None listed
Conditions
Brief summary
The primary objective of this study is to assess the feasibility, acceptability, and effectiveness of a multimodal early supportive care program delivered during neoadjuvant chemotherapy treatment for women with breast cancer. Who is it for? You may be eligible for this study if you are aged 18 years or older, have been diagnosed with breast cancer, and are planned to receive neoadjuvant (i.e. prior to surgery) chemotherapy. Study details All participants will receive the supportive care program for the duration of their chemotherapy treatment. The program will involve an holistic nursing assessment, tailored exercise (3x per week), three education modules and complementary therapies (acupuncture, massage etc) prescribed and provided when symptom burden is moderate to severe. Participants will complete a number of questionnaires, tests of physical function, and blood tests at the time of enrolment, mid-program, upon completion of the program, after completion of surgery, and at 6 months post-enrolment, in order to determine the safety, acceptability, and effectiveness of the program. It is hoped that this study may show that the multimodal early supportive care program is safe, acceptable to patients and their treating clinicians, and effective in modifying side effects of treatment, chemotherapy adherence, anthropometric measures, and selected cardiac, and disease recurrence risk factors, self-efficacy and satisfaction with surgery.
Interventions
Participants will be enrolled in a multimodal early supportive care program within four weeks of commencing neoadjuvant chemotherapy for breast cancer. The study intervention comprises four main components: exercise, education, holistic nursing +/- medical assessment and complementary therapies. This complex intervention is tailored to the needs and preferences of participants. Participants will receive an initial consultation with a nurse lasting approx 40 minutes (face to face or telehealth b
Participants will be enrolled in a multimodal early supportive care program within four weeks of commencing neoadjuvant chemotherapy for breast cancer. The study intervention comprises four main components: exercise, education, holistic nursing +/- medical assessment and complementary therapies. This complex intervention is tailored to the needs and preferences of participants. Participants will receive an initial consultation with a nurse lasting approx 40 minutes (face to face or telehealth based on patient preference), supportive care specialist (as needed) and exercise physiologist to tailor the intervention. Participants will be invited to participate in a core periodised exercise program, delivered by an exercise physiologist using both online and face-to-face (hospital) modes of delivery. The exercise plan includes a periodised model of aerobic, resistance, balance and flexibility prescribed according to a progression model adapted for individual symptoms. Sessions will last up to 60 minutes, 3 times a week for the duration of chemotherapy. Responses to treatment are often unpredictable therefore clinical decision-making will inform changes required. Three education modules will be delivered face-to-face by medical, allied health and complementary therapists. The content of the modules will cover lifestyle, nutrition, mindfulness, yoga, lymphoedema, sexuality and intimacy, and preparing for surgery. Sessions will last up to one hour and delivered as hybrid (ZOOM and face-to-face). Complementary therapies will be delivered at the hospital as required and include yoga, acupuncture, mindfulness, reflexology, oncology massage and lymphedema therapists. continue the program until the completion of their chemotherapy (approx. 20 weeks). All visits and online sessions will be recorded to monitor adherance.
Sponsors
Chris O'Brien Lifehouse Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Study participant Group 1: 1. Female, aged over 18 years, diagnosed with breast cancer. 2. Has been identified as a patient for the NACT pathway by treating breast surgeon and/or medical oncologist. 3. Willingness to provide written consent and able to complete written study assessments and understand instruction for program in English. Study participant Group 2: 1. HCP participants who have been involved in the program delivery.
Exclusion criteria
1. Women lactating, pregnant or of childbearing potential who are not willing to avoid becoming pregnant during the study. 2. Unable to give informed consent 3. Has completed more than 2 cycles of neoadjuvant chemotherapy at time of enrolment 4. Unable to participate due to no computer at home or device to teleconference. 5. Contraindications to participation will be determine based on oncologist and exercise physiologist review based on the PAR-Q and the Exercise and Sports Science Australia. The PAR-Q+ will be used as a preliminary tool. The PAR-Q+ is designed to identify symptoms or conditions requiring medical evaluation before participating in exercise. In this setting, cardiac risk is assessed to determine eligibility for NACT and medical records are reviewed before Exercise Physiology assessment. Additional information will be collected based on recommendations of Exercise and Sports Science Australia. These are outlined below: • Health history • physical activity and exercise history • cancer and non-cancer co-morbidities • expected treatment related toxicities • identification of patient capacity and contraindications • psychosocial and physiological constraints, accessibility, preferences, self-efficacy, barriers and facilitators to exercise • patient-centred requirements
Outcome results
None listed