SMART Study Intervention for Gynecologic Cancers

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Dana Farber Cancer Institute, Boston, MA
Gynecologic Cancers
SMART Study Intervention - Other
Eligibility
18+
Female
Eligible conditions
Select

Study Summary

This study is evaluating whether a new smartphone application and a Fitbit device can help improve quality of life for women with gynecologic cancers.

See full description

Treatment Effectiveness

Study Objectives

This trial is evaluating whether SMART Study Intervention will improve 5 primary outcomes and 11 secondary outcomes in patients with Gynecologic Cancers. Measurement will happen over the course of 3-months.

2 Years
Comparison of two wearable accelerometers (Fitbit Zip and Fitbit Charge HR) for use in pilot RCT.
2 years
Feasibility and acceptability of the HOPE app and the wearable accelerometers
3-months
SMART Enrollment and Adherence Rate
SMART Intervention Recommendation and Participant Burden
Month 6
Anxiety as assessed by GAD-7
Change from baseline in health-related quality of life (comparing patient-reported baseline and post-baseline EuroQoL EQ-5D).
Correlation between patient and physician estimates of performance status as assessed by ECOG-PS
Correlations between data collected from the HOPE app and the wearable accelerometers with additional clinical outcomes: PRO-CTCAE, CTCAE, and EQ-5D-5L
Depression as assessed by PHQ-9
Emotional acceptance of terminal illness as assessed by PEACE
Health care utilization (medical chart abstractions to capture number of ER visits, hospital/ICU admissions, palliative care visits, hospice referrals, chemotherapy treatments, change in chemotherapy treatments)
Participant evaluation of health as assessed by PEH
Patient symptoms (reported by patients) as assessed by PRO-CTCAE
Patient symptoms (reported by physicians) as assessed by CTCAE
Patient well-being as assessed by FACT-O
Treatment preferences and goals as assessed by qualitative survey

Trial Safety

Trial Design

5 Treatment Groups

Refined smartphone app (HOPE)
1 of 5
Refined smartphone app and accelerometer (HOPE)
1 of 5
SMART Study Arm
1 of 5
Wearable accelerometer (HOPE)
1 of 5
Comparing Steps Collected by Accelerometer (HOPE)
1 of 5
Experimental Treatment

This trial requires 140 total participants across 5 different treatment groups

This trial involves 5 different treatments. SMART Study Intervention is the primary treatment being studied. Participants will be divided into 5 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Refined smartphone app (HOPE)
Other
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
Refined smartphone app and accelerometer (HOPE)
Other
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
SMART Study Arm
Other
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.
Wearable accelerometer (HOPE)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
Comparing Steps Collected by Accelerometer (HOPE)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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fitbit Zip
2016
N/A
~40
Fitbit Charge 2
2019
N/A
~90

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 2 years for reporting.

Who is running the study

Principal Investigator
A. A. W.
Alexi A. Wright, MD
Dana-Farber Cancer Institute

Closest Location

Dana Farber Cancer Institute - Boston, MA

Eligibility Criteria

This trial is for female patients aged 18 and older. You must have received 1 prior treatment for Gynecologic Cancers. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Women ≥18 years of age
Who plan to receive chemotherapy at DFCI to treat recurrent, incurable gynecologic cancers (ovarian, uterine, cervical) that have recurred despite ≥1 prior treatments.
Own a smart-phone (Android or iOS)
Capable of downloading and running the study app without assistance
Can read and provide informed consent in English
Do not have cognitive or visual impairments that would preclude use of the app.

Patient Q&A Section

How many people get gynecologic cancers a year in the United States?

"Most cancers are rare--about 5000 in the US population a year. Oncologists use different levels of screening depending on their specialty and individual patient characteristics." - Anonymous Online Contributor

Unverified Answer

What is gynecologic cancers?

"Ovarian cancer affects more women than any other benign ovarian neoplasm. The most common form of ovarian cancer is serous carcinoma followed by endometrioid adenocarcinoma. Primary care physicians should be aware of the differential diagnosis of ovarian cancer." - Anonymous Online Contributor

Unverified Answer

What are common treatments for gynecologic cancers?

