An interventional study of Fitness Tracker and Social Incentive (Way to Health) in Ovarian Cancer, sponsored by Dana-Farber Cancer Institute. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-13.
Sponsored by Dana-Farber Cancer Institute · Not applicable, Interventional, and Supportive care
Among 36 studies in Ovarian Neoplasms by Dana-Farber Cancer Institute — 6 open to participants now, 8 under way, none of them phase 3. Ovarian Neoplasms · Dana-Farber Cancer Institute.
Among the 36 studies in Ovarian Neoplasms by Dana-Farber Cancer Institute, this one is the 19th largest by enrollment of the 35 interventional ones that give a count, is one of 4 that started in 2018, is one of 13 with no phase, and was the 23rd registered.
3,381 studies on the registry are indexed under Ovarian Neoplasms; 790 are open to participants now.
Browse Ovarian Neoplasms studies →6 of the 36 studies in Ovarian Neoplasms by Dana-Farber Cancer Institute are open now, in 1 country. Recruiting first, the newest first:
Dana-Farber Cancer Institute · Sites in United States
Ages 18+ · Women only
Dana-Farber Cancer Institute · Sites in United States
Ages 18+ · Women only
Dana-Farber Cancer Institute · Sites in United States
Ages 18+ · Women only
Dana-Farber Cancer Institute · Sites in United States
Ages 18–85
Dana-Farber Cancer Institute · Sites in United States
Ages 18+ · Women only
By country, each count listing its studies:
Of the 606 Ovarian Neoplasms studies recruiting now, 443 (73%) set no upper age limit and 107 (18%) stop at 75 or younger; 39 take children under 18; 45 take healthy volunteers.
This study: 18 Years and older · female · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
36 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 8 · Phase 2 15
First in 1998; this study’s year is marked. 4 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 29 is below the median of 54 across 2,548 interventional studies indexed under Ovarian Neoplasms.
Median enrollment 30 across the 35 interventional studies, 16 across the 1 observational. Of the 26 that completed or were terminated, 14 (54%) have results posted.
This tab as a report to print or save as PDF → With an account.
Dana-Farber Cancer Institute is the lead sponsor of 834 studies on the registry; 122 are open to participants now.
Of its 114 completed or terminated interventional studies of FDA-regulated products, 78 (68%) have results posted.
3 of the studies in Ovarian Neoplasms by Dana-Farber Cancer Institute that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06321484Dana-Farber Cancer InstituteIntraperitoneal Cytokine-Induced Memory Like (CIML) Natural Killer (NK) Cells in Recurrent Ovarian Cancer | 2026-11-30 |
| NCT06677190Dana-Farber Cancer InstituteBelzutifan in Recurrent Clear Cell Carcinoma of Gynecologic Origin | 2026-12-30 |
| NCT06543537Dana-Farber Cancer InstitutePilot Randomized Controlled Trial of a Collaborative Agenda-setting Intervention (CASI) for Patients With Ovarian Cancer | 2026-12-31 |
Among the 36 studies in Ovarian Neoplasms by Dana-Farber Cancer Institute, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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 · Other: Social Incentive (Way to Health)
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
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.
Feasibility of the Accelerometer + Social Support + Gamification
Feasibility will be defined as ≥60% of patients who participate in the pilot study complete the 24-week intervention
Time frame: 1 year pilot
Acceptability
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)
Time frame: 24 weeks
Perceived Effectiveness
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.
Time frame: 24 weeks
Change in Daily Steps From Baseline to 12 Weeks
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
Time frame: 12 weeks [from end of baseline (day 15) to day 98]
Change in Daily Steps From Baseline 24 Weeks
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
Time frame: 24 weeks [from end to baseline (day 15) to day 182]
| Milestone | Fitness Tracker + Social Incentive Intervention |
|---|---|
| Started | 29 |
| Completed | 24 |
| Not completed | 5 |
| Withdrew: Withdrawal by subject | 2 |
| Withdrew: Injury unrelated to study | 3 |
Feasibility will be defined as ≥60% of patients who participate in the pilot study complete the 24-week intervention
| Participants | Fitness Tracker + Social Incentive Intervention |
|---|---|
| Completed intervention and follow-up period | 24 |
| Did not complete intervention and follow-up period | 5 |
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)
| Participants | Fitness Tracker + Social Incentive Intervention |
|---|---|
| Participants indicate that the study was burdensome | 1 |
| Participants did not indicate that the study was burdensome | 23 |
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.
| Participants | Fitness Tracker + Social Incentive Intervention |
|---|---|
| "strongly agree" or "agree" | 21 |
| "strongly disagree", "disagree", or "neutral" | 3 |
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
| steps | Fitness Tracker + Social Incentive Intervention |
|---|---|
| Baseline (Day 1-14) | 6210.7 ± 3328.1 |
| Intervention (Day 15-98) | 7643.0 ± 3610.9 |
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
| steps | Fitness Tracker + Social Incentive Intervention |
|---|---|
| Baseline (Day 1-15) | 6210.7 ± 3328.1 |
| Follow-up (Day 98-182) | 6435.1 ± 3550.6 |
Collected over Adverse events were collected on an ongoing basis throughout the course of the study, Day 1-182.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fitness Tracker + Social Incentive Intervention | 0/29 (0%) | 0/29 (0%) | 0/29 (0%) |
| Age, Continuous(years) | Fitness Tracker + Social Incentive Intervention |
|---|---|
| Mean | 63 (37 to 79) |
| Sex: Female, Male(Participants) | Fitness Tracker + Social Incentive Intervention |
|---|---|
| Female | 24 |
| Male | 0 |
| Race (NIH/OMB)(Participants) | Fitness Tracker + Social Incentive Intervention |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 23 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Fitness Tracker + Social Incentive Intervention |
|---|---|
| United States | 24 |
| Marital status(Participants) | Fitness Tracker + Social Incentive Intervention |
|---|---|
| Married, partnered | 18 |
| Single | 4 |
| Widowed, separated | 2 |
| International Federation of Gynecology and Obstetrics (FIGO) stage(Participants) | Fitness Tracker + Social Incentive Intervention |
|---|---|
| IC | 5 |
| II | 1 |
| III | 1 |
| IIIB | 3 |
| IIIC | 6 |
| IVA | 3 |
| IVB | 5 |
| Histology(Participants) | Fitness Tracker + Social Incentive Intervention |
|---|---|
| Serous | 19 |
| Endometrioid | 3 |
| Carcinosarcoma | 1 |
| Clear cell | 1 |
| ECOG PS(Participants) | Fitness Tracker + Social Incentive Intervention |
|---|---|
| 0 | 5 |
| 1 | 15 |
| 2 | 4 |
3 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jul 2018 to primary completion in Oct 2019, 15 months.
Results were first posted in Sep 2021, 1 year 10 months after primary completion.
Of 282 non-industry interventional studies with no phase under Ovarian Neoplasms, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 76. This study's 15 months is below that.
Counting every sponsor, half of 293 studies reached it within 46 months; a quarter within 23 and three quarters within 76.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Dana-Farber Cancer Institute →