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UPLYFT For Lymphoma Survivors

Primary Purpose

Lymphoma, Survivorship

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Interview with Clinicians
Field Test of UPLYFT with Lymphoma Survivors
Pilot of UPLYFT with Lymphoma Survivors
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lymphoma focused on measuring Lymphoma, Survivorship

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dana-Farber Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Clinicians Interviews

Lymphoma Survivors Field Test

UPLYFT Pilot

Arm Description

Lymphoma and mental health clinicians will participate in 1x in-depth qualitative interview to provide feedback for the development of the UPLYFT program.

A six person group of lymphoma survivors will participate in a six session UPLYFT program field test to provide feedback for the development of the UPLYFT program.

Lymphoma survivors will participate in the phase 1 finalized, six session UPLYFT program. Participants will be randomized 1:1 to either UPLYFT or usual care.

Outcomes

Primary Outcome Measures

Feasibility: Enrollment Rate
Proportion of eligible patients approached that enroll in the study.
Feasibility: Program Session Completion Rate
Proportion of study participants randomized to the intervention arm (UPLYFT) who complete all intervention sessions.
Feasibility: Data Collection Completion Rate
Proportion of enrolled participants who complete assigned patient-reported questionnaires during the study.

Secondary Outcome Measures

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.
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.
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.
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)
Preliminary efficacy: Anxiety Change
Pre-intervention to post-intervention changes in anxiety as measured by the Hospital and Anxiety Scale (Anxiety subscale)
Preliminary efficacy: Depression Change
Pre-intervention to post-intervention changes in depression as measured by the Hospital Anxiety and Depression Scale (Depression subscale)
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)

Full Information

First Posted
October 5, 2021
Last Updated
July 3, 2023
Sponsor
Dana-Farber Cancer Institute
Collaborators
American Society of Hematology
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1. Study Identification

Unique Protocol Identification Number
NCT05080166
Brief Title
UPLYFT For Lymphoma Survivors
Official Title
An Intervention for Fear of Cancer Recurrence for Lymphoma Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 8, 2022 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
American Society of Hematology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Survivorship
Keywords
Lymphoma, Survivorship

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Clinicians Interviews
Arm Type
Experimental
Arm Description
Lymphoma and mental health clinicians will participate in 1x in-depth qualitative interview to provide feedback for the development of the UPLYFT program.
Arm Title
Lymphoma Survivors Field Test
Arm Type
Experimental
Arm Description
A six person group of lymphoma survivors will participate in a six session UPLYFT program field test to provide feedback for the development of the UPLYFT program.
Arm Title
UPLYFT Pilot
Arm Type
Experimental
Arm Description
Lymphoma survivors will participate in the phase 1 finalized, six session UPLYFT program. Participants will be randomized 1:1 to either UPLYFT or usual care.
Intervention Type
Other
Intervention Name(s)
Interview with Clinicians
Intervention Description
One time, qualitative interview of clinicians for feedback on UPLYFT intervention
Intervention Type
Other
Intervention Name(s)
Field Test of UPLYFT with Lymphoma Survivors
Intervention Description
6 session of UPLYFT intervention with Lymphoma Survivors for feedback
Intervention Type
Behavioral
Intervention Name(s)
Pilot of UPLYFT with Lymphoma Survivors
Intervention Description
6 session of UPLYFT intervention with Lymphoma Survivors
Primary Outcome Measure Information:
Title
Feasibility: Enrollment Rate
Description
Proportion of eligible patients approached that enroll in the study.
Time Frame
Up to 6 months
Title
Feasibility: Program Session Completion Rate
Description
Proportion of study participants randomized to the intervention arm (UPLYFT) who complete all intervention sessions.
Time Frame
Up to 6 months
Title
Feasibility: Data Collection Completion Rate
Description
Proportion of enrolled participants who complete assigned patient-reported questionnaires during the study.
Time Frame
Up to 6 months
Secondary Outcome Measure Information:
Title
Acceptability: Satisfaction Rate
Description
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
Title
Acceptability: Disenrollment Rate
Description
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
Title
Preliminary efficacy: Fear of Cancer Recurrence (FCR) Change
Description
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
Title
Preliminary efficacy: Quality of Life Change
Description
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
Title
Preliminary efficacy: Anxiety Change
Description
Pre-intervention to post-intervention changes in anxiety as measured by the Hospital and Anxiety Scale (Anxiety subscale)
Time Frame
Up to 6 months
Title
Preliminary efficacy: Depression Change
Description
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
Title
Preliminary efficacy: Psychological inflexibility Change
Description
Pre-intervention to post-intervention changes in psychological inflexibility as measured by the Acceptance and Action Questionnaire-II (a 7-item scale)
Time Frame
Up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Oreofe O Odejide, MD, MPH
Phone
(617) 632-6864
Email
Oreofe_Odejide@dfci.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oreofe O Odejide, MD, PhD
Organizational Affiliation
Oreofe_Odejide@dfci.harvard.edu
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oreofe O Odejide, MD, MPH
Phone
617-632-6864
Email
Oreofe_Odejide@dfci.harvard.edu
First Name & Middle Initial & Last Name & Degree
Oreofe O Odejide, MD, MPH

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
IPD Sharing Time Frame
Data can be shared no earlier than 1 year following the date of publication
IPD Sharing Access Criteria
Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Learn more about this trial

UPLYFT For Lymphoma Survivors

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