Breast CancerNCT02349217
Mindfulness Based Couples Therapy
A study testing Mindfulness-Based Relationship Enhancement (MBRE), Self-Help Materials and Pain Assessment in people with Breast Cancer, run by M.D. Anderson Cancer Center at 2 sites in United States.
Trial summary
The goal of this study is to explore the effects of a Mindfulness Based Couples Intervention on relationship satisfaction with quality of life and immune system function among breast cancer survivors and their partners. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Mindfulness-Based Relationship Enhancement (MBRE), Self-Help Materials and Pain Assessment
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Jan 2015to 1 Aug 2022
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Stage 0-IIIA breast cancer survivors and their partner
- All the female breast cancer survivors will be at least two months from receiving cancer treatment (surgery, adjuvant therapy or radiation) and within three years from completing cancer treatment, except for tamoxifen/aromatase inhibitors.
- Are able to read and write in English
- Are able to pass the Physical Activity Readiness Questionnaire or participant provides a letter from their physician or nurse practitioner clearing them for study participation
- All couples co-habiting for at least 3 years with current partner who is willing to participate in study
- Are 21 years of age or older
Who cannot join
- Male breast cancer survivors;
- Participants with a diagnosis of diabetes, unless they are able to provide a letter from a physician who will continue to monitor the participant during the research study
- Anti-inflammatory medications (e.g. statins, cholesterol medication)
- Consume excessive amounts of alcohol (>30 drinks/week)
- Pregnant or thinking about becoming pregnant during the study period
- Lactating women
Show all 10Show fewer
- Major medical conditions involving the immune system such as autoimmune and/or inflammatory diseases
- Pressure readings >/=140/90 mm Hg, as defined by the 7th Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure, will be deemed ineligible to participate and excluded from the study. They will be referred to their family physician or community services. Those ineligible based on their initial blood pressure reading are allowed to participate if they provide a letter from a physician who will continue to monitor the participant during the research study.
- A hemoglobin level < 10g/dl
- Person less than 21 years of age
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Lyndon B. Johnson General Hospital
Houston, Texas, 77026
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Mindfulness Based Couples Therapy for Breast Cancer Survivors: A Pilot Study
The goal of this study is to explore the effects of a Mindfulness Based Couples Intervention on relationship satisfaction with quality of life and immune system function among breast cancer survivors and their partners.
Read the detailed description
Baseline Visit:
If you are found to be eligible to take part in this research study, you will return to the clinic about a week later for the Baseline Visit. You will be instructed to fast (eat nothing and drink only water) for at least 8 hours before this visit.
- Blood (about 4-5 tablespoons) will be drawn for tests of your immune function, stress hormone levels, and blood sugar levels. After this blood test, you will be given breakfast.
- You will complete a pain assessment which involves you submerging your hand in cold water. Researchers will use your response to measure your pain tolerance.
- You will have electrocardiograms (EKGs) to check your heart function. The sensors will be attached at the beginning of the visit and then removed before you leave. You will be attached to the machine for several hours, but you will be able to be disconnected to take bathroom breaks, if needed.
- You will complete questionnaires about fatigue, mood, stress, social support, marital satisfaction, depression, and general demographics (age, race and so on). It should take about 1½ hours total to complete the questionnaires.
- You will complete a series of traditional neurocognitive tests (for example, tests to check your memory and thinking abilities). You will take these tests on the computer and with a pen and paper.
- Your blood pressure will be measured multiple times throughout the visit.
Study Groups and Interventions:
After the Baseline visit, you will be assigned to one of 2 groups. If you are in Group 1, you and your partner will take part in an 8-week Mindfulness-Based Relationship Enhancement (MBRE) intervention course designed to alleviate stress and other symptoms among couples. The MBRE course will consist of eight sessions taught by a professional Mindfulness instructor. The sessions will occur 1 time a week and last about 2½ hours each time. The MBRE course will consist of meditation and yoga techniques and handouts. The sessions will focus on teaching participants (all female breast cancer survivors and partners) the basics of Mindfulness Based Relationship Enhancement.
Attendance at these sessions and completion of daily homework assignments requiring up to 45 minutes per day are essential to the program.
If you are in Group 2, you will receive self-help materials that have been previously developed by MD Anderson's Office of Public Education, the American Cancer Society, and the National Cancer Institute.
Post-Intervention Follow-Up Visit:
If you are in Group 1, you will have a post-intervention follow-up visit about 12 weeks after your Baseline visit (4 weeks after you finish your 8-week intervention sessions). If you are in Group 2, you will have a post-intervention follow-up visit about 8 weeks after the Baseline Visit. You will fast for 8 hours before a post-intervention follow-up visit.
- Blood (about 4 to 5 tablespoons) will be drawn to check your immune function, stress hormone levels, and blood sugar. After the blood is drawn you will be given breakfast.
- You will complete the cold water pain tolerance test.
- You will have electrocardiograms (EKGs).
- You will complete questionnaires about fatigue, mood, stress, social support, marital satisfaction, depression, and general demographics (age, race and so on). It should take about 1½ hours total to complete the questionnaires.
- You will complete a series of traditional neurocognitive tests.
- Your blood pressure will be measured multiple times throughout the visit.
Cortisol Testing:
After the Baseline and Follow-up Visits, you will be asked to give samples to measure cortisol, a hormone related to stress. You will place a small cotton tube in your mouth for about 2 minutes, or until the swab is completely soaked with your saliva. After this, you will place the swab back in the tube, and freeze the sample. You will be given containers to hold the samples when you freeze them, as well as to mark which day and time each sample was collected. You will take these samples 7 times a day (right when you wake up; about 30, 45, and 60 minutes after waking; and then at noon, 4:00 p.m., and 8:00 p.m.). Researchers will use these samples to measure the changes in cortisol throughout the day. You will collect these samples for 2 days during the week, and 2 days on the weekend. After you complete 4 total days of collecting saliva samples after each visit, you will mail them back to MD Anderson in pre-paid envelopes.
Program Satisfaction Evaluations:
After the follow-up visits, the study staff will conduct individual interviews with a small group of participants. Interview questions will address participants' overall reactions to and satisfaction with the mind-body intervention, the impact they felt from social support, motivation, and their own ability for increasing physical activity and well-being. The study staff will also ask questions about both positive and negative effects of participating in the intervention. Interviews will be conducted by the PI or a trained research coordinator. All interviews will last no longer than 90 minutes and will be audio-taped using a digital recorder and transcribed. All audio files will be destroyed after they are transcribed.
This is an investigational study.
Up to 30 couples (60 participants) will take part in this research study. All will be enrolled at MD Anderson.
- Conditions
- Breast Cancer
- Being tested
- Mindfulness-Based Relationship Enhancement (MBRE), Self-Help Materials, Pain Assessment, Questionnaires, Neurocognitive Tests
- Keywords
- Breast cancer, Breast cancer survivors, Breast cancer partners, Mindfulness-Based Relationship Enhancement, MBRE, Standard of care, Pain Assessment, Questionnaires, Surveys, Neurocognitive Tests, Cortisol Tests, Saliva tests, Interviews, Meditation, Yoga, Self-help materials
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Relationship Enhancement (MBRE)Behavioural
Participant and partner take part in an 8-week Mindfulness-Based Relationship Enhancement (MBRE) intervention course. MBRE course consists of meditation and yoga techniques and handouts.
Self-Help MaterialsBehavioural
Participants and partner receive self-help materials.
Pain AssessmentBehavioural
Pain assessment administered at baseline and at follow up visit. Pain assessment involves submerging hand in cold water.
QuestionnairesBehavioural
Also called Surveys
Questionnaires completed at baseline and at follow up visit. Questionnaires ask about fatigue, mood, stress, social support, marital satisfaction, depression, and general demographics (age, race and so on). It should take about 1½ hours total to complete the questionnaires.
Neurocognitive TestsBehavioural
Neurocognitive tests administered at baseline and at follow up visit. Tests to check memory and thinking abilities.
Cortisol TestsProcedure or surgery
Also called Saliva tests
Cortisol testing performed after baseline visit and at follow up visit. Participants asked to collect saliva samples for cortisol assays immediately, 30, 45, and 60 minutes after awakening (representing the cortisol awakening response) and at noon, 4 P.M. and 8 P.M.
