Hematopoietic and Lymphoid System NeoplasmNCT06030427
Virtual Mindfulness and Weight Management to Mitigate Risk of Relapse and Improve Wellbeing in Cancer Survivors
A study testing Behavioral Dietary Intervention, Educational Intervention and Health Promotion and Education in people with Hematopoietic and Lymphoid System Neoplasm and Malignant Solid Neoplasm, run by Mayo Clinic at 1 site in United States.
Trial summary
This clinical trial tests how well a virtual mindfulness and weight management program to mitigate risk of relapse and improve well being for obese cancer survivors in community practice and rural areas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic and Lymphoid System Neoplasm, Malignant Solid Neoplasm, Obesity-Related Malignant Neoplasm
- What is being tested?
- Behavioral Dietary Intervention, Educational Intervention and Health Promotion and Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2023to 2 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 18 or over
- Identified stage I, II, or III cancer in remission
- Body mass index (BMI) of 30 or greater
- English as a primary language
- Has access to a device with a camera (computer, tablet, or video capable phone) that has wifi and reliable internet access
Who cannot join
- Unable to provide consent
- Eastern Cooperative Oncology Group (ECOG) performance status scale score of 3 or above
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic Health System-Franciscan Healthcare
La Crosse, Wisconsin, 54601
About this study
Official title: A Virtual Mindfulness and Weight Management Program for Those With Cancer Histories to Mitigate Risk of Relapse and Improve Wellbeing: A Feasibility Study
This clinical trial tests how well a virtual mindfulness and weight management program to mitigate risk of relapse and improve well being for obese cancer survivors in community practice and rural areas. Obesity has been linked to increased risk for certain kinds of cancer and is the second highest modifiable risk factor for cancer. It is also well documented that having a cancer diagnosis and treatment is a stressful experience. It is hoped that an addition of a 10-minute mindfulness-based stress reduction exercise to the virtual positive health habits group focused on weight management can improve wellbeing and distress. Virtual care options continue to extend the reach of medical providers to cancer survivors, particularly those in the rural setting. A virtual behavioral weight management program with an integrated mindfulness component may improve mood, coping strategies, stress management, and weight loss among community practice and rural obese cancer survivors.
Read the detailed description
PRIMARY OBJECTIVES:
- To assess if a 12-week virtual weight management program with a mindfulness component will improve well-being of obese cancer patients with a specific focus on self-reported measures of depression and anxiety.
II. To assess if a mindfulness component added to the virtual behavioral weight management will promote weight loss, improve mood, and increase physical activity.
OUTLINE:
Patients participate in a virtual behavioral weight management program with an integrated mindfulness component consisting of 12, 75-minute virtual group sessions over 12 weeks to help improve mood, coping strategies, stress management, and weight loss. Patents also receive patient education handouts, view behavioral educational PowerPoint presentations over 30 minutes, and wear a Fitbit on study.
- Conditions
- Hematopoietic and Lymphoid System Neoplasm, Malignant Solid Neoplasm, Obesity-Related Malignant Neoplasm
- Being tested
- Behavioral Dietary Intervention, Educational Intervention, Health Promotion and Education, Internet-Based Intervention, Interview
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Dietary InterventionBehavioural
Participate in weight management program
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Receive patient education handouts
Health Promotion and EducationOther
View behavioral educational PowerPoint presentation
Internet-Based InterventionOther
Complete virtual behavioral weight management with an integrated mindfulness component program
InterviewOther
Ancillary studies
Medical Device Usage and EvaluationOther
Wear Fitbit
Mindfulness RelaxationBehavioural
Also called MBSR, Mindful Meditation, Mindfulness Meditation, Mindfulness-Based Stress Reduction
Complete mindfulness components
Physical Performance TestingOther
Also called Physical Fitness Testing, Physical Function Testing
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (virtual mindfulness and weight management) | Experimental | Patients participate in a virtual behavioral weight management program with an integrated mindfulness component consisting of 12, 75-minute virtual group sessions over 12 weeks to help improve mood, coping strategies, stress management, and weight loss. Patents also receive patient education handouts, view behavioral educational PowerPoint presentations over 30 minutes, and wear a Fitbit on study. Receives: Behavioral: Behavioral Dietary Intervention; Other: Educational Intervention; Other: Health Promotion and Education; Other: Internet-Based Intervention; Other: Interview; Other: Medical Device Usage and Evaluation; Behavioral: Mindfulness Relaxation; Other: Physical Performance Testing; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
General anxiety disorder-7 (GAD-7)
Assessed by change in GAD-7 scores from a total score for seven items ranges from 0 to 21: 0-4 (minimal anxiety); 5-9 (mild anxiety); 10-14 (moderate anxiety); 15-21 (severe anxiety).
Measured: Baseline; 12 weeks
Patient Health Questionnaire (PHQ)-8
Assessed by change in PHQ-8 scores, as measured by a total score of 4 items from 0-12: 0-2 (normal); 3-5 (mild depression); 6-8 (moderate depression); 9-12 (severe depression).
Measured: Baseline; 12 weeks
Feasibility of virtual mindfulness and weight management program
Assessed by the extent to which participants adhere to the intervention. Will be quantified based on number of sessions attended out of a possible 12.
Measured: 12 weeks
Secondary outcomes (4)
Body weight
Assessed by change in body weight
Measured: Baseline; 12 weeks
Body composition parameter
Will be assessed in a fasted state or 3 hour post meal by subjects standing on a scale without socks or shoes.
Measured: Baseline; 12 weeks
Daily activity levels - heart rate
Will be assessed by heart rate monitoring as recorded by a wrist-worn accelerometer (Fitbit Inspire)
Measured: Baseline; 12 weeks
Daily activity levels - activity
Will be assessed from data recorded by a wrist-worn accelerometer monitoring fitness activity.
Measured: Baseline; 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start8 Sep 2023
- Primary completion2 Jan 2024
- Study completion2 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphoid System NeoplasmStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisa Howell, Ph.D., Principal investigator, Mayo Clinic Health System-Franciscan Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06030427
- Sponsor's protocol ID
- 23-004890
- Other IDs
- NCI-2023-06407, 23-004890
- Status last verified
- Nov 2024
- First submitted
- 28 Aug 2023
- Last updated
- 24 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Virtual Mindfulness and Weight Management Program for Those With Cancer Histories to Mitigate Risk of Relapse and Improve Wellbeing: A Feasibility Study
- ClinicalTrials.gov ID
- NCT06030427
- Acronym / sponsor ID
- 23-004890
- Conditions
- Hematopoietic and Lymphoid System Neoplasm, Malignant Solid Neoplasm, Obesity-Related Malignant Neoplasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 8 Sep 2023 (actual)
- Primary completion
- 2 Jan 2024 (actual)
- Study completion
- 2 Jan 2024 (actual)
- First posted
- 11 Sep 2023 (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.
This clinical trial tests how well a virtual mindfulness and weight management program to mitigate risk of relapse and improve well being for obese cancer survivors in community practice and rural areas. Obesity has been linked to increased risk for certain kinds of cancer and is the second highest modifiable risk factor for cancer. It is also well documented that having a cancer diagnosis and treatment is a stressful experience. It is hoped that an addition of a 10-minute mindfulness-based stress reduction exercise to the virtual positive health habits group focused on weight management can improve wellbeing and distress. Virtual care options continue to extend the reach of medical providers to cancer survivors, particularly those in the rural setting. A virtual behavioral weight management program with an integrated mindfulness component may improve mood, coping strategies, stress management, and weight loss among community practice and rural obese cancer survivors.
Detailed description
PRIMARY OBJECTIVES:
- To assess if a 12-week virtual weight management program with a mindfulness component will improve well-being of obese cancer patients with a specific focus on self-reported measures of depression and anxiety.
II. To assess if a mindfulness component added to the virtual behavioral weight management will promote weight loss, improve mood, and increase physical activity.
