Promoting Physical Activity in Breast Cancer Survivors on Aromatase Inhibitors

NCT05860621 | Unknown

• 2 other identifiers: PAC-WOMANPTDC/SAU-DES/2865/2020
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Female; Hormone-receptor-positive Breast Cancer

Outcome Measures

Primary Outcomes (10)

• Change from baseline in Physical activity on Actigraph GT9X accelerometers at 16 months

  Accelerometers Actigraph GT9X will be worn in the wrist for 7 days to assess the amount of activity expressed as minutes per day spent in different intensities (sedentary, light, moderate, vigorous).

  baseline and 16 months

• Change from baseline in Physical activity on Actigraph GT9X accelerometers at 4 months

  Accelerometers Actigraph GT9X will be worn in the wrist for 7 days to assess the amount of activity expressed as minutes per day spent in different intensities (sedentary, light, moderate, vigorous).

  baseline and 4 months

• Change from baseline in Physical activity on Actigraph GT9X accelerometers at 10 months

  Accelerometers Actigraph GT9X will be worn in the wrist for 7 days to assess the amount of activity expressed as minutes per day spent in different intensities (sedentary, light, moderate, vigorous).

  baseline and 10 months

• Change from baseline in self-reported physical activity on International Physical Activity Questionnaire (IPAQ-sf) at 16 months

  The 9-item IPAQ-sf measures the weekly frequency and duration of PA across three specific intensities (i.e., light, moderate, and vigorous), and time spent sitting during week and weekend days. Scores for weekly minutes of total physical activity, and discriminated by intensity, will be obtained. Total minutes of sitting time will be also obtained.

  baseline and 16 months

• Change from baseline in self-reported physical activity on International Physical Activity Questionnaire (IPAQ-sf) at 4 months

  The 9-item IPAQ-sf measures the weekly frequency and duration of PA across three specific intensities (i.e., light, moderate, and vigorous), and time spent sitting during week and weekend days. Scores for weekly minutes of total physical activity, and discriminated by intensity, will be obtained. Total minutes of sitting time will be also obtained.

  baseline and 4 months

• Change from baseline in self-reported physical activity on International Physical Activity Questionnaire (IPAQ-sf) at 10 months

  The 9-item IPAQ-sf measures the weekly frequency and duration of PA across three specific intensities (i.e., light, moderate, and vigorous), and time spent sitting during week and weekend days. Scores for weekly minutes of total physical activity, and discriminated by intensity, will be obtained. Total minutes of sitting time will be also obtained.

  baseline and 10 months

• 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

  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. Scores generally range from 1 to 4. Higher scores generally reflect worse quality of life.

  baseline and 16 months

• 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

  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. Scores generally range from 1 to 4. Higher scores generally reflect worse quality of life.

  baseline and 4 months

• 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

  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. Scores generally range from 1 to 4. Higher scores generally reflect worse quality of life.

  baseline and 10 months

• 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.

  6-month after the end of the intervention

Secondary Outcomes (59)

• Change from baseline in body composition on bioelectrical impedance at 16 months

  baseline, 4 months (intervention's end), 10 and 16 months

• Change from baseline in body composition on bioelectrical impedance at 4 months

  baseline and 4 months

• Change from baseline in body composition on bioelectrical impedance at 10 months

  baseline and 10 months

• Change from baseline in body mass index (BMI) at 16 months

  baseline and 16 months

• Change from baseline in body mass index (BMI) at 4 months

  baseline and 4 months

Study Arms (3)

Brief Physical Activity Counselling

EXPERIMENTAL

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

Behavioral: Brief Physical Activity Counselling

Structured Exercise Program

EXPERIMENTAL

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

Behavioral: Structured Exercise Program

Waitlist control

NO INTERVENTION

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.

Interventions

Brief Physical Activity Counselling 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.

Brief Physical Activity Counselling

Structured Exercise Program 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.

Structured Exercise Program

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 fulfill the proposed schedule.

Sponsors & Collaborators

• Grupo Lusófona: lead
• Fundação para a Ciência e a Tecnologia: collaborator
• Faculdade de Motricidade Humana: collaborator

Study Sites (1)

Universidade Lusófona, Campo Grande 376

Lisbon, 1749-024, Portugal

RECRUITING

Related Publications (2)

• 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.

  PMID: 39799368 DERIVED

• 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.

  PMID: 37407950 DERIVED

Study Officials

• Eliana V. Carraça, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eliana V. Carraça, PhD

CONTACT

+315912154907; p4890@ulusofona.pt

Flávio Jerónimo, MSc

CONTACT

+351964562662; pacwoman@ulusofona.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: April 20, 2023
• First Posted: May 16, 2023
• Study Start: January 5, 2022
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: May 16, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)