- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04931407
A Feasibility Study in Chronically Fatigued Cancer Survivors
Improved cancer survival has led to increased attention on long-term health and quality of life (QoL) among the survivors. Both the cancer diagnosis and intensive treatments increase the risk of late effects which may interfere with daily physical, psychological and social functioning, and thereby negatively affect their QoL. Well-documented late-effects among cancer survivors are second cancer, cardio-vascular disease, pain, hormone disturbances, mental distress and chronic fatigue (CF).
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.
CF is a complex condition best understood as a multifactorial phenomenon. Our and other research groups have examined various cohorts of cancer survivors in order to identify behavioral-, psychological-, and biological factors associated with CF, that can form the basis for targeted interventions. So far, few treatable biological factors have been identified, even though immune activation, flattened diurnal cortisol slopes and a blunted cortisol response to stress have been demonstrated in small studies among cancer survivors suffering from CF. On the other hand, 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 Division of Cancer Medicine at Oslo University Hospital (OUH) presently offers limited rehabilitation programs, including patient education, physical exercise, cognitive behavioral program and nutrition counselling to cancer survivors with CF. However, these programs are not offered as an interdisciplinary intervention integrated in a standardized patient care pathway, and the effects of these interventions have not been assessed. Based on the investigators clinical experience and published studies on single-targeted interventions, the investigators hypothesize that a complex intervention including psycho-educational elements, physical exercise and nutrition counseling delivered as a standardized patient care pathway is well-founded and doable, and will improve fatigue, functioning and QoL in cancer survivors with CF.
During the fall of 2021, the investigators will conduct a randomized controlled trial (RCT) with the overall objective to improve fatigue in lymphoma survivors with CF. To uncover strengths and weaknesses with the planned RCT, i.e. the inclusion procedures, the assessments and the complex intervention, the investigators are now conducting a small one-armed feasibility study before the RCT during spring 2021.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Oslo, Norway, 0379
- Oslo University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Seven lymphoma survivors will be included, with the same inclusion criteria as in the planned RCT:
Inclusion Criteria:
- Survivors of Hodgkin and aggressive non-Hodgkin lymphoma, diagnosed 2014 or 2019 (n=7)
- 18-65 years at diagnosis, and 19-67 years at participation.
- CF measured by Chalder FQ.
- Curatively treated, more than 2 years since last treatment.
- Participation approval from oncologist.
Exclusion Criteria:
- Indolent non-Hodgkin lymphoma.
- Fatigue more than one year before the cancer diagnosis.
- Ongoing cancer treatment, relapse or second cancer, somatic/physical conditions (i.e. severe heart failure/disease, lung disease, use of wheelchair /crutches).
- Psychiatric disorders (i.e. severe depression, schizophrenia), substance abuse disorder.
In addition, eight cancer survivors with various diagnosis, will be included from a waiting list for rehabilitation at the Cancer Rehabilitation Centre at Aker hospital.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Interdisciplinary complex intervention
The intervention includes patient education, physical exercise, a group-based cognitive behavioral program and individual nutritional counseling
|
The intervention will last for 12 weeks and includes four components; patient education, physical exercise, cognitive behavioral program and nutritional counseling. The patient education will include an online 2-hours group-based patient-education sessions in week 1. The physical exercise program includes two weekly exercise sessions, one supervised by a physiotherapist and one unsupervised, including aerobic exercise, resistance exercise and psychometric physiotherapy. Half of the intervention group (N=7) will perform the supervised exercise session individually with a physiotherapist in the municipality, while the other half (n=8) will exercise in online groups lead by physiotherapists. The cognitive behavioral program will begin in week 3 and include six group-based online sessions every week lead by a clinical psychologist. The nutritional counseling will include three individual digital nutrition counselling sessions in week 2, 6 and 10 by a clinical dietitian. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recruitment rate
Time Frame: The week before the intervention period (week 0)
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Assessed by the number who consent to participate
|
The week before the intervention period (week 0)
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Inclusion rate
Time Frame: The week before the intervention period (week 0)
|
Assessed by the number of consenting participants who are included (i.e. have chronic fatigue according to the Fatigue Questionnaire, and are cleared for participation by oncologist after the medical screening).
