EMERALD Study: youngEr woMen’s wEllness afteR cAncer feasibiLity stuDy

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2021
INTERVENTION: The intervention is a 12 week structured health promotion intervention targeted at improving health related quality of life and reducing chronic disease risk factors in women between 18 and 50 years of age who have previously been treated for cancer. All women in the intervention arm will receive health education material, including a specially‐designed Program Journal, and access to the study‐specific program website. The Book includes sections on healthy eating, sleep, exercise advice, tips for managing fatigue and stress, mindfulness, and will encourage women to bring together these various components of the health education provided and incorporate them into their lives over a 12‐week period. The Book includes a weekly exercise planner, where women are encouraged to use this journal daily and to plan ahead for their exercise in the following week. It is expected participants will engage with the materials for 1‐2 hours per week. Participants will receive access to self‐directed resources (via the website) and three 30‐60 minute individual, personalised consultations (via video conference) at weeks 1, 6 and 12 will be provided by a registered nurse trained in the intervention. The nurse consultations will include individual goal setting as well as discussion and health education about physical activity, healthy eating, stress, sleep, menopause and sexuality after cancer and strategies to promote intervention adherence. Adherence to the intervention will be assessed during these consults and via focus group interviews at the conclusion of the study period. CONDITION: Breast cancer; ; Breast cancer Cancer ‐ Breast PRIMARY OUTCOME: Change in health‐related quality of life scores, as assessed via the Short Form‐36 (SF‐36) questionnaire[Baseline, 6 weeks, 12 weeks (Primary timepoint) and 24 weeks after randomisation] SECONDARY OUTCOME: Change in body image scores, as assessed via the Body Image Scale (BIS) questionnaire ; [Baseline, 6 weeks, 12 weeks and 24 weeks after randomisation] Change in diet scores, as assessed via the Food Variety Checklist (FVC) questionnaire[Baseline, 6 weeks, 12 weeks and 24 weeks after randomisation] Change in distress scores, as assessed via the Distress Thermometer (DT) questionnaire[Baseline, 6 weeks, 12 weeks and 24 weeks after randomisation] Change in menopausal symptoms scores, as assessed via the Green Climacteric Scale (GCS) questionnaire ; [Baseline, 6 weeks, 12 weeks and 24 weeks after randomisation] Change in physical activity scores, as assessed via the Godin Leisure‐Time Exercise Questionnaire (GLTEQ) [Baseline, 6 weeks, 12 weeks and 24 weeks after randomisation] Change in sexual function scores, as assessed via the Female Sexual Function Index (FSFI) questionnaire[Baseline, 6 weeks, 12 weeks and 24 weeks after randomisation] Change in sleep quality scores, as assessed via the Pittsburgh Sleep Quality Index (PSQI) questionnaire INCLUSION CRITERIA: 1. Women who have completed any intensive treatment (surgery, chemotherapy, radiotherapy) for breast cancer in the previous 24 months (can be on endocrine or targeted therapy). 2. Aged between 18 years and 50 years (inclusive). 3. Reside in Australia. 4. Have no metastatic disease. 5. Have access to the internet. 6. Own, or have access to, a computer or tablet device. 7. Willing and able to comply with all study requirements, including intervention, timing and nature of required assessments. 8. Able to speak and read in English to ensure consent is informed and documentation of participant‐reported outcome measures can be adhered to. 9. Voluntary written informed consent. ; [Baseline, 6 weeks, 12 weeks and 24 weeks after randomisation] Change in waist circumference, as assessed via the World Health Organisation's standardised protocol using an anthropometry tape, collected virtually under supervision of a research assistant[Baseline, 6 weeks, 12 weeks and 24 weeks after randomisation] Feasibility of the study intervention, as assessed via a free text feasibility survey[12 weeks after randomisation] Impacts of COVID‐19 on study involvement and engagement, as assessed via a specially‐designed Likert scale and free text survey[Baseline, 6 weeks and 12 weeks after randomisation] Self‐reported use of support services and interventions offered, as assessed verbally during the nurse consults and the focus group interviews[Baseline, 6 weeks and 12 weeks after randomisation]
Epistemonikos ID: 6c962cbe3b02572dcfa50018e93bf051ebae79b9
First added on: Aug 25, 2024