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Behavioral Intervention for Cancer
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
Study Summary
This trial is testing whether two positive activities can help improve quality of life for cancer patients from collectivist cultures and their caregivers.
Who is the study for?
This trial is for cancer patients aged 35-70 from collectivist cultures (Asian American, African American, Latino, European American) within 1-5 years of diagnosis and undergoing treatment. They must have a caregiver of the same ethnicity who lives with them and both must be able to use English and have internet access. Excluded are those with major depression or less than 6 months to live.Check my eligibility
What is being tested?
The study tests two positive activities aimed at improving quality of life for collectivist culture cancer patients and their caregivers: acts of kindness like contributing to household duties, and writing gratitude letters. It assesses if these simple tasks can enhance feelings of competence, autonomy, and connectedness.See study design
What are the potential side effects?
Since this trial involves behavioral interventions rather than medical treatments or drugs, there are no typical side effects as seen in drug trials. However, participants may experience emotional responses related to the activities.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Consent rate
Intervention adherence rate
Study completion rate
Secondary outcome measures
Changes in interpersonal well-being of the intervention caregivers
Changes in interpersonal well-being of the intervention patients
Changes in physical well-being of the intervention caregivers
+3 moreOther outcome measures
Potential effectiveness of the intervention
Side 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%
Blurred vision
2%
Hemorrhoids
2%
Hypothyroidism
2%
Urticaria
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
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Condition II (gratitude)Experimental Treatment4 Interventions
Patients write a letter or note of gratitude BIW for 4 weeks to their caregivers who have helped with their treatment or recovery.
Group II: Condition I (contribution)Experimental Treatment4 Interventions
Patients do 1 nice thing (can be as large or as small as they wish) BIW for 4 weeks for their caregivers while at home.
Group III: Condition III (daily activities tracking)Active Control4 Interventions
Participants keep track of their daily activities.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Behavioral Intervention
2021
Completed Phase 4
~3740
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,973 Previous Clinical Trials
1,789,242 Total Patients Enrolled
Qian LuPrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
1,560 Total Patients Enrolled
Qian Lu, MDPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with severe depression or have high scores on a depression questionnaire.
Research Study Groups:
This trial has the following groups:- Group 1: Condition III (daily activities tracking)
- Group 2: Condition I (contribution)
- Group 3: Condition II (gratitude)
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.
What anticipated benefits can participants expect from this trial?
"The primary aim of this four-week clinical trial is to observe the rate of consent. Secondary aims include measuring changes in physical well-being, interpersonal closeness, and psychological health among participants using standardized scales such as the MDASI, Relationship Closeness Inventory, Affect-Adjective Scale, Perceived Stress Scale, and Center for Epidemiologic Studies Depression Scale (CES-D)."
Answered by AI
How many participants are receiving treatment as part of this research endeavor?
"That is correct. A quick look at clinicaltrials.gov reveals that the trial, which was originally launched on May 18th 2021, remains open for enrollment and has recently been updated on October 14th 2022. The team aims to recruit a total of 104 individuals from 1 site."
Answered by AI
Are participants still being sought for this clinical exploration?
"Affirmative, the research posted on clinicaltrials.gov signals that this medical trial is actively searching for participants. The original post was made on May 18th 2021 and has been revised as recently as October 14th 2022. In total, 104 individuals are sought across a single location."
Answered by AI
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