SurvivorshipNCT07539649
LiveWell mBc: Adapted Dialectical Behavioral Therapy Skills Training
A study testing LiveWell mBC: A Group-Based Adapted Dialectical Behavioral Therapy Skills Training Program in people with Survivorship, run by Medical University of South Carolina.
Trial summary
In this pilot randomized controlled trial, women with metastatic breast cancer and at least mild distress (N=48) will be randomized to receive LiveWell mBC, a group-based adapted Dialectical Behavioral Therapy (DBT) Skills Training protocol, or Usual Care. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Survivorship
- What is being tested?
- LiveWell mBC: A Group-Based Adapted Dialectical Behavioral Therapy Skills Training Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2026to 28 Feb 2027
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- identify as female
- be diagnosed with metastatic (AJCC stage IV) breast cancer
- be receiving care for metastatic breast cancer at Hollings Cancer Center
- endorse >3 out of 10 on the NCCN distress thermometer over the past week plus at least one emotional concern on the problem checklist
- be > 18 years of age
- be able to understand, speak, and read English
- be able to provide informed consent.
Who cannot join
- reported or suspected cognitive impairment
- presence of untreated serious mental illness (e.g., schizophrenia) indicated by the medical chart or treating oncologist
- expected survival <6 months, as indicated by a hospice referral
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: LiveWell mBC: Pilot Test of an Adapted Dialectical Behavioral Therapy Skills Training Program in Groups of Women Living With Metastatic Breast Cancer
In this pilot randomized controlled trial, women with metastatic breast cancer and at least mild distress (N=48) will be randomized to receive LiveWell mBC, a group-based adapted Dialectical Behavioral Therapy (DBT) Skills Training protocol, or Usual Care. The investigators will evaluate feasibility, acceptability, and preliminary efficacy of LiveWell to reduce distress (primary outcome) and improve psychological well-being, symptom burden, and quality of life (secondary outcomes).
Read the detailed description
Participants will be randomized 2:1 to receive LiveWell mBC, an adapted DBT Skills Training intervention delivered to small groups of women with mBC via telehealth, or usual care. LiveWell mBC involves orientation + an 8-session skills training protocol of mindfulness, emotion regulation, distress tolerance and interpersonal effectiveness.
Participants will complete self-report measures at baseline, mid-intervention (Week 5), post-intervention (Week 11) and 1 month post-intervention (Week 15). It is hypothesized that: 1) RCT methods will demonstrate evidence of feasibility (>70% overall retention rate, >70% LiveWell mBC completion rate); 2) RCT methods will demonstrated evidence of acceptability (>50% enrollment rate, >80% participant satisfaction); and 3) LiveWell participants will demonstrate reductions in distress (primary outcome) compared to Usual Care at 11-week follow-up.
- Conditions
- Survivorship
- Being tested
- LiveWell mBC: A Group-Based Adapted Dialectical Behavioral Therapy Skills Training Program
- Keywords
- Dialectical Behavioral Therapy, Metastatic Breast Cancer, Distress, Psychosocial Oncology
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiveWell mBC: A Group-Based Adapted Dialectical Behavioral Therapy Skills Training ProgramBehavioural
LiveWell mBC: A Group-Based Adapted Dialectical Behavioral Therapy Skills Training Program
| Study group | Role | What they receive |
|---|---|---|
| LiveWell mBC: A Group-Based Adapted Dialectical Behavioral Therapy Skills Training Program | Experimental | Will receive 9 telehealth-delivered small group (6-8 participants) sessions (orientation + 8 session DBT skills training protocol) co-facilitated by two skills trainers. Sessions will be 90 minutes each and delivered approximately weekly. Sessions will teach skills from dialectical behavioral therapy (e.g., mindfulness, distress tolerance, emotion regulation, interpersonal effectiveness) adapted for patients with metastatic breast cancer. Sessions follow a standardized structure, including 1) mindfulness practice, 2) home practice and diary card review, 3) learning and practicing new skills, and 4) closing ritual. Participants will have access to a resource library of skills training videos and mindfulness recordings. Receives: Behavioral: LiveWell mBC: A Group-Based Adapted Dialectical Behavioral Therapy Skills Training Program |
| Usual Care | No intervention | Will receive a handout with general support resources available at Hollings Cancer Center. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PROMIS Depression Short Form (8a)
Depression will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (8 items) Short Form Scale. PROMIS scores are expressed as T-scores, with a mean of 50 and a standard deviation of 10. Higher scores indicate greater depressive symptomology.
