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Self-monitoring and Reminder Texts to Increase Physical Activity After Cancer II (SmartPaceII)

Primary Purpose

Colorectal Cancer, Colon Cancer, Rectal Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fitbit and Text Messages
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Colorectal Cancer focused on measuring physical activity, digital health, text messages, intervention, exercise, randomized, Fitbit

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosed with colon or rectal adenocarcinoma
  • Expected to receive at least 12 weeks of chemotherapy
  • Able to speak and read English
  • Access to a mobile phone with Internet and text messaging capabilities
  • ≥4 weeks since last major surgery and fully recovered
  • ≥18 years old
  • Physician consent to participate in unsupervised moderate intensity physical activity
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Exclusion Criteria:

  • Engaging in 150 minutes/week or more of moderate physical activity, 75 minutes/week or more of vigorous physical activity, or an equivalent combination
  • Hypertension that is not well-controlled (≥160/90) on anti-hypertensive therapy
  • Any contraindications to exercise, including, but not limited to: brain metastases; current congestive heart failure (New York Heart Association Class II, III or IV); serious or nonhealing wound, ulcer, or bone fracture; spinal cord compromise or instrumentation due to metastatic disease; peripheral neuropathy ≥grade 3; advanced Chronic Obstructive Pulmonary Disease (COPD) on oxygen
  • Serious cardiovascular event within 6 months including, but not limited to, transient ischemic attack (TIA), cerebrovascular accident (CVA), or myocardial infarction (MI)
  • Has been told by a doctor that he/she has a heart condition and recommended to only engage in medically supervised activity

Sites / Locations

  • University of California, San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Fitbit and Text Messages

Usual Care

Arm Description

Participants randomized to this arm receive print materials and a Fitbit Flex 2 at baseline and daily text messages for 12 weeks.

Participants randomized to usual care receive print materials at baseline.

Outcomes

Primary Outcome Measures

Fitbit wear time
Number of study days Fitbit is worn
Acceptability of the intervention
Acceptability will be assessed with an investigator created questionnaire among participants in the intervention arm.
Text message response rate

Secondary Outcome Measures

Objective physical activity
Minutes of moderate-to-vigorous physical activity per week measured by accelerometer
Fatigue
Lee Fatigue Scale
Cardiorespiratory fitness
6 minute walk test
Anthropometrics, Waist circumference
Anthropometrics, Body weight
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.
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
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
Neuropathy
Will be assessed by the Chemotherapy-Induced Peripheral Neuropathy 20 (CIPN20) questionnaire, a 20-item quality of life questionnaire.
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.
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.
Leisure-time physical activity
Will be assessed via the Harvard Health Professionals Follow-up Study (HPFS) physical activity questionnaire.
Perceived barriers to physical activity
Modified from the Project Graduate Ready for Activity Daily(GRAD) survey - 24 items plus a write-in option.
Exercise Confidence
Modified from the Project GRAD (Graduate Ready for Activity Daily) survey - 11 items.
Social support
Modified from the Project GRAD (Graduate Ready for Activity Daily) survey - 13 items asked about social support.

Full Information

First Posted
April 4, 2018
Last Updated
August 24, 2020
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT03524716
Brief Title
Self-monitoring and Reminder Texts to Increase Physical Activity After Cancer II
Acronym
SmartPaceII
Official Title
Self-monitoring and Reminder Texts to Increase Physical Activity After Cancer II (Smart Pace II)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
March 6, 2018 (Actual)
Primary Completion Date
August 21, 2020 (Actual)
Study Completion Date
August 21, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Colon Cancer, Rectal Cancer
Keywords
physical activity, digital health, text messages, intervention, exercise, randomized, Fitbit

