NCT03022032 is a NA clinical trial of Fitbit Zip in Gynecologic Cancer, sponsored by Dana-Farber Cancer Institute.

Who is sponsoring NCT03022032?

NCT03022032 is sponsored by Dana-Farber Cancer Institute.

What drugs are being tested in NCT03022032?

Interventions in NCT03022032: Fitbit Zip, HOPE App, Standard of Care, Fitbit Charge 2, SMART Study Intervention.

What condition does NCT03022032 study?

NCT03022032 studies Gynecologic Cancer.

Is NCT03022032 still recruiting?

NCT03022032 is currently completed. Last updated 9 September 2025.

Are results published for NCT03022032?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-09-09 · How we verify

NCT03022032

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

The HOPE Trial and the SMART Study

Completed NA Results posted Last updated 9 September 2025

What this trial tests

NA trial testing Fitbit Zip in Gynecologic Cancer in 102 participants. Completed in 2 September 2020.

Timeline

12 April 2017

Primary endpoint
2 September 2020

2 September 2020

Quick facts

Lead sponsor	Dana-Farber Cancer Institute
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	102
Start date	12 April 2017
Primary completion	2 September 2020
Estimated completion	2 September 2020
Sites	1 location across United States

Drugs / interventions tested

Fitbit Zip
HOPE App
Standard of Care
Fitbit Charge 2
SMART Study Intervention

Conditions studied

Gynecologic Cancer — all drugs for Gynecologic Cancer →

Sponsor

Dana-Farber Cancer Institute

Who can join

18 and older, female only, with Gynecologic Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Feasibility (≥60% Enrollment Rate of Eligible Patients; ≥70% Survey Adherence; ≥80% FitBit Adherence) and Acceptability (≥60% Would Recommend the Intervention; <30% Rate the Study as Burdensome/Wish They Had Not Participated) in HOPE Pre-Pilot (n=10) Primary · 30 days

This outcome was limited to the HOPE pre-pilot, consisting of 10 patients. This open pilot aimed to identify patient preference of Fitbit Zip or Fitbit Charge 2 and whether this study was burdensome. This outcome informed appropriate study procedures before launching to a larger study with four arms across multiple sites. Feasibility defined as (1) greater than or equal to 60% enrollment rate among eligible patients approached, (2) greater than or equal to 70% adherence to daily smartphone surveys, (3) greater than or equal to 80% adherence to Fitbits at least 4 days per week. Acceptability d

Feasibility - (1) greater than or equal to 60% enrollment rate among eligible patients approached

Group	Value	95% CI
HOPE Pre-pilot	10

Feasibility - (2) greater than or equal to 70% adherence to daily smartphone surveys

Group	Value	95% CI
HOPE Pre-pilot	7

Feasibility - (3) greater than or equal to 80% adherence to Fitbits at least 4 days per week

Group	Value	95% CI
HOPE Pre-pilot	9

Acceptability - (1) "Participating in this study placed a substantial burden on me."

Group	Value	95% CI
HOPE Pre-pilot	1

Acceptability - (2) "I wish I had not agreed to participate in this study."

Group	Value	95% CI
HOPE Pre-pilot	1

Number of Participants Who Preferred the FitBit Zip vs. Number of Participants Who Preferred the FitBit Charge HR in the HOPE Pre-Pilot Study (n=10) Primary · 30 days

This outcome was limited to the HOPE Pre-pilot, consisting of 10 patients. This open pilot aimed to identify patient preference of Fitbit Zip or Fitbit Charge 2 and whether this study was burdensome. This outcome informed appropriate study procedures before launching to a larger study with four arms across multiple sites. This outcome is participant preference of the Fitbit Zip vs. Fitbit Charge in the HOPE Pre-Pilot study.

Preferred FitBit Charge

Group	Value	95% CI
HOPE Pre-pilot	9

Preferred FitBit Zip

Group	Value	95% CI
HOPE Pre-pilot	1

Feasibility (i.e. ≥50% 3-month Adherence Rates to Both Smartphone Apps and the Wearable Accelerometer) in the SMART Study Primary · 90 days

SMART Study: Participants received the Fitbit Charge 2 and access to the smartphone app. The app presented tailored advice if one or more low-risk symptoms were reported and prompted the patient to call their clinician for high-risk symptoms. Feasibility will be defined as greater than or equal to 50% 3-month adherence rates to both smartphone apps and the wearable accelerometer.

