UPLYFT for Lymphoma

Overseen By Oreofe O Odejide, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Other malignancy, Psychotic disorders, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

74 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the UPLYFT treatment for lymphoma?

Research shows that fear of cancer recurrence is a common issue for cancer patients, including those with lymphoma, and addressing this fear can improve quality of life. Similar treatments, like ConquerFear and FoRtitude, have been effective in reducing fear of recurrence in cancer survivors, suggesting that UPLYFT may also help lymphoma patients manage their fears. ^{1 2 3 4 5}

What makes the UPLYFT treatment unique for lymphoma?

UPLYFT is unique because it focuses on addressing the fear of cancer recurrence, which is a psychological aspect not typically targeted by standard lymphoma treatments that primarily focus on physical symptoms and disease progression. ^{6 7 8 9 10}

Research Team

Oreofe O Odejide, MD, PhD

Principal Investigator

[e-mail]

Eligibility Criteria

This trial is for adults over 18 who have been treated for lymphoma and are in remission but still experience significant fear of cancer recurrence. They must be within 3 to 24 months post-treatment, have access to a computer, and not have other untreated major psychiatric disorders or concurrent malignancies.

Inclusion Criteria

I finished my first lymphoma treatment between 3 and 24 months ago.

Lymphoma Survivors Phase 1 and 2: Clinically significant FCR (score of ≥ 16 on the validated FCR Inventory-Severity Subscale [FCRI-SS)

I am in complete remission from lymphoma after my first treatment.

Exclusion Criteria

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

I do not have untreated mental health conditions like psychosis, bipolar, or borderline personality disorder.

I do not have untreated mental health conditions like psychosis, bipolar, or borderline personality disorder.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Development

Development of the UPLYFT program based on feedback from clinicians and a field test with lymphoma survivors

Varies

Intervention

Lymphoma survivors participate in the finalized UPLYFT program consisting of 6 weekly sessions

6 weeks

6 visits (in-person or virtual)

Follow-up

Participants are monitored for changes in psychological inflexibility, depression, fear of cancer recurrence, quality of life, and anxiety

Up to 6 months

Treatment Details

Interventions

• UPLYFT

Trial Overview UPLYFT (Understand and Prevail: Lymphoma Fear of Recurrence Therapy) is being tested. It's an intervention designed to help lymphoma survivors improve their quality of life by providing information on survivorship and tools to manage worries about the disease returning.

Participant Groups

Group I: UPLYFT Pilot Experimental Treatment 1 Intervention

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.

Group II: Lymphoma Survivors Field Test Experimental Treatment 1 Intervention

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.

Group III: Clinicians Interviews Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

American Society of Hematology

Collaborator

Trials

14

Recruited

20,800+

Findings from Research

Fear of cancer recurrence or progression is a common and significant concern for cancer patients, impacting their quality of life and emotional well-being.

Early recognition and support for this fear, along with referrals to psychosocial oncology, can improve patient outcomes and help identify those at risk during key points in their treatment journey.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fear of Cancer Recurrence or Progression: What Is It and What Can We Do About It? Bergerot, CD., Philip, EJ., Bergerot, PG., et al.[2022]

About 16.3% of lymphoma patients experienced severe fear of cancer recurrence (FCR) after completing treatment, which was linked to a significantly higher risk of all-cause mortality (hazard ratio of 2.52) and lymphoma-specific mortality (hazard ratio of 2.62).

Patients with severe FCR reported worse quality of life, including lower scores in general health and various functioning areas, indicating that managing FCR is crucial for improving patient outcomes post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of fear of cancer recurrence on survival among lymphoma patients. Kim, SJ., Kang, D., Kim, IR., et al.[2020]

The targeted eHealth intervention 'FoRtitude' significantly reduced fear of recurrence (FoR) in breast cancer survivors, with scores decreasing from an average of 53.1 to 41.9 after the intervention, indicating its efficacy in addressing this prevalent concern.

Telecoaching enhanced participant adherence to the program and reduced dropout rates, suggesting that remote support can improve engagement in eHealth interventions for cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeted eHealth Intervention to Reduce Breast Cancer Survivors' Fear of Recurrence: Results From the FoRtitude Randomized Trial. Wagner, LI., Tooze, JA., Hall, DL., et al.[2022]

Approximately 50% of cancer survivors experience moderate to severe fear of progression, which can negatively impact their well-being and quality of life.

Targeted interventions, such as brief group therapy, have been shown to effectively treat clinical fear of progression in cancer patients, highlighting the need for psychological support in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fear of Progression in Cancer Patients and Survivors. Dinkel, A., Herschbach, P.[2019]

The ConquerFear intervention significantly reduced fear of cancer recurrence (FCR) in breast and colorectal cancer or melanoma survivors, showing greater improvements compared to a control group after therapy and maintaining these benefits for up to 6 months.

Participants in the ConquerFear group experienced not only lower FCR scores but also improvements in general anxiety, cancer-specific distress, and mental quality of life, indicating a broad positive impact on psychological well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Trial of ConquerFear: A Novel, Theoretically Based Psychosocial Intervention for Fear of Cancer Recurrence. Butow, PN., Turner, J., Gilchrist, J., et al.[2017]

In a study of 46 patients with relapsed or refractory B-cell lymphoma, the combination treatment of rituximab, gemcitabine, and oxaliplatin (R-GemOx) resulted in an impressive overall response rate of 83%, with 50% achieving complete or unconfirmed complete responses after four cycles.

R-GemOx demonstrated acceptable toxicity and promising long-term outcomes, with a 2-year overall survival rate of 66% and a 2-year event-free survival rate of 43%, making it a viable option for patients not eligible for high-dose therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rituximab, gemcitabine and oxaliplatin: an effective salvage regimen for patients with relapsed or refractory B-cell lymphoma not candidates for high-dose therapy. El Gnaoui, T., Dupuis, J., Belhadj, K., et al.[2022]

In patients with early treatment failure (ETF) in follicular lymphoma, autologous hematopoietic stem cell transplantation (auto-HCT) shows a promising 5-year overall survival rate of 70%, indicating its efficacy as a treatment option for this high-risk group.

Matched sibling donor (MSD) transplantation results in lower relapse rates compared to auto-HCT, but both have similar overall survival rates, suggesting that while MSD may reduce the chance of cancer returning, auto-HCT remains a viable option with low non-relapse mortality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autologous transplantation versus allogeneic transplantation in patients with follicular lymphoma experiencing early treatment failure. Smith, SM., Godfrey, J., Ahn, KW., et al.[2020]

In a study of 26 patients with aggressive B-cell non-Hodgkin lymphoma who remained FDG-PET positive after R-CHOP chemotherapy, radical radiotherapy (RT) showed the highest 3-year progression-free survival (PFS) rate of 51%, compared to 25% for autologous stem cell transplant (ASCT) and 20% for non-radical treatments.

The overall survival (OS) rates were also better for patients receiving RT, with a 3-year OS of 65%, indicating that radiotherapy is an effective salvage treatment option for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of salvage treatment modalities in patients with positive FDG-PET/CT after R-CHOP chemotherapy for aggressive B-cell non-Hodgkin lymphoma. Chin, V., Fulham, M., Hertzberg, M., et al.[2019]

In a study of 47 patients with aggressive lymphoma, 96% achieved complete remission after receiving a combination chemotherapy regimen (Pro-MACE-MOPP) followed by radiation therapy, with a median follow-up of 42 months and no relapses reported.

The treatment was found to be safe, with only 5% of chemotherapy cycles requiring hospital admissions for complications and no treatment-related deaths, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of localized aggressive lymphomas with combination chemotherapy followed by involved-field radiation therapy. Longo, DL., Glatstein, E., Duffey, PL., et al.[2017]

The all-oral chemotherapy regimen TEPIP was well-tolerated and showed a 23% overall response rate in 35 patients with advanced aggressive B-cell lymphoma, indicating its potential as a palliative treatment option.

Adding rituximab significantly improved the overall response rate to 67%, highlighting the benefit of combination therapy in this challenging patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

All-Oral Low-Dose Chemotherapy TEPIP is Effective and Well-Tolerated in Relapsed/Refractory Patients With Aggressive B-Cell Lymphoma. Fante, MA., Felsenstein, M., Mayer, S., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Fear of Cancer Recurrence or Progression: What Is It and What Can We Do About It? [2022]

2. England pubmed.ncbi.nlm.nih.gov

Impact of fear of cancer recurrence on survival among lymphoma patients. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Targeted eHealth Intervention to Reduce Breast Cancer Survivors' Fear of Recurrence: Results From the FoRtitude Randomized Trial. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Fear of Progression in Cancer Patients and Survivors. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Randomized Trial of ConquerFear: A Novel, Theoretically Based Psychosocial Intervention for Fear of Cancer Recurrence. [2017]

6. England pubmed.ncbi.nlm.nih.gov

Rituximab, gemcitabine and oxaliplatin: an effective salvage regimen for patients with relapsed or refractory B-cell lymphoma not candidates for high-dose therapy. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Autologous transplantation versus allogeneic transplantation in patients with follicular lymphoma experiencing early treatment failure. [2020]

8. Australia pubmed.ncbi.nlm.nih.gov

Impact of salvage treatment modalities in patients with positive FDG-PET/CT after R-CHOP chemotherapy for aggressive B-cell non-Hodgkin lymphoma. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Treatment of localized aggressive lymphomas with combination chemotherapy followed by involved-field radiation therapy. [2017]

10. Switzerland pubmed.ncbi.nlm.nih.gov

All-Oral Low-Dose Chemotherapy TEPIP is Effective and Well-Tolerated in Relapsed/Refractory Patients With Aggressive B-Cell Lymphoma. [2022]