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Supportive Care for Breast Cancer

N/A

Waitlist Available

Led By Meagan Whisenant

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to 3 months

Awards & highlights

Study Summary

This trial is testing an e-health support program to help newly diagnosed breast cancer patients with symptoms like pain, fatigue, depression, and anxiety. The goal is to improve overall health.

Eligible Conditions

Breast Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Impact of electronic (e)-health support program on patient reported outcomes

Side effects data

From 2023 Phase 1 & 2 trial • 28 Patients • NCT04345601

83%

Anemia

67%

Lymphocyte count decreased

58%

Platelet count decreased

58%

Alanine aminotransferase increased

50%

Hypokalemia

42%

Hyponatremia

42%

Fever

33%

Blood bicarbonate decreased

33%

Hypoalbuminemia

33%

Creatinine increased

33%

Diarrhea

33%

Hypocalcemia

33%

Lung infection

33%

Aspartate aminotransferase increased

25%

Hyperkalemia

25%

Atrial fibrillation

25%

Hypophosphatemia

25%

Hematuria

25%

Hypotension

25%

Hypertriglyceridemia

25%

Hypermagnesemia

25%

Proteinuria

17%

Hematoma

17%

Vomiting

17%

Glucosuria

17%

Dizziness

17%

Hyperphosphatemia

17%

Hypernatremia

17%

Anxiety

17%

Hypercalcemia

17%

Vascular disorders - Other, specify:DVT

17%

Pneumothorax

17%

Anorexia

17%

Hypoxia

17%

Urinary tract infection

Hyperuricemia

Sepsis

Pleural effusion

Multi-organ failure

White blood cell decreased

Sinus tachycardia

Blood bilirubin increased

Cardiac troponin I increased

Acute kidney injury

Blood lactate dehydrogenase increased

Urinary retention

Rash maculo-papular

Asystole

Acidosis

Constipation

Thromboembolic event

Syncope

Hypertension

Hypoglycemia

Ileus

Respiratory failure

Lipase increased

Cytomegalovirus infection reactivation

Palpitations

Bacteremia

Dyspepsia

Folliculitis

100%

80%

60%

40%

20%

Study treatment Arm

Control Group

Safety Run In

Mesenchymal Stromal Cells (MSCs)

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Group I (Pack Health Program)Experimental Treatment2 Interventions

Patients participate in the Pack Health Program which includes up to 60 scheduled touch points via phone, text, email and a mobile application and weekly interaction with a health coach over 3 months. They also have access to standard of care support services at MD Anderson including a telephone triage line 5 days a week between 8 a.m. and 5 p.m.

Group II: Group II (standard of care support services)Active Control2 Interventions

Patients receive standard of care support services with a telephone triage line available 5 days a week between 8 a.m. and 5 p.m.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Supportive Care

2013

Completed Phase 2

~1710

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,980 Previous Clinical Trials

1,789,390 Total Patients Enrolled

148 Trials studying Breast Cancer

63,286 Patients Enrolled for Breast Cancer

National Cancer Institute (NCI)NIH

13,701 Previous Clinical Trials

40,929,159 Total Patients Enrolled

942 Trials studying Breast Cancer

1,543,966 Patients Enrolled for Breast Cancer

Meagan WhisenantPrincipal InvestigatorM.D. Anderson Cancer Center

1 Previous Clinical Trials

287 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings to join this research endeavor?

"As per clinicaltrials.gov, this research is no longer actively recruiting patients. The trial was initially posted on May 19th 2017; however it hasn't been updated since November 1st 2022. Despite this fact, there are still 2291 other studies currently seeking out participants for enrolment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

E-Health Support Program (PACK Health Program) in Supporting Patient Reported Symptoms in Newly Diagnosed Patients With Breast Cancer

2017. "E-Health Support Program (PACK Health Program) in Supporting Patient Reported Symptoms in Newly Diagnosed Patients With Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05549687.