Clinical trial NCT04090619: Frequency of Cachexia in Ambulatory Cancer Patients and Psychological Burden in Patients and Their Primary Caregivers
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Advanced Malignant Solid Neoplasm
Caregiver
Metastatic Malignant Solid Neoplasm
Recurrent Leukemia
Recurrent Lymphoma
Recurrent Malignant Solid Neoplasm
Recurrent Plasma Cell Myeloma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-09-16
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with advanced cancer or relapsed hematological malignancies and their primary caregiver

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cancer Cachexia
timeFrame: Day 1
Secondary outcomes:
measure: Functional Assessment of Anorexia Therapy-Anorexia/Cachexia Subscale Questionnaire (FAACT-A/CS)
timeFrame: Day 1
measure: Hospital Anxiety and Depression Scale (HADS) for assessment of depression and anxiety
timeFrame: Day 1
measure: Edmonton Symptom Assessment Scale (ESAS)
timeFrame: Day 1
measure: Caregiver Quality of Life-Cancer (CQOLC) Questionnaire
timeFrame: Day 1
measure: Brief Illness Perception Questionnaire (IPQ) score
timeFrame: Day 1
measure: Patient-Generated Subjective Global Assessment (PG-SGA-SF)
timeFrame: Day 1
measure: Body Image Scale (BIS)
timeFrame: Day 1
measure: Perception of need for nutritional support
timeFrame: Day 1
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Rony Dev
role: PRINCIPAL_INVESTIGATOR
References: