Online vs In-Person Lifestyle Intervention for Weight Management and Improved Quality of Life in Breast Cancer Survivors

Official Title

A Randomized Controlled Trial Evaluating the Efficacy of an Online Versus Face-to-Face Lifestyle Intervention for Healthy Weight Management and Improved Quality of Life in Breast Cancer Survivors

Summary:

Obesity presents serious psychological and physical consequences for breast cancer survivors, including diminished quality of life, poorer prognosis and increased mortality. As such, there is a great need to develop strategies for these women to maintain optimal body weight. Diet and exercise have been shown to lead to successful weight loss among this population but these effects are seldom sustained, plausibly because these efforts alone overlook less obvious, but equally important, psychosocial factors that can interfere with prolonged progress. This study will implement a group-based intervention addressing diet and exercise along with other psychosocial issues related to survivorship such as depression, fatigue, body image and social support. Based on the growing popularity and benefits of computer-based health care, including convenience and anonymity, this intervention will also be offered online, representing the first of its kind. It is hypothesized that 1) women in both intervention groups will achieve significantly greater loss in weight and improvement in psychosocial well-being than those in a control group and 2) women in the online group will achieve outcomes comparable to those in the face-to-face group. This research has the ability to improve the long-term health of breast cancer survivors by incorporating psychosocial interventions into standard medical care practices and has the potential to increase accessibility of these services using online technology.

Trial Description

Primary Outcome:

