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Expressive Writing Therapy for Breast Cancer Survivors

N/A
Recruiting
Led By Qian Lu
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
Being diagnosed with stage 0-III breast cancer
Completed primary treatment, including surgery, chemotherapy, radiation therapy, immune therapy, and/or targeted therapy within the preceding 5 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial looks at whether a culturally-tailored writing intervention can help improve the health of early to mid-stage Chinese immigrant breast cancer survivors.

Who is the study for?
This trial is for foreign-born Chinese women, aged 18 or older, who have been living in the U.S. for at least six months and were diagnosed with stage 0-III breast cancer. Participants should have completed primary treatments like surgery or chemotherapy within the last five years.
What is being tested?
The study is testing a culturally tailored brief expressive writing intervention to see if it improves health outcomes for Chinese immigrant breast cancer survivors by having them write about their experiences.
What are the potential side effects?
Since this is a psychological intervention involving writing, there are no direct medical side effects; however, participants may experience emotional discomfort while reflecting on their cancer journey.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My breast cancer is at an early to mid-stage (0-III).
Select...
I finished my main cancer treatment within the last 5 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Quality of life (QOL)
Secondary study objectives
Number of medical appointments for cancer-related morbidities
Perceived stress
Stress biomarker - alpha amylase
+1 more

Side effects data

From 2022 Phase 3 trial • 87 Patients • NCT02066181
73%
Fatigue
71%
Palmar-plantar erythrodysesthesia syndrome
63%
Hypertension
61%
Papulopustular rash
55%
Diarrhea
51%
Nausea
39%
Myalgia
37%
Alopecia
35%
Arthralgia
33%
Abdominal pain
31%
Anorexia
27%
Vomiting
22%
Mucositis oral
22%
Constipation
18%
Anemia
18%
Alanine aminotransferase increased
16%
Platelet count decreased
14%
Pruritus
14%
Hyperglycemia
14%
Rash maculo-papular
14%
Skin and subcutaneous tissue disorders - Other, specify
12%
Aspartate aminotransferase increased
12%
Rash acneiform
12%
Peripheral sensory neuropathy
10%
Investigations - Other, specify
10%
Dry skin
10%
Neutrophil count decreased
10%
Blood bilirubin increased
8%
Back pain
8%
Headache
8%
Nervous system disorders - Other, specify
8%
Pain in extremity
6%
General disorders and administration site conditions - Other, specify
6%
Skin infection
6%
White blood cell decreased
6%
Hypercalcemia
6%
Hypokalemia
6%
Musculoskeletal and connective tissue disorder - Other, specify
6%
Dizziness
6%
Respiratory, thoracic and mediastinal disorders - Other, specify
6%
Eye disorders - Other, specify
6%
Hyperkalemia
6%
Pain
6%
Alkaline phosphatase increased
6%
Hypocalcemia
6%
Cough
4%
Flushing
4%
Tinnitus
4%
Dental caries
4%
Gastrointestinal disorders - Other, specify
4%
Hemoglobin increased
4%
Weight loss
4%
Metabolism and nutrition disorders - Other, specify
4%
Dysgeusia
4%
Anxiety
4%
Irregular menstruation
4%
Menorrhagia
4%
Sore throat
4%
Lymphocyte count decreased
4%
Hyperuricemia
4%
Non-cardiac chest pain
4%
Infections and infestations - Other, specify
4%
Hypernatremia
4%
Hypoglycemia
4%
Scalp pain
4%
Dry mouth
2%
Hemorrhoids
2%
Blurred vision
2%
Hypothyroidism
2%
Urticaria
2%
Acute kidney injury
2%
Palpitations
2%
Leukocytosis
2%
Myocardial infarction
2%
Vertigo
2%
Anal hemorrhage
2%
Dysphagia
2%
Esophageal pain
2%
Periodontal disease
2%
Fever
2%
Sinusitis
2%
Urinary tract infection
2%
Bruising
2%
Dermatitis radiation
2%
Cholesterol high
2%
Creatinine increased
2%
Neck pain
2%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
2%
Concentration impairment
2%
Memory impairment
2%
Spasticity
2%
Depression
2%
Insomnia
2%
Allergic rhinitis
2%
Productive cough
2%
Sleep apnea
2%
Pregnancy, puerperium and perinatal conditions - Other, specify
2%
Dry eye
2%
Lymphedema
2%
Chest pain - cardiac
2%
Heart failure
2%
Gastric perforation
2%
Hypertriglyceridemia
2%
Dyspnea
2%
Cardiac disorders - Other, specify
2%
Gastroesophageal reflux disease
2%
Oral dysesthesia
2%
Chills
2%
Hypophosphatemia
2%
Chest wall pain
2%
Psychiatric disorders - Other, specify
2%
Hematuria
2%
Urinary tract obstruction
2%
Dysmenorrhea
2%
Skin hypopigmentation
2%
Unintended pregnancy
2%
Flu like symptoms
2%
Nail infection
2%
Pancreatitis
2%
Blood and lymphatic system disorders - Other, specify
2%
Oral pain
2%
Fall
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm I (Sorafenib Tosylate)
Arm II (Placebo)
Crossover Group

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Arm III (self-cultivation writing)Experimental Treatment3 Interventions
Patients write about positive thoughts and feelings regarding their breast cancer experience for 3 weekly 30-minute sessions.
Group II: Arm II (self-regulation writing)Experimental Treatment3 Interventions
Patients write about stress and coping, emotional disclosure, and benefit finding for 3 weekly 30-minute sessions.
Group III: Arm I (control writing)Active Control3 Interventions
Patients write about facts regarding their cancer diagnosis and treatment for 3 weekly 30-minute sessions.

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,074 Previous Clinical Trials
1,803,107 Total Patients Enrolled
147 Trials studying Breast Cancer
63,202 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,957 Previous Clinical Trials
41,111,877 Total Patients Enrolled
943 Trials studying Breast Cancer
1,443,132 Patients Enrolled for Breast Cancer
Qian LuPrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
1,424 Total Patients Enrolled

Media Library

Culturally Based Brief Expressive Writing Intervention Clinical Trial Eligibility Overview. Trial Name: NCT04754412 — N/A
Breast Cancer Research Study Groups: Arm I (control writing), Arm II (self-regulation writing), Arm III (self-cultivation writing)
Breast Cancer Clinical Trial 2023: Culturally Based Brief Expressive Writing Intervention Highlights & Side Effects. Trial Name: NCT04754412 — N/A
Culturally Based Brief Expressive Writing Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT04754412 — N/A
~64 spots leftby Apr 2026
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