Advanced Malignant Solid NeoplasmNCT04090619

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

An observational study of Advanced Malignant Solid Neoplasm and Caregiver, run by M.D. Anderson Cancer Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Advanced Malignant Solid Neoplasm, Caregiver, Metastatic Malignant Solid Neoplasm
What is being tested?: Questionnaire Administration
How many people: 192 participants
Where: 1 siteUnited States
Study dates: 22 Jun 2021to 31 Dec 2027
Phase: Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

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

Who may be able to join

[Patient] Patients visiting the Supportive Care Clinic (SCC) for a consultation or a follow up.
[Patient] Patients who can identify a primary caregiver.
[Patient] Diagnosis of advanced cancer defined as locally advanced, recurrent, or metastatic.
[Patient] Be able to read and speak English.
[Patient] 18 years of age or older.
[Caregiver] Be identified or self-identified as a primary caregiver of the patient.

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[Caregiver] Provide informed consent
[Caregiver] Be able to read and speak English.
[Caregiver] 18 years of age or older.
[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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

M D Anderson Cancer Center
Houston, Texas, 77030

Other trials in United States

About this study

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

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.

Read the 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.

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.

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.

Conditions: Advanced Malignant Solid Neoplasm, Caregiver, Metastatic Malignant Solid Neoplasm, Recurrent Leukemia, Recurrent Lymphoma, Recurrent Malignant Solid Neoplasm
Being tested: Questionnaire Administration
Medical subject headings: Neoplasm Metastasis, Leukemia, Lymphoma, Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Questionnaire AdministrationOther
Complete questionnaires

Study groups in NCT04090619
Study group	Role	What they receive
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. Receives: Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Day 1

Secondary outcomes (8)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Jun 202131 Dec 2027

First posted16 Sep 2019
Study start22 Jun 2021
Primary completion31 Dec 2027 (estimated)
Study completion31 Dec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Advanced Malignant Solid NeoplasmStudies of the same condition, open and under way.
More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 192 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04090619
Sponsor's protocol ID: 2019-0203
Other IDs: NCI-2019-04590, 2019-0203
Status last verified: Jul 2026
First submitted: 5 Aug 2019
Last updated: 6 Aug 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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