Breast CancerNCT03770598
Team Based Psychosocial Care to Promote, Maintain and Restore Wellness of Breast Cancer Patients
A study testing Psycho-Education and Team Based Care in people with Breast Cancer, run by Mayo Clinic at 1 site in United States.
Trial summary
Researchers are trying to see if proactive identification and team based individualized care of cancer patients having emotional difficulties can improve quality of life relative to treatment as usual. 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?
- Psycho-Education and Team Based Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Nov 2018to 16 Nov 2021
- 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
- Diagnosis of breast cancer within last three years
- Able to communicate in English or with the help of an interpreter.
- Access to a device with internet connection
Who cannot join
- Breast cancer patients who are considered for hospice or expected survival of less than six months.
- Presence of active suicidal ideations.
- Presence of active psychosis.
- Presence of dementia
Trial locations and contacts
1 site in 1 country.
About this study
Researchers are trying to see if proactive identification and team based individualized care of cancer patients having emotional difficulties can improve quality of life relative to treatment as usual. Also, to see if proactive approaches to maintain wellness can prevent grief among breast cancer patients, experiencing no emotional difficulties relative to treatment as usual.
Read the detailed description
Consented subjects will be randomized into two separate groups. Groups will be distressed and non-distressed subjects. Each group will be randomized into either intervention education training or standard of care. Both groups will be asked to fill out questionnaires during the duration of the study. Subjects will be remain in the study for up to one year.
- Conditions
- Breast Cancer
- Being tested
- Standard of Care Distressed in study Arm Distressed, Psycho-Education, Team Based Care, Standard of Care Non-Distressed
- Keywords
- Psychosocial Care, Wellness
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of Care Distressed in study Arm DistressedBehavioural
Social worker evaluation and possible referral to Psychiatry/Psychology for evaluation and further treatment.
Psycho-EducationBehavioural
Mindfulness based stress reduction class, yoga and education material
Team Based CareBehavioural
Psychiatrist, Oncologist, clinical social worker, study coordinator
Standard of Care Non-DistressedBehavioural
No psycho-education about wellness promotion or health. These patients will be monitored only.
| Study group | Role | What they receive |
|---|---|---|
| Distressed | Active comparator | Study participants who do indicate distress or who do meet criteria for depression or anxiety will be randomized to receive either treatment as usual (referral to Psychiatry or Psychology for evaluation and further treatment) or team based care model. Receives: Behavioral: Standard of Care Distressed in study Arm Distressed; Behavioral: Team Based Care |
| Non-Distressed | Active comparator | Study participants who do not indicate distress or who do not meet criteria for depression or anxiety will be randomize to monitoring only or to receive psycho-education regarding subjects that when used can promote wellness. Receives: Behavioral: Psycho-Education; Behavioral: Standard of Care Non-Distressed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Wellness
Subject wellness scores based on Short Warwick-Edinburgh Mental-Wellbeing Scale. This is a 7 item scale monitoring of mental wellbeing in subjects. Responses are based on a 1 to 5 item scale with 1 = None of the time, 2 = Rarely, 3 = Some of the Time, 4 = Often, 5 = All of the Time.
Measured: baseline, 6 months
Secondary outcomes (2)
Improvement in depression compared to baseline
measured by using PHQ-8 (Patient Health Questionnaire); this is an 8 item scale. Scores of 5 or less are considered no depression, 5-10, mild depression, 11-15, moderate depression, 16-20 moderately severe and more than 20 is considered severe depression.
Measured: one year
Improvement in anxiety compared to baseline
Will be measured by GAD-7 (Generalized Anxiety Disorder 7-item Scale). Its a 7 item scale. Cut points of 5, 10, 15 represent mild, moderate and severe levels of anxiety.
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2018
- Study start28 Nov 2018
- Primary completion16 Nov 2021
- Study completion16 Nov 2021
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 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Non-Distressed patients will be randomized to receive intervention or standard of care. Distressed patients will be randomized to receive intervention or standard of care
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shehzad K. Niazi, Mayo Clinic
- Investigators
- Shehzad K Niazi, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03770598
- Sponsor's protocol ID
- 18-000718
- Status last verified
- Apr 2024
- First submitted
- 19 Nov 2018
- Last updated
- 19 Apr 2024
- 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 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Team Based Psychosocial Care to Promote, Maintain and Restore Wellness of Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT03770598
- Acronym / sponsor ID
- 18-000718
- Conditions
- Breast Cancer
- Keywords
- Psychosocial Care, Wellness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 28 Nov 2018 (actual)
- Primary completion
- 16 Nov 2021 (actual)
- Study completion
- 16 Nov 2021 (actual)
- First posted
- 10 Dec 2018 (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.
Researchers are trying to see if proactive identification and team based individualized care of cancer patients having emotional difficulties can improve quality of life relative to treatment as usual. Also, to see if proactive approaches to maintain wellness can prevent grief among breast cancer patients, experiencing no emotional difficulties relative to treatment as usual.
Detailed description
Consented subjects will be randomized into two separate groups. Groups will be distressed and non-distressed subjects. Each group will be randomized into either intervention education training or standard of care. Both groups will be asked to fill out questionnaires during the duration of the study. Subjects will be remain in the study for up to one year.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Non-Distressed patients will be randomized to receive intervention or standard of care. Distressed patients will be randomized to receive intervention or standard of care
| Arm | Type | Receives |
|---|---|---|
| Distressed | Active comparator | Behavioral: Standard of Care Distressed in study Arm Distressed, Behavioral: Team Based CareStudy participants who do indicate distress or who do meet criteria for depression or anxiety will be randomized to receive either treatment as usual (referral to Psychiatry or Psychology for evaluation and further treatment) or team based care model. |
| Non-Distressed | Active comparator | Behavioral: Psycho-Education, Behavioral: Standard of Care Non-DistressedStudy participants who do not indicate distress or who do not meet criteria for depression or anxiety will be randomize to monitoring only or to receive psycho-education regarding subjects that when used can promote wellness. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of breast cancer within last three years
- Able to communicate in English or with the help of an interpreter.
- Access to a device with internet connection
Key exclusion criteria (4 listed)
- Breast cancer patients who are considered for hospice or expected survival of less than six months.
- Presence of active suicidal ideations.
- Presence of active psychosis.
- Presence of dementia
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 |
|---|---|---|
| Standard of Care Distressed in study Arm DistressedSocial worker evaluation and possible referral to Psychiatry/Psychology for evaluation and further treatment. | Behavioural | Distressed |
| Psycho-EducationMindfulness based stress reduction class, yoga and education material | Behavioural | Non-Distressed |
| Team Based CarePsychiatrist, Oncologist, clinical social worker, study coordinator | Behavioural | Distressed |
| Standard of Care Non-DistressedNo psycho-education about wellness promotion or health. These patients will be monitored only. | Behavioural | Non-Distressed |
Primary outcome
Change in Wellness
Time frame: baseline, 6 months
Subject wellness scores based on Short Warwick-Edinburgh Mental-Wellbeing Scale. This is a 7 item scale monitoring of mental wellbeing in subjects. Responses are based on a 1 to 5 item scale with 1 = None of the time, 2 = Rarely, 3 = Some of the Time, 4 = Often, 5 = All of the Time.
2 secondary outcomes
Improvement in depression compared to baseline
Time frame: one year
Improvement in anxiety compared to baseline
Time frame: One Year
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 19 Apr 2024.
- 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.
Shehzad K Niazi principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psycho-Education and Team Based Care in people with Breast Cancer, 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 3 inclusion and 4 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 19 Apr 2024. 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?
Change in Wellness (time frame: baseline, 6 months). 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 19 Apr 2024.