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

Sponsor

M.D. Anderson Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT04090619

Collaborator

National Cancer Institute (NCI) (NIH)

300

Enrollment

Location

42.3

Anticipated Duration (Months)

7.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Advanced Malignant Solid Neoplasm Caregiver Metastatic Malignant Solid Neoplasm Recurrent Leukemia Recurrent Lymphoma Recurrent Malignant Solid Neoplasm Recurrent Plasma Cell Myeloma	Other: Questionnaire Administration

Detailed Description

PRIMARY OBJECTIVE:

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:

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.
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.
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.
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.
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 Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 22, 2021

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Cancer Cachexia [Day 1]
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.

Secondary Outcome Measures

Functional Assessment of Anorexia Therapy-Anorexia/Cachexia Subscale Questionnaire (FAACT-A/CS) [Day 1]
For assessment of decreased appetite. Total score ranges from 0 to 48, lower scores indicate decrease appetite.
Hospital Anxiety and Depression Scale (HADS) for assessment of depression and anxiety [Day 1]
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.
Edmonton Symptom Assessment Scale (ESAS) [Day 1]
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.
Caregiver Quality of Life-Cancer (CQOLC) Questionnaire [Day 1]
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.
Brief Illness Perception Questionnaire (IPQ) score [Day 1]
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.
Patient-Generated Subjective Global Assessment (PG-SGA-SF) [Day 1]
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.
Body Image Scale (BIS) [Day 1]
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.
Perception of need for nutritional support [Day 1]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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