Trials / Active Not Recruiting

Active Not RecruitingNCT04090619

Frequency of Cachexia in Ambulatory Cancer Patients and Psychological Burden in Patients and Their Primary Caregivers

Frequency of Cachexia in Ambulatory Cancer Patients and Psychological Burden in Both Patients and Their Primary Caregivers Who Are Referred to an Outpatient Supportive Care Clinic

Status: Active Not Recruiting
Phase: —
Study type: Observational
Enrollment: 192 (actual)

Sponsor: M.D. Anderson Cancer Center · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Accepted

Summary

This trial studies the frequency of cachexia in ambulatory cancer patients and the psychological burden in patients and their primary caregivers who are referred to an outpatient supportive care clinic. Studying how often loss of appetite and/or unintentional weight loss (cachexia) occurs in patients seen in the supportive care clinic may help researchers develop new ways to lower stress in patients who suffer from loss of appetite and weight loss as well as their family caregivers.

Detailed description

PRIMARY OBJECTIVE: I. To estimate the proportion of patients with cancer cachexia, as defined by various criteria including The European Society of Clinical Nutrition and Metabolism (ESPEN) as well as an International Consensus Criteria (ICC), in a group of ambulatory patients with advanced cancer who are referred to a Supportive Care Clinic at University of Texas MD Anderson Cancer Center (UTMDACC). SECONDARY OBJECTIVES: I. To estimate the proportion of patients with complications anorexia (Appetite Score Edmonton Symptom Assessment Scale \[ESAS\] \[\>= 3\] \& Functional Assessment of Anorexia Therapy-Anorexia/Cachexia Subscale Questionnaire \[FAACT-A/CS\] =\< 37); and the proportion of patients that have both anorexia and cancer cachexia. II. To examine the association between symptoms of anorexia and/or cancer cachexia and the degree of symptom distress in cancer patients seen in a supportive care clinic, as measured by Edmonton Symptom Assessment Scale (ESAS - total score), Hospital Anxiety and Depression Scale (HADS), and the Functional Assessment of Anorexia Therapy-Anorexia/Cachexia Subscale (FAACT-A/CS Questionnaire) and in their primary caregivers, ESAS-Caregiver, Caregiver Quality of Life-Cancer (CQOLC), and Brief Illness Perception (Brief-IPQ) questionnaire. III. To elucidate the frequency of Nutritional Impact Symptoms (NIS), evaluated by a Patient-Generated Subjective Global Assessment (PG-SGA-SF), and alterations in body composition (Inbody 770 Bio-Impedance Machine) experienced by patients with advanced cancer. IV. To evaluate the patient's perception of body image, Body Image Scale (BIS), as related to their change in weight and physical appearance due to cachexia in patients with advanced cancer. V. To evaluate the perception of need for nutritional support in cancer patients seen in a supportive care clinic. OUTLINE: Participants complete 8 questionnaires about appetite, quality of life, symptoms, history of weight loss, nutritional status, body image, and nutritional support over 30 minutes.

Conditions

Interventions

Type	Name	Description
OTHER	Questionnaire Administration	Complete questionnaires

Timeline

Start date: 2021-06-22
Primary completion: 2027-12-31
Completion: 2027-12-31
First posted: 2019-09-16
Last updated: 2026-02-13

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04090619. Inclusion in this directory is not an endorsement.