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The week before the intervention period (week 0)
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Completion rate
Time Frame: The week before the intervention period (week 0)
|
Assessed by the number of consenting participants consenting patients who complete any measurement at the final assessment
|
The week before the intervention period (week 0)
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Strengths and weaknesses with the inclusion procedure: participants
Time Frame: Week 4
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Assessed by structured conversations with the participants
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Week 4
|
Strengths and weaknesses with the inclusion procedure: study personnel
Time Frame: Week 4
|
Assessed by structured conversations with the study personnel
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Week 4
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Feasibility of the patient education session: participants
Time Frame: Week 4
|
Strengths, weaknesses, and usefulness of the contents in the education session will be assessed by structured conversations with the participants after the patient education session.
|
Week 4
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Feasibility of the patient education session: presenters
Time Frame: Week 4
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Strengths, weaknesses, and usefulness of the contents in the education session will be assessed by structured conversations with the presenters after the patient education session.
|
Week 4
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Feasibility of the exercise program part one (week 1-3): participants
Time Frame: Week 4
|
Strengths and weaknesses with the exercise program will be evaluated through structured conversations with the participants
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Week 4
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Feasibility of the exercise program part one (week 1-3): physiotherapists
Time Frame: Week 4
|
Strengths and weaknesses with the exercise program will be evaluated through structured conversations with the physiotherapists
|
Week 4
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Feasibility of the exercise program part two (week 4-7): participants
Time Frame: Week 8
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Strengths and weaknesses with the exercise program will be evaluated through structured conversations with the participants
|
Week 8
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Feasibility of the exercise program part two (week 4-7): physiotherapists
Time Frame: Week 8
|
Strengths and weaknesses with the exercise program will be evaluated through structured conversations with the physiotherapists
|
Week 8
|
Compliance to the cognitive behavioral therapy groups sessions
Time Frame: Week 8
|
Participation to the cognitive behavioral therapy groups sessions will be registered by the study coordinators/psychologists..
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Week 8
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Feasibility of the cognitive behavioral therapy groups sessions: participants
Time Frame: Week 8
|
Strengths, weaknesses, and usefulness of the groups sessions will be assessed by structured conversations with the participants after the last group session
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Week 8
|
Feasibility of the cognitive behavioral therapy groups sessions: psychologists
Time Frame: Week 8
|
Strengths, weaknesses, and usefulness of the groups sessions will be assessed by structured conversations with the psychologists after the last group session
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Week 8
|
Compliance to the nutrition counseling
Time Frame: Week 11
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Participation rate of the individual nutrition counseling sessions will be registered by the clinical dietitian.
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Week 11
|
Feasibility of the nutrition counseling: participants
Time Frame: Week 11
|
Strengths, weaknesses, and usefulness of the contents in the sessions will be assessed by structured conversations with the participants after the last counseling session.
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Week 11
|
Feasibility of the nutrition counseling: clinical dietitian
Time Frame: Week 11
|
Strengths, weaknesses, and usefulness of the contents in the sessions will be assessed by structured conversations with the clinical dietitian after the last counseling session.
|
Week 11
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Compliance to the exercise program: attendance
Time Frame: Week 13
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Registered by the physiotherapists in an exercise log
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Week 13
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Compliance to the exercise program: intensity during the aerobic exercise intervals
Time Frame: Week 13
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Registered by pulse sensors
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Week 13
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Compliance to the exercise program: implementation of the strength training exercises
Time Frame: Week 13
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Registered by the physiotherapists in an exercise log
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Week 13
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Feasibility of the exercise program part three (week 8-12): participants
Time Frame: Week 13
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Strengths and weaknesses with the exercise program will be evaluated through structured conversations with the participants
|
Week 13
|
Feasibility of the exercise program part three (week 8-12): physiotherapists
Time Frame: Week 13
|
Strengths and weaknesses with the exercise program will be evaluated through structured conversations with the physiotherapists
|
Week 13
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Feasibility of the questionnaires
Time Frame: Week 13
|
Strengths and weaknesses with the questionnaire will be evaluated through structured conversations with the participants.
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Week 13
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Feasibility of the physical tests: participants
Time Frame: Week 13
|
Strengths and weaknesses with the tests will be evaluated through structured conversations with the participants.
|
Week 13
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Feasibility of the physical tests: physiotherapists
Time Frame: Week 13
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Strengths and weaknesses with the tests will be evaluated through structured conversations with the physiotherapists conducting the tests.
