Supportive Care for Breast Cancer
(RESTORE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a nurse-led program designed to help individuals with triple-negative breast cancer cope better and improve their quality of life. The program includes five weekly virtual sessions and aims to reduce anxiety and fear of cancer recurrence. Participants will receive either this program or enhanced usual care, which includes educational materials and support. Individuals who have experienced stage 1-3 triple-negative breast cancer and feel significant distress may be well-suited for this study. As an unphased trial, this study offers a unique opportunity to contribute to innovative care strategies that could enhance emotional well-being for future patients.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this nurse-led intervention is safe for patients with triple-negative breast cancer?
Research has shown that breast cancer supportive therapy and survivorship services are generally safe. According to the Mayo Clinic, risks depend on the specific services received. While some risks may exist, they usually relate to the particular type of care. Overall, patients tolerate these therapies well.
Studies also indicate that supportive care plays a crucial role in improving the quality of life for breast cancer patients. Various supportive programs have been used without major side effects, suggesting they are safe. However, discussing any concerns with a healthcare provider remains important.12345Why are researchers excited about this trial?
Researchers are excited about the RESTORE program for breast cancer survivors because it offers a unique, supportive care approach beyond the usual medical treatments. Unlike standard treatments that focus primarily on medication and physical health, RESTORE provides emotional and psychological support through five weekly one-hour virtual sessions led by a trained nurse. This innovative method not only addresses the emotional well-being of participants but also offers flexibility and convenience by being conducted via teleconference. By incorporating regular check-ins and optional participation, RESTORE aims to improve the overall quality of life for breast cancer survivors, which is a crucial aspect often overlooked in traditional care.
What evidence suggests that this trial's treatments could be effective for improving psychosocial outcomes in patients with triple-negative breast cancer?
This trial will compare two supportive care options for breast cancer patients: RESTORE and Enhanced Usual Care. Studies have shown that supportive care programs can greatly improve the quality of life for breast cancer patients. Research indicates that online programs like RESTORE can help patients manage their symptoms and feel better overall. Specifically, a recent study found that patients with advanced breast cancer who joined supportive care programs experienced a better quality of life. Many patients find these programs helpful and would recommend them to others. Overall, supportive care options, including RESTORE, show promise in helping patients handle the challenges of breast cancer.26789
Who Is on the Research Team?
Kathryn E Post, PhD, RN, ANP-BC
Principal Investigator
Massachusetts General Hospital
Are You a Good Fit for This Trial?
This trial is for adults (18+) who have stage 1-3 triple-negative breast cancer, finished curative treatment within the past year, feel at least moderately distressed, and can read English or Spanish. People with advanced cancer or serious mental health issues can't join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Participants receive the RESTORE intervention, consisting of five weekly virtual sessions and two follow-up phone calls
Follow-up
Participants are monitored for psychosocial outcomes and complete questionnaires at 12 and 24 weeks post-enrollment
Optional RESTORE Session
Participants in the Enhanced Usual Care group are offered one optional RESTORE intervention session after completing the 24-week questionnaire
What Are the Treatments Tested in This Trial?
Interventions
- Enhanced Usual Care
- RESTORE
Trial Overview
The study compares a nurse-led coping and support program called RESTORE to enhanced usual care. It aims to see if RESTORE helps improve quality of life and reduce anxiety in patients after treatment.
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
Active Control
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Citations
Impact of a Multidisciplinary Supportive Care Model Using ...
In the intervention arm, the mean screening tool completion rate was 86.6% (SD = 22.9%) over 1 year, with 51 (61.5%) participants completing the ...
Long-Term Follow-Up Care After Treatment for Primary ...
Advancements in early detection and multimodal treatment strategies have significantly improved survival rates for early-stage breast cancer ...
A web-based intervention (RESTORE) to support self ...
RESTORE is the first web-based resource designed to enhance self-efficacy to manage CRF following curative-intent treatment.
4.
facingourrisk.org
facingourrisk.org/XRAY/supportive-care-improves-quality-of-life-for-metastatic-breast-cancer-patientsSupportive care can improve quality of life for people with ...
A recent study reported improvement in metastatic breast cancer patient quality of life and wellness with an intervention program called the Supportive, ...
Evaluation of the Pathways for Survivors Program to Address ...
The Pathways for Survivors workshop was well received by patients, and the overwhelming majority would recommend the workshop to other cancer ...
Breast cancer survivors–supportive care needs - PMC - NIH
This study aimed to identify supportive care needs from the point of view of breast cancer survivors.
Supporting women's health outcomes after breast cancer ...
The aim of this study is to evaluate the efficacy, feasibility and acceptability of a co-designed lifestyle-focused text message intervention (EMPOWER-SMS) ...
Research points to need for personalized supportive care
Almost half (47%) of participants reported a significant or catastrophic financial burden due to breast cancer. The burden was worse among ...
Transforming breast cancer management with real-world ...
This article reviews the integration of RWD into breast cancer research, highlighting the benefits and challenges.
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