Combating Cancer-Related Fatigue: A Personalized Supportive Care Program

June 25, 2025 updated by: UNC Lineberger Comprehensive Cancer Center
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

In order to participate in this study a subject must meet all of the eligibility criteria outlined below.

Inclusion Criteria:

  • Written informed consent was obtained to participate in the study and HIPAA authorization for the release of personal health information.
  • Subjects are willing and able to comply with study procedures based on the judgment of the investigator.
  • Age ≥ 18 years at the time of consent.
  • Confirmed diagnosis of indolent lymphoma, Waldenström's Macroglobulinemia, or Cutaneous T Cell Lymphoma.
  • Significant symptoms of fatigue, as defined by PROMIS Fatigue score >50.

Exclusion Criteria:

  • Other co-existing malignancies.
  • Significant cognitive impairment as defined by Mini-Cog score 0-2 (out of 5) that would prevent understanding of assessments or interventions.
  • Unstable or serious illness (e.g., unstable cardiac arrhythmia, severe anemia/thrombocytopenia) that would prevent safe participation in an exercise regimen, per the discretion of the treating physician.
  • Individuals who are not able to consume an oral diet, due to swallowing difficulties or other reasons, as this might interfere with the nutritional intervention

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Patients who are with chronic lymphocytic leukemia/small lymphocytic lymphoma
Patients who are with chronic lymphocytic leukemia/small lymphocytic lymphoma were assessed and received exercise and diet programs.
Other: Exercise
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.
Other: Diet
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of consented patients who are referred
Time Frame: Baseline
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall acceptability
Time Frame: Baseline and post-3 months follow-up
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.
Baseline and post-3 months follow-up
Differences in self-reported fatigue
Time Frame: Baseline and post-3 months follow-up
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
Time Frame: Baseline and post-3 months follow-up
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UNC Lineberger Comprehensive Cancer Center

Collaborators

CLL Society

Investigators

  • Principal Investigator: Christopher Jensen, MD MSCR, UNC Lineberger Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 3, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

February 28, 2025

First Submitted That Met QC Criteria

February 28, 2025

First Posted (Actual)

March 6, 2025

Study Record Updates

Last Update Posted (Actual)

June 27, 2025

Last Update Submitted That Met QC Criteria

June 25, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LCCC2403

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Lymphoma

Clinical Trials on Exercise

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Latvia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe