Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Behaviors and Mental Disorders

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Quality of Life

Ovarian Cancer

Ovarian Epithelial Cancer

Participants will enroll with a teammate (i.e. family or friend) and collaborate together. Teams will set a daily step goal, receive daily feedback on whether they achieved their goal, and receive a social incentive intervention.

Fitness trackers (e.g. Fitbit) are accelerometers that are worn on the wrist and tracks users' heart rate continuously in addition to steps, distance, calories, and active minutes

Fitness Tracker

The Way to Health platform is an automated information technology platform that integrates wireless devices, clinical trial randomization and enrollment processes, messaging (text, e-mail or voice), self-administered surveys, automatic transfers of financial incentives, and secure data capture for research purposes.

Social Incentive (Way to Health)

Alexi A. Wright, MD, MPH

This research study will test whether using wearable fitness trackers with a social incentive, delivered through a game-based mobile health intervention, increases physical activity and quality of life in ovarian cancer survivors.

Nearly 50% of ovarian cancer survivors experience poor quality of life, fatigue, and anxiety after completing surgery and chemotherapy to treat their disease. Moreover, many ovarian cancer survivors become deconditioned during treatment; 40% report significant drops in activity during the year after diagnosis, and only 20% meet the recommended guidelines for physical activity.

Interventional exercise studies are urgently needed to determine whether increasing physical activity improves outcomes in ovarian cancer survivors. In other cancers, physical activity improves quality of life and mental health, while reducing the risk of cancer recurrence and death. To date, however, most studies have focused on patients with curable breast and prostate cancers. The effects of physical activity on understudied populations, including ovarian cancer survivors, are unknown. Furthermore, although ovarian cancer survivors report an interest in participating in home-based walking programs, few formal programs exist.

Stepping into Survivorship is a single-arm study designed to test the effectiveness of a wearable fitness tracker with a game-based mobile health intervention that leverages social support to increase physical activity in ovarian cancer survivors. At the start of the study all participants will track their daily step counts using a wearable fitness tracker (e.g. Fitbit) to determine how many steps they walk in an average day. Next, they will set an increased step-goal and receive daily, individualized feedback based upon their performance.

Participants will also choose a team partner (i.e. family or friend) to receive a wearable fitness tracker and together they will track their steps, earning non-financial micro-incentives (e.g. points, levels, badges) when they achieve their collaborative goals. This game-based mobile health intervention is designed to enhance collaboration, accountability, peer support, and ultimately physical activity among ovarian cancer survivors and their friends/family members.

This research is being done to improve participants' quality of life. The investigators hope that the use of wearable fitness trackers with a game-based mobile health intervention will help participants increase their physical activity and improve quality of life.

Stepping Into Survivorship: Harnessing Behavioral Economics to Improve Quality of Life in Ovarian Cancer

Feasibility will be defined as ≥60% of patients who participate in the pilot study complete the 24-week intervention

Study burden: To what extent do you agree or disagree with: "Participating in this study placed a substantial burden on me." (Options: strongly agree, agree, neutral, disagree, strongly disagree)

To what extent do you agree or disagree with the following statements: "Participating in this study motivated me to increase my activity levels." Response options: strongly disagree, disagree, neutral, agree, strongly agree.

To compare the change in daily steps from end of baseline to 12 weeks (after the end of baseline) to estimate outcome parameters for future study

To compare the change in daily steps from end of baseline to 24 weeks (after the end of baseline) to estimate outcome parameters for future study

National Cancer Institute (NCI)

Dana-Farber Cancer Institute

Prinicipal Investigator

Participants will enroll with a teammate (i.e. family or friend) and collaborate together. Teams will set a daily step goal, receive daily feedback on whether they achieved their goal, and receive a social incentive intervention.

Fitness Tracker: Fitness trackers (e.g. Fitbit) are accelerometers that are worn on the wrist and tracks users' heart rate continuously in addition to steps, distance, calories, and active minutes

Social Incentive (Way to Health): The Way to Health platform is an automated information technology platform that integrates wireless devices, clinical trial randomization and enrollment processes, messaging (text, e-mail or voice), self-administered surveys, automatic transfers of financial incentives, and secure data capture for research purposes.

Fitness Tracker + Social Incentive Intervention

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Marital status

FIGO Stages range from I through IV. Median overall survival is greatest in early stage disease (IC and II) and worse is stage III-IV.

Staging is determined using criteria such as the size of the tumor, if the cancer has spread to nearby lymph nodes, and if the cancer has spread to distant sites or organs.

International Federation of Gynecology and Obstetrics (FIGO) stage

Histology

Eastern Cooperative Oncology Group Performance Status

0: Fully active; no performance restrictions.

1. Strenuous physical activity restricted; fully ambulatory and able to carry out light work.
2. Capable of all self-care but unable to carry out any work activities. Up and about \>50% of waking hours.

ECOG of 0 are considered to have fewer restrictions in their activities compared with those with an ECOG 1 or 2

ECOG PS

Time from treatment completion to intervention enrollment, days

Baseline daily steps

Self-selected family member or friend to participate as support partner

Teammate

* Single-arm pilot study without a control group
* Participants were recruited from a single academic center, were required to have a smartphone, and needed to be able to identify a teammate. This may have resulted in the selection of a more affluent, educated, and socially-connected population than is representative of ovarian cancer survivors nationwide.
* We did not specifically measure other types of activity not captured by Fitbits (e.g., swimming or biking).

Spots Global Cancer Trial Database for social incentive (way to health)