InterviewsBehavioural
Interviews conducted after follow up visit. These interviews are audio-taped and transcribed.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Based Stress Reduction Intervention (MBRE) | Experimental | Participant and partner take part in an 8-week Mindfulness-Based Relationship Enhancement (MBRE) intervention course. MBRE course consists of meditation and yoga techniques and handouts.
Pain assessment administered at baseline and at follow up visit. Questionnaires completed at baseline and at follow up visit. Neurocognitive tests administered at baseline and at follow up visit. Cortisol testing performed after baseline visit and at follow up visit. Interviews conducted after follow up visit. These interviews are audio-taped and transcribed. Receives: Behavioral: Mindfulness-Based Relationship Enhancement (MBRE); Behavioral: Pain Assessment; Behavioral: Questionnaires; Behavioral: Neurocognitive Tests; Procedure: Cortisol Tests; Behavioral: Interviews |
| Standard of Care | Active comparator | Participants receive self-help materials that have been previously developed by MD Anderson's Office of Public Education, the American Cancer Society, and the National Cancer Institute.
Pain assessment administered at baseline and at follow up visit. Questionnaires completed at baseline and at follow up visit. Neurocognitive tests administered at baseline and at follow up visit. Cortisol testing performed after baseline visit and at follow up visit. Interviews conducted after follow up visit. These interviews are audio-taped and transcribed. Receives: Behavioral: Self-Help Materials; Behavioral: Pain Assessment; Behavioral: Questionnaires; Behavioral: Neurocognitive Tests; Procedure: Cortisol Tests; Behavioral: Interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Mindfulness Based Couples Therapy Intervention Among Breast Cancer Survivors and Their Partners (intervention adherence rate, defined as the proportion of sessions completed out of a total of 8 sessions)
Feasibility endpoint is intervention adherence rate, defined as the proportion of sessions completed out of a total of 8 sessions.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2015 (estimated)
- Study start23 Jan 2015
- Primary completion1 Aug 2022
- Study completion1 Aug 2022
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.
- More trials run by M.D. Anderson Cancer CenterThe 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Dantzer, PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02349217
- Sponsor's protocol ID
- 2014-0233
- Other IDs
- NCI-2015-00507
- Status last verified
- Aug 2022
- First submitted
- 23 Jan 2015
- Last updated
- 24 Aug 2022
- 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 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Based Couples Therapy for Breast Cancer Survivors: A Pilot Study
- ClinicalTrials.gov ID
- NCT02349217
- Acronym / sponsor ID
- 2014-0233
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Breast cancer survivors, Breast cancer partners, Mindfulness-Based Relationship Enhancement, MBRE, Standard of care, Pain Assessment, Questionnaires
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 23 Jan 2015 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 28 Jan 2015 (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.
The goal of this study is to explore the effects of a Mindfulness Based Couples Intervention on relationship satisfaction with quality of life and immune system function among breast cancer survivors and their partners.
Detailed description
Baseline Visit:
If you are found to be eligible to take part in this research study, you will return to the clinic about a week later for the Baseline Visit. You will be instructed to fast (eat nothing and drink only water) for at least 8 hours before this visit.
- Blood (about 4-5 tablespoons) will be drawn for tests of your immune function, stress hormone levels, and blood sugar levels. After this blood test, you will be given breakfast.
- You will complete a pain assessment which involves you submerging your hand in cold water. Researchers will use your response to measure your pain tolerance.
- You will have electrocardiograms (EKGs) to check your heart function. The sensors will be attached at the beginning of the visit and then removed before you leave. You will be attached to the machine for several hours, but you will be able to be disconnected to take bathroom breaks, if needed.
- You will complete questionnaires about fatigue, mood, stress, social support, marital satisfaction, depression, and general demographics (age, race and so on). It should take about 1½ hours total to complete the questionnaires.
- You will complete a series of traditional neurocognitive tests (for example, tests to check your memory and thinking abilities). You will take these tests on the computer and with a pen and paper.
- Your blood pressure will be measured multiple times throughout the visit.
