Promoting Physical Activity in Breast Cancer Survivors on Aromatase Inhibitors

NCT ID: NCT05860621

Last Updated: 2023-05-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-05
• Study Completion Date: 2025-02-28

Brief 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.

Conditions

Breast Cancer Female; Hormone-receptor-positive Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Brief Physical Activity Counselling

The brief physical activity counselling (PAC) group will receive a group-based, light-touch, motivational counselling program to promote physical activity.

Group Type: EXPERIMENTAL

Brief Physical Activity Counselling

Intervention Type: BEHAVIORAL

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.

Structured Exercise Program

The structured exercise group will receive a group-based supervised multi-component exercise program, with progressive intensity.

Group Type: EXPERIMENTAL

Structured Exercise Program

Intervention Type: BEHAVIORAL

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.

Waitlist control

Patients allocated to the control group (i.e., waiting list) will keep daily routines and standard medical care. At the end of the study, the control group will be offered the structured exercise program.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Brief Physical Activity Counselling

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.

Intervention Type: BEHAVIORAL

Structured Exercise Program

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fundação para a Ciência e a Tecnologia

OTHER

Sponsor Role: collaborator

Faculdade de Motricidade Humana

OTHER

Sponsor Role: collaborator

Grupo Lusófona

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eliana V. Carraça, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidade Lusófona, Faculdade de Educação Física e Desporto, Lisboa, Portugal

Locations

Universidade Lusófona, Campo Grande 376

Lisbon, , Portugal

Site Status: RECRUITING

Countries

Portugal

Central Contacts

Eliana V. Carraça, PhD

Role: CONTACT

p4890@ulusofona.pt

+315912154907

Flávio Jerónimo, MSc

Role: CONTACT

pacwoman@ulusofona.pt

+351964562662

Facility Contacts

Eliana V. Carraça, PhD

Role: primary

p4890@ulusofona.pt

+351912154907

Flávio Jerónimo, MSc

Role: backup

pacwoman@ulusofona.pt

+351964562662

References

Franco S, Carraca EV, Nobre I, Rodrigues B, Ilharco V, Kahlert L, Silva MN. Developing and testing the feasibility of a theory-based brief counseling intervention to promote physical activity in breast cancer survivors enrolled in the PAC-WOMAN trial. Pilot Feasibility Stud. 2025 Jan 11;11(1):4. doi: 10.1186/s40814-024-01587-0.

Reference Type: DERIVED

PMID: 39799368 (View on PubMed)

Carraca EV, Rodrigues B, Franco S, Nobre I, Jeronimo F, Ilharco V, Gabriel F, Ribeiro L, Palmeira AL, Silva MN. Promoting physical activity through supervised vs motivational behavior change interventions in breast cancer survivors on aromatase inhibitors (PAC-WOMAN): protocol for a 3-arm pragmatic randomized controlled trial. BMC Cancer. 2023 Jul 5;23(1):632. doi: 10.1186/s12885-023-11137-1.

Reference Type: DERIVED

PMID: 37407950 (View on PubMed)

Other Identifiers

PTDC/SAU-DES/2865/2020

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PAC-WOMAN

Identifier Type: -

Identifier Source: org_study_id