Trial Title:
Promoting Physical Activity in Breast Cancer Survivors on Aromatase Inhibitors
NCT ID:
NCT05860621
Condition:
Breast Cancer Female
Hormone-receptor-positive Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
A 3-arm randomized controlled trial, involving a 4-month intervention period and a
12-month follow-up, will be implemented to compare: 1) a brief PA counseling
intervention; 2) a structured exercise program; and 3) a waiting-list control group.
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Brief Physical Activity Counselling
Description:
The brief physical activity counselling program will comprise 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.
Arm group label:
Brief Physical Activity Counselling
Intervention type:
Behavioral
Intervention name:
Structured Exercise Program
Description:
The structured exercise program was 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 organized 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.
Arm group label:
Structured Exercise Program
Summary:
Aromatase inhibitors (AI) are frequently used to treat hormone-receptor-positive breast
cancer, but they have multiple adverse effects (eg, arthralgia), resulting in premature
therapy discontinuation/switch. Physical activity (PA) can attenuate these negative
effects and improve quality of life (QoL). However, most cancer survivors fail to
perform/sustain adequate PA levels, especially in the long-term. Theory-based
interventions, using evidence-based behavior change techniques, aimed at promoting
long-term behavior change in breast cancer survivors are effective, but remain scarce and
fail to promote self-regulatory skills and better-quality motivations associated with
sustained PA adoption.
PAC-WOMAN will test the long-term effectiveness and cost-effectiveness of two state of
the art, group-based interventions encouraging sustained changes in PA, sedentary
behavior, and QoL. Additional aims include examining the impact of both interventions on
secondary outcomes (eg, body composition, physical function), and key
moderators/mediators of short and long-term changes in primary outcomes. A 3-arm
pragmatic randomized controlled trial, involving a 4-month intervention and a 12-month
follow-up, will be implemented, in a real exercise setting, to compare: 1) brief PA
counseling/motivational intervention; 2) structured exercise program vs. waiting-list
control group. Study recruitment goal is 122 hormone-receptor-positive breast cancer
survivors (stage I-III), on AI therapy (post-primary treatment completion) ≥1 month,
performance status 0-1. Outcome measures will be obtained at baseline, 4 months (i.e.,
post-intervention), 10 and 16 months. Process evaluation, analyzing implementation
determinants, will also be conducted.
PAC-WOMAN is expected to have a relevant impact on participants PA and QoL, and on the
improvement of interventions designed to promote sustained adherence to active lifestyle
behaviors, facilitating its translation to community settings.
Detailed description:
Aromatase inhibitors (AI) are frequently used to treat hormone-receptor-positive breast
cancer, but they have multiple adverse effects (eg, osteoporosis, arthralgia), resulting
in premature therapy discontinuation/switch. Physical activity (PA) is safe and should be
an integral and continuous part of care for all individuals diagnosed with cancer. There
is compelling evidence suggesting that PA plays an important role in improving longevity
among cancer survivors. PA effectively ameliorates short- and long-term adverse effects
of cancer therapies (eg, comorbid conditions, improves physical fitness and function,
attenuates cancer-related fatigue, enhances body image and quality of life (QoL), and
decreases cancer recurrence and mortality. PA also allows women to benefit from endocrine
therapy while being protected against the related risk of osteoporosis, fracture, and
ultimately cancer recurrence or death. Thus, PA in breast cancer survivors, and
specifically among women on AIs, is paramount to improve health outcomes, QoL, and
prevent therapy discontinuation. However, most cancer survivors fail to meet established
guidelines for PA.
Theory-based interventions, using evidence-based behavior change techniques, aimed at
promoting long-term health behavior change in breast cancer survivors are effective, but
remain scarce and predominantly focused on short-term adherence/outcomes. Also, most
interventions fail to provide validated self-regulatory tools or explore meaningful links
between PA and patients' values and life aspirations to foster lasting behavior changes.
