Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06860880

Combating Cancer-Related Fatigue: A Personalized Supportive Care Program for Patients with Indolent Lymphomas

Led by UNC Lineberger Comprehensive Cancer Center · Updated on 2025-06-27

40

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

C

CLL Society

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating a personalized supportive care program aimed at reducing fatigue in patients diagnosed with indolent lymphomas, including chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and other related lymphoma types such as Follicular Lymphoma, marginal zone lymphoma, lymphoplasmacytic lymphoma, Waldenstrm's Macroglobulinemia, and Cutaneous T Cell Lymphoma. The study focuses on addressing significant fatigue symptoms experienced by these patients and is sponsored by the UNC Lineberger Comprehensive Cancer Center. Participants will follow a combined exercise and dietary program tailored to their medical history, current exercise habits, and individual needs. The exercise plan includes aerobic and resistance training, aiming for 150 minutes of moderate physical activity weekly, with adaptations as needed. Nutritional consultations with an oncology-specialized dietitian will provide personalized diet plans considering each participant's health and treatment. Weekly exercise journals and dietary adherence assessments will monitor commitment to the program. Throughout the study, participants will engage in two consultations focused on exercise and nutrition. They will complete weekly logs to track their exercise activities and rate their adherence to the dietary plan. Researchers will measure the proportion of patients referred at baseline, acceptability of the program, changes in self-reported fatigue, and overall health at baseline and after three months. The study includes safety monitoring and runs until December 31, 2026.

CONDITIONS

Brief Title

Combating Cancer-Related Fatigue: A Personalized Supportive Care Program

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Written informed consent and authorization for personal health information release
  • Willingness and ability to comply with study procedures
  • Age 18 years or older at consent
  • Confirmed diagnosis of indolent lymphoma, Waldenstr�m's Macroglobulinemia, or Cutaneous T Cell Lymphoma
  • Significant fatigue symptoms defined by a PROMIS Fatigue score greater than 50
Not Eligible

You will not qualify if you...

  • Presence of other co-existing malignancies
  • Significant cognitive impairment as indicated by a Mini-Cog score of 0-2 out of 5
  • Unstable or serious illness that prevents safe exercise participation, such as unstable cardiac arrhythmia or severe anemia/thrombocytopenia
  • Inability to consume an oral diet due to swallowing difficulties or other reasons

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for eligibility assessment

Supportive Care Program

Duration - 3 months

Participants engage in a personalized exercise and dietary program tailored to their needs. This includes two consultations with clinicians for exercise and nutrition guidance. Participants track their exercise and diet adherence weekly through journals and assessments.

2 in-person consultations and weekly self-reporting

Post-Program Follow-up

Duration - Up to 3 months after program completion

Participants complete follow-up assessments to evaluate fatigue levels and overall health after the supportive care program.

1 follow-up visit

Trial Site Locations

Total: 1 location

1

North Carolina Basnight Cancer Hospital

Chapel Hill, North Carolina, United States, 27514

Actively Recruiting

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Research Team

D

Devin McCarthy

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

1

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