Clinical trial NCT06248918: Nurse-led Physical Activity Program Among Breast Cancer Survivors
Official title: 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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Breast Cancer Female
Survivorship
Health Behavior
Keywords: Breast Cancer
Survivors
Physical Activity
Social Cognitive Theory
Health-Related Quality Of Life
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
Collaborators: name: The Scientific and Technological Research Council of Turkey
First posted: 2024-02-08
Enrollment: 84
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Self Reported Physical Activity
timeFrame: Baseline, 12 weeks, 24 weeks
Secondary outcomes:
measure: Health Related Quality of Life: EORTC-QLQ-C30
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Health Related Quality of Life-Breast Cancer Specified: EORTC-QLQ-BR23
timeFrame: Baseline, 12 weeks, 24 weeks
measure: BMI
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Fatigue
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Self-efficacy For Exercise
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Outcome Expectations for Exercise
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Self-regulation
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Multidimensional Perceived Social Support Scale
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Perceived Environment
timeFrame: Baseline, 12 weeks, 24 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
Study officials:
affiliation: Medipol University
name: Sura Kaya, MSc
role: PRINCIPAL_INVESTIGATOR
References: