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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    300
  • sponsor
    M.D. Anderson Cancer Center
Updated on 10 October 2021
Accepts healthy volunteers

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.

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.

Details
Condition Advanced Malignant Solid Tumor, Recurrent Leukemia, metastatic malignant solid tumor, Recurrent Plasma Cell Myeloma, Advanced Solid Tumor, Recurrent Malignant Solid Neoplasm, CAREGİVER, Caregiver, Metastatic Solid Tumor, Recurrent Lymphoma, Metastatic Malignant Solid Neoplasm, Advanced Malignant Solid Neoplasm
Treatment questionnaire administration
Clinical Study IdentifierNCT04090619
SponsorM.D. Anderson Cancer Center
Last Modified on10 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients with designated primary caregiver with at least 1 visit to the outpatient Supportive Care Clinic at MD Anderson Cancer Center (MDACC)
Patient with any type of advanced cancer (defined as locally recurrent or metastatic for solid cancers) and as first relapse for hematological malignancies (leukemia, lymphoma and myeloma)

Exclusion Criteria

Patient without an identified primary caregiver
Patients with complications of delirium (Memorial Delirium Assessment Scale >= 7/30)
Patients with brain metastasis
Patients and their caregiver who are non-English speaking
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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