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Breast Cancer FemaleWATSOCPAPNCT06248918

Nurse-led Physical Activity Program Among Breast Cancer Survivors

A study testing WATSOCPAP in people with Breast Cancer Female and Survivorship, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years, women onlyHealthy volunteers can take part
What is being tested?
WATSOCPAP
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Mar 2024to 1 Oct 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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,
Show all 10Show fewer
  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Istanbul University-Cerrahpasa

    Istanbul

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the 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.

Being tested
WATSOCPAP
Keywords
Breast Cancer, Survivors, Physical Activity, Social Cognitive Theory, Health-Related Quality Of Life
Medical subject headings
Health Behavior, Breast Neoplasms, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • WATSOCPAPBehavioural

    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.

Study groups in NCT06248918
Study groupRoleWhat they receive
Intervention GroupExperimentalParticipants will receive an exercise plan, activity tracker, and physical activity coaching program based Social Cognitive Theory.
Receives: Behavioral: WATSOCPAP
Control GroupNo interventionThe 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Baseline, 12 weeks, 24 weeks

Secondary outcomes (9)
  1. 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.

    Measured: Baseline, 12 weeks, 24 weeks

  2. 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.

    Measured: Baseline, 12 weeks, 24 weeks

  3. BMI

    Change in BMI, as measured objectively with digital scales, from baseline to to 12 and 24 weeks.

    Measured: Baseline, 12 weeks, 24 weeks

  4. 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.

    Measured: Baseline, 12 weeks, 24 weeks

  5. 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.

    Measured: Baseline, 12 weeks, 24 weeks

  6. 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.

    Measured: Baseline, 12 weeks, 24 weeks

  7. 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.

    Measured: Baseline, 12 weeks, 24 weeks

  8. 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.

    Measured: Baseline, 12 weeks, 24 weeks

  9. 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.

    Measured: Baseline, 12 weeks, 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2024
  2. Study start1 Mar 2024
  3. Primary completion1 Sep 2024 (estimated)
  4. Study completion1 Oct 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
84 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06248918
Sponsor's protocol ID
IMUH-HEM-SK-01
Acronym
WATSOCPAP
Status last verified
Mar 2024
First submitted
31 Jan 2024
Last updated
18 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Study protocol was planned to share in one year with other researchers.

Questions about this trial

What is this clinical trial studying?

A study testing WATSOCPAP in people with Breast Cancer Female and Survivorship, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Self Reported Physical Activity (time frame: Baseline, 12 weeks, 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024.

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