Breast Cancer Stage INCT07745023
Mind-Body Interventions for the Improvement of Quality of Life, Stress, and Sleep Quality Among Survivors of Breast, Prostate, Endometrial, or Colorectal Cancer
A study testing Media Intervention, Mind-body intervention and Meditation Therapy in people with Breast Cancer Stage I and Colorectal Cancer, run by Roswell Park Cancer Institute.
Trial summary
This clinical trial studies how well mind-body interventions work in improving quality of life (QOL), stress, and sleep quality among survivors of breast, prostate, endometrial, or colorectal cancer. For many cancer survivors, the experience of cancer extends well beyond the completion of therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer Stage I, Colorectal Cancer
- What is being tested?
- Media Intervention, Mind-body intervention and Meditation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 30 Dec 2026to 2 Feb 2029
- 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
- Received a diagnosis of invasive, non-metastatic breast, colorectal, endometrial, or prostate cancer within the past 12 months
- Have completed active anti-cancer therapy (hormonal, bisphosphonate, or androgen therapy is allowed)
- Able to safely participate in light-weight physical activity (e.g. gentle yoga)
Who cannot join
- Individuals with skeletal instabilities, cardio-pulmonary comorbidities, or other conditions that may preclude safe participation in light physical activity
- Pregnant or nursing female participants
- Unwilling or unable to follow protocol requirements
- Any condition that, in the Investigator's opinion, deems the participant an unsuitable candidate
- Unable to complete survey questionnaires in English
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Influence of Mind-Body Interventions on Cancer-Related Symptom Management in Survivors
This clinical trial studies how well mind-body interventions work in improving quality of life (QOL), stress, and sleep quality among survivors of breast, prostate, endometrial, or colorectal cancer. For many cancer survivors, the experience of cancer extends well beyond the completion of therapy. Common long-term effects include fatigue, cognitive impairment, anxiety, depression, sleep disturbance, and diminished physical function, all of which contribute to reduced QOL and overall health. Yoga, a mind-body intervention, utilizes breathwork, meditation, and gentle movement to help reduce activity in the body's nervous system. Breathwork and meditation have been shown to improve heart rate variability (a measure of the body's ability to adapt to stress). Movement-based practices may offer added benefit by supporting coordination and physical resiliency, aspects that are often reduced after cancer treatment and can lead to decreased QOL. This trial may help researchers determine whether a mind-body intervention that includes breathwork and meditation, as well as an intervention that includes breathwork and meditation plus gentle movement can work to improve QOL, stress, and sleep quality among survivors of breast, prostate, endometrial, or colorectal cancer.
Read the detailed description
PRIMARY OBJECTIVE:
- Pilot test video and/or audio content consisting of six, 15-minute breathwork and meditation videos/audio, and six, 15-minute guided, gentle movement videos developed for this intervention for feasibility and acceptability, and provide preliminary data on QOL in cancer (breast, colon, endometrial, and prostate) survivors using patient-reported outcomes measurements completed at pre- and post- intervention.
SECONDARY OBJECTIVES:
- Evaluate program satisfaction using structured questionnaires for all participants at post-intervention.
II. Identify perceived barriers, evaluate facilitators, and identify recommendations for future scaling and delivery in varied survivorship settings
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- Conditions
- Breast Cancer Stage I, Colorectal Cancer
- Being tested
- Media Intervention, Mind-body intervention, Meditation Therapy
- Medical subject headings
- Breast Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Media InterventionOther
View breathwork and meditation videos
Media InterventionOther
View breathwork, meditation and gentle yoga videoos
Mind-body interventionProcedure or surgery
Complete breathwork exercises
Meditation TherapyProcedure or surgery
Complete Meditation exercises
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - breathwork and mediation videos | Experimental | Patients view guided breathwork and meditation videos and complete these exercises over 15 minutes weekly for 6 weeks on study. Patients also wear an activity tracker throughout the study. Receives: Other: Media Intervention; Procedure: Meditation Therapy |
| Arm 2 - breathwork, meditation and gentle yoga videos | Experimental | Patients view guided breathwork, meditation, and gentle yoga movement videos and complete these exercises over 30 minutes weekly for 6 weeks on study. Patients also wear an activity tracker throughout the study Receives: Other: Media Intervention; Procedure: Mind-body intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in quality of life
Patients view guided breathwork, meditation, and gentle yoga movement videos and complete these exercises over 30 minutes weekly for 6 weeks on study. Patients also wear an activity tracker throughout the study
Measured: Baseline up to 6 weeks
Secondary outcomes (1)
Adherence Rate
Proportion of participants who complete at least 80% of the assigned interventions
Measured: UP to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start30 Dec 2026 (estimated)
- Primary completion2 Feb 2028 (estimated)
- Study completion2 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Stage IStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07745023
- Sponsor's protocol ID
- I-4896826
- Status last verified
- Nov 2026
- First submitted
- 29 Jul 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Mind-Body Interventions on Cancer-Related Symptom Management in Survivors
- ClinicalTrials.gov ID
- NCT07745023
- Acronym / sponsor ID
- I-4896826
- Conditions
- Breast Cancer Stage I, Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- 30 Dec 2026 (estimated)
- Primary completion
- 2 Feb 2028 (estimated)
- Study completion
- 2 Feb 2029 (estimated)
- First posted
- 4 Aug 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.