  • Change in Body Mass Index
  • Change in Waist Circumference
Secondary Outcome:
  • Change in Quality of Life
  • Change in Subjective Health
  • Change in Life Satisfaction
  • Change in Symptoms of Anxiety and Depression
  • Change in Body Image
  • Change in Objectified Body Consciousness
  • Change in Dietary Intake
  • Change in 'Intuitive Eating' Habits
  • Change in Exercise Habits
  • Change in Self-Efficacy
Breast cancer (BC) is one of the most common types of cancer in Canadian women, and although the mortality rate is decreasing, there remain numerous challenges for survivorship. Among the most prevalent yet less commonly discussed post-treatment concerns, is substantial weight gain, with approximately 70% of women being overweight at diagnosis and additional weight gain often resulting from treatment5. Obesity has serious psychological and physical implications for both pre- and post-menopausal BC survivors; in addition to compromising body image and QoL, it increases risk for recurrence and mortality. Specifically, increased fat results in greater production of estrogen, insulin, leptin and pro-inflammatory cytokines, and lesser production of sex hormone binding globulin, all of which have been linked to the promotion of BC and tumour growth. As such, the development of strategies for the promotion and maintenance of optimal body mass has become a primary focus for BC survivorship. Trials of lifestyle interventions for this population are in their early stages and have primarily included modification of diet alone, exercise alone, or both. Results have been mixed, especially regarding the effects of dietary change alone but generally support the benefits of exercise and combined diet and exercise on weight loss and improved QoL in cancer survivors. However, despite indications that diet and exercise interventions lead to improvements in physical health and mental health, there remains a lack of consistent evidence that these gains are maintained long-term. As such, there is a need for more systematic follow-up of these interventions to determine their potential to produce enduring effects as well as for development and refinement of techniques that improve long-term weight management. Beyond developing effective services, a direction for future research should include outreach to underserved populations. Rural BC survivors represent one group, in particular, with limited access to healthy lifestyle interventions, and who could benefit greatly from participation. Compared to their urban counterparts, these women are less likely to have timely diagnostic biopsies and receive optimal treatment, and are diagnosed later, at more advanced stages when prognosis is less favourable. They are also more likely to be obese, be less physically active, have poor eating habits, experience psychological distress, and have less access to mental health resources, placing them at heightened risk for weight gain. Researchers and health care providers have a responsibility to develop ways of redressing such health disparities and helping these particularly vulnerable women make lasting changes to their overall health and QoL. Society's recent movement toward "eHealth", which refers to "the use of emerging information and communication technology, especially the Internet, to improve or enable health and health care", introduces an exciting opportunity to increase availability of health care to BC survivors. Numerous eHealth diet and exercise interventions have been evaluated using community samples and have generally yielded mixed findings along with recommendations for refinement of future programs and more rigorous evaluation, including the need for comparison of outcomes between in-person and F2F program interventions. Only one online community intervention has been in group-format, and to the investigators knowledge, no online, group-based lifestyle intervention has yet been developed specifically for BC survivors. Given the potential for broader delivery of health care services via the Internet, research surrounding the value of computer-based lifestyle interventions is especially warranted. Present Study Firstly, while trials to date demonstrate that diet and exercise interventions lead to improvements in physical and mental health, there remains a lack of consistent evidence that these gains are maintained long-term. Arguably, programs that focus primarily on modifying nutrition and/or physical activity render only short-term effects because they fail to address more subtle, but ingrained, psychosocial factors that interfere with sustained progress. This project will develop and evaluate a group-based lifestyle intervention that incorporates diet and exercise strategies along with education of issues more broadly related to healthy lifestyle in the context of BC survivorship such as depression, fatigue, body image, and social support. The program will be developed by an interdisciplinary team of clinicians/researchers (oncologist, nurse, dietician, physiotherapist and senior psychologist), and grounded in CBT and Social Cognitive Theory, which recognize how one's motivation and self-efficacy are influenced by personal, social, and environmental factors, and as such, goes beyond behavioural diet and exercise modification by incorporating self-monitoring, motivational interviewing, and cognitive restructuring techniques. Secondly, despite growing evidence for the efficacy of interactive computer-based programs aimed at behaviour change and the associated advantages (e.g., convenience, accessibility, anonymity), there are no such interventions to support weight loss and sustained management for BC survivors. This project aims to fill this gap in health care by developing and evaluating the first online, group-based lifestyle intervention for BC survivors by translating the F2F intervention protocol into an online format. Objectives. The primary objective is to develop an effective group-based lifestyle intervention that yields sustained weight loss and improved QoL among BC survivors. The secondary objective is to demonstrate that online delivery of this service is equally as effective as conventional F2F delivery, thereby lending support to online adaptation of valuable in-person programs that are currently under-accessed and under-utilized by BC survivors. Hypotheses. It is hypothesized that women in both intervention groups (F2F and online) will achieve significantly greater loss in weight and improvement in psychosocial well-being than those in a control group. It is also hypothesized that women in the online group will achieve outcomes comparable to those in the F2F version of the same program. Method This study will employ a randomized controlled trial entailing a 3-arm, repeated measures psychometric evaluation. Standardized measures will be completed at pre-treatment, mid-way through the 12-week intervention, post-treatment, and 6- and 12- months follow-up. Recruitment Participants will be accrued through the Louise Temerty Breast Centre at Sunnybrook Health Sciences Centre (SHSC). The study will be advertised by staff and through brochures in the hospital and community-based organizations such as 'Willow Breast Cancer Support Canada', and via electronic brochures posted on websites commonly accessed by BC survivors. Interested women will contact the principal investigator, who will provide detailed information about the nature of the project, the study objectives and procedures, answer any questions the prospective participants have, and determine eligibility using the screening questionnaire. Procedure Participants will follow an individualized diet and exercise plan for 3 months while participating, either in-person or online, in psychoeducational weekly group discussions about lifestyle modification and maintenance of health promoting behaviours. Relevant issues specific to BC (e.g., self-esteem, depression, fatigue, changes in social support) will also be addressed. Once screened, participants will be invited to SHSC to complete consent forms and baseline measures and a demographics questionnaire. They will then be stratified by age, baseline BMI and menopausal status and randomized to one of three conditions: (1) F2F intervention group; (2) online intervention group; or (3) control group. Women in the control group will receive an information package on healthy lifestyle maintenance post-treatment.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

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