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fitbit and Text Messages
Arm Type
Experimental
Arm Description
Participants randomized to this arm receive print materials and a Fitbit Flex 2 at baseline and daily text messages for 12 weeks.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Participants randomized to usual care receive print materials at baseline.
Intervention Type
Behavioral
Intervention Name(s)
Fitbit and Text Messages
Intervention Description
Physical activity tracker wristband and daily text messages delivered to the participants' phones.
Primary Outcome Measure Information:
Title
Fitbit wear time
Description
Number of study days Fitbit is worn
Time Frame
up to 12 weeks from study start
Title
Acceptability of the intervention
Description
Acceptability will be assessed with an investigator created questionnaire among participants in the intervention arm.
Time Frame
At 12 weeks from study start
Title
Text message response rate
Time Frame
up to 12 weeks from study start
Secondary Outcome Measure Information:
Title
Objective physical activity
Description
Minutes of moderate-to-vigorous physical activity per week measured by accelerometer
Time Frame
At 0 weeks and 12 weeks from study start
Title
Fatigue
Description
Lee Fatigue Scale
Time Frame
At 0 and 12 weeks from study start
Title
Cardiorespiratory fitness
Description
6 minute walk test
Time Frame
At 0 and 12 weeks from study start
Title
Anthropometrics, Waist circumference
Time Frame
At 0 and 12 weeks from study start
Title
Anthropometrics, Body weight
Time Frame
At 0 and 12 weeks from study start
Title
Sleep quality
Description
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.
Time Frame
At 0 and 12 weeks from study start
Title
Health-related quality of life in cancer patients
Description
Will be assessed via the European Organization for Research and Treatment (EORTC) of Cancer Quality of Life Questionnaire-Core 30
Time Frame
At 0 and 12 weeks from study start
Title
Health-related quality of life in colorectal cancer patients
Description
Will be assessed via the European Organization for Research and Treatment (EORTC) of Cancer Quality of Life Questionnaire-Core 29
Time Frame
At 0 and 12 weeks from study start
Title
Neuropathy
Description
Will be assessed by the Chemotherapy-Induced Peripheral Neuropathy 20 (CIPN20) questionnaire, a 20-item quality of life questionnaire.
Time Frame
At 0 and 12 weeks from study start
Title
Anxiety
Description
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.
Time Frame
At 0 and 12 weeks from study start
Title
Depression
Description
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.
Time Frame
At 0 and 12 weeks from study start
Title
Leisure-time physical activity
Description
Will be assessed via the Harvard Health Professionals Follow-up Study (HPFS) physical activity questionnaire.
Time Frame
At 0 and 12 weeks from study start
Title
Perceived barriers to physical activity
Description
Modified from the Project Graduate Ready for Activity Daily(GRAD) survey - 24 items plus a write-in option.
Time Frame
At 0 and 12 weeks from study start
Title
Exercise Confidence
Description
Modified from the Project GRAD (Graduate Ready for Activity Daily) survey - 11 items.
Time Frame
At 0 and 12 weeks from study start
Title
Social support
Description
Modified from the Project GRAD (Graduate Ready for Activity Daily) survey - 13 items asked about social support.
Time Frame
At 0 and 12 weeks from study start

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with colon or rectal adenocarcinoma Expected to receive at least 12 weeks of chemotherapy Able to speak and read English Access to a mobile phone with Internet and text messaging capabilities ≥4 weeks since last major surgery and fully recovered ≥18 years old Physician consent to participate in unsupervised moderate intensity physical activity Eastern Cooperative Oncology Group (ECOG) performance status 0-1 Exclusion Criteria: Engaging in 150 minutes/week or more of moderate physical activity, 75 minutes/week or more of vigorous physical activity, or an equivalent combination Hypertension that is not well-controlled (≥160/90) on anti-hypertensive therapy Any contraindications to exercise, including, but not limited to: brain metastases; current congestive heart failure (New York Heart Association Class II, III or IV); serious or nonhealing wound, ulcer, or bone fracture; spinal cord compromise or instrumentation due to metastatic disease; peripheral neuropathy ≥grade 3; advanced Chronic Obstructive Pulmonary Disease (COPD) on oxygen Serious cardiovascular event within 6 months including, but not limited to, transient ischemic attack (TIA), cerebrovascular accident (CVA), or myocardial infarction (MI) Has been told by a doctor that he/she has a heart condition and recommended to only engage in medically supervised activity
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erin L Van Blarigan, ScD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Results from this pilot clinical trial will be reported at national conferences and published in peer-review journals.
Citations:
PubMed Identifier
35014958
Citation
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.
Results Reference
derived

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Self-monitoring and Reminder Texts to Increase Physical Activity After Cancer II

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