Group	Value	95% CI
SMART Study	4

Acceptability (i.e. ≥60% of Study Participants Would Recommend the Intervention to Other Patients; and <30% of Patients Rate the Study as Burdensome or Wish They Had Not Participated) in the SMART Study Primary · 90 days

SMART Study: Participants received the Fitbit Charge 2 and access to the smartphone app. The app presented tailored advice if one or more low-risk symptoms were reported and prompted the patient to call their clinician for high-risk symptoms. Acceptability defined as responses to three questions: (1) "Participating in this study placed a substantial burden on me."; (2) "I wish I had not agreed to participate in this study."; and (3) "I would recommend the application to a friend going through treatment."

Acceptability - (1) "Participating in this study placed a substantial burden on me."

Group	Value	95% CI
SMART Study	0

Acceptability - (2) "I wish I had not agreed to participate in this study."

Group	Value	95% CI
SMART Study	0

Acceptability - (3) "I would recommend the application to a friend going through treatment."

Group	Value	95% CI
SMART Study	4

Anxiety as Assessed by GAD-7 (HOPE RCT) Secondary · Baseline, 30 days, 90 days, 180 days (Phase II)

Patients' GAD-7 measurements taken at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. \[The General Anxiety Disorder-7 (GAD-7) total score has a minimum value of 0 and a maximum value of 21, with higher values corresponding to worse outcome.}

Baseline

Group	Value	95% CI
Arm 1: Fitbit + Active App	3.43	± 2.98
Arm 2: Fitbit+Passive App	3.74	± 4.19
Arm 3: Active App	5.45	± 4.82
Arm 4: Passive App	4.10	± 3.43

30 days post-baseline

Group	Value	95% CI
Arm 1: Fitbit + Active App	3.17	± 3.24
Arm 2: Fitbit+Passive App	5.09	± 4.46
Arm 3: Active App	2.64	± 2.54
Arm 4: Passive App	4.00	± 2.24

90 days post-baseline

Group	Value	95% CI
Arm 1: Fitbit + Active App	3.50	± 3.55
Arm 2: Fitbit+Passive App	3.38	± 4.03
Arm 3: Active App	2.92	± 2.47
Arm 4: Passive App	3.07	± 2.13

180 days post-baseline

Group	Value	95% CI
Arm 1: Fitbit + Active App	0.78	± 0.97
Arm 2: Fitbit+Passive App	3.78	± 4.09
Arm 3: Active App	3.00	± 2.26
Arm 4: Passive App	3.22	± 2.82

Depression as Assessed by PHQ-9 (HOPE RCT) Secondary · Baseline, 30 days, 90 days, 180 days (Phase II)

Patients' PHQ-9 measurements taken at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {The Patient Health Questionnaire (PHQ-9) total score has a minimum value of 0 and a maximum value of 27, with higher values corresponding to worse outcome.}

Baseline

Group	Value	95% CI
Arm 1: Fitbit + Active App	4.43	± 3.73
Arm 2: Fitbit + Passive App	3.70	± 3.48
Arm 3: Active App	4.95	± 3.61
Arm 4: Passive App	5.59	± 4.62

30 days post-baseline

Group	Value	95% CI
Arm 1: Fitbit + Active App	3.20	± 4.18
Arm 2: Fitbit + Passive App	4.58	± 4.46
Arm 3: Active App	3.27	± 2.90
Arm 4: Passive App	4.80	± 3.38

90 days post-baseline

Group	Value	95% CI
Arm 1: Fitbit + Active App	5.90	± 4.95
Arm 2: Fitbit + Passive App	4.58	± 5.04
Arm 3: Active App	3.46	± 3.26
Arm 4: Passive App	3.87	± 1.96

180 days post-baseline

Group	Value	95% CI
Arm 1: Fitbit + Active App	1.22	± 1.39
Arm 2: Fitbit + Passive App	3.56	± 4.00
Arm 3: Active App	3.42	± 2.43
Arm 4: Passive App	5.09	± 2.98

Patient Well-being as Assessed by FACIT-Pal (HOPE RCT) Secondary · Baseline, 30 days, 90 days, 180 days (Phase II)

Patients' FACIT-Pal measurements taken at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {The Functional Assessment of Chronic Illness Therapy - Palliative Care (FACIT-Pal) total score has a minimum value of 0 and a maximum value of 184, with higher values corresponding to better outcome.}

Baseline

Group	Value	95% CI
Arm 1: Fitbit + Active App	142.1	± 24.3
Arm 2: Fitbit + Passive App	147.0	± 23.2
Arm 3: Active App	139.7	± 22.4
Arm 4: Passive App	139.4	± 21.1

30 days post-baseline

Group	Value	95% CI
Arm 1: Fitbit + Active App	150.7	± 22.0
Arm 2: Fitbit + Passive App	145.7	± 26.4
Arm 3: Active App	147.4	± 19.6
Arm 4: Passive App	145.6	± 18.7

90 days post-baseline

Group	Value	95% CI
Arm 1: Fitbit + Active App	132.3	± 27.2
Arm 2: Fitbit + Passive App	143.8	± 34.3
Arm 3: Active App	150.9	± 20.1
Arm 4: Passive App	141.0	± 18.4

180 days post-baseline

Group	Value	95% CI
Arm 1: Fitbit + Active App	161.4	± 15.6
Arm 2: Fitbit + Passive App	155.2	± 22.8
Arm 3: Active App	144.1	± 17.7
Arm 4: Passive App	140.4	± 23.6

Constipation as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Secondary · Baseline, 30 days, 90 days, 180 days (Phase II)

Participants reporting Grade 1-3 constipation at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.}

Baseline

Group	Value	95% CI
Arm 1: Fitbit + Active App	10
Arm 2: Fitbit + Passive App	6
Arm 3: Active App	10
Arm 4: Passive App	11

30 days post-baseline

Group	Value	95% CI
Arm 1: Fitbit + Active App	5
Arm 2: Fitbit + Passive App	2
Arm 3: Active App	5
Arm 4: Passive App	8

90 days post-baseline

Group	Value	95% CI
Arm 1: Fitbit + Active App	2
Arm 2: Fitbit + Passive App	6
Arm 3: Active App	5
Arm 4: Passive App	8

180 days post-baseline

Group	Value	95% CI
Arm 1: Fitbit + Active App	4
Arm 2: Fitbit + Passive App	6
Arm 3: Active App	8
Arm 4: Passive App	7

Diarrhea as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Secondary · Baseline, 30 days, 90 days, 180 days (Phase II)

Participants reporting Grade 1-3 diarrhea at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.}

Baseline

Group	Value	95% CI
Arm 1: Fitbit + Active App	10
Arm 2: Fitbit + Passive App	8
Arm 3: Active App	7
Arm 4: Passive App	11

30 days post-baseline

Group	Value	95% CI
Arm 1: Fitbit + Active App	5
Arm 2: Fitbit + Passive App	3
Arm 3: Active App	4
Arm 4: Passive App	5

90 days post-baseline

Group	Value	95% CI
Arm 1: Fitbit + Active App	5
Arm 2: Fitbit + Passive App	5
Arm 3: Active App	4
Arm 4: Passive App	9

180 days post-baseline

Group	Value	95% CI
Arm 1: Fitbit + Active App	0
Arm 2: Fitbit + Passive App	2
Arm 3: Active App	2
Arm 4: Passive App	4

Nausea as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Secondary · Baseline, 30 days, 90 days, 180 days (Phase II)

Participants reporting Grade 1-3 nausea at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.}

Baseline

Group	Value	95% CI
Arm 1: Fitbit + Active App	12
Arm 2: Fitbit + Passive App	7
Arm 3: Active App	11
Arm 4: Passive App	12

30 days post-baseline

Group	Value	95% CI
Arm 1: Fitbit + Active App	7
Arm 2: Fitbit + Passive App	4
Arm 3: Active App	5
Arm 4: Passive App	7

90 days post-baseline

Group	Value	95% CI
Arm 1: Fitbit + Active App	7
Arm 2: Fitbit + Passive App	1
Arm 3: Active App	6
Arm 4: Passive App	11

180 days post-baseline

Group	Value	95% CI
Arm 1: Fitbit + Active App	2
Arm 2: Fitbit + Passive App	1
Arm 3: Active App	5
Arm 4: Passive App	8

Vomiting as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Secondary · Baseline, 30 days, 90 days, 180 days (Phase II)

Participants reporting Grade 1-3 vomiting at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.}

Baseline

Group	Value	95% CI
Arm 1: Fitbit + Active App	2
Arm 2: Fitbit + Passive App	1
Arm 3: Active App	4
Arm 4: Passive App	5