OUTLINE:
Patients participate in a virtual behavioral weight management program with an integrated mindfulness component consisting of 12, 75-minute virtual group sessions over 12 weeks to help improve mood, coping strategies, stress management, and weight loss. Patents also receive patient education handouts, view behavioral educational PowerPoint presentations over 30 minutes, and wear a Fitbit on study.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (virtual mindfulness and weight management) | Experimental | Behavioral: Behavioral Dietary Intervention, Other: Educational Intervention, Other: Health Promotion and Education, Other: Internet-Based Intervention, Other: Interview, Other: Medical Device Usage and Evaluation, Behavioral: Mindfulness Relaxation, Other: Physical Performance Testing, Other: Questionnaire AdministrationPatients participate in a virtual behavioral weight management program with an integrated mindfulness component consisting of 12, 75-minute virtual group sessions over 12 weeks to help improve mood, coping strategies, stress management, and weight loss. Patents also receive patient education handouts, view behavioral educational PowerPoint presentations over 30 minutes, and wear a Fitbit on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 or over
- Identified stage I, II, or III cancer in remission
- Body mass index (BMI) of 30 or greater
- English as a primary language
- Has access to a device with a camera (computer, tablet, or video capable phone) that has wifi and reliable internet access
Key exclusion criteria (2 listed)
- Unable to provide consent
- Eastern Cooperative Oncology Group (ECOG) performance status scale score of 3 or above
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 |
|---|---|---|
| Behavioral Dietary InterventionParticipate in weight management program | Behavioural | Supportive care (virtual mindfulness and weight management) |
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalReceive patient education handouts | Other | Supportive care (virtual mindfulness and weight management) |
| Health Promotion and EducationView behavioral educational PowerPoint presentation | Other | Supportive care (virtual mindfulness and weight management) |
| Internet-Based InterventionComplete virtual behavioral weight management with an integrated mindfulness component program | Other | Supportive care (virtual mindfulness and weight management) |
| InterviewAncillary studies | Other | Supportive care (virtual mindfulness and weight management) |
| Medical Device Usage and EvaluationWear Fitbit | Other | Supportive care (virtual mindfulness and weight management) |
| Mindfulness RelaxationAlso: MBSR, Mindful Meditation, Mindfulness Meditation, Mindfulness-Based Stress ReductionComplete mindfulness components | Behavioural | Supportive care (virtual mindfulness and weight management) |
| Physical Performance TestingAlso: Physical Fitness Testing, Physical Function TestingAncillary studies | Other | Supportive care (virtual mindfulness and weight management) |
| Questionnaire AdministrationAncillary studies | Other | Supportive care (virtual mindfulness and weight management) |
Primary outcome
General anxiety disorder-7 (GAD-7)
Time frame: Baseline; 12 weeks
Assessed by change in GAD-7 scores from a total score for seven items ranges from 0 to 21: 0-4 (minimal anxiety); 5-9 (mild anxiety); 10-14 (moderate anxiety); 15-21 (severe anxiety).
Patient Health Questionnaire (PHQ)-8
Time frame: Baseline; 12 weeks
Assessed by change in PHQ-8 scores, as measured by a total score of 4 items from 0-12: 0-2 (normal); 3-5 (mild depression); 6-8 (moderate depression); 9-12 (severe depression).
Feasibility of virtual mindfulness and weight management program
Time frame: 12 weeks
Assessed by the extent to which participants adhere to the intervention. Will be quantified based on number of sessions attended out of a possible 12.
4 secondary outcomes
Body weight
Time frame: Baseline; 12 weeks
Body composition parameter
Time frame: Baseline; 12 weeks
Daily activity levels - heart rate
Time frame: Baseline; 12 weeks
Daily activity levels - activity
Time frame: Baseline; 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2025.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Lisa Howell, Ph.D. principal investigator
Mayo Clinic Health System-Franciscan Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Dietary Intervention, Educational Intervention and Health Promotion and Education in people with Hematopoietic and Lymphoid System Neoplasm and Malignant Solid Neoplasm, run by Mayo Clinic 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 5 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: finished, as of the sponsor's last update on 24 Oct 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
General anxiety disorder-7 (GAD-7) (time frame: Baseline; 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Oct 2025.