Behavioral Interventions for Chronic Lymphocytic Leukemia
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: M.D. Anderson Cancer Center
Disqualifiers: Other malignancy, Major surgery, Pregnancy, others
No Placebo Group
Trial Summary
What is the purpose of this trial?To learn if exercise and weight management can help to improve feelings of fatigue in CLL survivors.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It focuses on exercise and weight management for CLL survivors.
What data supports the effectiveness of the treatment Exercise and Weight Management for Chronic Lymphocytic Leukemia?
Research shows that exercise can improve physical function and quality of life in people with blood cancers like chronic lymphocytic leukemia. Exercise programs, including high-intensity interval training, have been found to reduce fatigue and improve overall well-being in these patients.
12345Is exercise safe for people with chronic lymphocytic leukemia?
Exercise, including high-intensity interval training and resistance training, is generally safe and feasible for individuals with chronic diseases like chronic lymphocytic leukemia. It may help reduce cancer-related fatigue and improve quality of life.
15678How does the Exercise and Weight Management treatment for Chronic Lymphocytic Leukemia differ from other treatments?
This treatment is unique because it focuses on improving physical function and body composition through exercise and weight management, rather than using medication. It aims to enhance overall health and quality of life for patients with Chronic Lymphocytic Leukemia by incorporating physical activity and nutrition, which is different from traditional drug-based therapies.
127910Eligibility Criteria
This trial is for adults aged 18-85 with Chronic Lymphocytic Leukemia (CLL) who feel tired and aren't very active. They must be able to give consent. People won't qualify if they're already as active as the study requires.Inclusion Criteria
I am less active than the study requires.
I am between 18-85 years old with confirmed CLL and can consent to treatment.
Exclusion Criteria
I have not had any cancer other than non-melanoma skin cancer in the past year.
Richter's transformation or another medical condition which would prevent safe participation in the behavioral intervention
Pregnancy
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants engage in a diet and exercise training program using a Fitbit and resistance bands, with educational materials provided
1 year
Regular virtual check-ins and in-person visits as needed
Follow-up
Participants are monitored for changes in fatigue, physical activity, dietary behavior, and other health metrics
4 weeks
Participant Groups
The trial tests whether using a Fitbit activity tracker and following weight management plans can reduce fatigue in CLL survivors. Participants will be randomly assigned to start these interventions immediately or after a waiting period.
2Treatment groups
Experimental Treatment
Group I: Group 2 (Waitlist)Experimental Treatment2 Interventions
Participants are randomly assigned a study group, pariticipants will be given the following:
* A Fitbit to wear every day during the study. A Fitbit is a physical activity tracking device that will help measure your physical activity. Participants will also receive a Fitbit Aria weight scale. Participants need to create a Fitbit account on the Fitbit website, which will allow participants to track your physical activity and log your diet information and weight. A member of the study team will call you or help you in-person (if you are in the clinic) to help set up the Fitbit and scale.
* Resistance bands with an instructional video on how to use them.
* Educational materials, such as handouts about diabetes prevention, as well as written/verbal/video instructions on setting up the Fitbit and scale. This will also include information about online safety/privacy.
Group II: Group 1 (Behavioral)Experimental Treatment2 Interventions
Participants are randomly assigned a study group, pariticipants will be given the following:
* A Fitbit to wear every day during the study. A Fitbit is a physical activity tracking device that will help measure your physical activity. Participants will also receive a Fitbit Aria weight scale. Participants need to create a Fitbit account on the Fitbit website, which will allow participants to track your physical activity and log your diet information and weight. A member of the study team will call you or help you in-person (if you are in the clinic) to help set up the Fitbit and scale.
* Resistance bands with an instructional video on how to use them.
* Educational materials, such as handouts about diabetes prevention, as well as written/verbal/video instructions on setting up the Fitbit and scale. This will also include information about online safety/privacy.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
M D Anderson Cancer CenterHouston, TX
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Who Is Running the Clinical Trial?
M.D. Anderson Cancer CenterLead Sponsor
CLL Global Research FoundationCollaborator
References
Relationships between T-lymphocytes and physical function in adults with chronic lymphocytic leukemia: Results from the HEALTH4CLL pilot study. [2023]Examine physical function and T-cell phenotype in patients with chronic lymphocytic leukemia (CLL) before and after a physical activity (PA) intervention.
Perceived Benefits and Barriers to Exercise for Recently Treated Adults With Acute Leukemia [2019]To explore perceived exercise benefits and barriers in adults with acute leukemia who recently completed an inpatient exercise intervention during induction therapy. .
Effects of Exercise Rehabilitation on Physical Function in Adults With Hematological Cancer Receiving Active Treatment: A Systematic Review and Meta-Analysis. [2023]Evaluate the efficacy of exercise rehabilitation at improving physical function during active treatment for adults diagnosed with a hematological malignancy.
