Breast CancerPhase 2NCT01034215
Multi-Media Imagery Program for Breast Cancer Patients (Phase II)
A Phase 2 study testing Envision the Rhythms of Life Program and Envision the Rhythms of Life Program/Distance in people with Breast Cancer, run by Mind Matters Research LLC at 1 site in United States.
Trial summary
Global Objective: To improve quality of life and reduce stress for breast cancer survivors. To address the late-term and long-term effects of breast cancer treatment, as defined by the Institute of Medicine, including chemo brain, fatigue, sleep deprivation, stress, anxiety, depression, and PTSD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Envision the Rhythms of Life Program and Envision the Rhythms of Life Program/Distance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to 11 Oct 2011
- Phase
- Phase 2
- 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
- Participants must be a community-dwelling member 18 years of age or older. - The participant must be at least 18 because the assessment tools are not validated for use in minors.
- Participants should be able to read, write, and speak English.
- Participants must have been diagnosed with breast cancer and have completed surgery, which did not include Level III dissection of the axilla.
- Participants must obtain verification of diagnosis and treatment from their physician.
- Participants must agree to complete assessment instruments and take part in psychophysiological data gathering at baseline, 8 and 17 weeks and to provide required demographic information.
- Participants must sign informed consent, stating he/she understands the nature of the research and that he/she wishes to participate in the study. -
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- Participants must agree to complete the required diaries, graphs and notebooks related to behavior assessment.
- Participants must display the ability to understand and respond to the assessment process and must demonstrate they are oriented to person, place, and time.
- Participants must agree to fully participate in all five imagery classes and to practice imagery skills for 20 minutes a day for 17 weeks.
- Participants must have completed major cancer treatment (i.e., surgery, and/or radiation and/or IV chemotherapy) for six weeks; participant must be visual and hearing capable.
- Oral chemotherapy does not preclude participation.
Who cannot join
- Participant will be excluded if he/she has a history of uncontrolled epileptic seizures.
- The investigators will exclude patients who cannot speak, read and write English.
- Patients will be excluded if they are not oriented to place, person, and time.
- Participants will be excluded if they have a major psychiatric diagnosis (schizophrenia, bi-polar disorder).
- The investigators will exclude patients who received a Level III dissection of the axilla.
- Participants will be excluded if they are visually or hearing impaired.
- Although imagery can be modified for the visually or hearing impaired, that model is significantly different from an imagery program for the visual and hearing capable.
Trial locations and contacts
1 site in 1 country.
About this study
Global Objective: To improve quality of life and reduce stress for breast cancer survivors. To address the late-term and long-term effects of breast cancer treatment, as defined by the Institute of Medicine, including chemo brain, fatigue, sleep deprivation, stress, anxiety, depression, and PTSD.
Phase II Aims: (1) To demonstrate the clinical efficacy (i.e., improved quality of life, stress reduction, participant satisfaction with product) of the "Envision the Rhythms of Life" program and (2) to establish the technical merits of the program's distance-delivery (videoconferencing hardware and software) and instructional technology (i.e., animations, graphically enhanced PowerPoint instructional materials, full-color program manuals, art-as-imagery, and audio-imagery). "Envision the Rhythms of Life" instructs breast cancer survivors in the practice of individualized, emotionally supportive, and biologically accurate imagery and consists of 5, 4-hour long, interactive classes and between-class instructor support.
Read more
Instructional Options: Option 1 delivers the program technology (animations, PowerPoint, manuals, art, audio-art) with instructor and participants in the same room. Option 2 delivers the program at-a-distance, to a small group of, via videoconferencing software and camera systems (Alaska and Seattle) to low, moderate or high bandwidth areas. Each option delivers program three times (total of 45 participants for each option). A website portal provides all program information and materials.
Design and Method: Program will be delivered to 135 breast cancer survivors who have completed conventional care (surgery, radiation, IV chemotherapy) for at least six weeks. Differences in option 1 and 2 outcomes will be compared to each other and to controls; combined outcomes of option 1 and 2 will be compared to controls; and waitlist control outcomes will be compared to their extended baseline. Hypothesis: Options 1 and 2 will both produce significantly better outcomes than waitlist control group.
