App and Fitbit for Gynecologic Cancers

Overseen By Alexi A Wright, MD MPH

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Severe cognitive impairments, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new combination of a smartphone app and Fitbit to improve the quality of life for women with gynecologic cancers, such as ovarian, uterine, or cervical cancer. Participants will use these tools to monitor their health and receive personalized advice based on their daily input and activity data. The study is open to women planning to undergo chemotherapy for these cancers who own a smartphone and can use apps independently. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance daily life for women with gynecologic cancers.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on using a smartphone app and Fitbit to improve quality of life, so it's best to ask the study team for guidance.

What prior data suggests that the HOPE app and Fitbit devices are safe for women with gynecologic cancers?

Research shows that using the HOPE app and Fitbit devices for patients with gynecologic cancer is generally safe. Studies have found that similar online health tools are well-received by cancer patients. No reports of serious side effects suggest these tools are safe for everyday use. Participants use the app to track symptoms and receive advice, while the Fitbit records data like steps taken.

Research has examined the use of Fitbit devices in cancer care, and they are considered safe for tracking physical activity. Evidence from past studies shows that wearables like Fitbits are often used in cancer trials without causing harm.

In summary, both the HOPE app and Fitbit devices appear safe based on existing research. They help patients monitor their health with little risk of side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to support women with gynecologic cancers using technology. Traditional treatments often focus solely on medical interventions, but this trial integrates smartphone apps and wearable devices like the Fitbit to actively monitor and manage patient symptoms. The HOPE App and SMART Study Intervention are unique because they provide tailored advice and symptom management based on real-time data collected from patients, potentially improving their quality of life. By using passive data collection and prompting patients to report symptoms, this approach could lead to more personalized and timely care. This trial could pave the way for more tech-driven, patient-centered care in cancer treatment.

What evidence suggests that this trial's treatments could be effective for improving quality-of-life in women with gynecologic cancers?

Research has shown that the HOPE app, one of the interventions in this trial, can help manage symptoms for people with gynecologic cancers. In an initial study, patients found it easier to handle mild side effects by using the app. The app provides personalized advice and alerts users to contact a doctor for serious symptoms. Meanwhile, the SMART Study Arm, another intervention in this trial, uses a smartphone app and a Fitbit to help reduce symptom severity and anxiety. Early results suggest that these tools can boost physical activity and improve the overall quality of life for cancer patients. These approaches appear promising in supporting patients' well-being during treatment. ^{1 6 7 8 9}

Who Is on the Research Team?

Alexi A. Wright

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

The HOPE Trial and SMART Study are for women over 18 with recurrent gynecologic cancers planning to receive chemotherapy. Participants must own a smartphone, be able to use the study app without help, and read English. Excluded are those with severe cognitive issues or participating in other drug trials requiring symptom reporting.

Inclusion Criteria

I am a woman over 18 with recurrent gynecologic cancer planning to receive chemotherapy.

Capable of downloading and running the study app without assistance

Own a smart-phone (Android or iOS)

Exclusion Criteria

I am currently in a drug trial that needs me to report symptoms or side effects.

Patients with severe cognitive impairments

Patients who appear too weak, emotionally distraught, agitated, or ill to participate, as judged by either the research study staff or an oncology provider

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Assessment

Initial assessment of the app with a diverse group of 10 patients to refine the app and test two different wearable accelerometers

4 weeks

Pilot Randomized Controlled Trial

Conduct a 4-arm pilot RCT in 100 patients with gynecologic cancers receiving palliative chemotherapy to establish preliminary effect sizes

90 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Fitbit Charge 2
• Fitbit Zip
• HOPE App
• SMART Study Intervention

Trial Overview These studies test a 'Helping Our Patients Excel (HOPE)' app alongside a Fitbit device aiming to enhance life quality for women with gynecologic cancers. The intervention involves using these technologies together during their treatment process.

How Is the Trial Designed?

