Cancer SurvivorPTWNCT03025139
Mindfulness Meditation or Survivorship Education in Improving Behavioral Symptoms in Younger Stage 0-III Breast Cancer Survivors (Pathways to Wellness)
A study testing Educational Intervention, Laboratory Biomarker Analysis and Meditation Therapy in people with Cancer Survivor and Early-Stage Breast Carcinoma, run by Jonsson Comprehensive Cancer Center at 3 sites in United States.
Trial summary
This randomized phase III trial studies how well mindfulness meditation or survivorship education work in improving behavioral symptoms in younger stage 0-III breast cancer survivors. Read more about this study
- Who is it for?
- Ages Up to 49 years, women only
- Conditions the study is for
- Cancer Survivor, Early-Stage Breast Carcinoma, Stage 0 Breast Cancer
- What is being tested?
- Educational Intervention, Laboratory Biomarker Analysis and Meditation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 3 sitesUnited States
- Study dates
- 20 Feb 2017to 1 Feb 2024
- 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 Up to 49 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Women diagnosed with early stage, resectable breast cancer (Stage 0, I, II, or III) prior to age 50, and are within 5 years of diagnosis
- Have completed all surgery, radiation, and/or chemotherapy treatments at least 6 months previously; may still be receiving trastuzumab or endocrine adjuvant therapy
- Ability to complete evaluation surveys in English
- Have evidence of at least mild clinical depression on a standardized screening questionnaire
Who cannot join
- Has a breast cancer recurrence, metastasis, or another interval cancer diagnosis following the breast cancer (excluding non-melanoma skin cancer)
- Unable to commit to intervention schedule (6 weekly group meetings)
- Actively practicing mindfulness meditation
- Has another serious or chronic medical or psychiatric condition that contributes to substantial physical or emotional disability that would detract from participating in either of the intervention programs or from the measurement of intervention outcomes
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
About this study
Official title: Improving Outcomes for Younger Breast Cancer Survivors: A Phase III Randomized Trial Targeting Behavioral Symptoms in Younger Breast Cancer Survivors
This randomized phase III trial studies how well mindfulness meditation or survivorship education work in improving behavioral symptoms in younger stage 0-III breast cancer survivors. Behavioral interventions, such as mindfulness meditation, use techniques to help patients change the way they react to environmental triggers that may cause a negative reaction. Survivorship education after treatment may reduce stress and improve the well-being and quality of life of patients with breast cancer. Mindfulness meditation or survivorship education may help improve the health behaviors of younger breast cancer survivors.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate the efficacy of two different types of group interventions (mindfulness and survivorship education), specifically tailored to the needs of younger female breast cancer survivors, in reducing depressive symptoms, compared to a usual care control group.
SECONDARY OBJECTIVES:
- To compare the efficacy of the two interventions relative to a usual care control group on fatigue, sleep disturbance, and vasomotor symptoms.
II. To examine the efficacy of the two interventions relative to a usual care control group on circulating and genomic markers of inflammation.
III. To explore potential moderators and mediators of intervention efficacy in the two intervention groups.
OUTLINE: Patients are randomized to 1 of 3 arms.
ARM A (MINDFULNESS AWARENESS PRACTICES [MAPs]): Patients attend a mindfulness meditation class over 2 hours once weekly for 6 weeks. Patients then attend in person booster sessions that include guided meditation, questions, and discussion of how to maintain a mindfulness practice over 1 hour once monthly for 3 months.
ARM B (SURVIVORSHIP EDUCATION INTERVENTION [SE]): Patients attend a survivorship education class over 2 hours once weekly for 6 weeks. Patients also receive monthly electronic newsletters with tailored information about topics of interest to younger survivors, including cancer-related events in the community and tips about following through on recommendations for healthy living.
ARM C (USUAL CARE/DELAYED TREATMENT CONTROL GROUP): Patients receive usual care for 9 months. Patients are then offered a choice of participating in Arm A or Arm B.
After completion of study, patients are followed up at 3 and 6 months.
- Conditions
- Cancer Survivor, Early-Stage Breast Carcinoma, Stage 0 Breast Cancer, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage IIA Breast Cancer
- Being tested
- Educational Intervention, Laboratory Biomarker Analysis, Meditation Therapy, Questionnaire Administration
- Keywords
- breast cancer, younger women, education, mindfulness meditation, depression, cancer survivor
- Medical subject headings
- Breast Neoplasms, Breast Carcinoma In Situ, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Attend survivorship education
Laboratory Biomarker AnalysisOther
Correlative studies
Meditation TherapyProcedure or surgery
Also called Meditation
Attend mindfulness meditation
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm A (MAPs) | Active comparator | Patients attend a mindfulness meditation class over 2 hours once weekly for 6 weeks. Patients then attend in person booster sessions that include guided meditation, questions, and discussion of how to maintain a mindfulness practice over 1 hour once monthly for 2 months. Receives: Other: Laboratory Biomarker Analysis; Procedure: Meditation Therapy; Other: Questionnaire Administration |
| Arm B (SE) | Active comparator | Patients attend a survivorship education class over 2 hours once weekly for 6 weeks. Patients also receive monthly electronic newsletters with tailored information about topics of interest to younger survivors, including cancer-related events in the community and tips about following through on recommendations for healthy living. Receives: Other: Educational Intervention; Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration |
| Arm C (USUAL CARE/DELAYED TREATMENT CONTROL GROUP) | Active comparator | Patients receive usual care for 9 months. Patients are then offered a choice of participating in Arm A or Arm B. Receives: Other: Educational Intervention; Other: Laboratory Biomarker Analysis; Procedure: Meditation Therapy; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depressive symptoms measured by Center for Epidemiologic Studies Depression Scale score
The data will be analyzed using linear mixed effects models, with fixed effects for time and condition and random effects for individuals. Differences between conditions in change over time will be examined by testing condition-by-time interaction terms. All tests will be two-sided. The Hochberg procedure will be applied to the two p-values for each intervention to control the familywise error rate at 0.05.
Measured: 2 weeks post-intervention to 6 months
Secondary outcomes (6)
Change in fatigue assessed by Fatigue Symptom Inventory
Will be tested using the mixed modeling approach, and p-values reported both with and without multiplicity adjustment. All tests will be two-sided.
Measured: 2 weeks post-intervention to 6 months
Change in hot flashes measured by the vasomotor symptom severity subscale of the BCPT symptom scales questionnaire.
Will be tested using the mixed modeling approach, and p-values reported both with and without multiplicity adjustment. All tests will be two-sided.
Measured: 2 weeks post-intervention to 6 months
Change in inflammatory biomarkers will focus on laboratory measurements of Interleukin-6 (IL-6) and high sensitivity C-Reactive Protein (hsCRP)
Will be tested using the mixed modeling approach, and p-values reported both with and without multiplicity adjustment. All tests will be two-sided.
Measured: 2 weeks post-intervention to 6 months
Change in sleep disturbance assessed by Insomnia Severity Index
Will be tested using the mixed modeling approach, and p-values reported both with and without multiplicity adjustment. All tests will be two-sided.
Measured: 2 weeks post-intervention to 6 months
Mediators of intervention efficacy assessed by questionnaire
Mediators assessed will include self-efficacy, mindfulness, self-kindness, and rumination.
Measured: Up to 6 months
Moderators of intervention efficacy assessed by questionnaire
Moderators will include preparedness for survivorship, intervention preference, and childhood adversity. Will be assessed using condition-by-moderator interaction terms in mixed models.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2017 (estimated)
- Study start20 Feb 2017
- Primary completion1 Feb 2023 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cancer SurvivorStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive 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
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Patricia Ganz, Principal investigator, UCLA / Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03025139
- Sponsor's protocol ID
- 16-000817
- Other IDs
- NCI-2016-01396, R01CA200977
- Acronym
- PTW
- Status last verified
- Jul 2022
- First submitted
- 17 Jan 2017
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Korecki JRT, Ganz PA, Partridge AH, Wolff AC, Petersen L, Crespi CM, Bower JE. Mediators of a Mindfulness-Based Intervention for Younger Breast Cancer Survivors: Effects on Depressive Symptoms. Psychosom Med. 2024 Oct 1;86(8):700-709. doi: 10.1097/PSY.0000000000001340. Epub 2024 Aug 10.
PubMed 39132946Tyrus Korecki JR, Ganz PA, Partridge AH, Wolff AC, Petersen L, Crespi CM, Bower JE. Moderators of Intervention Efficacy in the Pathways to Wellness Trial of Survivorship Education and Mindfulness Meditation for Younger Breast Cancer Survivors. JCO Oncol Pract. 2024 Oct;20(10):1410-1419. doi: 10.1200/OP.23.00617. Epub 2024 Jun 25.
PubMed 38917400Bower JE, Partridge AH, Wolff AC, Cole SW, Irwin MR, Thorner ED, Joffe H, Petersen L, Crespi CM, Ganz PA. Improving biobehavioral health in younger breast cancer survivors: Pathways to Wellness trial secondary outcomes. J Natl Cancer Inst. 2023 Jan 10;115(1):83-92. doi: 10.1093/jnci/djac180.
PubMed 36130057Bower JE, Partridge AH, Wolff AC, Thorner ED, Irwin MR, Joffe H, Petersen L, Crespi CM, Ganz PA. Targeting Depressive Symptoms in Younger Breast Cancer Survivors: The Pathways to Wellness Randomized Controlled Trial of Mindfulness Meditation and Survivorship Education. J Clin Oncol. 2021 Nov 1;39(31):3473-3484. doi: 10.1200/JCO.21.00279. Epub 2021 Aug 18.
PubMed 34406839
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Outcomes for Younger Breast Cancer Survivors: A Phase III Randomized Trial Targeting Behavioral Symptoms in Younger Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT03025139
- Acronym / sponsor ID
- PTW / 16-000817
- Conditions
- Cancer Survivor, Early-Stage Breast Carcinoma, Stage 0 Breast Cancer, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage IIA Breast Cancer
- Keywords
- breast cancer, younger women, education, mindfulness meditation, depression, cancer survivor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institutes of Health (NIH)
- Study start
- 20 Feb 2017 (actual)
- Primary completion
- 1 Feb 2023 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 19 Jan 2017 (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.
This randomized phase III trial studies how well mindfulness meditation or survivorship education work in improving behavioral symptoms in younger stage 0-III breast cancer survivors. Behavioral interventions, such as mindfulness meditation, use techniques to help patients change the way they react to environmental triggers that may cause a negative reaction. Survivorship education after treatment may reduce stress and improve the well-being and quality of life of patients with breast cancer. Mindfulness meditation or survivorship education may help improve the health behaviors of younger breast cancer survivors.
Detailed description
PRIMARY OBJECTIVES:
- To evaluate the efficacy of two different types of group interventions (mindfulness and survivorship education), specifically tailored to the needs of younger female breast cancer survivors, in reducing depressive symptoms, compared to a usual care control group.
SECONDARY OBJECTIVES:
- To compare the efficacy of the two interventions relative to a usual care control group on fatigue, sleep disturbance, and vasomotor symptoms.
II. To examine the efficacy of the two interventions relative to a usual care control group on circulating and genomic markers of inflammation.
III. To explore potential moderators and mediators of intervention efficacy in the two intervention groups.
OUTLINE: Patients are randomized to 1 of 3 arms.
ARM A (MINDFULNESS AWARENESS PRACTICES [MAPs]): Patients attend a mindfulness meditation class over 2 hours once weekly for 6 weeks. Patients then attend in person booster sessions that include guided meditation, questions, and discussion of how to maintain a mindfulness practice over 1 hour once monthly for 3 months.
ARM B (SURVIVORSHIP EDUCATION INTERVENTION [SE]): Patients attend a survivorship education class over 2 hours once weekly for 6 weeks. Patients also receive monthly electronic newsletters with tailored information about topics of interest to younger survivors, including cancer-related events in the community and tips about following through on recommendations for healthy living.
ARM C (USUAL CARE/DELAYED TREATMENT CONTROL GROUP): Patients receive usual care for 9 months. Patients are then offered a choice of participating in Arm A or Arm B.
After completion of study, patients are followed up at 3 and 6 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A (MAPs) | Active comparator | Other: Laboratory Biomarker Analysis, Procedure: Meditation Therapy, Other: Questionnaire AdministrationPatients attend a mindfulness meditation class over 2 hours once weekly for 6 weeks. Patients then attend in person booster sessions that include guided meditation, questions, and discussion of how to maintain a mindfulness practice over 1 hour once monthly for 2 months. |
| Arm B (SE) | Active comparator | Other: Educational Intervention, Other: Laboratory Biomarker Analysis, Other: Questionnaire AdministrationPatients attend a survivorship education class over 2 hours once weekly for 6 weeks. Patients also receive monthly electronic newsletters with tailored information about topics of interest to younger survivors, including cancer-related events in the community and tips about following through on recommendations for healthy living. |
| Arm C (USUAL CARE/DELAYED TREATMENT CONTROL GROUP) | Active comparator | Other: Educational Intervention, Other: Laboratory Biomarker Analysis, Procedure: Meditation Therapy, Other: Questionnaire AdministrationPatients receive usual care for 9 months. Patients are then offered a choice of participating in Arm A or Arm B. |
Who may qualify
- Ages
- Up to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Women diagnosed with early stage, resectable breast cancer (Stage 0, I, II, or III) prior to age 50, and are within 5 years of diagnosis
- Have completed all surgery, radiation, and/or chemotherapy treatments at least 6 months previously; may still be receiving trastuzumab or endocrine adjuvant therapy