Read the detailed description
DESCRIPTION: To improve quality of life and reduce stress for breast cancer survivors. Phase II Aims: (1) To demonstrate the clinical efficacy (i.e., improved quality of life, stress reduction, participant satisfaction with product) of the "Envision the Rhythms of Life" program and (2) to establish the technical merits of the program's distance-delivery (videoconferencing hardware and software) and instructional technology (i.e., animations, graphically enhanced PowerPoint instructional materials, full-color program manuals, art-as-imagery, and audio-imagery). "Envision the Rhythms of Life" instructs breast cancer survivors in the practice of individualized, emotionally supportive, and biologically accurate imagery and consists of 5, 3-hour long, interactive classes and between-class instructor support. Instructional Options: Option 1 delivers the program technology (animations, PowerPoint, manuals, art, audio-art) with instructor and 15 participants in the same room. Option 2 delivers the program at-a-distance, to a small group of 15, via videoconferencing software and camera systems (Alaska and Seattle) to low, moderate or high bandwidth areas. Each option delivers program three times (total of 45 participants for each option). A website portal provides all program information and materials. Design and Method: Program will be delivered to 135 breast cancer survivors who have completed conventional care (surgery, radiation, IV chemotherapy) for at least six weeks. Differences in option 1 and 2 outcomes will be compared to each other and to controls; combined outcomes of option 1 and 2 will be compared to controls; and waitlist control outcomes will be compared to their extended baseline. Long-Term Objectives: This innovative project integrates technology with bandwidth-sensitive multi-media conferencing strategies to deliver a virtual mind-body, imagery intervention. The technology will allow seamless program delivery to interested survivors across the country during Phase III. Instructional technology, designed per Phase I participant feedback, will serve to 'jump-start' potent imagery practice and will optimize clinical efficacy. Commercial application and survivor participation is not limited by location, work schedule, or health status, addressing issues of barriers to access of care. Although desirable, instructional options 1 and 2 do not require survivors to have computer skills or internet access. The program is designed to be culturally sensitive and supports individual spiritual practices. PUBLIC HEALTH RELEVANCE: This program addresses NCI and IOM summary reports that call for individualized supportive care for cancer survivors suffering disease-related distress. Changes in two disease-education program modules would allow the program to be used as supportive therapy for other forms of cancer across the country.
- Conditions
- Breast Cancer
- Being tested
- Envision the Rhythms of Life Program, Envision the Rhythms of Life Program/Distance
- Keywords
- Behavioral, Quality of Life, Breast Cancer
- Medical subject headings
- Breast Neoplasms, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Envision the Rhythms of Life ProgramBehavioural
Also called Envision the Rhythms of Life, Live delivery
Patients learn to practice passive, active and targeted imagery for the purpose of improving mood state, modifying physiology (HRV, Body temperature, pain reduction) and also to mitigate the effects of their treatments, as defined by the IOM: chemo brain, fatigue, sleep deprivation, stress, anxiety, depression, and/or PTSD. Program is delivered with trainer present in the room.
Envision the Rhythms of Life Program/DistanceBehavioural
Also called Envision the Rhythms of Life Program, Distance Delivery
Patients learn to practice passive, active and targeted imagery for the purpose of improving mood state, modifying physiology (HRV, Body temperature, pain reduction) and also to mitigate the effects of their treatments, as defined by the IOM: chemo brain, fatigue, sleep deprivation, stress, anxiety, depression, and/or PTSD. Program is delivered by videoconference equipment
| Study group | Role | What they receive |
|---|---|---|
| Imagery Practice, live trainer | Active comparator | Patients attend a five week training program, with the instructor in the room with them, and actively practice imagery techniques, both in the classroom, and daily, outside of the classroom. Classes are four hours a week for five weeks. Patients practice what they learn for a full 17 weeks, beginning with the first week of class. Receives: Behavioral: Envision the Rhythms of Life Program |
| "Envision the Rhythms of Life" /video | Active comparator | Patients learn to practice passive, active and targeted imagery for the purpose of improving mood state, modifying physiology (HRV, Body temperature, pain reduction) and also to mitigate the effects of their treatments, as defined by the IOM: chemo brain, fatigue, sleep deprivation, stress, anxiety, depression, and/or PTSD. Receives: Behavioral: Envision the Rhythms of Life Program/Distance |
| Waitlist Control Group | No intervention | No treatment delivery during the 17 weeks of testing live delivery (trainer in the room with patients) vs. distance delivery (trainer delivers program via telemedicine/videoconferencing equipment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Objective: Measure QOL differences between treatment groups: (delivered live vs videoconferencing) and as compared to the control group and their extended baseline.
Measured: Data is gathered at baseline (before intervention) and 8 weeks, and at 17 weeks.
