Nurse-led Physical Activity Program Among Breast Cancer Survivors (WATSOCPAP)

The Effects of a Nurse-led Using Wearable Technology Physical Activity Program on Health-Related Quality of Life and Physical Activity Level Among Breast Cancer Survivors

A nurse-led physical activity program including an individualized exercise program using wearable technology and health coaching based on Social Cognitive Theory will be implemented for women surviving cancer. The impact of the nurse-led physical activity program on physical activity level, health-related quality of life and cognitive factors (self regulation, outcome expectation, self efficacy, perceived social support, perceived environment) will be evaluated in the study.

Study Overview

• Status: Enrolling by invitation
• Conditions: Health Behavior; Breast Cancer Female; Survivorship
• Intervention / Treatment: Behavioral: WATSOCPAP

Detailed Description

This study protocol describes a randomized controlled trial with parallel group design. Participants will be Breast cancer survivors who aged 18-65, have finished active treatment (surgery, chemotherapy, and/or radiotherapy) in the previous 5 years, no evidence of recurrence and contraindications, and are completing less than 150-minutes of Moderate-Vigorous intensity Physical Activity (MVPA) per week. Participants will be randomly assigned to the intervention and control group.

Wearable Technology using Social Cognitive Theory based physical activity program (WATSOCPAP) created for the Intervention Group includes 3 different intervention components: (1) Supervised and individualized exercise plan; (2) Physical activity monitoring with activity tracker; (3) Nurse-led physical activity coaching program. Participants will be administered strengthening and aerobic exercise program, structured and individualized according to the person's individual capacity and needs, under the supervision of a physiotherapist. The activity tracker will provide real-time activity information about daily steps, time spent with MVPA (minutes/day) and sedentary time. The nurse-led physical activity coaching program was planned according to the Social Cognitive Theory (SCT) components such as self-regulation, outcome expectation, social support and perceived environment. WATSOCPAP is a 12-week program that includes text messages, face-to-face and online interviews. The first intervention in this group will begin with a 60-minute face-to-face individual training. After the first interview, text messages will be made according to the Social Cognitive Theory (SCT) components per weeks. Control group will receive standard care. Follow-up questionnaires will be applied by repeating the post-test at the 24th week. In the intervention and control groups, post-test will be applied 12 weeks after the pre-test, and follow-up questionnaires will be applied 24 weeks after the pre-test.

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Istanbul University-Cerrahpasa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Between the ages of 18-65
• Female gender
• Diagnosed with stage I-III breast cancer survivors,
• Completed active cancer primary treatment (surgery, chemotherapy, and/or radiotherapy) in the previous 5 years, excluding hormone therapy,
• No evidence of recurrence,
• No contraindications,
• Less than 150 minutes of moderate-intensity physical activity or 75 minutes of vigorous-intensity physical activity per week,
• Having a smart mobile phone and to access and use the internet,
• Live in Istanbul city,
• No medical condition(s) that non-adherence to an exercise program

Exclusion Criteria:

• Currently pregnant or planning to become pregnant during the study period,
• Musculoskeletal, neurological, respiratory, metabolic or cardiovascular health problems which preclude exercise,
• Cancer recurrence and resumption of active cancer treatment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; Participants will receive an exercise plan, activity tracker, and physical activity coaching program based Social Cognitive Theory.	Behavioral: WATSOCPAP; Participants will receive an supervised and individualized exercise plan, activity tracker, and physical activity coaching program based Social Cognitive Theory. Participants will be administered strengthening and aerobic exercise program, structured and individualized according to the person's individual capacity and needs, under the supervision of a physiotherapist. The activity tracker will provide real-time activity information about daily steps, time spent with MVPA (minutes/day) and sedentary time. The nurse-led physical activity coaching program was planned according to the Social Cognitive Theory (SCT) components such as self-regulation, outcome expectation, social support and perceived environment. The interventions will continue with online and the 12-week program will be completed.
No Intervention: Control Group; The control group will not take any intervention but take a standard care, the post-tests will be collected at the end of 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self Reported Physical Activity	Change in physical activity, as measured by the "International Physical Activity Questionnaire-Short Form", from baseline to 12 and 24 weeks. Participants report frequency of light, moderate and vigorous physical activity, and average duration (minutes/week) bouts for 10 minutes or longer in the last seven days. Scores for light, moderate and vigorous exercise are combined to compute total physical activity minutes/week. Computation of the total score for the short form requires summation of the duration (in minutes) and frequency (days) of walking, moderate-intensity and vigorous-intensity activities. Standard MET (metabolic equivalent) values for activities were established. The 'MET-min/week' value is obtained by multiplying the MET value of each physical activity level with the days and minutes this physical activity is performed every week. The obtained MET value is classified as HEPA active (MET>3000), minimally active (MET=600-3000), and inactive (MET<600).	Baseline, 12 weeks, 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BMI	Change in BMI, as measured objectively with digital scales, from baseline to to 12 and 24 weeks.	Baseline, 12 weeks, 24 weeks
Self-efficacy For Exercise	Change in self-efficacy for exercise, as measured by the The Exercise Self-efficacy Scale, from baseline to 12 and 24 weeks. Responses 18 items, ranging from 0 (cannot do it) to 100 (definitely can do it), are summed, with higher values representing higher efficacy beliefs for exercises.	Baseline, 12 weeks, 24 weeks
Outcome Expectations for Exercise	Change in outcome expectations for exercise, as measured by the Multidimensional Outcome Expectations for Exercise Scale, from baseline to 12 and 24 weeks. Responses for three subscales (physical subscale, social subscale, self-evaluative subscale), ranging from 1 (strongly disagree) to 5 (strongly agree), are summed, with higher values representing higher outcome expectations for exercise.	Baseline, 12 weeks, 24 weeks
Self-regulation	Change in self-regulation, as measured using by self-report questionnaire, from baseline to 12 and 24 weeks. Responses to two subscales (Exercise goal-setting, Exercise planning and scheduling), ranging from 1 (does not describe) to 5 (describes completely), are averaged to yield two subscales. Higher subscale scores represent higher self-regulation.	Baseline, 12 weeks, 24 weeks
Multidimensional Perceived Social Support Scale	Change in social support, as measured by the Multidimensional Perceived Social Support Scale, from baseline to 12 and 24 weeks. Responses for three factors (Family participation, Friend participation, a special person participation), ranging from 1 to 7, are summed, with higher values representing higher perceived social support.	Baseline, 12 weeks, 24 weeks
Perceived Environment	Change in perceived environment, as measured using the Physical Activity Neighborhood Environment Scale (PANES) survey, from baseline to 12 and 24 weeks. PANES is a 17-item measure perceived attributes of the neighborhood environment related to physical activity. Concepts assessed by PANES include residential density (1 item), access to destinations (3 items), pedestrian and bicycling facilities (4 items), recreational facilities (1 item), aesthetic qualities (1 item), social environment (1 item), street connectivity (1 item), traffic safety (2 items), crime safety (2 items), and household motor vehicles (1 item). With the exception of the residential density and household motor vehicle questions, items ranging ranging from 1 (strongly disagree) to 5 (strongly agree), as well as don't know or doesn't apply response option.	Baseline, 12 weeks, 24 weeks
Health Related Quality of Life: EORTC-QLQ-C30	Change in general health-related quality of life, as measured using the The European Organization for Research and Treatment of Cancer (EORTC) developed a cancer-specific core questionnaire (QLQ-C30), from baseline to 12 and 24 weeks. QLQ-C30 is composed of 30 items assessing global perceived health status and QoL. These items are grouped in five functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning); three symptom scales (fatigue, nausea & vomiting, and pain); six single item scales. Responses are coded on a scale of 0 to 4 where 0 is not at all and 4 is very much. A rise in the functional dimension score and a fall in the symptom dimension score signify an improvement in QoL. High general well-being dimension scores are indicative of a QoL. The computation yields scores for every dimension out of a possible 100, with scores ranging from 0 to 100.	Baseline, 12 weeks, 24 weeks
Health Related Quality of Life-Breast Cancer Specified: EORTC-QLQ-BR23	Change in health-related quality of life-Breast Cancer Specified, as measured using the EORTC-QLQ-BR23, from baseline to 12 and 24 weeks. QLQ-BR23 questionnaire has 23 items to assess functional scales (body image), sexual functioning, sexual enjoyment, and future perspective); symptom scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). The total score range of the scale is 0-100. A high quality of life is indicated by a low score in the symptom dimension and a high score in the functional dimension of the scale.	Baseline, 12 weeks, 24 weeks
Fatigue	Change in fatigue, as measured by the The Functional Assessment of Chronic Illness Treatment-Fatigue Scale (FACIT-F), from baseline to 12 and 24 weeks. The FACIT-F Scale is composed of 13 expressions that measure the fatigue that the patients had in the last seven days.7 The expressions on the scale consist of Likert type question form which is scored between 0 and 4 and con- sists of ''Not at all'', ''A little bit'', ''Somewhat'', ''Quite a bit'', and ''Very much''. The total score range of the scale is 0-52. The higher the scale score, the lower the fatigue level of the patient.	Baseline, 12 weeks, 24 weeks

Collaborators and Investigators

• Sponsor: Istanbul Medipol University Hospital
• Collaborators: The Scientific and Technological Research Council of Turkey
• Investigators: Principal Investigator: Sura Kaya, MSc, Medipol University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: January 31, 2024
• First Submitted That Met QC Criteria: January 31, 2024
• First Posted (Actual): February 8, 2024

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Physical Activity; Breast Cancer; Health-Related Quality Of Life; Social Cognitive Theory; Survivors
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: IMUH-HEM-SK-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study protocol was planned to share in one year with other researchers.
• IPD Sharing Time Frame: One year
• IPD Sharing Access Criteria: Individual participants data that underlie the results reported in this article, after de identification (text, tables, figures, appendices).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No