Prior research has shown that internal (better quality) forms of motivation play an
important role in PA and behavior sustainability, suggesting that self-determination
theory (SDT) can be a valid framework to promote sustained adherence to PA. A
need-supportive intervention climate enhances people's wellbeing and their ability to
self-regulate and sustain behavior changes. Finally, skills such as self-monitoring, goal
setting or action planning have also been identified as important mediators of long-term
PA and as core features of effective behavior change/maintenance interventions in breast
cancer survivors.
In sum, although regular PA is a promising and safe way of helping cancer survivors
navigate their disease, alleviating the growing pressure on the health care system, most
cancer survivors do not meet the recommended PA doses. It is a goal of this project to
overcome the abovementioned shortcomings, by testing an intervention model informed by
solid evidence and a robust theoretical rationale (SDT), provided by qualified exercise
professionals, which appear to add value to the treatment process, improving the
therapeutic effect and safety of the exercise practice.
PAC-WOMAN will test the long-term effectiveness and cost-effectiveness of two 4-month
group-based interventions aimed at promoting sustained changes in PA, sedentary behavior,
and QoL. Additional aims include examining the impact of both interventions on secondary
outcomes (eg, body composition, physical function), and key moderators and mediators of
short and long-term changes in primary outcomes. A 3-arm randomized controlled trial,
involving a 4-month intervention period and a 12-month follow-up, will be implemented to
compare: 1) a brief PA counseling intervention; 2) a structured exercise program; and 3)
a. waiting-list control group. Study recruitment goal is 122 breast cancer survivors with
hormone-receptor-positive breast cancer (stage I-III), on AI therapy (post-primary
treatment completion) for at least 1 month, ECOG performance status 0-1. Outcome measures
will be obtained at baseline, 4 months (i.e., post-intervention), 10 and 16 months.
Process evaluation, analyzing implementation determinants, will also be conducted.
PAC-WOMAN is expected to have a relevant impact on the improvement of interventions
designed to promote sustained adherence to active lifestyle behaviors and facilitate its
translation to community settings.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. post-menopausal women, below 70 years old;
2. histologically confirmed hormone-receptor-positive breast cancer (stage I, II, III);
3. having initiated aromatase inhibitor hormonal therapy following the primary
treatment (surgery, radiotherapy, chemotherapy, etc.), at least 1 month before being
enrolled;
4. ECOG-Performance Status 0-1.
Exclusion Criteria:
1. evidence of stage IV cancer or synchronous tumors;
2. uncontrolled hypertension, cardiac or pulmonary disease;
3. contraindications to exercise training according to the assistant doctor;
4. inability to provide informed consent;
5. expected inability to fulfill the proposed schedule.
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Universidade Lusófona, Campo Grande 376
Address:
City:
Lisboa
Zip:
1749-024
Country:
Portugal
Status:
Recruiting
Contact:
Last name:
Eliana V. Carraça, PhD
Phone:
+351912154907
Email:
p4890@ulusofona.pt
Contact backup:
Last name:
Flávio Jerónimo, MSc
Phone:
+351964562662
Email:
pacwoman@ulusofona.pt
Investigator:
Last name:
Marlene N Silva, PhD
Email:
Principal Investigator
Investigator:
Last name:
António L Palmeira, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Sofia Franco, MSc
Email:
Sub-Investigator
Investigator:
Last name:
Inês Nobre, MSc
Email:
Sub-Investigator
Investigator:
Last name:
Flávio Jerónimo, MSc
Email:
Sub-Investigator
Investigator:
Last name:
Bruno Rodrigues, MSc
Email:
Sub-Investigator
Investigator:
Last name:
Vítor Ilharco, MSc
Email:
Sub-Investigator
Start date:
January 5, 2022
Completion date:
February 2025
Lead sponsor:
Agency:
Grupo Lusófona
Agency class:
Other
Collaborator:
Agency:
Fundação para a Ciência e a Tecnologia
Agency class:
Other
Collaborator:
Agency:
Faculdade de Motricidade Humana
Agency class:
Other
Source:
Grupo Lusófona
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05860621
