Chronic Fatigue Syndrome Clinical Trial
Official title:
A Complex Intervention for a Complex Symptom - a Randomized Controlled Trial in Chronically Fatigued Lymphoma Survivors
The present study is a randomized controlled trial (RCT) with an overall objective to examine the effect of an interdisciplinary complex intervention on the level of fatigue in lymphoma survivors with chronic fatigue. Secondary aims are to examine the effects of the intervention on daily functioning, work status/ability, physical fitness and QoL among the survivors, on QoL of their relatives and on the societal costs.The intervention will last for 12+12 weeks and include four components; patient education, supervised physical exercise, cognitive behavioral program and nutritional counselling. Outcomes will be assessed at baseline,post-intervention (12 weeks after baseline) and at 3-month, 6-month, 12-month and 24-month follow-up after completed intervention.
Chronic fatigue (CF) is a subjective experience of substantial lack of energy, exhaustion and cognitive difficulties lasting for six months or longer. CF is one of the most common and distressing late effects after cancer, affecting 15-35 % of survivors, often for years beyond treatment. Despite the high prevalence and the huge negative consequences of CF on daily functioning and QoL and the economic and societal costs, effective treatment of CF and standardized follow-up care are currently lacking. Today, there is no curative treatment of CF. However, several modifiable behavioral factors including emotional distress, physical inactivity, sleep disturbances and unhealthy diets are found to be associated with CF. So far, most of the interventions aiming to reduce fatigue during and shortly after cancer treatment have targeted only one of these factors at a time, with small to moderate effect sizes. No prior study has examined if CF in cancer survivors is better treated by a complex intervention targeting combinations of these factors, an approach which seems logical due to the complexity of the symptom. The project is a two-armed RCT in which chronically fatigued lymphoma survivors are randomized to an interdisciplinary complex intervention or to usual care. Eligible participants will receive written information about the study by mail. Survivors who perceive themselves as having physical and mental fatigue, and who are willing to participate, will be asked to fill out and return the Chalder Fatigue Questionnaire (FQ) to the study coordinator. Those who have chronic fatigue as measured by the FQ will be invited to a medical screening by an oncologist in the project group, for evaluation of inclusion. The interdisciplinary complex intervention will last for 12 + 12 weeks and include four components; patient education, physical exercise (and follow-up), cognitive behavioral program and nutritional counselling, organized in a systematic way, i.e. a standardized patient care pathway. All outcomes will be assessed in all participants at four points; pre-intervention (baseline) (T0), post-intervention (12 weeks after baseline) (T1) and at 3-month (T2) and 6-month (T3) after T1. Moreover, selected patient reported outcomes will be assessed in all participants at 12-month (T4) and 24-month (T5) after T1. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05454683 -
Melatonin and Zinc Administration on Cardinal Symptoms in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
|
N/A | |
Completed |
NCT01686074 -
Motor Control in Chronic Fatigue Syndrome and Fibromyalgia
|
N/A | |
Completed |
NCT02075489 -
Acupressure for Pain Management and Fatigue Relief in Gulf War Veterans
|
N/A | |
Completed |
NCT01651754 -
Humoral and Cellular Immune Responses After Influenza Vaccination in Patients With Postcancer Fatigue and in Patients With Chronic Fatigue Syndrome
|
N/A | |
Completed |
NCT00540254 -
Behavioral Insomnia Therapy With Chronic Fatigue Syndrome
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT00071162 -
Genetics of Fibromyalgia
|
N/A | |
Withdrawn |
NCT04870476 -
Feasibility and Acceptability of the Internet-delivered Treatment "One Step at the Time" for Bodily Distress Syndrome
|
N/A | |
Completed |
NCT05730660 -
Quercetin Phytosome® Chronic Fatigue Syndrome
|
N/A | |
Recruiting |
NCT04542161 -
Assessment of N-Acetylcysteine as Therapy for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
|
Phase 2 | |
Recruiting |
NCT03807973 -
Tracking Peripheral Immune Cell Infiltration of the Brain in Central Inflammatory Disorders Using [Zr-89]Oxinate-4-labeled Leukocytes.
|
Phase 1 | |
Recruiting |
NCT05719493 -
Effectiveness and Health Benefits of a Nutritional, Chronobiological and Physical Exercise Intervention in Fibromyalgia and Chronic Fatigue Syndrome (SYNCHRONIZE +)
|
N/A | |
Recruiting |
NCT05967052 -
Investigation of Treating Chronic Fatigue Syndrome After COVID With Pharmacotherapy (Pregabalin) or Complex Rehabilitation
|
Phase 2 | |
Terminated |
NCT01730495 -
Tumor Necrosis Factor-alpha Inhibition Using Etanercept in Chronic Fatigue Syndrome
|
Phase 2 | |
Completed |
NCT01156909 -
B-cell Depletion Using the Monoclonal Anti-CD20 Antibody Rituximab in Chronic Fatigue Syndrome
|
Phase 2 | |
Completed |
NCT01650636 -
Patient-Partner Stress Management Effects on Chronic Fatigue Syndrome Symptoms and Neuroimmune Process
|
N/A | |
Completed |
NCT01046370 -
A Pilot Study of Amygdala Retraining Program in Patients With Chronic Fatigue Syndrome, Chronic Fatigue and Fibromyalgia
|
N/A | |
Completed |
NCT00100412 -
Hyporeactivity and Gulf War Illness
|
N/A | |
Recruiting |
NCT06128967 -
A Multicenter, Adaptive, Randomized, doublE-blinded, Placebo-controlled Study in Participants With Long COVID-19: The REVIVE Trial
|
Phase 3 | |
Completed |
NCT02669212 -
Myalgic Encephalomyelitis Chronic Fatigue at the National Institutes of Health
|
N/A | |
Not yet recruiting |
NCT06011135 -
Exploring Worry in CFS/ME
|