Colon Cancer, Colorectal Cancer, Rectal Cancer
Conditions
Keywords
physical activity, digital health, text messages, intervention, exercise, randomized, Fitbit
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.
Interventions
BEHAVIORALFitbit and Text Messages
Physical activity tracker wristband and daily text messages delivered to the participants' phones.
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fitbit wear time | up to 12 weeks from study start | Number of study days Fitbit is worn |
| Acceptability of the intervention | At 12 weeks from study start | Acceptability will be assessed with an investigator created questionnaire among participants in the intervention arm. |
| Text message response rate | up to 12 weeks from study start | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anthropometrics, Waist circumference | At 0 and 12 weeks from study start | — |
| Anthropometrics, Body weight | At 0 and 12 weeks from study start | — |
| Sleep quality | At 0 and 12 weeks from study start | 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 | At 0 and 12 weeks from study start | 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 | At 0 and 12 weeks from study start | Will be assessed via the European Organization for Research and Treatment (EORTC) of Cancer Quality of Life Questionnaire-Core 29 |
| Neuropathy | At 0 and 12 weeks from study start | Will be assessed by the Chemotherapy-Induced Peripheral Neuropathy 20 (CIPN20) questionnaire, a 20-item quality of life questionnaire. |
| Objective physical activity | At 0 weeks and 12 weeks from study start | Minutes of moderate-to-vigorous physical activity per week measured by accelerometer |
| Depression | At 0 and 12 weeks from study start | 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 | At 0 and 12 weeks from study start | Will be assessed via the Harvard Health Professionals Follow-up Study (HPFS) physical activity questionnaire. |
| Perceived barriers to physical activity | At 0 and 12 weeks from study start | Modified from the Project Graduate Ready for Activity Daily(GRAD) survey - 24 items plus a write-in option. |
| Exercise Confidence | At 0 and 12 weeks from study start | Modified from the Project GRAD (Graduate Ready for Activity Daily) survey - 11 items. |
| Social support | At 0 and 12 weeks from study start | Modified from the Project GRAD (Graduate Ready for Activity Daily) survey - 13 items asked about social support. |
| Anxiety | At 0 and 12 weeks from study start | 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. |
| Fatigue | At 0 and 12 weeks from study start | Lee Fatigue Scale |
| Cardiorespiratory fitness | At 0 and 12 weeks from study start | 6 minute walk test |
Countries
United States
Outcome results
None listed