"The treatment regimens for gynecologic cancer vary according to the primary histology; uterine, ovarian, and cervical cancers are largely managed by surgery. Radiotherapy is typically used to treat pelvic lymph nodes, but can also be used after surgery, depending on the stage of the disease. Tissue engineered techniques are being studied. Treatment of breast cancer varies by tumor type; surgery and radiation therapy are used if the tumor is early. Treatments for vulvar and vaginal cancer have improved in recent years. Surgery is the treatment of choice for anal cancer. When prostate cancer is the focus of treatment it is treated by radiation therapy, surgery, and chemotherapy." - Anonymous Online Contributor

Unverified Answer

What are the signs of gynecologic cancers?

"Gynecologic cancers, particularly cervical cancer, are relatively fast-growing cancers, resulting in high prevalence and great morbidity and mortality. In order to get this cancer diagnosed at an early stage before it becomes metastatic and inoperable, it is critical to have specific clinical findings and to be aware of symptoms that are seen in the early stages of this disease, especially for ovarian cancer and cervical cancer." - Anonymous Online Contributor

Unverified Answer

Can gynecologic cancers be cured?

"Despite advances in surgical treatment over the last 40 years, the disease remains a progressive and difficult incurable disease for many patients. Despite this fact, the disease can be cured in the sense of prolonged survival." - Anonymous Online Contributor

Unverified Answer

What causes gynecologic cancers?

"It appears that in the United States, the incidence of both endometrial and cervical cancers is increasing, and there is a correlation between the two, especially among the nulliparous women. However, at least two factors may be involved in this process. The first relates to the nulliparous woman and exposure to risk factors such as tobacco, alcohol, and a diet high in fat, protein, and/or sugar and also to the hormonal environment. The second relates to the incidence of premalignant lesions in the endometrium. When the incidence of such lesions in the endometrium in nulliparous women is plotted against the age of the woman, a gradual increase is seen as women become older." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating gynecologic cancers?

"While overall, there are no new clinically approved Gynecologic Oncology Drugs (excluding hormonal therapy) and no new onco-genetics, there have been significant advances in the understanding of how these cancers interact (in an epigenetic fashion) with the [stroma surrounding them. These stromal components may be therapeutically exploited, which would represent a vast improvement." - Anonymous Online Contributor

Unverified Answer

What is the latest research for gynecologic cancers?

"The advancement of research from clinical trials is fast. This enables patients to be better educated and better treated. As the quality of research continues to improve, so will advancements in research for gynecologic cancers. It is critical that patients are informed by the information and treatment that is available to pursue their healthcare." - Anonymous Online Contributor

Unverified Answer

Has smart study intervention proven to be more effective than a placebo?

"For this study, it was difficult to assess whether the group receiving the smart intervention had a better survival rate than the group receiving the placebo." - Anonymous Online Contributor

Unverified Answer

How serious can gynecologic cancers be?

"The outcomes of gynecologic cancer surgery are poor. There are important ramifications of the disparity in outcomes depending on geographic location. Patients who live in rural areas who undergo major surgery for gynecologic cancer may experience significant morbidity and mortality. Strategies to expand access to adequate care and to improve outcomes for patients undergoing surgery for gynecologic cancer are needed." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in smart study intervention for therapeutic use?

"Smart study intervention is a strategy aiming to improve the quality of medical education. By changing the ways students participate in an intervention from passive observers to active actors, it is possible to increase their perceived relevance. Therefore, the quality of interventions for clinical practice would be [improved]. Students are [very] critical on their clinical reasoning on all levels. Findings from a recent study indicate that they would prefer to be more trained as smart study intervention teaches about the importance of [improving your clinical reasoning and reasoning skills, in order to be better physicians, nurses and health care specialists]." - Anonymous Online Contributor

Unverified Answer

Does gynecologic cancers run in families?

"A clear family history exists in patients diagnosed with gynecologic cancers. However, if family history is present, it is less significant than in other types of cancers." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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