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

M.D. Anderson Cancer Center

Status: Active, not recruiting

Conditions: Recurrent Malignant Solid Neoplasm; Metastatic Malignant Solid Neoplasm; Recurrent Plasma Cell Myeloma; Advanced Malignant Solid Neoplasm; Recurrent Lymphoma; Recurrent Leukemia; Caregiver

Treatments: Other: Questionnaire Administration

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04090619

NCI-2019-04590 (Registry Identifier)

2019-0203 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 192 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. [Patient] Patients visiting the Supportive Care Clinic (SCC) for a consultation or a follow up.
2. [Patient] Patients who can identify a primary caregiver.
3. [Patient] Diagnosis of advanced cancer defined as locally advanced, recurrent, or metastatic.
4. [Patient] Be able to read and speak English.
5. [Patient] 18 years of age or older.
6. [Caregiver] Be identified or self-identified as a primary caregiver of the patient.
7. [Caregiver] Provide informed consent
8. [Caregiver] Be able to read and speak English.
9. [Caregiver] 18 years of age or older.
10. [Caregiver] Caregivers who are not able to complete the questionnaire on the day of patients' SCC visit must be willing to engage in a telephone questionnaire with research staff within 60 days of the patient's enrollment.

Exclusion criteria

1. [Patient] Refusal to participate in this study. This study requires both patient and caregiver enrollment.
2. [Patient] Patients with no caregiver or only paid caregivers.
3. [Patient] Patients with cognitive impairment as identified by research staff, treating physician or nurse (Memorial Delirium Assessment Scale score of >/= 7).
4. [Caregiver] Refusal to participate in this study. This study requires both patient and caregiver enrollment.
5. [Caregiver] Not a primary caregiver or is a paid caregiver.
6. [Caregiver] Evidence of cognitive impairment, as determined based on orientation questions pertaining to the date, day of the week, time, and place

Trial design

192 participants in 1 patient group

Observational (questionnaires)

Description:

Participants complete 8 questionnaires about appetite, quality of life, symptoms, history of weight loss, nutritional status, body image, and nutritional support over 30 minutes.

Treatment:

Other: Questionnaire Administration