- Ability to complete evaluation surveys in English
- Have evidence of at least mild clinical depression on a standardized screening questionnaire
Key exclusion criteria (4 listed)
- Has a breast cancer recurrence, metastasis, or another interval cancer diagnosis following the breast cancer (excluding non-melanoma skin cancer)
- Unable to commit to intervention schedule (6 weekly group meetings)
- Actively practicing mindfulness meditation
- Has another serious or chronic medical or psychiatric condition that contributes to substantial physical or emotional disability that would detract from participating in either of the intervention programs or from the measurement of intervention outcomes
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 |
|---|---|---|
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalAttend survivorship education | Other | Arm B (SE), Arm C (USUAL CARE/DELAYED TREATMENT CONTROL GROUP) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Arm A (MAPs), Arm B (SE), Arm C (USUAL CARE/DELAYED TREATMENT CONTROL GROUP) |
| Meditation TherapyAlso: MeditationAttend mindfulness meditation | Procedure or surgery | Arm A (MAPs), Arm C (USUAL CARE/DELAYED TREATMENT CONTROL GROUP) |
| Questionnaire AdministrationAncillary studies | Other | Arm A (MAPs), Arm B (SE), Arm C (USUAL CARE/DELAYED TREATMENT CONTROL GROUP) |
Primary outcome
Change in depressive symptoms measured by Center for Epidemiologic Studies Depression Scale score
Time frame: 2 weeks post-intervention to 6 months
The data will be analyzed using linear mixed effects models, with fixed effects for time and condition and random effects for individuals. Differences between conditions in change over time will be examined by testing condition-by-time interaction terms. All tests will be two-sided. The Hochberg procedure will be applied to the two p-values for each intervention to control the familywise error rate at 0.05.
6 secondary outcomes
Change in fatigue assessed by Fatigue Symptom Inventory
Time frame: 2 weeks post-intervention to 6 months
Change in hot flashes measured by the vasomotor symptom severity subscale of the BCPT symptom scales questionnaire.
Time frame: 2 weeks post-intervention to 6 months
Change in inflammatory biomarkers will focus on laboratory measurements of Interleukin-6 (IL-6) and high sensitivity C-Reactive Protein (hsCRP)
Time frame: 2 weeks post-intervention to 6 months
Change in sleep disturbance assessed by Insomnia Severity Index
Time frame: 2 weeks post-intervention to 6 months
Mediators of intervention efficacy assessed by questionnaire
Time frame: Up to 6 months
Moderators of intervention efficacy assessed by questionnaire
Time frame: Up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
- Derived from this study: PubMed 39132946Korecki JRT, Ganz PA, Partridge AH, Wolff AC, Petersen L, Crespi CM, Bower JE. Mediators of a Mindfulness-Based Intervention for Younger Breast Cancer Survivors: Effects on Depressive Symptoms. Psychosom Med. 2024 Oct 1;86(8):700-709. doi: 10.1097/PSY.0000000000001340. Epub 2024 Aug 10.
- Derived from this study: PubMed 38917400Tyrus Korecki JR, Ganz PA, Partridge AH, Wolff AC, Petersen L, Crespi CM, Bower JE. Moderators of Intervention Efficacy in the Pathways to Wellness Trial of Survivorship Education and Mindfulness Meditation for Younger Breast Cancer Survivors. JCO Oncol Pract. 2024 Oct;20(10):1410-1419. doi: 10.1200/OP.23.00617. Epub 2024 Jun 25.
- Derived from this study: PubMed 36130057Bower JE, Partridge AH, Wolff AC, Cole SW, Irwin MR, Thorner ED, Joffe H, Petersen L, Crespi CM, Ganz PA. Improving biobehavioral health in younger breast cancer survivors: Pathways to Wellness trial secondary outcomes. J Natl Cancer Inst. 2023 Jan 10;115(1):83-92. doi: 10.1093/jnci/djac180.
- Derived from this study: PubMed 34406839Bower JE, Partridge AH, Wolff AC, Thorner ED, Irwin MR, Joffe H, Petersen L, Crespi CM, Ganz PA. Targeting Depressive Symptoms in Younger Breast Cancer Survivors: The Pathways to Wellness Randomized Controlled Trial of Mindfulness Meditation and Survivorship Education. J Clin Oncol. 2021 Nov 1;39(31):3473-3484. doi: 10.1200/JCO.21.00279. Epub 2021 Aug 18.
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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.
Patricia Ganz principal investigator
UCLA / Jonsson Comprehensive Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Intervention, Laboratory Biomarker Analysis and Meditation Therapy in people with Cancer Survivor and Early-Stage Breast Carcinoma, run by Jonsson Comprehensive Cancer Center at 3 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 4 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: status not confirmed, as of the sponsor's last update on 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Results are not available in the source record.
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 depressive symptoms measured by Center for Epidemiologic Studies Depression Scale score (time frame: 2 weeks post-intervention to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03025139, which also lists 4 linked publications.
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 21 Jul 2022.