30 days post-baseline

Group	Value	95% CI
Arm 1: Fitbit + Active App	2
Arm 2: Fitbit + Passive App	0
Arm 3: Active App	2
Arm 4: Passive App	1

90 days post-baseline

Group	Value	95% CI
Arm 1: Fitbit + Active App	3
Arm 2: Fitbit + Passive App	0
Arm 3: Active App	1
Arm 4: Passive App	1

180 days post-baseline

Group	Value	95% CI
Arm 1: Fitbit + Active App	1
Arm 2: Fitbit + Passive App	1
Arm 3: Active App	3
Arm 4: Passive App	3

Numbness and Tingling as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Secondary · Baseline, 30 days, 90 days, 180 days (Phase II)

Participants reporting Grade 1-3 numbness and tingling at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.}

Baseline

Group	Value	95% CI
Arm 1: Fitbit + Active App	10
Arm 2: Fitbit + Passive App	14
Arm 3: Active App	11
Arm 4: Passive App	15

30 days post-baseline

Group	Value	95% CI
Arm 1: Fitbit + Active App	8
Arm 2: Fitbit + Passive App	10
Arm 3: Active App	4
Arm 4: Passive App	11

90 days post-baseline

Group	Value	95% CI
Arm 1: Fitbit + Active App	6
Arm 2: Fitbit + Passive App	7
Arm 3: Active App	7
Arm 4: Passive App	11

180 days post-baseline

Group	Value	95% CI
Arm 1: Fitbit + Active App	5
Arm 2: Fitbit + Passive App	7
Arm 3: Active App	4
Arm 4: Passive App	5

Adverse events — posted to ClinicalTrials.gov

Time frame: HOPE Pre-Pilot: 30 days; HOPE RCT (4 arms): 180 days; SMART: 90 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

HOPE Pre-Pilot

Serious: 0/10 (0%)

Deaths: 0/10

Refined Smartphone App and Accelerometer (HOPE)

Serious: 0/23 (0%)

Deaths: 0/23

Wearable Accelerometer (HOPE)

Serious: 0/21 (0%)

Deaths: 0/21

Refined Smartphone App (HOPE)

Serious: 0/22 (0%)

Deaths: 0/22

Usual Care (HOPE)

Serious: 0/22 (0%)

Deaths: 2/22

SMART Study Arm

Serious: 0/4 (0%)

Deaths: 0/4

Other adverse events (10 terms — click to expand)

Reaction	System	HOPE Pre-Pilot	Refined Smartphone App and…	Wearable Accelerometer (HO…	Refined Smartphone App (HO…	Usual Care (HOPE)	SMART Study Arm
Fatigue	Nervous system disorders	—	—	—	—	—	—
Anxiety	Nervous system disorders	—	—	—	—	—	—
Neuropathy	Nervous system disorders	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—
Depression	Nervous system disorders	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—
Diarrhea	Gastrointestinal disorders	—	—	—	—	—	—
Vomit	Gastrointestinal disorders	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—

Data from ClinicalTrials.gov NCT03022032 adverse events section.

Sponsor's own description

This research study is evaluating a new smartphone application named the "Helping Our Patients Excel (HOPE)" app with a Fitbit device. The SMART Study is a sub-study of the HOPE Trial. Both studies evaluate an almost identical intervention using a Fitbit device and smartphone app(s) with the goal of improving quality-of-life for women with gynecologic cancers.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

The HOPE Pilot Study: Harnessing Patient-Reported Outcomes and Biometric Data to Enhance Cancer Care.
Wright AA, Raman N, Staples P, Schonholz S, et al · · 2018 · cited 68× · PMID 30652585 · DOI 10.1200/cci.17.00149

Verify or expand the search:

Other recruiting trials for Gynecologic Cancer

Currently open trials in the same condition.

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Other Dana-Farber Cancer Institute trials

Trials by the same sponsor.

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NCT05825469 — Development and Testing of Nutritional Algorithms (NACHO) · NA · not yet recruiting
NCT07516353 — my.naviGATE: A Guide to After-Treatment Effects for Adolescents and Young Adults · NA · not yet recruiting
NCT07513324 — Risk-adapted Therapy in HPV-positive Oropharyngeal Cancer Using Circulating Tumor (ct) HPV DNA Profiling (ReACT 2.0) · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03022032 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Dana-Farber Cancer Institute
Last refreshed: 9 September 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03022032.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT03022032

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Gynecologic Cancer

Other Dana-Farber Cancer Institute trials

Verify against primary sources