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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05080166
Other study ID # 21-409
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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