Measured: Baseline (week 0), post-intervention (week 11), and 1-month follow-up (week 15)
PROMIS Anxiety Short Form (7a)
Anxiety will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety (7 items) Short Form Scale. PROMIS scores are expressed as T-scores, with a mean of 50 and a standard deviation of 10. Higher scores indicate greater anxiety symptomology.
Measured: Baseline (week 0), post-intervention (week 11), and 1 month follow-up (week 15)
Secondary outcomes (12)
Intolerance of Uncertainty Scale - Short Form (IUS-12)
The 12-item Intolerance of Uncertainty Scale (IUS) Short Form will be used to measure emotional, cognitive, and behavioral reactions to uncertain situations. The IUS has a score range of 12-60, where a higher score indicates greater intolerance of uncertainty.
Measured: Baseline (week 0), post-intervention (week 11), and 1 month follow-up (week 15)
Peace, Equanimity, and Acceptance in the Cancer (PEACE) - Peaceful Acceptance of Illness Subscale
The 5-item Peace, Equanimity, and Acceptance in the Cancer (PEACE) - Peaceful Acceptance of Illness Subscale will be used to assess patient-reported acceptance, inner peace, and tranquility in the context of cancer. The subscale has a score range of 5-20, where a higher score indicates greater peaceful acceptance of illness.
Measured: Baseline (week 0), post-intervention (week 11), and 1 month follow-up (week 15)
PROMIS Positive Affect Short Form (15a)
The PROMIS Positive Affect Short Form 15a will be used to assess patient-reported positive emotions and well-being over the past 7 days. PROMIS scores are expressed as T-scores, with a mean of 50 and a standard deviation of 10. Higher scores indicate greater positive affect.
Measured: Baseline (week 0), post-intervention (week 11), and 1 month follow-up (week 15)
Difficulty in Regulating Emotions Scale (DERS-18)
The DERS-18 will be used to assess emotion dysregulation. The DERS-18 has a score range of 18-80, where a higher score indicates greater difficulty with regulating emotions.
Measured: Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 1 month follow-up (week 15)
Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)
The 10-item Cognitive and Affective Mindfulness Scale-Revised will be used to assess patient-reported mindfulness qualities, including present-moment awareness, acceptance, and attention. The CAMS-R has a score range of 10-40, where a higher score indicates greater mindfulness.
Measured: Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 1 month follow-up (week 15)
DBT Ways of Coping Checklist (DBT-WCCL) - DBT Skills Subscale (DSS)
The DBT Ways of Coping Checklist (DBT-WCCL) -DBT Skills Subscale (DSS) will be used to assess patient-reported frequency of skill use to manage difficult situations. The DBT-WCCL has a score range of 0 to 4, where a higher score indicates greater DBT skill use.
Measured: Baseline (week 0), post-intervention (week 11), and 1 month follow-up (week 15)
NCI Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (NCI-PRO-CTCAE)
The NCI-PRO-CTCAE will be used to assess patient-reported symptom frequency, severity, and interference related to breast cancer and its treatment. Items are rated on a 5-point Likert scale, with higher scores indicating greater symptom burden.
Measured: Baseline (week 0), post-intervention (week 11), and 1 month follow-up (week 15)
PROMIS Self-Efficacy for Managing Emotions Short Form (8a)
The PROMIS Self-Efficacy for Managing Emotions 8-item Short Form will be used to assess patient-reported confidence in managing negative emotions and emotional distress related to chronic illness. PROMIS scores are expressed as T-scores, with a mean of 50 and a standard deviation of 10. Higher scores indicate greater self-efficacy for managing emotions.
