Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Location status: Recruiting
Location contact
Oreofe O Odejide, MD, MPH
CONTACT
Oreofe O Odejide, MD, MPH
PRINCIPAL_INVESTIGATOR
NCT Number: NCT05080166
The main purpose of this study is to field test and pilot an intervention called UPLYFT (Understand and Prevail: Lymphoma Fear of Recurrence Therapy) that includes information about lymphoma survivorship and tools to improve quality of life and reduce lymphoma-related worries among lymphoma survivors.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02215, United States
Location status: Recruiting
Oreofe O Odejide, MD, MPH
CONTACT
Oreofe O Odejide, MD, MPH
PRINCIPAL_INVESTIGATOR
This is a two phase pilot study to develop and pilot the UPLYFT (Understand and Prevail: Lymphoma Fear of Recurrence Therapy) program intervention that includes lymphoma survivorship information and acceptance and commitment therapy strategies to alleviate fear of cancer recurrence, reduce distress, and improve quality of life among lymphoma survivors.
Phase 1 will be a two-part development process of the UPLYFT program based on interview feedback from lymphoma and mental health clinicians and then feedback from a six-person group of lymphoma survivors after participation in an UPLYFT program field test. Phase 2 is a randomized pilot study using the UPLFYT program finalized in Phase 1.
Research procedures include:
74 people are expected to participate in this study with 14 in Phase 1 and 60 in Phase 2.
The American Society of Hematology is providing funding for the trial.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Lymphoma Survivors Phase 1 and 2:
Lymphoma clinicians and mental health clinicians Phase 1:
Exclusion criteria
Lymphoma Survivors Phase 1:
Lymphoma Survivors Phase 2:
One time, qualitative interview of clinicians for feedback on UPLYFT intervention
6 session of UPLYFT intervention with Lymphoma Survivors for feedback
6 session of UPLYFT intervention with Lymphoma Survivors
Time frame: Up to 6 months
Proportion of eligible patients approached that enroll in the study.
Time frame: Up to 6 months
Proportion of study participants randomized to the intervention arm (UPLYFT) who complete all intervention sessions.
Time frame: Up to 6 months
Proportion of enrolled participants who complete assigned patient-reported questionnaires during the study.
Time frame: Up to 6 months
Satisfaction rate is defined as the proportion of study participants randomized to the intervention arm who are satisfied with the UPLYFT program and proportion who are likely to recommend the program.
Time frame: Up to 6 months
Disenrollment rate is defined as the proportion of eligible patients who enroll in the study who then choose to disenroll from the study.
Time frame: Up to 6 months
Pre-intervention to post-intervention changes in Fear of Cancer Recurrence (FCR) measured with the Fear of Cancer Recurrence Inventory (FCRI, 42-item questionnaire), with a focus on the FCRI severity subscale.
Time frame: Up to 6 months
Pre-intervention to post-intervention changes in quality of life measured with the Quality of Life- Cancer Survivor instrument (a 41-item questionnaire)
Time frame: Up to 6 months
Pre-intervention to post-intervention changes in anxiety as measured by the Hospital and Anxiety Scale (Anxiety subscale)
Time frame: Up to 6 months
Pre-intervention to post-intervention changes in depression as measured by the Hospital Anxiety and Depression Scale (Depression subscale)
Time frame: Up to 6 months
Pre-intervention to post-intervention changes in psychological inflexibility as measured by the Acceptance and Action Questionnaire-II (a 7-item scale)
Contact information is provided by the study sponsor or research team.
Dana-Farber Cancer Institute
Other
An Intervention for Fear of Cancer Recurrence for Lymphoma Survivors
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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