quality of Life and Perceived Self-Care Self-Efficacy of Breast Cancer Patients Undergoing Chemotherapy in Central China: A Randomized Controlled Trial. Healthcare (Basel). 2022 Sep 14;10(9):1762. doi: 10.3390/healthcare10091762.
- Background: PubMed 30605517Day MA, Ward LC, Ehde DM, Thorn BE, Burns J, Barnier A, Mattingley JB, Jensen MP. A Pilot Randomized Controlled Trial Comparing Mindfulness Meditation, Cognitive Therapy, and Mindfulness-Based Cognitive Therapy for Chronic Low Back Pain. Pain Med. 2019 Nov 1;20(11):2134-2148. doi: 10.1093/pm/pny273.
- Background: PubMed 26064068Rouleau CR, Garland SN, Carlson LE. The impact of mindfulness-based interventions on symptom burden, positive psychological outcomes, and biomarkers in cancer patients. Cancer Manag Res. 2015 Jun 1;7:121-31. doi: 10.2147/CMAR.S64165. eCollection 2015.
- Background: PubMed 33449510Hanley AW, Gililland J, Erickson J, Pelt C, Peters C, Rojas J, Garland EL. Brief preoperative mind-body therapies for total joint arthroplasty patients: a randomized controlled trial. Pain. 2021 Jun 1;162(6):1749-1757. doi: 10.1097/j.pain.0000000000002195.
- Background: PubMed 28702870Garland EL, Baker AK, Larsen P, Riquino MR, Priddy SE, Thomas E, Hanley AW, Galbraith P, Wanner N, Nakamura Y. Randomized Controlled Trial of Brief Mindfulness Training and Hypnotic Suggestion for Acute Pain Relief in the Hospital Setting. J Gen Intern Med. 2017 Oct;32(10):1106-1113. doi: 10.1007/s11606-017-4116-9. Epub 2017 Jul 12.
- Background: PubMed 26968850Zgierska AE, Burzinski CA, Cox J, Kloke J, Stegner A, Cook DB, Singles J, Mirgain S, Coe CL, Backonja M. Mindfulness Meditation and Cognitive Behavioral Therapy Intervention Reduces Pain Severity and Sensitivity in Opioid-Treated Chronic Low Back Pain: Pilot Findings from a Randomized Controlled Trial. Pain Med. 2016 Oct;17(10):1865-1881. doi: 10.1093/pm/pnw006. Epub 2016 Mar 10.
- Background: PubMed 34812790Teresi JA, Yu X, Stewart AL, Hays RD. Guidelines for Designing and Evaluating Feasibility Pilot Studies. Med Care. 2022 Jan 1;60(1):95-103. doi: 10.1097/MLR.0000000000001664.
- Background: PubMed 23961782Billingham SA, Whitehead AL, Julious SA. An audit of sample sizes for pilot and feasibility trials being undertaken in the United Kingdom registered in the United Kingdom Clinical Research Network database. BMC Med Res Methodol. 2013 Aug 20;13:104. doi: 10.1186/1471-2288-13-104.
- Background: PubMed 26092476Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016 Jun;25(3):1057-73. doi: 10.1177/0962280215588241. Epub 2015 Jun 19.
- Background: PubMed 26535150Rampakakis E, Ste-Marie PA, Sampalis JS, Karellis A, Shir Y, Fitzcharles MA. Real-life assessment of the validity of patient global impression of change in fibromyalgia. RMD Open. 2015 Sep 14;1(1):e000146. doi: 10.1136/rmdopen-2015-000146. eCollection 2015.
- Background: PubMed 30793414Perrot S, Lanteri-Minet M. Patients' Global Impression of Change in the management of peripheral neuropathic pain: Clinical relevance and correlations in daily practice. Eur J Pain. 2019 Jul;23(6):1117-1128. doi: 10.1002/ejp.1378. Epub 2019 Mar 18.
- Background: PubMed 28584390Hanley AW, Garland EL. Clarity of mind: Structural equation modeling of associations between dispositional mindfulness, self-concept clarity and psychological well-being. Pers Individ Dif. 2017 Feb 1;106:334-339. doi: 10.1016/j.paid.2016.10.028. Epub 2016 Nov 9. No abstract available.
- 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.
Erin Ward, MD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Intervention and Non-mindfulness Intervention in people with Psychological Distress and Intra-abdominal Cancer, run by University of Utah 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 2 inclusion and 2 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 7 Apr 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?
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?
Feasibility and acceptability of delivering video based mindfulness interventions (time frame: From enrollment to 6 months post-enrollment.). 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 NCT06858202, which also lists 30 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 7 Apr 2026.