This federal Project Grant award, in the amount of $594,734, was provided by the National Cancer Institute (NCI) under the Cancer Treatment Research program (CFDA 93.395) to investigate the effects of a telehealth exercise program for rural cancer survivors experiencing cancer-related fatigue. The primary objectives are to evaluate the efficacy of the "BFITBWell Telehealth Program" for improving cancer-related fatigue in rural breast and prostate cancer survivors, and to examine the...
The National Cancer Institute (NCI) awarded a $638,326 Project Grant (CFDA 93.395 - Cancer Treatment Research) to the H. Lee Moffitt Cancer Center and Research Institute Hospital, Inc. on September 18, 2024. The purpose of this grant is to adapt a cognitive behavioral therapy for fatigue (CBTF) intervention for women with metastatic breast cancer (MBC) treated with CDK4/6 inhibitors, and to evaluate the feasibility, acceptability, and preliminary efficacy of the adapted...
This Project Grant award of $752,588 from the National Cancer Institute (CFDA 93.395 - Cancer Treatment Research) supports a 12-week randomized controlled trial to evaluate the effects of time-restricted eating on cancer-related fatigue among survivors of hematological malignancies. The study will recruit 96 eligible participants and assess patient-reported fatigue, circadian activity rhythm, and glucose metabolism at baseline, 6 weeks, and 12 weeks. The University of Maryland, Baltimore is...
The National Cancer Institute (NCI) awarded a $578,467 Project Grant (CFDA 93.395 - Cancer Treatment Research) to Duke University to conduct a randomized controlled trial evaluating the efficacy of a telehealth-delivered psychosocial intervention called ENGAGE. The goal of the ENGAGE intervention is to decrease symptom interference (e.g., pain, fatigue, distress) and improve quality of life for patients with advanced cancer receiving care in medically underserved areas. The 5-year project will...
This $656,014 Project Grant award from the National Cancer Institute (CFDA 93.393 - Cancer Cause and Prevention Research) will fund a randomized clinical trial at The Ohio State University to evaluate the effectiveness of a telemedicine-mHealth symptom management intervention, called FOCUS, for advanced cancer patients in underserved rural communities. The FOCUS intervention aims to improve a symptom cluster including sleep difficulties, anxiety, depression, and fatigue, and enhance functional...
The National Cancer Institute (NCI) awarded a 5-year, $708,091 Project Grant under the Cancer Cause and Prevention Research program (CFDA 93.393) to Emory University to develop and test the effectiveness of an "Algorithm-Enabled Patients Activated in Cancer Care through Teams" (A-PACT) intervention. The A-PACT program uses machine learning algorithms to automatically identify high-risk cancer patients who can benefit from structured education and engagement in goals of care...
This Project Grant award from the National Cancer Institute (CFDA 93.394 - Cancer Detection and Diagnosis Research) will fund a $414,446 study at Colorado State University to evaluate the efficacy of a group-based videoconference intervention to increase moderate-to-vigorous physical activity (MVPA) in cancer survivors. The 12-week intervention will include twice-weekly instructor-led group exercise sessions and behavior change discussions, delivered virtually via videoconferencing. The...
This Cooperative Agreement award, valued at $294,787, was made by the National Cancer Institute (NCI) under the Cancer Treatment Research (CFDA 93.395) program. The award supports the planning and development of a virtual exercise intervention trial aimed at preventing functional decline in cancer patients undergoing chemotherapy. Key components include: Assessing factors associated with functional decline in cancer survivors enrolled in the American Cancer Society Cancer Prevention Study-3...
The National Cancer Institute (NCI), under the federal Cancer Cause and Prevention Research program (CFDA 93.393), awarded a $1,019,587 Project Grant to 5 Point App, Inc. to conduct a decentralized clinical trial of the effectiveness of the EnergyPoints mobile app in guiding acupressure use for fatigue and sleep disturbances in cancer survivors. The project aims to 1) determine the effectiveness of the EnergyPoints app on clinical outcomes such as fatigue, sleep, and quality of life, and 2)...
This Project Grant award from the National Cancer Institute (CFDA 93.398 Cancer Research Manpower) to Northwestern University is intended to examine physical activity promotion intervention outcomes, barriers, and facilitators in breast cancer survivors with fatigue. The $130,001 award will fund a study that includes secondary data analyses from a prior mobile health physical activity intervention, as well as a needs assessment to understand multi-level stakeholder perspectives on barriers and...
RANDOMIZED TRIAL OF REVITALIZE: A TELEHEALTH INTERVENTION TO REDUCE FATIGUE INTERFERENCE AMONG ADULTS WITH ADVANCED OVARIAN CANCER ON PARP INHIBITORS - ABSTRACT IN THE ERA OF PRECISION ONCOLOGY, MORE PATIENTS ARE LIVING LONGER WITH ADVANCED CANCER, YET MANY OF THE NEW STRATEGIES REQUIRE YEARS OF FATIGUING TREATMENT. WHILE COGNITIVE BEHAVIORAL THERAPY (CBT) IS AN EFFECTIVE TREATMENT FOR FATIGUE IN EARLY-STAGE CANCER, FOR ADVANCED CANCER A RECENT COCHRANE META-ANALYSIS FOUND FEW TRIALS AND "VERY LOW-QUALITY EVIDENCE" FOR ITS ENDURING BENEFIT ON FATIGUE AT FOLLOW-UP. IT IS ALSO UNKNOWN IF ADDRESSING FATIGUE IMPROVES ADHERENCE TO CANCER TREATMENT. FINALLY, GIVEN THAT ADVANCED CANCER TYPICALLY REQUIRES ONGOING TREATMENT, IT IS MORE REALISTIC TO REDUCE THE NEGATIVE INTERFERENCE OF FATIGUE WITH QUALITY OF LIFE ("FATIGUE INTERFERENCE") THAN TO ELIMINATE FATIGUE ITSELF. THUS, FULLY POWERED TRIALS OF PROMISING INTERVENTIONS FOR FATIGUE INTERFERENCE ARE CRITICALLY NEEDED TO IMPROVE OUTCOMES IN ADVANCED CANCER SURVIVORS. OVARIAN CANCER REPRESENTS AN IDEAL CONTEXT TO TEST SUCH INTERVENTIONS AS MOST PATIENTS ARE DIAGNOSED WITH ADVANCED DISEASE AND, AFTER INITIAL TREATMENT, ARE PRESCRIBED ORAL POLY ADP-RIBOSE POLYMERASE (PARP) INHIBITORS FOR 2-3 YEARS. PARP INHIBITORS, WHICH ARE INCREASINGLY USED TO TREAT OTHER CANCERS, CAUSE LIFE-INTERFERING FATIGUE IN NEARLY HALF OF PATIENTS (RELATIVE TO PLACEBO). TO ADDRESS THESE LIMITATIONS, WE DEVELOPED, REFINED, AND PILOTED REVITALIZE - A TELEHEALTH INTERVENTION TO ADDRESS FATIGUE INTERFERENCE AMONG PATIENTS WITH ADVANCED OVARIAN CANCER TAKING PARP INHIBITORS. BASED ON ACCEPTANCE AND COMMITMENT THERAPY (ACT), A CBT VARIANT WELL-MATCHED TO THE CONTEXT OF ADVANCED CANCER, REVITALIZE HAS PATIENTS IDENTIFY AND REDUCE CONTRIBUTORS TO FATIGUE BEYOND PARP INHIBITORS, CLARIFY AND ALIGN THEIR BEHAVIOR WITH THEIR VALUES, AND USE ACTIVE ACCEPTANCE STRATEGIES TO REDUCE FATIGUE INTERFERENCE IN DAILY LIFE. IN A PILOT RANDOMIZED TRIAL (N=44), RELATIVE TO ENHANCED USUAL CARE (EUC), REVITALIZE REDUCED FATIGUE INTERFERENCE AT 12-WEEK FOLLOW-UP, P=.008, BY A LARGE EFFECT; IMPROVED FATIGUE SEVERITY, SELF- EFFICACY, AND CATASTROPHIZING, AND QUALITY OF LIFE; AND LED TO FEWER DOSE DELAYS AND REDUCTIONS. WE PROPOSE TO CONDUCT A FULLY-POWERED, RANDOMIZED CONTROLLED TRIAL THAT INCLUDES ADHERENCE OUTCOMES AND LONGER FOLLOW-UP ACROSS BOTH COMMUNITY AND ACADEMIC CANCER CLINICS THAT SERVE DIVERSE COMMUNITIES, COMPARING REVITALIZE TO EUC (N=240) ASSESSED AT BASELINE, MID-INTERVENTION (TO ASSESS MECHANISMS), POST-INTERVENTION, AND 4- AND 6- MONTH FOLLOW-UP. AIMS ARE (1) TO EVALUATE REVITALIZE VS. EUC EFFECTS ON FATIGUE INTERFERENCE (PRIMARY OUTCOME), FATIGUE SEVERITY, SELF-EFFICACY, AND CATASTROPHIZING, AND QUALITY OF LIFE (SECONDARY OUTCOMES); (2) TO ASSESS THE EFFECT OF REVITALIZE VS. EUC ON OBJECTIVE PARP INHIBITOR MONTHLY ADHERENCE, DOSE INTERRUPTIONS AND REDUCTIONS, AND PERSISTENCE USING WISEPILL MEDICATION MONITORING DEVICES AND CHART REVIEW; (3) TO ASSESS THE THEORY-DRIVEN MECHANISMS OF REVITALIZE-ACTIVE ACCEPTANCE AND ALIGNMENT OF BEHAVIOR WITH VALUES-BY EXAMINING MEDIATORS OF REVITALIZE EFFECTS COMPARED TO EUC. IF EFFICACIOUS, REVITALIZE WILL PROVIDE A SCALABLE TELEHEALTH INTERVENTION TO IMPROVE SURVIVORSHIP IN ADVANCED OVARIAN CANCER, THAT CAN BE READILY ADAPTED TO ADDRESS FATIGUE AMONG THE GROWING COMMUNITY OF ADVANCED CANCER SURVIVORS.