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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-00621 | Registry Identifier | NCI Clinical Trials Reporting Program (CTRP) |
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There is a critical need for physical activity interventions in colorectal cancer (CRC). The investigators have developed a digital health physical activity intervention, Smart Pace, which includes a wearable tracker (Fitbit) and text messaging and aims to have patients build up to 150 min/wk of moderate activity. In this study, the investigators propose to expand and improve Smart Pace, including: 1) enrolling patients during chemotherapy; 2) tailoring text messages to individual preferences and treatment timing; and 3) adding resources to support home-based exercise. The study is a 12-week pilot randomized controlled trial (RCT) to evaluate the feasibility of this novel digital health physical activity intervention among 48 CRC patients on chemotherapy. The specific aims are to: 1) Determine the feasibility of the intervention via adherence and attrition, and determine the acceptability of the intervention via questionnaires and semi-structured interviews . 2) Estimate the effect of the intervention vs. usual care on physical activity, QOL, and symptoms at 12-weeks . And 3) Explore the impact of the intervention vs. usual care on fitness, weight, waist circumference, and blood pressure at 12-weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fitbit and Text Messages | Experimental | Participants randomized to this arm receive print materials and a Fitbit Flex 2 at baseline and daily text messages for 12 weeks. |
|
| Usual Care | No Intervention | Participants randomized to usual care receive print materials at baseline. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fitbit and Text Messages | Behavioral | Physical activity tracker wristband and daily text messages delivered to the participants' phones. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fitbit wear time | Number of study days Fitbit is worn | up to 12 weeks from study start |
| Acceptability of the intervention | Acceptability will be assessed with an investigator created questionnaire among participants in the intervention arm. | At 12 weeks from study start |
| Text message response rate | up to 12 weeks from study start |
| Measure | Description | Time Frame |
|---|---|---|
| Objective physical activity | Minutes of moderate-to-vigorous physical activity per week measured by accelerometer | At 0 weeks and 12 weeks from study start |
| Fatigue | Lee Fatigue Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erin L Van Blarigan, ScD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35014958 | Derived | Van Blarigan EL, Dhruva A, Atreya CE, Kenfield SA, Chan JM, Milloy A, Kim I, Steiding P, Laffan A, Zhang L, Piawah S, Fukuoka Y, Miaskowski C, Hecht FM, Kim MO, Venook AP, Van Loon K. Feasibility and Acceptability of a Physical Activity Tracker and Text Messages to Promote Physical Activity During Chemotherapy for Colorectal Cancer: Pilot Randomized Controlled Trial (Smart Pace II). JMIR Cancer. 2022 Jan 11;8(1):e31576. doi: 10.2196/31576. |
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Results from this pilot clinical trial will be reported at national conferences and published in peer-review journals.
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| At 0 and 12 weeks from study start |
| Cardiorespiratory fitness | 6 minute walk test | At 0 and 12 weeks from study start |
| Anthropometrics, Waist circumference | At 0 and 12 weeks from study start |
| Anthropometrics, Body weight | At 0 and 12 weeks from study start |
| Sleep quality | Will be assessed by the Pittsburgh Sleep Quality Index, providing a score ranging from 0 to 21, where lower scores denote a healthier sleep quality. | At 0 and 12 weeks from study start |
| Health-related quality of life in cancer patients | Will be assessed via the European Organization for Research and Treatment (EORTC) of Cancer Quality of Life Questionnaire-Core 30 | At 0 and 12 weeks from study start |
| Health-related quality of life in colorectal cancer patients | Will be assessed via the European Organization for Research and Treatment (EORTC) of Cancer Quality of Life Questionnaire-Core 29 | At 0 and 12 weeks from study start |
| Neuropathy | Will be assessed by the Chemotherapy-Induced Peripheral Neuropathy 20 (CIPN20) questionnaire, a 20-item quality of life questionnaire. | At 0 and 12 weeks from study start |
| Anxiety | Will be assessed by the Spielberger State-Trait Anxiety Inventories (STAI), consisting of 40 questions on a self-report basis. Scores range from 20 to 80, with higher scores correlating with greater anxiety. | At 0 and 12 weeks from study start |
| Depression | Will be assessed by the Center for Epidemiological Studies-Depression Scale (CES-D), a brief self-report questionnaire which consists of 20 questions. Scores on the CES-D range from 0 to 60, in which higher scores suggest a greater presence of depressive symptoms. | At 0 and 12 weeks from study start |
| Leisure-time physical activity | Will be assessed via the Harvard Health Professionals Follow-up Study (HPFS) physical activity questionnaire. | At 0 and 12 weeks from study start |
| Perceived barriers to physical activity | Modified from the Project Graduate Ready for Activity Daily(GRAD) survey - 24 items plus a write-in option. | At 0 and 12 weeks from study start |
| Exercise Confidence | Modified from the Project GRAD (Graduate Ready for Activity Daily) survey - 11 items. | At 0 and 12 weeks from study start |
| Social support | Modified from the Project GRAD (Graduate Ready for Activity Daily) survey - 13 items asked about social support. | At 0 and 12 weeks from study start |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D001519 | Behavior |