The Women’s wellness after cancer program: a multisite, single-blinded, randomised controlled trial protocol

Abstract

BackgroundDespite advances in cancer diagnosis and treatment have significantly improved survival rates, patients post-treatment-related health needs are often not adequately addressed by current health services. The aim of the Women’s Wellness after Cancer Program (WWACP), which is a digitised multimodal lifestyle intervention, is to enhance health-related quality of life in women previously treated for blood, breast and gynaecological cancers.MethodsA single-blinded, multi-centre randomized controlled trial recruited a total of 330 women within 24 months of completion of chemotherapy (primary or adjuvant) and/or radiotherapy. Women were randomly assigned to either usual care or intervention using computer-generated permuted-block randomisation. The intervention comprises an evidence-based interactive iBook and journal, web interface, and virtual health consultations by an experienced cancer nurse trained in the delivery of the WWACP. The 12 week intervention focuses on evidence-based health education and health promotion after a cancer diagnosis. Components are drawn from the American Cancer Research Institute and the World Cancer Research Fund Guidelines (2010), incorporating promotion of physical activity, good diet, smoking cessation, reduction of alcohol intake, plus strategies for sleep and stress management. The program is based on Bandura’s social cognitive theoretical framework. The primary outcome is health-related quality of life, as measured by the Functional Assessment of Cancer Therapy-General (FACT-G). Secondary outcomes are menopausal symptoms as assessed by Greene Climacteric Scale; physical activity elicited with the Physical Activity Questionnaire Short Form (IPAQ-SF); sleep measured by the Pittsburgh Sleep Quality Index; habitual dietary intake monitored with the Food Frequency Questionnaire (FFQ); alcohol intake and tobacco use measured by the Australian Health Survey and anthropometric measures including height, weight and waist-to-hip ratio. All participants were assessed with these measures at baseline (at the start of the intervention), 12 weeks (at completion of the intervention), and 24 months (to determine the level of sustained behaviour change). Further, a simultaneous cost-effectiveness evaluation will consider if the WWACP provides value for money and will be reported separately.DiscussionWomen treated for blood, breast and gynaecological cancers demonstrate increasingly good survival rates. However, they experience residual health problems that are potentially modifiable through behavioural lifestyle interventions such as the WWACP.Trial registrationThe protocol for this study was registered with the Australian and New Zealand Clinical Trials Registry, Trial ID: ACTRN12614000800628, July 28, 2014.

Exploring the provision of alcohol advice by clinicians to breast cancer patients

“…Multiple studies exploring the effect of health behaviour interventions in cancer patients have found both clinician-led face-to-face sessions and access to educational resources to result in, at the very least, short-term improvement in certain modifiable lifestyle factors (Greenlee et al, 2016;Hebert et al, 2001). However, where the widespread application of personalised, face-to-face sessions are not considered feasible, other methods such as telephone counselling and the provision of quality and directed educational resources are viable alternatives that should continue to be explored (Anderson et al, 2017;Pierce et al, 2004).…”

Life stress and symptoms of anxiety and depression in women after cancer: The mediating effect of stress appraisal and coping

“…This paper presents baseline data from 278 of the 351 women aged 18 years and older previously treated for breast, gynaecological, or blood cancer, participating in the Women's Wellness After Cancer Program multisite lifestyle intervention (see Anderson et al for trial details). For this analysis, we excluded 73 women with incomplete data on anxiety and depressive symptoms (outcome variables), SLEs (predictor), perceived stress and resilience (mediators), or the covariates derived through the bivariate analyses (discussed in detail in the results).…”

“…Ethical approval was obtained from relevant Human Research and Ethics Committees (QUT Approval number: 1300000048) prior to participant recruitment, and the protocol for this intervention study has been described elsewhere …”

“…To test this hypothesis, we analysed a subset of data from the Women's Wellness After Cancer Programwith the aim of (1) examining the prevalence and patterns of life stress reported by women after cancer and (2) determining the direct and intermediary relationship of stress appraisal and resilience, and symptoms of anxiety and depression in women previously treated for cancer. This paper presents baseline data from 278 of the 351 women aged 18 years and older previously treated for breast, gynaecological, or blood cancer, participating in the Women's Wellness After Cancer Program multisite lifestyle intervention (see Anderson et al 19,20 for trial details). For this analysis, we excluded 73 women with incomplete data on anxiety and depressive symptoms (outcome variables), SLEs (predictor), perceived stress and resilience (mediators), or the covariates derived through the bivariate analyses (discussed in detail in the results).…”

Systematic review and meta-analysis of patient reported outcomes for nurse-led models of survivorship care for adult cancer patients

“…The meta-analysis strengthened findings of this review however we observed that three of the four significant findings included data from the same four publications due to the limited number of papers which used the EORTC-QLQ instrument in the time period analysed; this may have biased results however the studies used diverse tumour groups (n=2 gastric; n=1 head and neck, and n=1 breast). An exploratory literature search identified that a number of randomised controlled trials of nurse-led models of cancer survivorship care are currently underway [68][69][70][71]. As more data is published this meta-analysis should be repeated to verify the findings.…”