This clinical trial studies how well mind-body interventions work in improving quality of life (QOL), stress, and sleep quality among survivors of breast, prostate, endometrial, or colorectal cancer. For many cancer survivors, the experience of cancer extends well beyond the completion of therapy. Common long-term effects include fatigue, cognitive impairment, anxiety, depression, sleep disturbance, and diminished physical function, all of which contribute to reduced QOL and overall health. Yoga, a mind-body intervention, utilizes breathwork, meditation, and gentle movement to help reduce activity in the body's nervous system. Breathwork and meditation have been shown to improve heart rate variability (a measure of the body's ability to adapt to stress). Movement-based practices may offer added benefit by supporting coordination and physical resiliency, aspects that are often reduced after cancer treatment and can lead to decreased QOL. This trial may help researchers determine whether a mind-body intervention that includes breathwork and meditation, as well as an intervention that includes breathwork and meditation plus gentle movement can work to improve QOL, stress, and sleep quality among survivors of breast, prostate, endometrial, or colorectal cancer.
Detailed description
PRIMARY OBJECTIVE:
- Pilot test video and/or audio content consisting of six, 15-minute breathwork and meditation videos/audio, and six, 15-minute guided, gentle movement videos developed for this intervention for feasibility and acceptability, and provide preliminary data on QOL in cancer (breast, colon, endometrial, and prostate) survivors using patient-reported outcomes measurements completed at pre- and post- intervention.
SECONDARY OBJECTIVES:
- Evaluate program satisfaction using structured questionnaires for all participants at post-intervention.
II. Identify perceived barriers, evaluate facilitators, and identify recommendations for future scaling and delivery in varied survivorship settings
r.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - breathwork and mediation videos | Experimental | Other: Media Intervention, Procedure: Meditation TherapyPatients view guided breathwork and meditation videos and complete these exercises over 15 minutes weekly for 6 weeks on study. Patients also wear an activity tracker throughout the study. |
| Arm 2 - breathwork, meditation and gentle yoga videos | Experimental | Other: Media Intervention, Procedure: Mind-body interventionPatients view guided breathwork, meditation, and gentle yoga movement videos and complete these exercises over 30 minutes weekly for 6 weeks on study. Patients also wear an activity tracker throughout the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Received a diagnosis of invasive, non-metastatic breast, colorectal, endometrial, or prostate cancer within the past 12 months
- Have completed active anti-cancer therapy (hormonal, bisphosphonate, or androgen therapy is allowed)
- Able to safely participate in light-weight physical activity (e.g. gentle yoga)
Key exclusion criteria (5 listed)
- Individuals with skeletal instabilities, cardio-pulmonary comorbidities, or other conditions that may preclude safe participation in light physical activity
- Pregnant or nursing female participants
- Unwilling or unable to follow protocol requirements
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 |
|---|---|---|
| Media InterventionView breathwork and meditation videos | Other | Arm 1 - breathwork and mediation videos |
| Media InterventionView breathwork, meditation and gentle yoga videoos | Other | Arm 2 - breathwork, meditation and gentle yoga videos |
| Mind-body interventionComplete breathwork exercises | Procedure or surgery | Arm 2 - breathwork, meditation and gentle yoga videos |
| Meditation TherapyComplete Meditation exercises | Procedure or surgery | Arm 1 - breathwork and mediation videos |
Primary outcome
Change in quality of life
Time frame: Baseline up to 6 weeks
Patients view guided breathwork, meditation, and gentle yoga movement videos and complete these exercises over 30 minutes weekly for 6 weeks on study. Patients also wear an activity tracker throughout the study
1 secondary outcome
Adherence Rate
Time frame: UP to 6 weeks
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 5 Nov 2026.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Media Intervention, Mind-body intervention and Meditation Therapy in people with Breast Cancer Stage I and Colorectal Cancer, run by Roswell Park Cancer Institute.
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 3 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: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Kathryn G Glaser (716*845-2300, AskRPCI@roswellpark.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in quality of life (time frame: Baseline up to 6 weeks). 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 5 Nov 2026.