RECRUITING

Living Well With Lymphoma

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

In this study the investigators are proposing to evaluate the efficacy, sustainability, and mechanisms of 3 months of individualized counseling of the FRD delivered by registered dietitians, over 8 sessions by phone/video conferencing on fatigue, quality of life, and associated symptoms in persistently fatigued lymphoma cancer survivors compared to 3 months of individualized counseling of the attention control (matched for time and frequency of interactions with the FRD) the General Health Curriculum (GHC). The investigators will randomize and follow 68 lymphoma cancer survivors; accounting for a \~10% drop out rate to achieve a target of 60 patients that will complete the study. The investigators hypothesize that persistently fatigued lymphoma cancer survivors will experience improvements in fatigue, quality of life, and symptoms commonly associated with fatigue, which are then maintained at 15-months post-enrollment; and decreased CRP and alterations in inflammation-associated DNA methylation consistent with reduced inflammation from following the FRD as compared to the GHC.

Official Title

Living Well With Lymphoma: Improving Diet Quality to Improve Energy, Sleep and Quality of Life

Quick Facts

Study Start:2024-03-07
Study Completion:2028-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06047626

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Women and men aged 18 years and older
  2. * Diagnosis of lymphoma (Hodgkin and non-Hodgkin)
  3. * Have an average persistent fatigue defined as ≥ 4 on the Brief Fatigue Inventory
  4. * Fatigue must have started at or after the diagnosis of Lymphoma
  5. * Fruit and vegetable intake ≤5.5 servings/day
  6. * Have, or be willing to create, an email address to receive study questionnaires electronically.
  1. * Medically unstable
  2. * BMI\<18.5 kg/m2
  3. * Have a current untreated diagnosis of mood disorder, e.g., bipolar or major depressive disorder
  4. * Have a current untreated diagnosis of anemia
  5. * Have a current untreated diagnosis of hypothyroidism
  6. * Have an initiation, a cessation or change of treatment of any chronic medications, dietary supplements, behavioral therapy, physical therapy etc., or any planned change of medications, supplements, or therapies during the study
  7. * Have a current diagnoses of cachexia
  8. * Planning on becoming pregnant, currently pregnant or lactating

Contacts and Locations

Study Contact

Sara Snyder
CONTACT
734-998-7124
fammed-szickstudy@med.umich.edu

Principal Investigator

Suzie Zick
PRINCIPAL_INVESTIGATOR
University of Michigan Rogel Cancer Center

Study Locations (Sites)

University of Michigan
Ann Arbor, Michigan, 48109
United States

Collaborators and Investigators

Sponsor: University of Michigan Rogel Cancer Center

  • Suzie Zick, PRINCIPAL_INVESTIGATOR, University of Michigan Rogel Cancer Center

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 Registration Dates

Study Start Date2024-03-07
Study Completion Date2028-09

Study Record Updates

Study Start Date2024-03-07
Study Completion Date2028-09

Terms related to this study

Additional Relevant MeSH Terms

  • Lymphoma