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Mindfulness Relaxation for Cancer Caregivers

N/A

Recruiting

Led By Larkin Strong

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

ECOG (Eastern Cooperative Oncology Group) performance status of =< 2

Diagnosed with a stage III-IV solid tumor

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 6 and 12 weeks

Awards & highlights

Study Summary

This trial is testing mindfulness-based interventions to help Latino cancer patients and their caregivers. These interventions focus on building awareness of thoughts, emotions, and sensations. The study may improve mental well-being and reduce stress and anxiety.

Who is the study for?

This trial is for Latino adults with stage III-IV solid tumors who are on active treatment and have an ECOG performance status of <=2. Participants must be willing to join the study with a family caregiver they live with, who also consents. Both must self-identify as Hispanic/Latino, be at least 18 years old, speak English or Spanish, and have internet access.Check my eligibility

What is being tested?

The trial is testing mindfulness-based interventions designed for Latino cancer patients and their caregivers. It includes mindfulness relaxation techniques, filling out questionnaires, and assessing quality of life to see if these methods can improve mental well-being and reduce stress related to cancer.See study design

What are the potential side effects?

Mindfulness-based interventions typically do not cause physical side effects but may bring up emotional discomfort initially as participants become more aware of their thoughts and feelings related to cancer.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself but might not be able to do heavy physical work.

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My cancer is at an advanced stage (III-IV).

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 6 and 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 6 and 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6 and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acceptability

Adherence

Attrition

+1 more

Secondary outcome measures

Patient and caregiver psychological distress

Patient cancer symptoms

Quality of life questionnaire

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

Back pain

Headache

Nervous system disorders - Other, specify

Pain in extremity

General disorders and administration site conditions - Other, specify

Skin infection

White blood cell decreased

Hypercalcemia

Hypokalemia

Musculoskeletal and connective tissue disorder - Other, specify

Dizziness

Respiratory, thoracic and mediastinal disorders - Other, specify

Eye disorders - Other, specify

Hyperkalemia

Pain

Alkaline phosphatase increased

Hypocalcemia

Cough

Flushing

Tinnitus

Dental caries

Gastrointestinal disorders - Other, specify

Hemoglobin increased

Weight loss

Metabolism and nutrition disorders - Other, specify

Dysgeusia

Anxiety

Irregular menstruation

Menorrhagia

Sore throat

Lymphocyte count decreased

Hyperuricemia

Non-cardiac chest pain

Infections and infestations - Other, specify

Hypernatremia

Hypoglycemia

Scalp pain

Dry mouth

Acute kidney injury

Blurred vision

Hemorrhoids

Hypothyroidism

Urticaria

Palpitations

Leukocytosis

Myocardial infarction

Vertigo

Anal hemorrhage

Dysphagia

Esophageal pain

Periodontal disease

Fever

Sinusitis

Urinary tract infection

Bruising

Dermatitis radiation

Cholesterol high

Creatinine increased

Neck pain

Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify

Concentration impairment

Memory impairment

Spasticity

Depression

Insomnia

Allergic rhinitis

Productive cough

Sleep apnea

Pregnancy, puerperium and perinatal conditions - Other, specify

Dry eye

Lymphedema

Chest pain - cardiac

Heart failure

Gastric perforation

Hypertriglyceridemia

Dyspnea

Cardiac disorders - Other, specify

Gastroesophageal reflux disease

Oral dysesthesia

Chills

Hypophosphatemia

Chest wall pain

Psychiatric disorders - Other, specify

Hematuria

Urinary tract obstruction

Dysmenorrhea

Skin hypopigmentation

Unintended pregnancy

Flu like symptoms

Nail infection

Pancreatitis

Blood and lymphatic system disorders - Other, specify

Oral pain

Fall

100%

80%

60%

40%

20%

Study treatment Arm

Arm I (Sorafenib Tosylate)

Arm II (Placebo)

Crossover Group

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Group I (mindfulness program)Experimental Treatment3 Interventions

Patients and their partners participate in mindfulness program over 60 minutes consisting of meeting with a mindfulness coach to build awareness of thoughts, emotions, feelings, and sensations QW for 4 weeks.

Group II: Group II (mindfulness waitlist)Active Control3 Interventions

Patients and their partners participate in mindfulness program as in Group I beginning 12 weeks after starting the study

0 / 2Eligibility criteria met