The Younger Women's Wellness after Cancer program: A pilot study of an E-Health Enabled Lifestyle Modification Intervention.

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12614001087640
• Date of registration: 10/10/2014
• Prospective Registration: Yes
• Primary sponsor: Queensland University of Technology
• Public title: The Younger Women's Wellness after Cancer program: A pilot study of an E-Health Enabled Lifestyle Modification Intervention.
• Scientific title: The Younger Women's Wellness after Cancer program: A pilot study of an E-Health Enabled Lifestyle Modification Intervention to Improve the Health and Wellness of Younger Women after Cancer Treatment.
• Date of first enrolment: 29/05/2015
• Target sample size: 80
• Recruitment status: Stopped early
• URL: https://anzctr.org.au/ACTRN12614001087640.aspx
• Study type: Interventional
• Study design: Purpose: Educational / counselling / training; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Prof Debra Anderson

• Name: Ms Janine Porter-Steele

Key inclusion & exclusion criteria

Inclusion criteria: (1) Completed surgery or chemotherapy (primary or adjuvant) and/or radiotherapy for blood, breast and/or gynaecological cancer (2) Able to speak and read Level 10 English (3) Must have access to internet (4) not currently receiving any cytotoxic maintenance treatments
Exclusion criteria: (1) Metastatic or advanced cancer and inoperable or active loco-regional disease (2) Any clinical, cognitive or psychiatric contraindication identified by treating staff (3) Participants on cytotoxic maintenance treatments will be excluded

Age minimum: 20 Years
Age maximum: 50 Years
Gender: Females

Health Condition(s) or Problem(s) studied

Cancer - Cervical (cervix)

Cancer - Breast

Breast Cancer ;Gynaecological cancer;Haematological cancer;
Breast Cancer
Gynaecological cancer
Haematological cancer

Cancer - Ovarian and primary peritoneal

Intervention(s)

The intervention is a 12 week, e-health enabled, structured health promotion intervention targeted at improving health related quality of life and reducing chronic disease risk factors in women between 20 and 50 years of age who have previously been treated for breast, haematological and gynaecological cancers. All women in the intervention arm will receive health education material, including a Program Journal (in the form of an interactive iBook), and access to an interactive web interface. The iBook 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 iBook 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. Participants will receive access to self-directed resources (via the website) and personal consultations (via videoconference) with a nurse. Three individual, virtual 30 minute consultations at 0, 6 and 12 weeks will be provided by a registered nurse trained in the intervention.

Primary Outcome(s)

The primary outcome measure is change in health-related quality of life as measured by The Functional Assessment of Cancer Therapy-General (FACT-G)[Baseline, 12 weeks and 24 weeks ]

Secondary Outcome(s)

Habitual dietary intake will be monitored through the Food Frequency Questionnaire [Baseline, 12 weeks and 24 weeks ]

Menopausal symptoms - Greene Climacteric Scale[Baseline, 12 weeks and 24 weeks ]

Internet and technology use. This will be assessed with 13 questions incorporated into the online survey (e.g. how often do you access the internet?; have you ever used health-related mobile apps?; how often to you access health forums?) [Baseline, 12 weeks and 24 weeks ]

Stress, anxiety and depression - Perceived Stress, and List of Threatening Experiences (LTE), Connor-Davidson Resilience Scale, Zung self-rated anxiety scale, Centre for Epidemiologic Studies Depression Scale.[Baseline, 12 weeks and 24 weeks ]

Body image, sexuality and sexual function. These will be assessed with validated tools incorporated into the online survey (the Body Image Scale, the Female Sexual Function Index, and the Emotional Intimacy Scale). [Baseline, 12 weeks and 24 weeks]

Health behaviours, including smoking and alcohol consumption, will be assessed in the online survey at baseline (0 weeks), 12 week and 24 weeks. Alcohol consumption is also measured as part of the Food Frequency Questionnaire (described above).[Baseline, 12 weeks and 24 weeks]

Physical activity will be measured using the validated International Physical Activity Questionnaire (IPAQ)[Baseline, 12 weeks and 24 weeks ]

Sleep activity and quality - Pittsburgh sleep quality index [Baseline, 12 weeks and 24 weeks ]

The FACT-Cog tool has been included in the online component of the survey and is a 37 questionnaire assessing cognitive function. [baseline, 12 weeks and 24 weeks]

Anthropometry using standard protocols; including measures of height, weight, waist-to-hip ratio and BMI.[Baseline, 12 weeks and 24 weeks ]

Secondary ID(s)

NIL

Source(s) of Monetary Support

Princess Alexandra Hospital.

Royal Brisbane and Women's Hospital - Diamond Care Grant

Secondary Sponsor(s)

Royal Brisbane and Women's Hospital

Ethics review

Status: Approved
Approval date:
Contact:

Royal Brisbane Women's Hospital Human Research Ethics Committee