Study Groups and Interventions:
After the Baseline visit, you will be assigned to one of 2 groups. If you are in Group 1, you and your partner will take part in an 8-week Mindfulness-Based Relationship Enhancement (MBRE) intervention course designed to alleviate stress and other symptoms among couples. The MBRE course will consist of eight sessions taught by a professional Mindfulness instructor. The sessions will occur 1 time a week and last about 2½ hours each time. The MBRE course will consist of meditation and yoga techniques and handouts. The sessions will focus on teaching participants (all female breast cancer survivors and partners) the basics of Mindfulness Based Relationship Enhancement.
Attendance at these sessions and completion of daily homework assignments requiring up to 45 minutes per day are essential to the program.
If you are in Group 2, you will receive self-help materials that have been previously developed by MD Anderson's Office of Public Education, the American Cancer Society, and the National Cancer Institute.
Post-Intervention Follow-Up Visit:
If you are in Group 1, you will have a post-intervention follow-up visit about 12 weeks after your Baseline visit (4 weeks after you finish your 8-week intervention sessions). If you are in Group 2, you will have a post-intervention follow-up visit about 8 weeks after the Baseline Visit. You will fast for 8 hours before a post-intervention follow-up visit.
- Blood (about 4 to 5 tablespoons) will be drawn to check your immune function, stress hormone levels, and blood sugar. After the blood is drawn you will be given breakfast.
- You will complete the cold water pain tolerance test.
- You will have electrocardiograms (EKGs).
- You will complete questionnaires about fatigue, mood, stress, social support, marital satisfaction, depression, and general demographics (age, race and so on). It should take about 1½ hours total to complete the questionnaires.
- You will complete a series of traditional neurocognitive tests.
- Your blood pressure will be measured multiple times throughout the visit.
Cortisol Testing:
After the Baseline and Follow-up Visits, you will be asked to give samples to measure cortisol, a hormone related to stress. You will place a small cotton tube in your mouth for about 2 minutes, or until the swab is completely soaked with your saliva. After this, you will place the swab back in the tube, and freeze the sample. You will be given containers to hold the samples when you freeze them, as well as to mark which day and time each sample was collected. You will take these samples 7 times a day (right when you wake up; about 30, 45, and 60 minutes after waking; and then at noon, 4:00 p.m., and 8:00 p.m.). Researchers will use these samples to measure the changes in cortisol throughout the day. You will collect these samples for 2 days during the week, and 2 days on the weekend. After you complete 4 total days of collecting saliva samples after each visit, you will mail them back to MD Anderson in pre-paid envelopes.
Program Satisfaction Evaluations:
After the follow-up visits, the study staff will conduct individual interviews with a small group of participants. Interview questions will address participants' overall reactions to and satisfaction with the mind-body intervention, the impact they felt from social support, motivation, and their own ability for increasing physical activity and well-being. The study staff will also ask questions about both positive and negative effects of participating in the intervention. Interviews will be conducted by the PI or a trained research coordinator. All interviews will last no longer than 90 minutes and will be audio-taped using a digital recorder and transcribed. All audio files will be destroyed after they are transcribed.
This is an investigational study.
Up to 30 couples (60 participants) will take part in this research study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Based Stress Reduction Intervention (MBRE) | Experimental | Behavioral: Mindfulness-Based Relationship Enhancement (MBRE), Behavioral: Pain Assessment, Behavioral: Questionnaires, Behavioral: Neurocognitive Tests, Procedure: Cortisol Tests, Behavioral: InterviewsParticipant and partner take part in an 8-week Mindfulness-Based Relationship Enhancement (MBRE) intervention course. MBRE course consists of meditation and yoga techniques and handouts. Pain assessment administered at baseline and at follow up visit. Questionnaires completed at baseline and at follow up visit. Neurocognitive tests administered at baseline and at follow up visit. Cortisol testing performed after baseline visit and at follow up visit. Interviews conducted after follow up visit. These interviews are audio-taped and transcribed. |
| Standard of Care | Active comparator | Behavioral: Self-Help Materials, Behavioral: Pain Assessment, Behavioral: Questionnaires, Behavioral: Neurocognitive Tests, Procedure: Cortisol Tests, Behavioral: InterviewsParticipants receive self-help materials that have been previously developed by MD Anderson's Office of Public Education, the American Cancer Society, and the National Cancer Institute. Pain assessment administered at baseline and at follow up visit. Questionnaires completed at baseline and at follow up visit. Neurocognitive tests administered at baseline and at follow up visit. Cortisol testing performed after baseline visit and at follow up visit. Interviews conducted after follow up visit. These interviews are audio-taped and transcribed. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Stage 0-IIIA breast cancer survivors and their partner
- All the female breast cancer survivors will be at least two months from receiving cancer treatment (surgery, adjuvant therapy or radiation) and within three years from completing cancer treatment, except for tamoxifen/aromatase inhibitors.
- Are able to read and write in English
- Are able to pass the Physical Activity Readiness Questionnaire or participant provides a letter from their physician or nurse practitioner clearing them for study participation
- All couples co-habiting for at least 3 years with current partner who is willing to participate in study
Key exclusion criteria (10 listed)
- Male breast cancer survivors;
- Participants with a diagnosis of diabetes, unless they are able to provide a letter from a physician who will continue to monitor the participant during the research study
- Anti-inflammatory medications (e.g. statins, cholesterol medication)
- Consume excessive amounts of alcohol (>30 drinks/week)
- Pregnant or thinking about becoming pregnant during the study period
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-Based Relationship Enhancement (MBRE)Participant and partner take part in an 8-week Mindfulness-Based Relationship Enhancement (MBRE) intervention course. MBRE course consists of meditation and yoga techniques and handouts. | Behavioural | Mindfulness Based Stress Reduction Intervention (MBRE) |
| Self-Help MaterialsParticipants and partner receive self-help materials. | Behavioural | Standard of Care |
| Pain AssessmentPain assessment administered at baseline and at follow up visit. Pain assessment involves submerging hand in cold water. | Behavioural | Mindfulness Based Stress Reduction Intervention (MBRE), Standard of Care |
| QuestionnairesAlso: SurveysQuestionnaires completed at baseline and at follow up visit. Questionnaires ask about fatigue, mood, stress, social support, marital satisfaction, depression, and general demographics (age, race and so on). It should take about 1½ hours total to complete the questionnaires. | Behavioural | Mindfulness Based Stress Reduction Intervention (MBRE), Standard of Care |
| Neurocognitive TestsNeurocognitive tests administered at baseline and at follow up visit. Tests to check memory and thinking abilities. | Behavioural | Mindfulness Based Stress Reduction Intervention (MBRE), Standard of Care |
| Cortisol TestsAlso: Saliva testsCortisol testing performed after baseline visit and at follow up visit. Participants asked to collect saliva samples for cortisol assays immediately, 30, 45, and 60 minutes after awakening (representing the cortisol awakening response) and at noon, 4 P.M. and 8 P.M. | Procedure or surgery | Mindfulness Based Stress Reduction Intervention (MBRE), Standard of Care |
| InterviewsInterviews conducted after follow up visit. These interviews are audio-taped and transcribed. | Behavioural | Mindfulness Based Stress Reduction Intervention (MBRE), Standard of Care |
Primary outcome
Feasibility of Mindfulness Based Couples Therapy Intervention Among Breast Cancer Survivors and Their Partners (intervention adherence rate, defined as the proportion of sessions completed out of a total of 8 sessions)
Time frame: 12 weeks
Feasibility endpoint is intervention adherence rate, defined as the proportion of sessions completed out of a total of 8 sessions.
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 Aug 2022.
- MD Anderson Cancer CenterLink 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.
Robert Dantzer, PHD principal investigator
M.D. Anderson Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Relationship Enhancement (MBRE), Self-Help Materials and Pain Assessment in people with Breast Cancer, run by M.D. Anderson Cancer Center at 2 sites 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 6 inclusion and 10 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 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Feasibility of Mindfulness Based Couples Therapy Intervention Among Breast Cancer Survivors and Their Partners (intervention adherence rate, defined as the proportion of sessions completed out of a total of 8 sessions) (time frame: 12 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 24 Aug 2022.