Effects of exercise interventions for physical fitness, fatigue, and quality of life in adult hematologic malignancy patients without receiving hematopoietic stem cell transplantation: a systematic review and meta-analysis. [2022]To investigate the effects of exercise interventions on the physical fitness, fatigue, and quality of life (QOL) in adults with hematological malignancy (HM) who did not receive hematopoietic stem cell transplantation (HSCT).
Effects of high-intensity interval training on health-related quality of life in chronic lymphocytic leukemia: A pilot study. [2023]Chronic lymphocytic leukemia (CLL) is the most common incurable leukemia/lymphoma in the United States. Individuals with CLL are at risk for disability, frailty, and cancer-specific complications that negatively affect health-related quality of life (HRQOL). High-intensity interval training (HIIT) and resistance training (RT) are safe and feasible for individuals with chronic diseases and when combined, they may be beneficial for reducing cancer-related fatigue, symptom burden, and global quality of life. However, no studies have examined the impact of HIIT or RT on HRQOL in CLL. The purpose of this study was to investigate the effects of a 12-week HIIT and RT (HIIT+RT) intervention on HRQOL in adults with treatment naïve CLL.
Safety and feasibility of exercise interventions in patients with hematological cancer undergoing chemotherapy: a systematic review. [2023]Exercise during and after cancer treatment has established quality of life and health benefits. However, particularly for patients with hematological cancer clear recommendations regarding the safety and feasibility of exercise are under-investigated. The aim of our systematic review was to summarize the literature regarding the feasibility and safety of exercise interventions in patients diagnosed with hematological cancer undergoing chemotherapy.
Exercise in adult and pediatric hematological cancer survivors: an intervention review. [2013]Observational research has shown that the physical activity levels of survivors of hematological cancer are low, with deleterious health consequences. This review summarizes the research on exercise interventions in adult and pediatric hematological cancer survivors. We searched MEDLINE, SPORTDiscus, CINAHL, Embase, Cochrane and PEDro through September 2009 for exercise intervention studies in children and adults with any type of hematological cancer. In the 24 adult intervention studies reviewed, we found strong evidence (that is, > or =3 high-quality studies and > or =75% reporting a significant benefit) for a benefit on body composition. Weak, but promising, evidence (> or =3 high-quality studies, but
Feasibility and initial effectiveness of home exercise during maintenance therapy for childhood acute lymphoblastic leukemia. [2022]Children with acute lymphoblastic leukemia (ALL) are at increased risk of obesity and deconditioning from cancer therapy. This pilot study assessed feasibility/initial efficacy of an exercise intervention for patients with ALL undergoing maintenance therapy.
Predictors of adherence to supervised exercise in lymphoma patients participating in a randomized controlled trial. [2018]Exercise improves health in lymphoma patients but the determinants of adherence in this population are unknown. The purpose of this study is to examine predictors of exercise adherence in lymphoma patients. In a randomized trial, 60 lymphoma patients were assigned to the exercise group and asked to attend three supervised exercise sessions per week for 12 weeks. Baseline data were collected on demographic, medical, fitness, psychosocial, and motivational variables. Adherence was assessed by objective attendance. Adherence was 77.8% and was significantly predicted by age (beta = 0.29; p = 0.016) and past exercise (beta = 0.27; p = 0.024); and borderline significantly predicted by previous treatments (beta = 0.22; p = 0.053), body mass index (beta = -0.21; p = 0.076), and smoking (beta = -0.19; p = 0.092). Poorer exercise adherence was experienced by lymphoma patients under age 40, insufficiently active at baseline, previously treated with radiation therapy, overweight or obese, and smokers. Findings may facilitate the development of targeted interventions to improve exercise adherence in this understudied patient population.
An Anecdotal Case Report of Chronic Lymphatic Leukemia with del(11q) Treated with Ibrutinib: Artificial Nourishment and Physical Activity Program. [2021]Chronic lymphatic leukemia (CLL) is the most frequent type of leukemia in western countries and when association with del(11q) is correlated with a worse prognosis. We reported the clinical case of an 80-year-old patient with CLL related to del(11q) and a BMI of 16.4 kg/m2, who presented a voluminous mass in abdominal cavity (23 × 14 × 4 cm) which occupied the whole of the mesentery and the retroperitoneal space, treated with ibrutinib, adequate nutrition, and a program of physical activity. He showed a great improvement under ibrutinib therapy and took to artificial nourishment and adequate muscle rehabilitation until he recovered his autonomy. In August 2018, a 5-days-a-week training program was started: Physical activity for at least 20 min consisting of a fast walk in the open air three times a week and a moderate physical activity in the remaining two days of at least 20 consecutive minutes (cycling at a regular pace, carrying light weights). The exercise program included also aerobic, upper and lower limb resistance training, chore stability and stretches. The physical condition further improved and remained excellent throughout the follow-up period. In December 2018, his clinical condition was quite normal; a CT showed a great decrease of all lymphoadenomegaly, and FISH test did not show del(11q). He continued to cultivate his land, while still being treated with ibrutinib. The combination of the right therapy, adequate nutrition, and muscle rehabilitation is the best solution to improve the clinical condition of old cachectic CLL del(11q) patient.