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Behavioral Intervention
Physical Activity Intervention for Cancer-Related Distress
N/A
Recruiting
Led By Scherezade K Mama
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 through study completion, an average of 1 year
Awards & highlights
Study Summary
This trial adapts and assesses an existing physical activity intervention to see if it can reduce psychosocial distress for cancer patients in rural areas.
Who is the study for?
This trial is for adults over 18 with a history of cancer, particularly those living in rural Texas areas and currently undergoing or recently finished treatment. Participants must be able to engage in moderate physical activity, have internet access, and speak English. It's not for those already meeting physical activity guidelines or with conditions preventing exercise.Check my eligibility
What is being tested?
The study tests a program designed to increase physical activity and reduce stress among cancer survivors. It involves behavioral changes through virtual sessions using smartphones or computers, best practices sharing, informational interventions, quality-of-life assessments, and questionnaires.See study design
What are the potential side effects?
Since this is a non-drug intervention focusing on lifestyle changes like increased physical activity, side effects may include typical exercise-related discomforts such as muscle soreness or fatigue but are generally minimal compared to medicinal treatments.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To establish a multicomponent intervention that assesses the perspective of cancer survivors
To establish a multicomponent intervention that assesses the perspective of health care provider
Secondary outcome measures
To establish the daily number of steps (collected using the activPAL over 7 days at week 8; data will be averaged over 7 days to get minutes per day)
To establish the health-related quality of life measured using the SF-36 short form
Thermometer, device
+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%
Blurred vision
2%
Acute kidney injury
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
2Treatment groups
Experimental Treatment
Active Control
Group I: Group I (physical activity intervention)Experimental Treatment4 Interventions
Patients attend face-to-face mind-body sessions focused on stretching, breathing, and relaxation twice a week and receive targeted text messages daily on their smartphone for 8 weeks.
Group II: Group II (usual care)Active Control3 Interventions
Patients receive usual care.
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
2,966 Previous Clinical Trials
1,804,705 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,077 Total Patients Enrolled
1 Trials studying Blood Cancers
70 Patients Enrolled for Blood Cancers
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,833 Previous Clinical Trials
47,306,420 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You must be able to understand and communicate in English.The study is only looking for participants from rural counties in Texas.You have had cancer in the past.We are looking for survivors who are either receiving treatment or have recently completed treatment, but still have follow-up appointments at UTHealth North Campus Tyler within the last year.You must be 18 years old or older.You need a smartphone, tablet, or computer with internet access to participate in virtual sessions, and you are willing to attend them.The study is open to both men and women who are 18 years old or older.You can communicate effectively in English through reading, speaking, and writing.The study is looking for healthcare professionals who have experience working with people who have had cancer, such as doctors, nurses, and patient navigators.You have a device like a smartphone, tablet or computer with internet access, and you are willing to participate in virtual sessions.
Research Study Groups:
This trial has the following groups:- Group 1: Group I (physical activity intervention)
- Group 2: Group II (usual care)
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.
How many participants are currently recruited for this clinical trial?
"Affirmative, the information on clinicaltrials.gov specifies that this experiment is actively accepting participants. This trial was initially advertised on June 21st 2021 and its details were modified for a final time September 7th 2022. At present, 76 patients need to be enrolled at one study centre."
Answered by AI
Is this research still actively seeking participants?
"The clinical trial, originally listed on June 21st 2021 and most recently updated on September 7th 2022, is actively seeking participants according to the information provided by clinicaltrials.gov."
Answered by AI
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