A Pilot Study to Evaluate a Nutritional Assessment Intervention to Improve Cancer-Related Fatigue Among Post-Allogeneic Blood and Marrow Transplantation Recipients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 10
- Locations
- 2
- Primary Endpoint
- Patient Fatigue Scores <Brief Fatigue Inventory (BFI)>
Study Overview
Brief Summary
Primary Objective:
- To use the results from this pilot study to estimate the effect size of the nutritional intervention on fatigue and caloric intake.
Secondary Objectives:
- To apply nutritional assessment tools for early detection of patients at risk for malnutrition.
- To examine the feasibility of conducting this intervention study.
- To describe cancer-related fatigue patterns among BMT patients at multiple time points during ambulatory visits.
- To evaluate the effects of a nutritional intervention for post-allogeneic BMT recipients on adequacy of caloric intake in order to improve cancer-related fatigue scores.
Detailed Description
Recipients of an allogeneic BMT often experience fatigue as a side effect due to several factors, including high-dose chemotherapy and/or radiation therapy as well as stress from everyday activities that increase fatigue. In addition, after transplantation, the patient's ability to maintain regular nutritional needs (usually due to the unique diet that is required to help increase marrow function) is affected, which further increases fatigue levels. Researchers want to use information learned in this study to find out if nutritional intervention can help decrease fatigue levels and increase caloric intake.
Participating in this study involves routine visits to M. D. Anderson at the ambulatory treatment center. Before you can start on this study, you will be asked about any allergies you may have. You will also be asked some questions about your caregivers, such as how many caregivers you have, whether your caregiver will be able to attend the nutrition class with you, and whether the caregiver will record the food intake information. You will be asked these questions to help the study researcher decide if you are eligible to take part in this study. It should take about 30 minutes to collect this data. Your caregiver will be present while this data is being collected. You will be asked to fill out questionnaires about your medical history, personal demographics (such as your name, age, race, and gender), and fatigue levels. These questionnaires should take about less than 1 hour to complete. The study researcher will collect these questionnaires and put them in an envelope with a code ID number on the front cover, instead of your name or other personal information.
A dietitian will then set-up an appointment (within 3 days after your first visit to the ambulatory clinics) for a baseline test called indirect calorimetry. This test will be performed in your treatment room in the ambulatory treatment clinic to find out how many calories you need to have on a daily basis. For this test, you will be asked to sit quietly in your treatment room and breathe through a mouth piece with a nose clip on your nose for 10 minutes. This test will use a machine to collect the air that you breathe in (inhalation) and out (exhalation). The machine will use the information from your breathing to calculate how many calories you will need to intake each day. This entire process should take about 1 hour to complete. You will be given recommended levels of dietary caloric intake and your schedule for study activities within the first week of enrolling in this study. After this test, you will be randomized (as in the toss of a coin) to a group.
There will be 2 groups in this study. There will be about 6 participants in each group. If you are found to be eligible and you agree to take part in this study, you will be asked to draw a sealed envelope from a bag, which will show which study group you will be in. You will be allowed to draw only 1 envelope from the bag. You will have an equal chance of being assigned to either group.
Participants in 1 group will be given standard care (for the next 42 days) for allogeneic BMT at the ambulatory center. Participants in the other group will be given standard care (for the next 45 days) for allogeneic BMT at the ambulatory center as well as nutritional assessment and intervention. If your envelope has a label that says "standard," you will receive standard care only. If your envelope has a label that says "intervention," you will receive standard care as well as nutritional assessment and intervention.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subject has been diagnosed with cancer (leukemia or lymphoma).
- •Age 18 years or older
- •Subject has received their allogeneic BMT, fully ablative transplants, from either related or unrelated donors in the past 40 days
- •Subject can read, write, speak, and understand English
- •Subject has a caregiver (family member or friend) to keep the food diary record.
- •Subject voluntarily agrees and signs informed consent prior to participate in this study.
- •Subject is oriented to time, place, and person.
Exclusion Criteria
- •Subject has major organ failure such as kidney, heart, or liver failure.
- •Subject has allergies to latex preventing use of the mouthpiece during indirect calorimetry testing.
- •Subject has been scheduled to withhold oral intake or parenteral nutrition support for more than 4 days during the week of dietary record (week 2, 4, and 6)
- •Subject has a diagnosis of gastro-intestinal graft versus host disease (GI-GVHD).
- •Subject has pre-transplant pulmonary function tests (PFTs) with force vital capacity (FVC) or forced expiratory volume in one second (FEV1) or diffusing capacity of the lung for carbon monoxide (DLCO) < 65% of predicted value.
- •Subject who is physically unable to complete the indirect calorimetry or who refuses calorimetry or who cannot understand the instructions.
Outcomes
Primary Outcomes
Patient Fatigue Scores <Brief Fatigue Inventory (BFI)>
Time Frame: BFI at study day 0, 14, 28, and 42
Secondary Outcomes
No secondary outcomes reported