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| ID | Type | Description | Link |
|---|---|---|---|
| 1K08CA286755-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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The purpose of this study is to explore the feasibility and acceptability of a nurse-led, coping, and supportive care intervention for patients with triple-negative breast cancer. The intervention aims to improve psychosocial outcomes in patients with triple-negative breast cancer (e.g., quality of life (QOL), anxiety, fear of cancer recurrence (FCR)).
Background: Patients with triple-negative breast cancer (TNBC) account for approximately 10-15% of all breast cancer diagnoses but are disproportionately burdened with metastatic disease and breast cancer death due to high rates of recurrence and a lack of risk-reducing treatment options in the surveillance phase. The transition to surveillance is marked with distress and prognostic uncertainty regarding fears of cancer recurrence at a time when contact with the oncology team decreases. Despite the dire needs of patients with TNBC, no coping and supportive care interventions currently exist for this population.
Objective: To address this gap, the proposed study, funded by the National Cancer Institute, aims to develop, refine, and pilot-test a nurse-led, coping, and supportive care intervention to address the needs of patients with TNBC as they transition from curative therapy to surveillance.
Specific Aims: The aims of this project are to (1) to evaluate the feasibility and acceptability of the study protocol and intervention by conducting a pilot randomized controlled trial (RCT) of RESTORE, compared to an enhanced usual care control group (N=75), and (2) to estimate the preliminary effects of RESTORE for improving psychosocial outcomes (i.e., QOL, anxiety, FCR) in the pilot RCT.
Study Design: The investigators will conduct a pilot RCT (n=75) to assess the feasibility of the intervention and an enhanced usual care group with assessments over the course of six months. The intervention is a brief, virtual, small-group, coping, and supportive care intervention that aims to improve psychosocial outcomes for patients with TNBC transitioning from curative therapy to surveillance. Participants will be recruited at Massachusetts General Hospital Cancer Center and three community satellite sites. Eligible participants will be patients with early-stage TNBC. This research study involves completing a questionnaire battery at enrollment, 12 weeks, and 24 weeks. If the participants are randomized to receive the intervention, they will have five weekly 45-60-minute virtual (videoconferencing) sessions in small groups with a trained nurse, followed by two 15-minute check-in phone calls later in the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RESTORE | Experimental | RESTORE is delivered as five weekly one-hour virtual (teleconference) sessions in small groups with a trained nurse and two 15-minute check-in phone calls later in the study. Participants will complete questionnaires at enrollment, 12-weeks, and 24-weeks post-enrollment. |
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| Enhanced Usual Care | Active Comparator | Participants will receive educational information on breast cancer survivorship care in addition to usual care. Participants will complete questionnaires at enrollment, 12-weeks and 24-weeks post-enrollment. Participants will be offered one optional RESTORE intervention session after completing the 24-week questionnaire. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RESTORE | Behavioral | RESTORE is a nurse-led, small group-based, virtual (teleconference) cognitive-behavioral therapy-based intervention. The intervention incorporates psychoeducation, problem-solving, cognitive restructuring, relaxation training, symptom management skills training, coping effectiveness training, and mindfulness techniques. |
| Measure | Description | Time Frame |
|---|---|---|
| Program Feasibility - Enrollment | The investigators will evaluate program feasibility by examining enrollment metrics. Enrollment feasibility is defined as ≥ 60% of eligible, approached patients who were offered study participation enrolling in the study. | 12 weeks |
| Program Feasibility - Retention | The investigators will evaluate program feasibility by examining retention rates. Retention feasibility is defined as ≥ 70% of participants completing the 12-week follow-up assessment. | 12 weeks |
| Program Feasibility - Session Attendance | The investigators will evaluate program feasibility by examining session attendance. Attendance feasibility is defined as ≥ 70% of participants completing at least 4 of 5 RESTORE intervention sessions. | 12 weeks |
| Intervention Acceptability | The investigators will evaluate intervention acceptability by examining satisfaction scores on the Client Satisfaction Questionnaire (CSQ). The intervention will be deemed acceptable if ≥75% of participants report average satisfaction scores above the CSQ's midpoint. The CSQ is evaluated on a 1-4 scale, with higher scores indicating greater satisfaction. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Intervention Session Acceptability | The investigators will assess the acceptability of intervention sessions using a 5-item survey on timing, content, and satisfaction with the RESTORE intervention. The measure is investigator-developed and is evaluated on a 1-4 scale. A higher score indicates greater acceptability of intervention sessions. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kathryn E Post, PhD, RN, ANP-BC | Contact | 617-726-6500 | kepost@mgh.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Kathryn E Post, PhD, RN, ANP-BC | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02144 | United States |
The Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to the principal investigator, Dr. Kathryn Post. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Data can be shared no earlier than one year following publication.