Group I: Wearable accelerometer (HOPE) Experimental Treatment 2 Interventions

* Participants will be asked to wear the Fitbit * The Hope App will measure daily steps * The app will also collect passive data from the smartphone

Group II: Usual care (HOPE) Experimental Treatment 2 Interventions

Stage 2 will consist of arm 2-5 and will enroll 100 randomized patients. * Usual care * The app will also collect passive data from the smartphone

Group III: SMART Study Arm Experimental Treatment 1 Intervention

* Two smartphone apps and a wearable accelerometer (Fitbit) in 30 patients with gynecologic cancers receiving chemotherapy at two NCI Community Oncology sites. * The SMART intervention refers to the combination of both smartphone apps (SMART app and Beiwe app) and the accelerometer (Fitbit). * The SMART app is the technology that is actively collecting symptom reporting information from patients (e.g. patients are receiving surveys, recording their symptoms daily, and receiving tailored symptom management materials on their phone in response). * The Beiwe app is the technology involved in the passive data collection of participants' symptoms (GPS and accelerometer data) without their involvement.

Group IV: Refined smartphone app and accelerometer (HOPE) Experimental Treatment 1 Intervention

* Participants will be prompted to answer questions about their quality of life and physical health daily * The HOPE App will present tailored advice to improve symptoms if one or more low-risk toxicities are reported. If the symptoms are determined to be high-risk, the App will prompt the patient to call their clinician. Participants will be asked to wear the Fitbit -The Hope App will measure daily steps The app will also collect passive data from the smartphone

Group V: Refined smartphone app (HOPE) Experimental Treatment 1 Intervention

* Participants will be prompted to answer questions about their quality of life and physical health daily * The HOPE App will present tailored advice to improve symptoms if one or more low-risk toxicities are reported. If the symptoms are determined to be high-risk, the App will prompt the patient to call their clinician. * The app will also collect passive data from the smartphone

Group VI: Comparing Steps Collected by Accelerometer (HOPE) Experimental Treatment 3 Interventions

* 10 patients will be enrolled in stage 1 to refine the HOPE App intervention * All participants will receive : * HOPE App * The Fitbit Zip * The Fitbit Charge 2 The amount of step collected by each device will be compared. This will allow the team to identify which wearable accelerometer to use in stage 2

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6556148/

The HOPE Pilot Study: Harnessing Patient-Reported ... We developed and pilot tested an intervention to assess the symptoms of patients with cancer in situ, address low-risk toxicities via a smartphone application, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03022032

NCT03022032 | The HOPE Trial and the SMART Study ... smartphone apps in 30 patients receiving chemotherapy to treat recurrent gynecologic cancers. ... Gynecologic cancer. Additional Relevant MeSH Terms. Quality ...

3. ascopubs.org ascopubs.org/doi/abs/10.1200/CCI.17.00149

The HOPE Pilot Study: Harnessing Patient-Reported ... This work was a pilot intervention with 10 patients with gynecologic cancers who received palliative chemotherapy. The HOPE (Helping Our ...

4. researchgate.net researchgate.net/publication/326075196_The_HOPE_Pilot_Study_Harnessing_Patient-Reported_Outcomes_and_Biometric_Data_to_Enhance_Cancer_Care

The HOPE Pilot Study: Harnessing Patient-Reported ... Patients and methods: This work was a pilot intervention with 10 patients with gynecologic cancers who received palliative chemotherapy. The ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30652585/

Harnessing Patient-Reported Outcomes and Biometric Data to ... ... effective in improving symptom management in patients with advanced gynecologic cancers ... Outcomes and Biometric Data to Enhance Cancer Care. JCO Clin Cancer ...

6. withpower.com withpower.com/trial/phase-3-2017-396c5

App and Fitbit for Gynecologic Cancers · Info for Participants This research study is evaluating a new smartphone application named the "Helping Our Patients Excel (HOPE)" app with a Fitbit device.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7688381/

The Use of Wearables in Clinical Trials During Cancer ... The purpose of this review is to explore the use of wearables in clinical trials during cancer treatment, with a special focus on adherence.

8. gynecologiconcology-online.net gynecologiconcology-online.net/article/S0090-8258(21)00093-7/abstract

Phase II trial evaluating efficacy of a Fitbit program for ... We aimed to evaluate the efficacy of a Fitbit program to improve physical activity in endometrial cancer survivors.

9. sciencedirect.com sciencedirect.com/science/article/pii/S1040842823000677

The association between wearable device metrics and ... We conducted a systematic review with best evidence synthesis to examine the association between WD metrics and clinical outcomes in patients with cancer.