Clinical trial NCT05860621: Promoting Physical Activity in Breast Cancer Survivors on Aromatase Inhibitors
Official 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer Female
Hormone-receptor-positive Breast Cancer
Lead sponsor: Grupo Lusófona
Sponsor class: OTHER
Collaborators: name: Fundação para a Ciência e a Tecnologia
name: Faculdade de Motricidade Humana
First posted: 2023-05-16
Enrollment: 122
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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.

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.

Primary outcomes:
measure: Change from baseline in Physical activity on Actigraph GT9X accelerometers at 16 months
timeFrame: baseline and 16 months
measure: Change from baseline in Physical activity on Actigraph GT9X accelerometers at 4 months
timeFrame: baseline and 4 months
measure: Change from baseline in Physical activity on Actigraph GT9X accelerometers at 10 months
timeFrame: baseline and 10 months
measure: Change from baseline in self-reported physical activity on International Physical Activity Questionnaire (IPAQ-sf) at 16 months
timeFrame: baseline and 16 months
measure: Change from baseline in self-reported physical activity on International Physical Activity Questionnaire (IPAQ-sf) at 4 months
timeFrame: baseline and 4 months
measure: Change from baseline in self-reported physical activity on International Physical Activity Questionnaire (IPAQ-sf) at 10 months
timeFrame: baseline and 10 months
measure: Change from baseline in cancer-related quality of fife on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and its breast cancer module (EORTC-BR23) at 16 months
timeFrame: baseline and 16 months
measure: Change from baseline in cancer-related quality of fife on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and its breast cancer module (EORTC-BR23) at 4 months
timeFrame: baseline and 4 months
measure: Change from baseline in cancer-related quality of fife on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and its breast cancer module (EORTC-BR23) at 10 months
timeFrame: baseline and 10 months
measure: Healthcare Use
timeFrame: 6-month after the end of the intervention
Secondary outcomes:
measure: Change from baseline in body composition on bioelectrical impedance at 16 months
timeFrame: baseline, 4 months (intervention's end), 10 and 16 months
measure: Change from baseline in body composition on bioelectrical impedance at 4 months
timeFrame: baseline and 4 months
measure: Change from baseline in body composition on bioelectrical impedance at 10 months
timeFrame: baseline and 10 months
measure: Change from baseline in body mass index (BMI) at 16 months
timeFrame: baseline and 16 months
measure: Change from baseline in body mass index (BMI) at 4 months
timeFrame: baseline and 4 months
measure: Change from baseline in body mass index (BMI) at 10 months
timeFrame: baseline and 10 months
measure: Change from baseline in cardio-respiratory fitness at 16 months
timeFrame: baseline and 16 months
measure: Change from baseline in cardio-respiratory fitness at 4 months
timeFrame: baseline and 4 months
measure: Change from baseline in cardio-respiratory fitness at 10 months
timeFrame: baseline and 10 months
measure: Change from baseline in strength at 16 months
timeFrame: baseline and 16 months
measure: Change from baseline in strength at 4 months
timeFrame: baseline and 4 months
measure: Change from baseline in strength at 10 months
timeFrame: baseline and 10 months
measure: Change from baseline in physical function on the Stand on one foot Test at 16 months
timeFrame: baseline and 16 months
measure: Change from baseline in physical function on the Stand on one foot Test at 4 months
timeFrame: baseline and 4 months
measure: Change from baseline in physical function on the Stand on one foot Test at 10 months
timeFrame: baseline and 10 months
measure: Change from baseline in physical function on the Sit to Stand Test at 16 months
timeFrame: baseline and 16 months
measure: Change from baseline in physical function on the Sit to Stand Test at 4 months
timeFrame: baseline and 4 months
measure: Change from baseline in physical function on the Sit to Stand Test at 10 months
timeFrame: baseline and 10 months
measure: Change from baseline in physical function on the Timed up and go Test at 16 months
timeFrame: baseline and 16 months
measure: Change from baseline in physical function on the Timed up and go Test at 4 months
timeFrame: baseline and 4 months
measure: Change from baseline in physical function on the Timed up and go Test at 10 months
timeFrame: baseline and 10 months
measure: Change from baseline in flexibility using angular measures at 16 months
timeFrame: baseline and 16 months
