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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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My breast cancer is at an early to mid-stage (0-III).
Select...
I finished my main cancer treatment within the last 5 years.
Select...
I am a Chinese woman, over 18, who has lived in the U.S. for at least six months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Quality of life (QOL)
Secondary outcome measures
Number of medical appointments for cancer-related morbidities
Perceived stress
Stress biomarker - alpha amylase
+1 moreSide effects data
From 2022 Phase 3 trial • 87 Patients • NCT0206618173%
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%
Acute kidney injury
2%
Hypothyroidism
2%
Hemorrhoids
2%
Blurred vision
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%
Urticaria
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
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
2,962 Previous Clinical Trials
1,803,125 Total Patients Enrolled
148 Trials studying Breast Cancer
63,286 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,101 Total Patients Enrolled
939 Trials studying Breast Cancer
1,543,343 Patients Enrolled for Breast Cancer
Qian LuPrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
1,424 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a Chinese woman, over 18, who has lived in the U.S. for at least six months.My breast cancer is at an early to mid-stage (0-III).I finished my main cancer treatment within the last 5 years.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (control writing)
- Group 2: Arm II (self-regulation writing)
- Group 3: Arm III (self-cultivation writing)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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 remaining in this experiment for participants?
"Confirmed, this research study is actively searching for participants. The initial posting date was July 23rd 2021 and the last update was on May 11th 2022 according to clinicaltrials.gov."
Answered by AI
How many research participants are enrolled in this clinical experiment?
"Affirmative. As indicated on clinicaltrials.gov, this medical research endeavour is currently recruiting participants; it was initially posted on July 23rd 2021 and modified lastly on May 11th 2022. The trial seeks to enlist 240 individuals at a single site."
Answered by AI
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