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

Colorectal Cancer Clinical Trial

— SmartPaceII  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03524716
• Other study ID #: 174525
• Secondary ID: NCI-2018-00621
• Status: Completed
• Phase: N/A
• Start date: March 6, 2018
• Est. completion date: August 21, 2020

Study information

• Verified date: August 2020
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: August 21, 2020
• Est. primary completion date: August 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms
• Colorectal Cancer
• Colorectal Neoplasms
• Rectal Cancer
• Rectal Neoplasms

Intervention

Behavioral:
• Fitbit and Text Messages
Physical activity tracker wristband and daily text messages delivered to the participants' phones.

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fitbit wear time	Number of study days Fitbit is worn	up to 12 weeks from study start
Primary	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
Primary	Text message response rate		up to 12 weeks from study start
Secondary	Objective physical activity	Minutes of moderate-to-vigorous physical activity per week measured by accelerometer	At 0 weeks and 12 weeks from study start
Secondary	Fatigue	Lee Fatigue Scale	At 0 and 12 weeks from study start
Secondary	Cardiorespiratory fitness	6 minute walk test	At 0 and 12 weeks from study start
Secondary	Anthropometrics, Waist circumference		At 0 and 12 weeks from study start
Secondary	Anthropometrics, Body weight		At 0 and 12 weeks from study start
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Exercise Confidence	Modified from the Project GRAD (Graduate Ready for Activity Daily) survey - 11 items.	At 0 and 12 weeks from study start
Secondary	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