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

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



Sponsors


Source

Dana-Farber Cancer Institute

Oversight Info

Has Dmc

Yes

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


Brief Summary

This research study will test whether using wearable fitness trackers with or without a
social incentive, delivered through a game-based mobile health intervention, increases
physical activity and quality of life in ovarian cancer survivors.

Detailed Description

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.

Randomized trials of interventions 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 randomized clinical trial designed to test the effectiveness
of wearable fitness trackers with or without 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 randomized to the game-based intervention 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 or without a game-based mobile health
intervention will help participants increase their physical activity and improve quality of
life.

Overall Status

Not yet recruiting

Start Date

2018-01-01

Completion Date

2021-12-01

Primary Completion Date

2020-12-01

Phase

N/A

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Feasibility of the accelerometer + social support + gamification
1 year pilot
To compare the change in daily steps baseline to the 14-week intervention period by study arm
14 weeks

Secondary Outcome

Measure

Time Frame

To compare the change in daily steps from baseline to 26 weeks by study arm
26 weeks
Compare the change in quality of life (EuroQol EQ-5D index) by study arm
26 weeks
Compare the change in mental health outcomes (HADS) by study arm
26 weeks
Compare health care utilization (number of emergency department visits and hospitalizations) by study arm
26 weeks

Enrollment

148

Condition


Intervention

Intervention Type

Other

Intervention Name


Description

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

Arm Group Label

Fitness Tracker + Social Incentive Intervention

Fitness Tracker



Intervention Type

Other

Intervention Name


Description

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.

Arm Group Label

Fitness Tracker + Social Incentive Intervention



Eligibility

Criteria

Inclusion Criteria:

- Patients will be eligible if they have newly diagnosed ovarian cancer

- Are ≤3 months of completing chemotherapy

- Read English

- Do not have cognitive or visual impairments that would preclude participation

Exclusion Criteria:

- Participants will be excluded if they are already participating in an mHealth
intervention

- Are unable to ambulate

- Do not have a smartphone to transmit data from the wearable tracker

Gender

Female

Minimum Age

18 Years

Maximum Age

N/A

Healthy Volunteers

Accepts Healthy Volunteers


Overall Official

Last Name

Role

Affiliation

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

Overall Contact

Last Name

Nikita Raman

Phone

617-632-5747

Email



Location

Facility

Status

Contact

Investigator

Dana Farber Cancer Institute
Boston Massachusetts 02115 United States
Not yet recruiting
Last Name: Nikita Raman
Phone: 617-632-5747
Email: [email protected]
Last Name: Alexi A. Wright, MD MPH
Role: Principal Investigator

Location Countries

Country

United States


Verification Date

2017-12-01

Lastchanged Date

2017-12-05

Firstreceived Date

2017-10-17

Responsible Party

Responsible Party Type

Principal Investigator

Investigator Affiliation

Dana-Farber Cancer Institute

Investigator Full Name

Alexi A. Wright

Investigator Title

Prinicipal Investigator


Keywords


Has Expanded Access

No

Condition Browse


Secondary Id

CA166210

Number Of Arms

2

Arm Group

Arm Group Label

Fitness Tracker + Social Incentive Intervention

Arm Group Type

Experimental

Description

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.


Arm Group Label

Fitness Tracker

Arm Group Type

Active Comparator

Description

Participants will set a daily step goal and receive daily feedback on whether she achieved the goal or not. They will participate individually and will not receive the social incentive intervention.



Firstreceived Results Date

N/A

Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary Purpose

Supportive Care

Masking

None (Open Label)


Study First Submitted

October 17, 2017

Study First Submitted Qc

December 5, 2017

Study First Posted

December 6, 2017

Last Update Submitted

December 5, 2017

Last Update Submitted Qc

December 5, 2017

Last Update Posted

December 6, 2017


ClinicalTrials.gov processed this data on December 06, 2017

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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