Secondary outcomes (1)
The secondary objective is for the purposes of improving program materials, documenting patient satisfaction, and recording patient experience of imagery. Focus groups, summary reports, and 10-point likert scales, rated from very dissatisfied (1) to very
Measured: Data gathered across each week, beginning with first week of intervention, for a period of 17 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2009 (estimated)
- Study startAug 2008
- Primary completionSep 2010
- Study completion11 Oct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mind Matters Research LLC
- Sponsor type
- University, hospital or other
- Investigators
- Lynda W Freeman, Ph.D., Principal investigator, Mind Matters Research LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01034215
- Sponsor's protocol ID
- MMR-117597
- Status last verified
- Dec 2009
- First submitted
- 16 Dec 2009
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Media Imagery Program for Breast Cancer Patients (Phase II)
- ClinicalTrials.gov ID
- NCT01034215
- Acronym / sponsor ID
- MMR-117597
- Conditions
- Breast Cancer
- Keywords
- Behavioral, Quality of Life, Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Mind Matters Research LLCUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Sep 2010 (actual)
- Study completion
- 11 Oct 2011 (actual)
- First posted
- 17 Dec 2009 (estimated)
- 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.
Global Objective: To improve quality of life and reduce stress for breast cancer survivors. To address the late-term and long-term effects of breast cancer treatment, as defined by the Institute of Medicine, including chemo brain, fatigue, sleep deprivation, stress, anxiety, depression, and PTSD.
Phase II Aims: (1) To demonstrate the clinical efficacy (i.e., improved quality of life, stress reduction, participant satisfaction with product) of the "Envision the Rhythms of Life" program and (2) to establish the technical merits of the program's distance-delivery (videoconferencing hardware and software) and instructional technology (i.e., animations, graphically enhanced PowerPoint instructional materials, full-color program manuals, art-as-imagery, and audio-imagery). "Envision the Rhythms of Life" instructs breast cancer survivors in the practice of individualized, emotionally supportive, and biologically accurate imagery and consists of 5, 4-hour long, interactive classes and between-class instructor support.
Instructional Options: Option 1 delivers the program technology (animations, PowerPoint, manuals, art, audio-art) with instructor and participants in the same room. Option 2 delivers the program at-a-distance, to a small group of, via videoconferencing software and camera systems (Alaska and Seattle) to low, moderate or high bandwidth areas. Each option delivers program three times (total of 45 participants for each option). A website portal provides all program information and materials.
Design and Method: Program will be delivered to 135 breast cancer survivors who have completed conventional care (surgery, radiation, IV chemotherapy) for at least six weeks. Differences in option 1 and 2 outcomes will be compared to each other and to controls; combined outcomes of option 1 and 2 will be compared to controls; and waitlist control outcomes will be compared to their extended baseline. Hypothesis: Options 1 and 2 will both produce significantly better outcomes than waitlist control group.
Detailed description
DESCRIPTION: To improve quality of life and reduce stress for breast cancer survivors. Phase II Aims: (1) To demonstrate the clinical efficacy (i.e., improved quality of life, stress reduction, participant satisfaction with product) of the "Envision the Rhythms of Life" program and (2) to establish the technical merits of the program's distance-delivery (videoconferencing hardware and software) and instructional technology (i.e., animations, graphically enhanced PowerPoint instructional materials, full-color program manuals, art-as-imagery, and audio-imagery). "Envision the Rhythms of Life" instructs breast cancer survivors in the practice of individualized, emotionally supportive, and biologically accurate imagery and consists of 5, 3-hour long, interactive classes and between-class instructor support. Instructional Options: Option 1 delivers the program technology (animations, PowerPoint, manuals, art, audio-art) with instructor and 15 participants in the same room. Option 2 delivers the program at-a-distance, to a small group of 15, via videoconferencing software and camera systems (Alaska and Seattle) to low, moderate or high bandwidth areas. Each option delivers program three times (total of 45 participants for each option). A website portal provides all program information and materials. Design and Method: Program will be delivered to 135 breast cancer survivors who have completed conventional care (surgery, radiation, IV chemotherapy) for at least six weeks. Differences in option 1 and 2 outcomes will be compared to each other and to controls; combined outcomes of option 1 and 2 will be compared to controls; and waitlist control outcomes will be compared to their extended baseline. Long-Term Objectives: This innovative project integrates technology with bandwidth-sensitive multi-media conferencing strategies to deliver a virtual mind-body, imagery intervention. The technology will allow seamless program delivery to interested survivors across the country during Phase III. Instructional technology, designed per Phase I participant feedback, will serve to 'jump-start' potent imagery practice and will optimize clinical efficacy. Commercial application and survivor participation is not limited by location, work schedule, or health status, addressing issues of barriers to access of care. Although desirable, instructional options 1 and 2 do not require survivors to have computer skills or internet access. The program is designed to be culturally sensitive and supports individual spiritual practices. PUBLIC HEALTH RELEVANCE: This program addresses NCI and IOM summary reports that call for individualized supportive care for cancer survivors suffering disease-related distress. Changes in two disease-education program modules would allow the program to be used as supportive therapy for other forms of cancer across the country.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Imagery Practice, live trainer | Active comparator | Behavioral: Envision the Rhythms of Life ProgramPatients attend a five week training program, with the instructor in the room with them, and actively practice imagery techniques, both in the classroom, and daily, outside of the classroom. Classes are four hours a week for five weeks. Patients practice what they learn for a full 17 weeks, beginning with the first week of class. |
| "Envision the Rhythms of Life" /video | Active comparator | Behavioral: Envision the Rhythms of Life Program/DistancePatients learn to practice passive, active and targeted imagery for the purpose of improving mood state, modifying physiology (HRV, Body temperature, pain reduction) and also to mitigate the effects of their treatments, as defined by the IOM: chemo brain, fatigue, sleep deprivation, stress, anxiety, depression, and/or PTSD. |
| Waitlist Control Group | No intervention | –No treatment delivery during the 17 weeks of testing live delivery (trainer in the room with patients) vs. distance delivery (trainer delivers program via telemedicine/videoconferencing equipment) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Participants must be a community-dwelling member 18 years of age or older. - The participant must be at least 18 because the assessment tools are not validated for use in minors.
- Participants should be able to read, write, and speak English.
- Participants must have been diagnosed with breast cancer and have completed surgery, which did not include Level III dissection of the axilla.
- Participants must obtain verification of diagnosis and treatment from their physician.
- Participants must agree to complete assessment instruments and take part in psychophysiological data gathering at baseline, 8 and 17 weeks and to provide required demographic information.
Key exclusion criteria (7 listed)
- Participant will be excluded if he/she has a history of uncontrolled epileptic seizures.
- The investigators will exclude patients who cannot speak, read and write English.
- Patients will be excluded if they are not oriented to place, person, and time.
- Participants will be excluded if they have a major psychiatric diagnosis (schizophrenia, bi-polar disorder).
- The investigators will exclude patients who received a Level III dissection of the axilla.
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 |
|---|---|---|
| Envision the Rhythms of Life ProgramAlso: Envision the Rhythms of Life, Live deliveryPatients learn to practice passive, active and targeted imagery for the purpose of improving mood state, modifying physiology (HRV, Body temperature, pain reduction) and also to mitigate the effects of their treatments, as defined by the IOM: chemo brain, fatigue, sleep deprivation, stress, anxiety, depression, and/or PTSD. Program is delivered with trainer present in the room. | Behavioural | Imagery Practice, live trainer |
| Envision the Rhythms of Life Program/DistanceAlso: Envision the Rhythms of Life Program, Distance DeliveryPatients learn to practice passive, active and targeted imagery for the purpose of improving mood state, modifying physiology (HRV, Body temperature, pain reduction) and also to mitigate the effects of their treatments, as defined by the IOM: chemo brain, fatigue, sleep deprivation, stress, anxiety, depression, and/or PTSD. Program is delivered by videoconference equipment | Behavioural | "Envision the Rhythms of Life" /video |
Primary outcome
Primary Objective: Measure QOL differences between treatment groups: (delivered live vs videoconferencing) and as compared to the control group and their extended baseline.
Time frame: Data is gathered at baseline (before intervention) and 8 weeks, and at 17 weeks.
1 secondary outcome
The secondary objective is for the purposes of improving program materials, documenting patient satisfaction, and recording patient experience of imagery. Focus groups, summary reports, and 10-point likert scales, rated from very dissatisfied (1) to very
Time frame: Data gathered across each week, beginning with first week of intervention, for a period of 17 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 10 Mar 2020.
- Website for "Envision the Rhythms of Life" cllinical trial and programLink 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.
Lynda W Freeman, Ph.D. principal investigator
Mind Matters Research LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Envision the Rhythms of Life Program and Envision the Rhythms of Life Program/Distance in people with Breast Cancer, run by Mind Matters Research LLC 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 11 inclusion and 7 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 10 Mar 2020. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Primary Objective: Measure QOL differences between treatment groups: (delivered live vs videoconferencing) and as compared to the control group and their extended baseline. (time frame: Data is gathered at baseline (before intervention) and 8 weeks, and at 17 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 10 Mar 2020; AzTrials last refreshed its copy on 3 Nov 2026.