Lymphoma, Survivorship
Conditions
Keywords
Lymphoma, Survivorship
Brief 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.
Detailed 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.
Interventions
OTHERInterview with Clinicians
One time, qualitative interview of clinicians for feedback on UPLYFT intervention
OTHERField Test of UPLYFT with Lymphoma Survivors
6 session of UPLYFT intervention with Lymphoma Survivors for feedback
BEHAVIORALPilot of UPLYFT with Lymphoma Survivors
6 session of UPLYFT intervention with Lymphoma Survivors
Sponsors
Dana-Farber Cancer Institute
American Society of Hematology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility: Enrollment Rate | Up to 6 months | Proportion of eligible patients approached that enroll in the study. |
| Feasibility: Program Session Completion Rate | Up to 6 months | Proportion of study participants randomized to the intervention arm (UPLYFT) who complete all intervention sessions. |
| Feasibility: Data Collection Completion Rate | Up to 6 months | Proportion of enrolled participants who complete assigned patient-reported questionnaires during the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability: Satisfaction Rate | 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. |
| Acceptability: Disenrollment Rate | 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. |
| Preliminary efficacy: Fear of Cancer Recurrence (FCR) Change | 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. |
| Preliminary efficacy: Quality of Life Change | 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) |
| Preliminary efficacy: Anxiety Change | Up to 6 months | Pre-intervention to post-intervention changes in anxiety as measured by the Hospital and Anxiety Scale (Anxiety subscale) |
| Preliminary efficacy: Depression Change | Up to 6 months | Pre-intervention to post-intervention changes in depression as measured by the Hospital Anxiety and Depression Scale (Depression subscale) |
| Preliminary efficacy: Psychological inflexibility Change | 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) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATOROreofe O Odejide, MD, PhD
Oreofe_Odejide@dfci.harvard.edu
Outcome results
None listed