UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050945 |
|---|---|
| Receipt number | R000058070 |
| Scientific Title | Promoting Physical Activity Through Supervised vs Motivational Behavior Change Interventions in Breast Cancer Survivors on Aromatase Inhibitors (PAC-WOMAN): A 3-arm Pragmatic Randomized Controlled Trial |
| Date of disclosure of the study information | 2023/04/27 |
| Last modified on | 2023/04/27 22:17:26 |
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Basic information
Public title
Promoting Physical Activity in Breast Cancer Survivors on Aromatase Inhibitors: A Randomized Controlled Trial (PAC-WOMAN)
Acronym
PAC-WOMAN
Scientific Title
Promoting Physical Activity Through Supervised vs Motivational Behavior Change Interventions in Breast Cancer Survivors on Aromatase Inhibitors (PAC-WOMAN): A 3-arm Pragmatic Randomized Controlled Trial
Scientific Title:Acronym
PTDC/SAU-DES/2865/2020
Region
| Europe |
Condition
Condition
hormone-receptor-positive breast cancer (stage I, II, III) breast cancer women on hormonal therapy with aromatase inhibitors
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Develop and test the long-term effectiveness and cost-effectiveness of two group-based interventions, compared to a control waiting list, on promoting sustained changes in physical activity, sedentary behavior, quality of life (primary outcomes)
Compare the effects of both interventions (ie, brief PA counseling vs. structured exercise) on long-term changes in our primary outcomes
Evaluate pretreatment moderators of 4-month and 16-month changes in physical activity, sedentary behavior, and quality of life
Identify critical motivational (theoretical) mediators of change in primary outcomes
Study the impact of both interventions on AI therapy continuation, adverse events of treatment, disease-free survival, body composition, sleep quality, physical and psychosocial factors.
Basic objectives2
Others
Basic objectives -Others
Effectiveness and cost-effectiness of two interventions
Trial characteristics_1
Others
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1.Physical activity
Physical activity will be objectively measured with a seven-day accelerometer monitoring (Actigraph GT9X). Self-reported physical activity will be measured using the short version of the International Physical Activity Questionnaire Short-Form. The Activity Choice Index (ACI) is employed to assess physically active lifestyle behaviors.
[Time Frame: baseline, 4 months (intervention's end), 10 and 16 months]
2.Sedentary Behavior
Sedentary behavior will be objectively measured with a seven-day accelerometer monitoring (Actigraph GT9X). Self-reported sedentary behavior (sitting time) will be measured using the short version of the International Physical Activity Questionnaire Short-Form.
[Time Frame: baseline, 4 months (intervention's end), 10 and 16 months]
3.Cancer-related Quality of Life
Quality of life will be assessed with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and its breast cancer module (EORTC QLQ-BR23). Five items specifically related to joint, bone, and muscle pain/discomfort, derived from the new EORTC QLQ-BR45, were added provided the specificity of aromatase inhibitors' side effects.
[Time Frame: baseline, 4 months (intervention's end), 10 and 16 months]
4.Healthcare Use
Healthcare use will be assessed by phone interview 6 months after ending the intervention period. Data will be collected on healthcare resources use during the study period, namely number and type of consultations, drugs, medical tests and exams, in-patient stays and day care sessions. Absenteeism will be assessed using participants' reports of their number of absence days or percentage of normal working hours worked, valued at patients' hourly wage. These resources will then be valued using usual official sources.
[Time Frame: 6-month after the end of the intervention]
Key secondary outcomes
Physical measures:
Body composition
Body weight, height and BMI.
Cardiorespiratory fitness
Muscular strength (handgrip and maximal strength)
Shoulder mobility/flexibility (angular and linear measures)
Physical function
Psychosocial measures:
Perceived intervention climate will be measured with the Interpersonal Behaviors Questionnaire (IBQ
Exercise motivational regulations
Basic psychological needs satisfaction/frustration for exercise
Affective valence of exercise
Exercise Self-Efficacy Scale
Self-regulatory skills
Subjective pain (intensity and severity)
Sleep Quality
Body Image
Depressive symptoms
Psychological well-being
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Brief physical activity counselling program: It comprises 8 sessions (120 minutes each), every fifteen days, addressing the following themes: reasons to change, an introduction to the PAC-WOMAN program and principles, types of physical activity and their benefits, strategies on how to become more active and less sedentary, how to safely practice exercise at home, the importance of social support for doing more physical activity, barriers and facilitators for becoming more active, development of coping plans and strategies to overcome those barriers, establishing SMART goals, self-monitoring, medical aspects related to symptom management in breast cancer survivors, body image and self-acceptance, sharing experiences with role models, and re-evaluating action plans. It will be delivered in a need-supportive interpersonal climate, according to Self-Determination Theory principles.
Interventions/Control_2
Structured exercise program: Informed by the most recent guidelines for exercise prescription and safe practice in cancer populations. A supervised program of 32 sessions (over 4 months), lasting 90 min each, and taking place twice a week, was developed. The program combines aerobic, strength and mobility exercises, and is organised in four mesocycles, with progressive intensity, always adapted according to participants' initial assessments and evolution throughout the weeks. Once every 15 days, a thematic group class will be offered to participants, so that they can experiment and discover new physical activities, and more easily maintain regular practice in the future.
Interventions/Control_3
Control group (ie, waiting list): Participants will keep daily routines and standard medical care. At the end of the study, the control group will be offered the structured exercise program.
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Female
Key inclusion criteria
Post-menopausal women, below 70 years old;
Histologically confirmed hormone-receptor-positive breast cancer (stage I, II, III);
Having initiated aromatase inhibitor hormonal therapy following the primary treatment (surgery, radiotherapy, chemotherapy, etc.), at least 1 month before being enrolled;
ECOG-Performance Status 0-1.
Key exclusion criteria
Evidence of stage IV cancer or synchronous tumors;
Uncontrolled hypertension, cardiac or pulmonary disease;
Contraindications to exercise training according to the assistant doctor;
Inability to provide informed consent;
Expected inability to fulfil the proposed schedule.
Target sample size
122
Research contact person
Name of lead principal investigator
| 1st name | Eliana |
| Middle name | Veiga |
| Last name | Carraca |
Organization
Lusofona University
Division name
Faculty of Physical Education and Sport
Zip code
1749-024
Address
Campo Grande 376, 1749-024 Lisboa, Portugal
TEL
+3517515500
pacwoman@ulusofona.pt
Public contact
Name of contact person
| 1st name | Eliana |
| Middle name | Veiga |
| Last name | Carraca |
Organization
Lusofona University
Division name
Faculty of Physical Education and Sport
Zip code
1749-024
Address
Campo Grande 376, 1749-024 Lisboa, Portugal
TEL
+3517515500
Homepage URL
https://pac-woman.ulusofona.pt/
pacwoman@ulusofona.pt
Sponsor or person
Institute
Lusofona University
Institute
Department
Personal name
Eliana Carraca
Funding Source
Organization
Portuguese Science and Technology Foundation
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Portuguese
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Faculty of Physical Education and Sport, Lusofona University
Address
Campo Grande 376, 1749-024 Lisboa, Portugal
Tel
+3517515500
susana.cordeiro@ulusofona.pt
Secondary IDs
Secondary IDs
YES
Study ID_1
PTDC/SAU-DES/2865/2020
Org. issuing International ID_1
Portuguese Science and Technology Foundation
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Lusofona University
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 04 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 01 | Month | 05 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 05 | Day |
Last follow-up date
| 2025 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 04 | Month | 27 | Day |
Last modified on
| 2023 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058070
