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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Advanced Malignant Solid Neoplasm; Recurrent Lymphoma; Recurrent Malignant Solid Neoplasm; Metastatic Malignant Solid Neoplasm; Recurrent Plasma Cell Myeloma; Caregiver; Recurrent Leukemia
• Intervention / Treatment: Other: Questionnaire Administration

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.

• Study Type: Observational
• Enrollment (Actual): 192

Contacts and Locations

• Study Contact: Name: Rony Dev; Phone Number: 713-792-6085; Email: rdev@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients with advanced cancer or relapsed hematological malignancies and their primary caregiver

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observational (questionnaires); Participants complete 8 questionnaires about appetite, quality of life, symptoms, history of weight loss, nutritional status, body image, and nutritional support over 30 minutes.	Other: Questionnaire Administration; Complete questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cancer Cachexia	Assessed by either European Society for Clinical Nutrition and Metabolism (ESPEN) includes body mass index (BMI) < 18.5 (mandatory) or combined finding of unintentional weight loss (mandatory) and at least one of either reduced BMI or a low fat free mass index (FFMI), or International Consensus Criteria (ICC) defined as cachexia weight loss greater than 5% over 6 month period or weight loss greater than 2% showing depletion according to current bodyweight and height over an indefinite time point.	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Assessment of Anorexia Therapy-Anorexia/Cachexia Subscale Questionnaire (FAACT-A/CS)	For assessment of decreased appetite. Total score ranges from 0 to 48, lower scores indicate decrease appetite.	Day 1
Hospital Anxiety and Depression Scale (HADS) for assessment of depression and anxiety	A validated tool consists of 14 items scored from 0 to 3 for a total score of 0 to 21. A cut-off score of 8 out of 21 will be used.	Day 1
Edmonton Symptom Assessment Scale (ESAS)	Edmonton Symptom Assessment Scale ESAS is a validated tool for regular assessment of symptom distress. Grading severity of patient symptoms from "no" 0 to "worst symptom" 10 in the last 24 hours.	Day 1
Caregiver Quality of Life-Cancer (CQOLC) Questionnaire	Caregiver Quality of Life-Cancer CQOLC is a 35 item cancer-specific instrument that assesses the quality of life of caregiver. Score range from 0-140, with higher scores to reflect better wellbeing.	Day 1
Brief Illness Perception Questionnaire (IPQ) score	Illness Perception Questionnaire IPQ is a validated self-report to assess perceptions of patient's illness. Each item is scored from 0-10, A higher score reflects a threatening view of illness.	Day 1
Patient-Generated Subjective Global Assessment (PG-SGA-SF)	Patient-Generated Subjective Global Assessment PG-SGA-SF is a tool used to measure risks for malnutrition. The total score of 4 boxes are calculated, a higher score places patients at a higher risk for developing weight loss.	Day 1
Body Image Scale (BIS)	Body Image Scale BIS is a validated 10-item scale used to assess body image changes in cancer patients. Each item is answered either "not at all", "a little", "quite a bit", or "very much", scoring as 0 to 3. Higher scores indicate body image dissatisfaction.	Day 1
Perception of need for nutritional support	is a survey of 3 questions to describe patients' opinions about nutritional support. And evaluates the perception of need for intervention regarding nutrition and interventions for weight loss.	Day 1

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Rony Dev, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2021
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: August 5, 2019
• First Submitted That Met QC Criteria: September 12, 2019
• First Posted (Actual): September 16, 2019

Study Record Updates

• Last Update Posted (Estimated): January 11, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Immunoproliferative Disorders; Disease Attributes; Hematologic Diseases; Body Weight; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Body Weight Changes; Weight Loss; Thinness; Neoplasms; Multiple Myeloma; Neoplasms, Plasma Cell; Recurrence; Cachexia
• Other Study ID Numbers: 2019-0203 (Other Identifier: M D Anderson Cancer Center); NCI-2019-04590 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No