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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
No Placebo-Only Group

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.
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.
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 weeks
Treatment ~ Varies
Follow Up ~30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Consent rate
Intervention adherence rate
Study completion rate
Secondary study objectives
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 more
Other study objectives
Potential effectiveness of the intervention

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: 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
3,074 Previous Clinical Trials
1,803,441 Total Patients Enrolled
Qian LuPrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
1,704 Total Patients Enrolled
Qian Lu, MDPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Positive Activities Intervention Clinical Trial Eligibility Overview. Trial Name: NCT04810052 — N/A
Blood Cancers Research Study Groups: Condition III (daily activities tracking), Condition I (contribution), Condition II (gratitude)
Blood Cancers Clinical Trial 2023: Positive Activities Intervention Highlights & Side Effects. Trial Name: NCT04810052 — N/A
Positive Activities Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT04810052 — N/A
~36 spots leftby Dec 2026
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