Ovarian Cancer
Conditions
Keywords
Ovarian Cancer, Physical Activity, Mobile Health, Fitness Tracker, Survivorship, Quality of Life
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.
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. 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.
Interventions
OTHERFitness 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
OTHERSocial 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.
Sponsors
National Cancer Institute (NCI)
Dana-Farber Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the Accelerometer + Social Support + Gamification | 1 year pilot | Feasibility will be defined as ≥60% of patients who participate in the pilot study complete the 24-week intervention |
| Acceptability | 24 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) |
| Perceived Effectiveness | 24 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Daily Steps From Baseline to 12 Weeks | 12 weeks [from end of baseline (day 15) to day 98] | 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 |
| Change in Daily Steps From Baseline 24 Weeks | 24 weeks [from end to baseline (day 15) to day 182] | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 24 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Injury unrelated to study | 3 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Fitness Tracker + Social Incentive Intervention |
|---|---|
| Age, Continuous | 63 years |
| Baseline daily steps | 6210 steps STANDARD_DEVIATION 3328 |
| ECOG PS 0 | 5 Participants |
| ECOG PS 1 | 15 Participants |
| ECOG PS 2 | 4 Participants |
| Histology Carcinosarcoma | 1 Participants |
| Histology Clear cell | 1 Participants |
| Histology Endometrioid | 3 Participants |
| Histology Serous | 19 Participants |
| International Federation of Gynecology and Obstetrics (FIGO) stage IC | 5 Participants |
| International Federation of Gynecology and Obstetrics (FIGO) stage II | 1 Participants |
| International Federation of Gynecology and Obstetrics (FIGO) stage III | 1 Participants |
| International Federation of Gynecology and Obstetrics (FIGO) stage IIIB | 3 Participants |
| International Federation of Gynecology and Obstetrics (FIGO) stage IIIC | 6 Participants |
| International Federation of Gynecology and Obstetrics (FIGO) stage IVA | 3 Participants |
| International Federation of Gynecology and Obstetrics (FIGO) stage IVB | 5 Participants |
| Marital status Married, partnered | 18 Participants |
| Marital status Single | 4 Participants |
| Marital status Widowed, separated | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 23 Participants |
| Region of Enrollment United States | 24 participants |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 0 Participants |
| Teammate Child | 2 Participants |
| Teammate Other | 4 Participants |
| Teammate Parent | 3 Participants |
| Teammate Sibling | 4 Participants |
| Teammate Spouse, partner | 11 Participants |
| Time from treatment completion to intervention enrollment, days | 45 days STANDARD_DEVIATION 35 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 29 |
| other Total, other adverse events | 0 / 29 |
| serious Total, serious adverse events | 0 / 29 |
Outcome results
Primary
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fitness Tracker + Social Incentive Intervention | Acceptability | Participants indicate that the study was burdensome | 1 Participants |
| Fitness Tracker + Social Incentive Intervention | Acceptability | Participants did not indicate that the study was burdensome | 23 Participants |
Primary
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
Population: Participants who initially consented to the study
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fitness Tracker + Social Incentive Intervention | Feasibility of the Accelerometer + Social Support + Gamification | Completed intervention and follow-up period | 24 Participants |
| Fitness Tracker + Social Incentive Intervention | Feasibility of the Accelerometer + Social Support + Gamification | Did not complete intervention and follow-up period | 5 Participants |
Primary
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fitness Tracker + Social Incentive Intervention | Perceived Effectiveness | strongly agree or agree | 21 Participants |
| Fitness Tracker + Social Incentive Intervention | Perceived Effectiveness | strongly disagree, disagree, or neutral | 3 Participants |
Secondary
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]
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fitness Tracker + Social Incentive Intervention | Change in Daily Steps From Baseline 24 Weeks | Baseline (Day 1-15) | 6210.7 steps | Standard Deviation 3328.1 |
| Fitness Tracker + Social Incentive Intervention | Change in Daily Steps From Baseline 24 Weeks | Follow-up (Day 98-182) | 6435.1 steps | Standard Deviation 3550.6 |
Secondary
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]
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fitness Tracker + Social Incentive Intervention | Change in Daily Steps From Baseline to 12 Weeks | Baseline (Day 1-14) | 6210.7 steps | Standard Deviation 3328.1 |
| Fitness Tracker + Social Incentive Intervention | Change in Daily Steps From Baseline to 12 Weeks | Intervention (Day 15-98) | 7643.0 steps | Standard Deviation 3610.9 |