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Trial record 32 of 600 for:    Recruiting, Not yet recruiting, Available Studies | Ovarian cancer

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

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ClinicalTrials.gov Identifier: NCT03364673
Recruitment Status : Recruiting
First Posted : December 6, 2017
Last Update Posted : February 28, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alexi A. Wright, Dana-Farber Cancer Institute

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Other: Fitness Tracker Other: Social Incentive (Way to Health) Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Stepping Into Survivorship: Harnessing Behavioral Economics to Improve Quality of Life in Ovarian Cancer
Actual Study Start Date : July 20, 2018
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arm Intervention/treatment
Experimental: Fitness Tracker + Social Incentive Intervention
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.
Other: 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

Other: 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.




Primary Outcome Measures :
  1. Feasibility of the accelerometer + social support + gamification [ Time Frame: 1 year pilot ]
    ≥60% of patients who participate in the pilot study complete the 26-week intervention

  2. Acceptability [ Time Frame: 26 weeks ]
    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)


Secondary Outcome Measures :
  1. To compare the change in daily steps from baseline to 14 weeks to estimate outcome parameters for future study [ Time Frame: 14 weeks ]
  2. To compare the change in daily steps from baseline 26 weeks to estimate outcome parameters for future study [ Time Frame: 26 weeks ]
  3. Perceived effectiveness [ Time Frame: 26 weeks ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients will be eligible if they have newly diagnosed ovarian cancer
  • Are ≤6 months of completing chemotherapy
  • Read English
  • Do not have cognitive, visual, or orthopedic impairments that would preclude participation
  • Plan to continue treatment at Dana-Farber Cancer Institute

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03364673


Contacts
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Contact: Embree Thompson 617-632-5747 embreem_thompson@dfci.harvard.edu

Locations
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United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Elizabeth Schrier    617-582-7396    elizabeth_schrier@dfci.harvard.edu   
Principal Investigator: Alexi A. Wright, MD MPH         
Sponsors and Collaborators
Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Alexi A. Wright, MD MPH Dana-Farber Cancer Institute

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Responsible Party: Alexi A. Wright, Prinicipal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT03364673     History of Changes
Other Study ID Numbers: 17-361
CA166210 ( Other Grant/Funding Number: NIH/NCI )
First Posted: December 6, 2017    Key Record Dates
Last Update Posted: February 28, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alexi A. Wright, Dana-Farber Cancer Institute:
Ovarian Cancer
Physical Activity
Mobile Health
Fitness Tracker
Survivorship
Quality of Life
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders
Carcinoma