MGH - Contact the Partners Innovations team at http://www.partners.org/innovation
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| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
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| ID | Term |
|---|---|
| C094068 | Restore polishing paste |
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| Enhanced Usual Care | Behavioral | Participants will receive educational information on breast cancer survivorship care in addition to usual care. |
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| Changes in Symptoms of Anxiety Between Groups on the PROMIS Emotional Distress Anxiety Short Form From Baseline to 12-weeks Post-baseline. | The investigators will assess changes in anxiety using the Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress Anxiety Short Form, an 8-item survey assessing symptoms of anxiety over the last week. Each item is scored on a 1-5 scale, with higher scores indicating greater anxiety symptoms. | 12 weeks |
| Changes in Symptoms of Depression Between Groups on the PROMIS Emotional Distress Depression Short Form From Baseline to 12-weeks Post-baseline. | The investigators will assess changes in depression using the Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress Depression Short Form, an 8-item survey assessing symptoms of depression over the last week. Each item is evaluated on a 1-5 scale, with higher scores indicating greater depressive symptoms. | 12 weeks |
| Changes in Symptoms of Anxiety and Depression on the Hospital Anxiety and Depression Scale Between Groups at Baseline and 12-weeks Post-baseline. | Investigators will assess changes in symptoms of depression and anxiety via the Hospital Anxiety and Depression Scale (HADS). The HADS is a 14-item, well-validated survey used widely in patients with cancer that contains two subscales assessing symptoms of depression and anxiety over the past week. Items are scored on a 0-3 scale, with higher scores indicating greater anxiety and depressive symptoms. | 12 weeks |
| Changes in Fear of Cancer Recurrence Between Groups on the Fear of Cancer Recurrence Inventory - Short Form From Baseline to 12-weeks Post-baseline. | Investigators will assess changes in fear of cancer recurrence using the Fear of Cancer Recurrence Inventory - Short Form (FCRI-SF). The FCRI-SF is a validated, 9-item survey assessing fear of cancer recurrence over the last month. Each item is evaluated on a 0-4 scale and a higher score reflects higher fear of cancer recurrence. | 12 weeks |
| Changes in Fear of Cancer Recurrence Between Groups on the Fear of Cancer Recurrence-1 From Baseline to 12-weeks Post-baseline. | Investigators will assess changes in fear of cancer recurrence using the Fear of Cancer Recurrence-1 (FCR-1). The FCR-1 is a validated 1-item survey that assesses fear of cancer recurrence among cancer survivors. Participants report a score between 0 and 100, with higher scores indicating greater fear of cancer recurrence. | 12 weeks |
| Changes in Quality of Life Between Groups at Baseline and 12-weeks Post-baseline. | The investigators will assess changes in quality of life using the Functional Assessment of Cancer Therapy- Breast (FACT-B). The FACT-B is a well-validated, 37-item survey of five domains of quality of life in patients with breast cancer over the last week: physical, social, emotional, functional, well-being, and a breast cancer-specific subscale. Each item is evaluated on a 0-4 scale. Higher scores indicate greater quality of life. | 12 weeks |
| Changes in Coping Between Groups at Baseline and 12-weeks Post-baseline. | Investigators will assess changes in coping via the Measure of Current Stress - Part A (MOCS-A). The MOCS-A is a 13-item survey used to evaluate participants' perceived ability to cope using several skills. Each item is scored on a 0-4 scale, with higher scores indicating greater coping ability. | 12 weeks |
| Changes in Social Support Between Groups at Baseline and 12-weeks Post-baseline. | Investigators will assess changes in social support using the PROMIS Social Isolation Short Form. The Patient-Reported Outcomes Measurement Information System (PROMIS) Social Isolation Short Form is a 6-item survey evaluating perceived social support on a 5-point Likert scale. Higher scores indicate increased social support. | 12 weeks |
| Changes in Fear of Recurrence and Health Concerns Between Groups at Baseline and 12-weeks Post-baseline | Investigators will assess changes in fear about recurrence and health via the Assessment of Survivorship Concerns (ASC). The ASC is a 5-item survey scored on a 1-4 scale and includes two subscales: cancer worry and health worry. Higher scores indicate greater worry. | 12 weeks |
| D012871 |
| Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |