Promoting Physical Activity in Breast Cancer Survivors on Aromatase Inhibitors

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.

Sex

Female

Minimum age

18 Years

Maximum age

70 Years

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.

• DERIVEDFranco 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. PMID 39799368
• DERIVEDCarraca 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. PMID 37407950