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| Name | Class |
|---|---|
| CLL Society | UNKNOWN |
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This health services study will assess a multidisciplinary intervention program directed at fatigue mitigation among patients diagnosed with indolent lymphomas. Specifically, 30 subjects with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and 10 subjects with Follicular Lymphoma (FL), marginal zone lymphoma (MZL), lymphoplasmacytic lymphoma (LPL), Waldenström's Macroglobulinemia, or Cutaneous T Cell Lymphoma (CTCL) will be included.
All subjects will be assigned to an exercise and dietary intervention program. Patients will engage in two patient-clinician consultations for exercise and nutrition. The individualized exercise plan designed based on the subject's medical history, current exercise habits, and specific needs, will include a mix of aerobic and resistance training.
Concurrently, participants will receive nutritional consultations from a specialized oncology dietitian. These sessions will focus on creating a diet plan tailored to each participant's nutritional needs, considering their treatment and overall health. Study participants will complete weekly exercise journals to track adherence to the exercise prescription and complete weekly assessments of their adherence to dietary recommendations on an integer scale ranging from 0-10.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients who are with chronic lymphocytic leukemia/small lymphocytic lymphoma | Other | Patients who are with chronic lymphocytic leukemia/small lymphocytic lymphoma were assessed and received exercise and diet programs. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Other | Each patient will receive an individualized exercise prescription that will encompass both aerobic and resistance training, with modifications as necessary to accommodate each patient's needs, abilities, and medical condition. For those not participating in any formal exercise at baseline, the exercise prescription will consist of a basic conditioning program targeting 150 minutes of moderate physical activity weekly with the assistance of a physical therapist if deemed appropriate. |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of consented patients who are referred | The proportion of consented patients with chronic lymphocytic leukemia (CLL) or other forms of indolent lymphoma who are referred to cancer rehabilitation and dietician and attend an initial appointment with each. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Overall acceptability | Overall acceptability will be measured as the proportion of participants who report being "Neutral," "Satisfied" or "Very Satisfied" with the intervention utilizing the Cancer Fatigue Program Participant Feedback Questionnaire- Part 1. The questionnaire has 2 parts and the first part has 8 multiple choice questions. Options are very Dissatisfied, Dissatisfied, Neutral, Satisfied, Very Satisfied. |
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In order to participate in this study a subject must meet all of the eligibility criteria outlined below.
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Devin McCarthy | Contact | (919)-445-4852 | devin_mccarthy@med.unc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Christopher Jensen, MD MSCR | UNC Lineberger Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Carolina Basnight Cancer Hospital | Recruiting | Chapel Hill | North Carolina | 27514 | United States |
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| Label | URL |
|---|---|
| UNC Lineberger Comprehensive Cancer Center Clinical Trials | View source |
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| Diet | Other | Participants will undergo nutritional consultations with a registered dietitian who specializes in oncology. The dietitian will provide tailored dietary recommendations using evidence-based nutrition guidelines. Participants will also be screened ffor ormal nutrition based on American Society for Parenteral and Enteral Nutrition (ASPEN) guidelines as indicated. |
|
| Baseline and post-3 months follow-up |
| Differences in self-reported fatigue | Differences in self-reported fatigue will be determined by the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue (PROMIS Item Bank v1.0 Fatigue Short Form13a (FACIT-Fatigue)) questionnaire. It uses a scoring system to assess the severity of fatigue and its impact on daily activities. There are 13 items and each item in the short form has five response options, typically ranging from 1 (not at all) to 5 (very much), the lowest possible raw score is 13, and the highest possible raw score is 65. | Baseline and post-3 months follow-up |
| Differences in overall health | Differences in overall health will be determined by Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health (PROMIS Scale v1.2 Global Health) scores. The PROMIS Scale v1.2 Global Health measures both physical and mental health through a set of items. Each item has five response options, typically ranging from 1 (poor) to 5 (excellent). Higher Scores: Indicate better health and lower Scores: Indicate poorer health. | Baseline and post-3 months follow-up |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D008224 | Lymphoma, Follicular |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| D008258 | Waldenstrom Macroglobulinemia |
| D016410 | Lymphoma, T-Cell, Cutaneous |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008228 | Lymphoma, Non-Hodgkin |
| D016393 | Lymphoma, B-Cell |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D016399 | Lymphoma, T-Cell |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D004032 | Diet |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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