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

NCT04090619 | Active Not Recruiting

• 2 other identifiers: 2019-0203NCI-2019-04590
• Study Type: observational
• Target: 192
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Malignant Solid Neoplasm; Caregiver; Metastatic Malignant Solid Neoplasm; Recurrent Leukemia; Recurrent Lymphoma; Recurrent Malignant Solid Neoplasm; Recurrent Plasma Cell Myeloma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Functional Assessment of Anorexia Therapy-Anorexia/Cachexia Subscale Questionnaire (FAACT-A/CS)

  Day 1

• Hospital Anxiety and Depression Scale (HADS) for assessment of depression and anxiety

  Day 1

• Edmonton Symptom Assessment Scale (ESAS)

  Day 1

• Caregiver Quality of Life-Cancer (CQOLC) Questionnaire

  Day 1

• Brief Illness Perception Questionnaire (IPQ) score

  Day 1

Study Arms (1)

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

Interventions

Questionnaire Administration OTHER

Complete questionnaires

Observational (questionnaires)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• \[Patient\] 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.
• \[Caregiver\] 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.

You may not qualify if:

• \[Patient\] 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Neoplasm Metastasis; Leukemia; Lymphoma; Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders

Study Officials

• Rony Dev

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2019
• First Posted: September 16, 2019
• Study Start: June 22, 2021
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 13, 2026

Record last verified: 2026-02

Locations

US (1)