Measured: Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 1 month follow-up (week 15)
PROMIS Self-Efficacy for Managing Symptoms Short Form (8a)
The PROMIS Self-Efficacy for Managing Symptoms 8-item Short Form will be used to assess patient-reported confidence in managing symptoms and limiting their interference with daily life. PROMIS scores are expressed as T-scores, with a mean of 50 and a standard deviation of 10. Higher scores indicate greater self-efficacy for managing symptoms.
Measured: Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 1 month follow-up (week 15)
Functional Assessment of Cancer Therapy - Breast (FACT-B)
The FACT-B will be used to assess patient-reported quality of life across physical, social/family, emotional, and functional domains, as well as breast cancer-specific concerns. Items are rated on a 5-point Likert scale (0 = Not at all to 4 = Very much) and summed to form subscale and total scores. Higher subscale and total scores indicate better quality of life.
Measured: Baseline (week 0), post-intervention (week 11), and 1 month follow-up (week 15)
PROMIS Emotional Support
The PROMIS Emotional Support (4a) Short Form will assess social support. The PROMIS scores are expressed as T-scores, with a mean of 50 and a standard deviation of 10. Higher scores indicate greater access to social support networks.
Measured: Baseline (week 0), post-intervention (week 11), and 1 month follow-up (week 15)
Group Therapy Experience Scale
The Group Therapy Experience Scale will measure perceived cohesion, self-disclosure, and satisfaction with group therapy. The 16 item scale uses a Likert scale with responses ranging from 1(strongly disagree) to 5(strongly agree). Higher scores indicate higher satisfaction with group therapy.
Measured: Post-intervention (week 11)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start30 Sep 2026 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurvivorshipStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Principal investigator, Kelly Hyland, Medical University of South Carolina
- Investigators
- Kelly Hyland, PhD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07539649
- Sponsor's protocol ID
- Pro00149650
- Status last verified
- Jun 2026
- First submitted
- 13 Apr 2026
- Last updated
- 20 Aug 2026
- 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 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LiveWell mBC: Pilot Test of an Adapted Dialectical Behavioral Therapy Skills Training Program in Groups of Women Living With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT07539649
- Acronym / sponsor ID
- Pro00149650
- Conditions
- Survivorship
- Keywords
- Dialectical Behavioral Therapy, Metastatic Breast Cancer, Distress, Psychosocial Oncology
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 20 Apr 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.
In this pilot randomized controlled trial, women with metastatic breast cancer and at least mild distress (N=48) will be randomized to receive LiveWell mBC, a group-based adapted Dialectical Behavioral Therapy (DBT) Skills Training protocol, or Usual Care. The investigators will evaluate feasibility, acceptability, and preliminary efficacy of LiveWell to reduce distress (primary outcome) and improve psychological well-being, symptom burden, and quality of life (secondary outcomes).
Detailed description
Participants will be randomized 2:1 to receive LiveWell mBC, an adapted DBT Skills Training intervention delivered to small groups of women with mBC via telehealth, or usual care. LiveWell mBC involves orientation + an 8-session skills training protocol of mindfulness, emotion regulation, distress tolerance and interpersonal effectiveness.
Participants will complete self-report measures at baseline, mid-intervention (Week 5), post-intervention (Week 11) and 1 month post-intervention (Week 15). It is hypothesized that: 1) RCT methods will demonstrate evidence of feasibility (>70% overall retention rate, >70% LiveWell mBC completion rate); 2) RCT methods will demonstrated evidence of acceptability (>50% enrollment rate, >80% participant satisfaction); and 3) LiveWell participants will demonstrate reductions in distress (primary outcome) compared to Usual Care at 11-week follow-up.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LiveWell mBC: A Group-Based Adapted Dialectical Behavioral Therapy Skills Training Program | Experimental | Behavioral: LiveWell mBC: A Group-Based Adapted Dialectical Behavioral Therapy Skills Training ProgramWill receive 9 telehealth-delivered small group (6-8 participants) sessions (orientation + 8 session DBT skills training protocol) co-facilitated by two skills trainers. Sessions will be 90 minutes each and delivered approximately weekly. Sessions will teach skills from dialectical behavioral therapy (e.g., mindfulness, distress tolerance, emotion regulation, interpersonal effectiveness) adapted for patients with metastatic breast cancer. Sessions follow a standardized structure, including 1) mindfulness practice, 2) home practice and diary card review, 3) learning and practicing new skills, and 4) closing ritual. Participants will have access to a resource library of skills training videos and mindfulness recordings. |
| Usual Care | No intervention | –Will receive a handout with general support resources available at Hollings Cancer Center. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- identify as female
- be diagnosed with metastatic (AJCC stage IV) breast cancer
- be receiving care for metastatic breast cancer at Hollings Cancer Center
- endorse >3 out of 10 on the NCCN distress thermometer over the past week plus at least one emotional concern on the problem checklist
- be > 18 years of age
Key exclusion criteria (3 listed)
- reported or suspected cognitive impairment
- presence of untreated serious mental illness (e.g., schizophrenia) indicated by the medical chart or treating oncologist
- expected survival <6 months, as indicated by a hospice referral
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 |
|---|---|---|
| LiveWell mBC: A Group-Based Adapted Dialectical Behavioral Therapy Skills Training ProgramLiveWell mBC: A Group-Based Adapted Dialectical Behavioral Therapy Skills Training Program | Behavioural | LiveWell mBC: A Group-Based Adapted Dialectical Behavioral Therapy Skills Training Program |
Primary outcome
PROMIS Depression Short Form (8a)
Time frame: Baseline (week 0), post-intervention (week 11), and 1-month follow-up (week 15)
Depression will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (8 items) Short Form Scale. PROMIS scores are expressed as T-scores, with a mean of 50 and a standard deviation of 10. Higher scores indicate greater depressive symptomology.
PROMIS Anxiety Short Form (7a)
Time frame: Baseline (week 0), post-intervention (week 11), and 1 month follow-up (week 15)
Anxiety will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety (7 items) Short Form Scale. PROMIS scores are expressed as T-scores, with a mean of 50 and a standard deviation of 10. Higher scores indicate greater anxiety symptomology.
12 secondary outcomes
Intolerance of Uncertainty Scale - Short Form (IUS-12)
Time frame: Baseline (week 0), post-intervention (week 11), and 1 month follow-up (week 15)
Peace, Equanimity, and Acceptance in the Cancer (PEACE) - Peaceful Acceptance of Illness Subscale
Time frame: Baseline (week 0), post-intervention (week 11), and 1 month follow-up (week 15)
PROMIS Positive Affect Short Form (15a)
Time frame: Baseline (week 0), post-intervention (week 11), and 1 month follow-up (week 15)
Difficulty in Regulating Emotions Scale (DERS-18)
Time frame: Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 1 month follow-up (week 15)
Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)
Time frame: Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 1 month follow-up (week 15)
DBT Ways of Coping Checklist (DBT-WCCL) - DBT Skills Subscale (DSS)
Time frame: Baseline (week 0), post-intervention (week 11), and 1 month follow-up (week 15)
NCI Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (NCI-PRO-CTCAE)
Time frame: Baseline (week 0), post-intervention (week 11), and 1 month follow-up (week 15)
PROMIS Self-Efficacy for Managing Emotions Short Form (8a)
Time frame: Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 1 month follow-up (week 15)
PROMIS Self-Efficacy for Managing Symptoms Short Form (8a)
Time frame: Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 1 month follow-up (week 15)
Functional Assessment of Cancer Therapy - Breast (FACT-B)
Time frame: Baseline (week 0), post-intervention (week 11), and 1 month follow-up (week 15)
PROMIS Emotional Support
Time frame: Baseline (week 0), post-intervention (week 11), and 1 month follow-up (week 15)
Group Therapy Experience Scale
Time frame: Post-intervention (week 11)
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 20 Aug 2026.
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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.
Kelly Hyland, PhD principal investigator
Medical University of South Carolina
Questions about this trial
What is this clinical trial studying?
A study testing LiveWell mBC: A Group-Based Adapted Dialectical Behavioral Therapy Skills Training Program in people with Survivorship, run by Medical University of South Carolina.
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 7 inclusion and 3 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 20 Aug 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 Moody (843-792-9698, moodykat@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PROMIS Depression Short Form (8a) (time frame: Baseline (week 0), post-intervention (week 11), and 1-month follow-up (week 15)). The study lists 2 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 20 Aug 2026.