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1

Vagus Nerve Stimulator for Insomnia in People with Stage I-IV Breast Cancer

Investigating the Feasibility of Using taVNS to Treat Insomnia in Individuals With Stage I-IV Breast Cancer

Purpose: To study the ability of vagus nerve stimulation to improve sleep, anxiety, <span class="highlight">depression,</span> and cancer related fatigue.

Who is this for?: People with stage I, stage II, stage III, or stage IV (metastatic) breast cancer who have difficulty falling asleep, staying asleep, or waking up too early. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Vagus nerve stimulator, daily for 2 weeks</li> <li class="seamTextUnorderedListItem">Fitbit</li> <li class="seamTextUnorderedListItem">Sleep diary</li> <li class="seamTextUnorderedListItem">Surveys</li> <li class="seamTextUnorderedListItem">Interviews</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Vagus nerve stimulation delivers low-intensity electrical currents in the inner ear to stimulate nerves that may improve sleep.</li> <li class="seamTextUnorderedListItem">Insomnia is difficulty falling asleep, staying asleep, or waking up too early.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06006299' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/tests-procedures/vagus-nerve-stimulation/about/pac-20384565' target='_blank'>Mayo Clinic: Vagus Nerve Stimulation</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment-side-effects/insomnia#:~:text=Advertisement-,Insomnia%20can%20be%20caused%20by%20the%20stress%20of%20a%20breast,get%20a%20good%20night's%20sleep.' target='_blank'>Breastcancer.org: Insomnia and Breast Cancer</a> </li></ul>
1

Vagus Nerve Stimulator for Insomnia in People with Stage I-IV Breast Cancer

Investigating the Feasibility of Using taVNS to Treat Insomnia in Individuals With Stage I-IV Breast Cancer
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Nearest Location:
2011 miles
UAB Spain Rehabilitation Center
Birmingham, AL

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT06006299

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Phase NA

2

Improving Mental Health for Older Adults with Breast Cancer

Mental Health Care Initiation Intervention for Older Adults With Cancer

Purpose: To study the ability of the Open Door for Cancer (OD-C) approach to improve mental health for older adults with breast cancer.

Who is this for?: People with stage I, stage II, stage III, or stage IV (metastatic) breast cancer who were diagnosed at age 65 or older and are currently receiving treatment. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Open Door for Cancer (OD-C) approach, by phone or videoconference, 3 sessions within 1.5 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Usual Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Mental health screening</li> <li class="seamTextUnorderedListItem">Referrals to support resources</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The Open Door for Cancer (OD-C) approach includes the following: 1) Provide education about <span class="highlight">depression</span> and treatment options; 2) Identify treatment preferences and a personal goal achievable with mental health care; 3) Assess barriers to starting treatment; 4) Referrals to additional support; 5) Address barriers to accessing care.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06037954' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/managing-life/taking-care-of-mental-health/how-breast-cancer-affects-mental-health' target='_blank'>Breastcancer.org: How Breast Cancer Can Affect Mental Health</a> </li></ul>
2

Improving Mental Health for Older Adults with Breast Cancer

Mental Health Care Initiation Intervention for Older Adults With Cancer
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Nearest Location:
2567 miles
Memorial Sloan Kettering Cancer Center
New York, NY

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT06037954

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Phase NA

3

Telehealth CALM Therapy for People with Metastatic Breast Cancer with Brain Metastasis

Managing Distress in Malignant Brain Cancer - Phase IIc RCT

Purpose: To study if telehealth CALM therapy decreases distress.

Who is this for?: People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastasis) who are experiencing <span class="highlight">depression</span> or anxiety. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Telehealth CALM therapy, 6 sessions over 3-6 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Usual Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">List of resources for distress</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Managing Cancer and Living Meaningfully (CALM) sessions address four topics: 1) Symptom management and communication with healthcare providers, 2) Changes in personal relationships, 3) Sense of meaning and purpose, and 4) The future, hope and mortality.</li> <li class="seamTextUnorderedListItem">If you are in Group 1, you will receive CALM therapy virtually through telehealth.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06180460' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li></ul>
3

Telehealth CALM Therapy for People with Metastatic Breast Cancer with Brain Metastasis

Managing Distress in Malignant Brain Cancer - Phase IIc RCT
No Travel Required
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Visits:
No visits required

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ClinicalTrials.gov: NCT06180460

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Phase NA

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