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Week 13
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Compliance to the physical tests
Time Frame: Week 13
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Assessed by the completion rate of the physical tests (i.e. the number of participants who conduct the tests as planned).
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Week 13
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Completeness of the questionnaires
Time Frame: Week 13
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Assessed by the completion rate of the questionnaire (i.e.
proportion of missing).
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Week 13
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in level of fatigue
Time Frame: Change from baseline (week 0) and to post-intervention (week 13)
|
Measured by Chalder Fatigue Questionnaire.
Total score range from 0 to 33, with increasing score implying more fatigue.
|
Change from baseline (week 0) and to post-intervention (week 13)
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Change in level of fatigue
Time Frame: Change from baseline (week 0) to 4 months follow-up (week 29)
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Measured by Chalder Fatigue Questionnaire.
Total score range from 0 to 33, with increasing score implying more fatigue.
|
Change from baseline (week 0) to 4 months follow-up (week 29)
|
Change in level of fatigue
Time Frame: Change from baseline (week 0) to 7 months follow-up (week 42)
|
Measured by Chalder Fatigue Questionnaire.
Total score range from 0 to 33, with increasing score implying more fatigue.
|
Change from baseline (week 0) to 7 months follow-up (week 42)
|
Change in daily functioning and global quality of life
Time Frame: Change from baseline (week 0) and to post-intervention (week 13)
|
Measured by the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC-QLQ-C30).
Scores range fro 0 to 100, a higher score represents a higher (better) level of functioning or a higher (worse) level of symptoms.
|
Change from baseline (week 0) and to post-intervention (week 13)
|
Change in daily functioning and global quality of life
Time Frame: Change from baseline (week 0) to 4 months follow-up (week 29)
|
Measured by the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC-QLQ-C30).
Scores range fro 0 to 100, a higher score represents a higher (better) level of functioning or a higher (worse) level of symptoms.
|
Change from baseline (week 0) to 4 months follow-up (week 29)
|
Change in daily functioning and global quality of life
Time Frame: Change from baseline (week 0) to 7 months follow-up (week 42)
|
Measured by the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC-QLQ-C30).
Scores range fro 0 to 100, a higher score represents a higher (better) level of functioning or a higher (worse) level of symptoms.
|
Change from baseline (week 0) to 7 months follow-up (week 42)
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Change in subjective well-being
Time Frame: Change from baseline (week 0) and to post-intervention (week 13)
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Measured by the Satisfaction with Life Scale.
Total score range from 5 to 35, with increasing score implying higher subjective well-being.
|
Change from baseline (week 0) and to post-intervention (week 13)
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Change in vitality
Time Frame: Change from baseline (week 0) and to post-intervention (week 13)
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Measured by the Subjective Vitality Scale.
The total score ranges from 6 to 36 with a higher score indicating a better condition
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Change from baseline (week 0) and to post-intervention (week 13)
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Change in general health
Time Frame: Change from baseline (week 0) and to post-intervention (week 13)
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Measured by European Quality of Life Five-dimension Scale Questionnaire (EQ-5D).
Total score range from 5 (worst health) to 25 (best health).
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Change from baseline (week 0) and to post-intervention (week 13)
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Change in work ability
Time Frame: Change from baseline (week 0) and to post-intervention (week 13)
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Measured by Work Ability Index.
Total score range from 7 to 49 points, with higher score indicating better work ability.
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Change from baseline (week 0) and to post-intervention (week 13)
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Change in work ability
Time Frame: Change from baseline (week 0) to 4 months follow-up (week 29)
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Measured by Work Ability Index.
Total score range from 7 to 49 points, with higher score indicating better work ability.
|
Change from baseline (week 0) to 4 months follow-up (week 29)
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Change in work ability
Time Frame: Change from baseline (week 0) to 7 months follow-up (week 42)
|
Measured by Work Ability Index.
Total score range from 7 to 49 points, with higher score indicating better work ability.
|
Change from baseline (week 0) to 7 months follow-up (week 42)
|
Change in anxiety symptoms
Time Frame: Change from baseline (week 0) and to post-intervention (week 13)
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Measured by the General Anxiety Disorder 7-items.
Total score range from 0 to 21 with increasing score implying higher level of anxiety.
|
Change from baseline (week 0) and to post-intervention (week 13)
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Change in anxiety symptoms
Time Frame: Change from baseline (week 0) to 4 months follow-up (week 29)
|
Measured by the General Anxiety Disorder 7-items.
Total score range from 0 to 21 with increasing score implying higher level of anxiety.
|
Change from baseline (week 0) to 4 months follow-up (week 29)
|
Change in anxiety symptoms
Time Frame: Change from baseline (week 0) to 7 months follow-up (week 42)
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Measured by the General Anxiety Disorder 7-items.
Total score range from 0 to 21 with increasing score implying higher level of anxiety.
|
Change from baseline (week 0) to 7 months follow-up (week 42)
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Change in depressive symptoms
Time Frame: Change from baseline (week 0) and to post-intervention (week 13)
|
Measured by the Patient Health Questionnaire-9.
Total score from 0 to 27, increasing score implying higher depressive symptoms.
|
Change from baseline (week 0) and to post-intervention (week 13)
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Change in depressive symptoms
Time Frame: Change from baseline (week 0) to 4 months follow-up (week 29)
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Measured by the Patient Health Questionnaire-9.
Total score from 0 to 27, increasing score implying higher depressive symptoms.
|
Change from baseline (week 0) to 4 months follow-up (week 29)
|
Change in depressive symptoms
Time Frame: Change from baseline (week 0) to 7 months follow-up (week 42)
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Measured by the Patient Health Questionnaire-9.
Total score from 0 to 27, increasing score implying higher depressive symptoms.
|
Change from baseline (week 0) to 7 months follow-up (week 42)
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Change in level of physical activity
Time Frame: Change from baseline (week 0) and to post-intervention (week 13)
|
Measured by the Godin Leisure Time Exercise Questionnaire
|
Change from baseline (week 0) and to post-intervention (week 13)
|
Change in level of physical activity
Time Frame: Change from baseline (week 0) to 4 months follow-up (week 29)
|
Measured by the Godin Leisure Time Exercise Questionnaire
|
Change from baseline (week 0) to 4 months follow-up (week 29)
|
Change in level of physical activity
Time Frame: Change from baseline (week 0) to 7 months follow-up (week 42)
|
Measured by the Godin Leisure Time Exercise Questionnaire
|
Change from baseline (week 0) to 7 months follow-up (week 42)
|
Change in exercise mastery
Time Frame: Change from baseline (week 0) and to post-intervention (week 13)
|
Assessed by the Perceived Competence Scale.
The scale consists of 4 items (statements).
On each item, participants are asked to rate how true a statement is using a 7-point scale.Total score range from 4 to 28, with increasing score reflecting higher exercise mastery.
|
Change from baseline (week 0) and to post-intervention (week 13)
|
Change in exercise mastery
Time Frame: Change from baseline (week 0) to 4 months follow-up (week 29)
|
Assessed by the Perceived Competence Scale.
The scale consists of 4 items (statements).
On each item, participants are asked to rate how true a statement is using a 7-point scale.Total score range from 4 to 28, with increasing score reflecting higher exercise mastery.
|
Change from baseline (week 0) to 4 months follow-up (week 29)
|
Change in exercise mastery
Time Frame: Change from baseline (week 0) to 7 months follow-up (week 42)
|
Assessed by the Perceived Competence Scale.
The scale consists of 4 items (statements).
On each item, participants are asked to rate how true a statement is using a 7-point scale.Total score range from 4 to 28, with increasing score reflecting higher exercise mastery.
|
Change from baseline (week 0) to 7 months follow-up (week 42)
|
Change in dietary intake of the participants
Time Frame: Change from baseline (week 0) and to post-intervention (week 13)
|
Measured by a digital food frequency questionnaire (DIGIKOST-FFQ)
|
Change from baseline (week 0) and to post-intervention (week 13)
|
Change in meal pattern
Time Frame: Change from baseline (week 0) and to post-intervention (week 13)
|
Measured by the Meal Pattern Questionnaire
|
Change from baseline (week 0) and to post-intervention (week 13)
|
Change in body mass index
Time Frame: Change from baseline (week 0) and to post-intervention (week 13)
|
Calculated by measuring weight and height
|
Change from baseline (week 0) and to post-intervention (week 13)
|
Change in body mass index
Time Frame: Change from baseline (week 0) to 4 months follow-up (week 29)
|
Calculated by measuring weight and height
|
Change from baseline (week 0) to 4 months follow-up (week 29)
|
Change in body mass index
Time Frame: Change from baseline (week 0) to 7 months follow-up (week 42)
|
Calculated by measuring weight and height
|
Change from baseline (week 0) to 7 months follow-up (week 42)
|
Change in sleep problems
Time Frame: Change from baseline (week 0) and to post-intervention (week 13)
|
Measured by questions from the Trøndelag Health Survey
|
Change from baseline (week 0) and to post-intervention (week 13)
|
Change in sleep problems
Time Frame: Change from baseline (week 0) to 4 months follow-up (week 29)
|
Measured by questions from the Trøndelag Health Survey
|
Change from baseline (week 0) to 4 months follow-up (week 29)
|
Change in sleep problems
Time Frame: Change from baseline (week 0) to 7 months follow-up (week 42)
|
Measured by questions from the Trøndelag Health Survey
|
Change from baseline (week 0) to 7 months follow-up (week 42)
|
Change in cardiorespiratory fitness
Time Frame: Change from baseline (week 0) and to post-intervention (week 13)
|
Assessed by a submaximal and indirect treadmill test (modified Balke protocol)
|
Change from baseline (week 0) and to post-intervention (week 13)
|
Change in cardiorespiratory fitness
Time Frame: Change from baseline (week 0) to 4 months follow-up (week 29)
|
Assessed by a submaximal and indirect treadmill test (modified Balke protocol)
|
Change from baseline (week 0) to 4 months follow-up (week 29)
|
Change in cardiorespiratory fitness
Time Frame: Change from baseline (week 0) to 7 months follow-up (week 42)
|
Assessed by a submaximal and indirect treadmill test (modified Balke protocol)
|
Change from baseline (week 0) to 7 months follow-up (week 42)
|
Change in lower body muscle strength
Time Frame: Change from baseline (week 0) and to post-intervention (week 13)
|
Assessed by 30 second sit-to-stand test
|
Change from baseline (week 0) and to post-intervention (week 13)
|
Change in lower body muscle strength
Time Frame: Change from baseline (week 0) to 4 months follow-up (week 29)
|
Assessed by 30 second sit-to-stand test
|
Change from baseline (week 0) to 4 months follow-up (week 29)
|
Change in lower body muscle strength
Time Frame: Change from baseline (week 0) to 7 months follow-up (week 42)
|
Assessed by 30 second sit-to-stand test
|
Change from baseline (week 0) to 7 months follow-up (week 42)
|
Change in upper body muscle strength
Time Frame: Change from baseline (week 0) and to post-intervention (week 13)
|
Assessed by maximum repetitions of push-ups with various starting positions
|
Change from baseline (week 0) and to post-intervention (week 13)
|
Change in upper body muscle strength
Time Frame: Change from baseline (week 0) to 4 months follow-up (week 29)
|
Assessed by maximum repetitions of push-ups with various starting positions
|
Change from baseline (week 0) to 4 months follow-up (week 29)
|
Change in upper body muscle strength
Time Frame: Change from baseline (week 0) to 7 months follow-up (week 42)
|
Assessed by maximum repetitions of push-ups with various starting positions
|
Change from baseline (week 0) to 7 months follow-up (week 42)
|
Change in quality of life among relatives
Time Frame: Change from baseline (week 0) and to post-intervention (week 13)
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Assessed by the Research and Development 36-item Short Form Survey (RAND SF-36).The eight scales are standardized with a scoring algorithm or by the SF-36v2 scoring software to obtain a score ranging from 0 to 100.
Higher scores indicate better quality of life.
|
Change from baseline (week 0) and to post-intervention (week 13)
|
Change in global health status among relatives
Time Frame: Change from baseline (week 0) and to post-intervention (week 13)
|
The global health status / quality of life scale from the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC-QLQ-C30).
Scores range from 0 to 100, a higher score represents a higher (better) level of functioning or a higher (worse) level of symptoms.
|
Change from baseline (week 0) and to post-intervention (week 13)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Lene Thorsen, Oslo University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 153665
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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