Nurse-led Physical Activity Program Among Breast Cancer Survivors

NCT ID: NCT06248918

Last Updated: 2024-03-18

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2024-10-01

Brief Summary

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.

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.

Conditions

Breast Cancer Female; Survivorship; Health Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Intervention Group

Participants will receive an exercise plan, activity tracker, and physical activity coaching program based Social Cognitive Theory.

Group Type: EXPERIMENTAL

WATSOCPAP

Intervention Type: BEHAVIORAL

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

The Scientific and Technological Research Council of Turkey

OTHER

Sponsor Role: collaborator

Istanbul Medipol University Hospital

OTHER

Sponsor Role: lead

Responsible Party

sura kaya

Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sura Kaya, MSc

Role: PRINCIPAL_INVESTIGATOR

Medipol University

Locations

Istanbul University-Cerrahpasa

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

IMUH-HEM-SK-01

Identifier Type: -

Identifier Source: org_study_id