measure: Change from baseline in flexibility using angular measures at 4 months
timeFrame: baseline and 4 months
measure: Change from baseline in flexibility using angular measures at 10 months
timeFrame: baseline and 10 months
measure: Change from baseline in flexibility using linear measures at 16 months
timeFrame: baseline and 16 months
measure: Change from baseline in flexibility using linear measures at 4 months
timeFrame: baseline and 4 months
measure: Change from baseline in flexibility using linear measures at 10 months
timeFrame: baseline and 10 months
measure: Change from baseline in pain severity on the Brief Pain Inventory at 16 months
timeFrame: baseline and 16 months
measure: Change from baseline in pain severity on the Brief Pain Inventory at 4 months
timeFrame: baseline and 4 months
measure: Change from baseline in pain severity on the Brief Pain Inventory at 10 months
timeFrame: baseline and 10 months
measure: Change from baseline in pain interference on the Pain Disability Index at 16 months
timeFrame: baseline and 16 months
measure: Change from baseline in pain interference on the Pain Disability Index at 4 months
timeFrame: baseline and 4 months
measure: Change from baseline in pain interference on the Pain Disability Index at 10 months
timeFrame: baseline and 10 months
measure: Change from baseline in sleep quality on the Pittsburgh Sleep Quality Index at 16 months
timeFrame: baseline and 16 months
measure: Change from baseline in sleep quality on the Pittsburgh Sleep Quality Index at 4 months
timeFrame: baseline and 4 months
measure: Change from baseline in sleep quality on the Pittsburgh Sleep Quality Index at 10 months
timeFrame: baseline and 10 months
measure: Change from baseline in Body Image on the Body Image Scale at 16 months
timeFrame: baseline and 16 months
measure: Change from baseline in Body Image on the Body Image Scale at 4 months
timeFrame: baseline and 4 months
measure: Change from baseline in Body Image on the Body Image Scale at 10 months
timeFrame: baseline and 10 months
measure: Change from baseline in depressive symptoms on the Hospital Anxiety and Depression Scale at 16 months
timeFrame: baseline and 16 months
measure: Change from baseline in depressive symptoms on the Hospital Anxiety and Depression Scale at 4 months
timeFrame: baseline and 4 months
measure: Change from baseline in depressive symptoms on the Hospital Anxiety and Depression Scale at 10 months
timeFrame: baseline and 10 months
measure: Change from baseline in psychological well-being at 16 months
timeFrame: baseline and 16 months
measure: Change from baseline in psychological well-being at 4 months
timeFrame: baseline and 4 months
measure: Change from baseline in psychological well-being at 10 months
timeFrame: baseline and 10 months
measure: Change from baseline in exercise motivations on the Behavioral Regulation in Exercise Questionnaire-3 at 16 months
timeFrame: baseline and 16 months
measure: Change from baseline in exercise motivations on the Behavioral Regulation in Exercise Questionnaire-3 at 4 months
timeFrame: baseline and 4 months
measure: Change from baseline in exercise motivations on the Behavioral Regulation in Exercise Questionnaire-3 at 10 months
timeFrame: baseline and 10 months
measure: Change from baseline in Exercise Needs Satisfaction and Frustration at 16 months
timeFrame: baseline and 16 months
measure: Change from baseline in Exercise Needs Satisfaction and Frustration at 4 months
timeFrame: baseline and 4 months
measure: Change from baseline in Exercise Needs Satisfaction and Frustration at 10 months
timeFrame: baseline and 10 months
measure: Change from baseline in Affective Response to Exercise at 16 months
timeFrame: baseline and 16 months
measure: Change from baseline in Affective Response to Exercise at 4 months
timeFrame: baseline and 4 months
measure: Change from baseline in Affective Response to Exercise at 10 months
timeFrame: baseline and 10 months
measure: Change from baseline in Exercise Self-Efficacy at 16 months
timeFrame: baseline and 16 months
measure: Change from baseline in Exercise Self-Efficacy at 4 months
timeFrame: baseline and 4 months
measure: Change from baseline in Exercise Self-Efficacy at 10 months
timeFrame: baseline and 10 months
measure: Self-regulation skills
timeFrame: 4 months (intervention's end), 10 and 16 months
measure: Perceived intervention climate
timeFrame: 4 months (intervention's end)
Other outcomes:
Locations:
city: Lisboa
country: Portugal
facility: Universidade Lusófona, Campo Grande 376
Study officials:
affiliation: Universidade Lusófona, Faculdade de Educação Física e Desporto, Lisboa, Portugal
name: Eliana V. Carraça, PhD
role: PRINCIPAL_INVESTIGATOR
References: