UPLYFT For Lymphoma Survivors

Lymphoma Clinical Trial

Official title:

An Intervention for Fear of Cancer Recurrence for Lymphoma Survivors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05080166
• Other study ID #: 21-409
• Status: Recruiting
• Phase: N/A
• Start date: February 8, 2022
• Est. completion date: April 30, 2025

Study information

• Verified date: March 2024
• Source: Dana-Farber Cancer Institute
• Contact: Oreofe O Odejide, MD, MPH
• Phone: (617) 632-6864
• Email: Oreofe_Odejide[@]dfci.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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:

• In depth interview (lymphoma and mental health clinicians)

• Screening for eligibility

• 6 weekly intervention sessions (lymphoma survivors)

• Baseline Assessments and Questionnaires (lymphoma survivors)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. completion date: April 30, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Lymphoma Survivors Phase 1 and 2:

• Diagnosis of lymphoma (indolent non-Hodgkin lymphoma, aggressive non-Hodgkin lymphoma, or classic Hodgkin lymphoma)

• Age = 18 years

• Interval of 3 months to 24 months from completion of first-line treatment

• In complete remission after first line of treatment

• Clinically significant FCR (score of = 16 on the validated FCR Inventory-Severity Subscale [FCRI-SS).

• Access to computer (for videoconferencing)

Lymphoma clinicians and mental health clinicians Phase 1:

• Lymphoma clinicians = 1 year from oncology fellowship completion OR mental health clinicians (psychologists, social workers, psychiatrists) = 1 year from completion of clinical training.

• Longitudinal clinical care for patients with lymphoma by oncologists OR provision of care for patients with cancer by mental health clinicians

Exclusion Criteria:

Lymphoma Survivors Phase 1:

• Age < 18 years

• Concurrent other malignancy

• Patients with uncontrolled/untreated psychotic disorders or untreated bipolar and borderline personality disorder (as ascertained from medical record screen).

Lymphoma Survivors Phase 2:

• Age < 18 years

• Concurrent other malignancy

• Patients with uncontrolled/untreated psychotic disorders or untreated bipolar and borderline personality disorders (as ascertained from medical record screen).

• Our study will exclude members of the following special populations:

• Adults unable to consent

• Individuals who are not yet adults (infants, children, teenagers)

• Pregnant women

• Prisoners

Related Conditions & MeSH terms

• Lymphoma
• Survivorship

Intervention

Other:
• Interview with Clinicians
One time, qualitative interview of clinicians for feedback on UPLYFT intervention
• Field Test of UPLYFT with Lymphoma Survivors
6 session of UPLYFT intervention with Lymphoma Survivors for feedback

Behavioral:
• Pilot of UPLYFT with Lymphoma Survivors
6 session of UPLYFT intervention with Lymphoma Survivors

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	American Society of Hematology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility: Enrollment Rate	Proportion of eligible patients approached that enroll in the study.	Up to 6 months
Primary	Feasibility: Program Session Completion Rate	Proportion of study participants randomized to the intervention arm (UPLYFT) who complete all intervention sessions.	Up to 6 months
Primary	Feasibility: Data Collection Completion Rate	Proportion of enrolled participants who complete assigned patient-reported questionnaires during the study.	Up to 6 months
Secondary	Acceptability: Satisfaction Rate	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.	Up to 6 months
Secondary	Acceptability: Disenrollment Rate	Disenrollment rate is defined as the proportion of eligible patients who enroll in the study who then choose to disenroll from the study.	Up to 6 months
Secondary	Preliminary efficacy: Fear of Cancer Recurrence (FCR) Change	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.	Up to 6 months
Secondary	Preliminary efficacy: Quality of Life Change	Pre-intervention to post-intervention changes in quality of life measured with the Quality of Life- Cancer Survivor instrument (a 41-item questionnaire)	Up to 6 months
Secondary	Preliminary efficacy: Anxiety Change	Pre-intervention to post-intervention changes in anxiety as measured by the Hospital and Anxiety Scale (Anxiety subscale)	Up to 6 months
Secondary	Preliminary efficacy: Depression Change	Pre-intervention to post-intervention changes in depression as measured by the Hospital Anxiety and Depression Scale (Depression subscale)	Up to 6 months
Secondary	Preliminary efficacy: Psychological inflexibility Change	Pre-intervention to post-intervention changes in psychological inflexibility as measured by the Acceptance and Action Questionnaire-II (a 7-item scale)	Up to 6 months