Pilot Feasibility Study of an Online Lifestyle Intervention for Overweight Breast Cancer Survivors

NCT02861703 | Completed

• 1 other identifier: CBCF-092014
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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 the intervention will be feasible to implement and acceptable to its participants. It is also hypothesized that the intervention will yield meaningful and sustained changes in body weight, body mass index, waist circumference (primary outcomes), as well as mental well-being, quality of life, and body image (secondary outcomes). 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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

• Change in Body Mass Index

  Measured as a function of participants' weight (kg), divided by their height (squared metres)

  Baseline, 6 months (mid-treatment), 12 months (post-treatment), 18 months (6-month follow-up), 24 months (12-month follow-up)

• Change in Waist Circumference

  Measured as the difference across time points on participants' waist circumference in inches, using a nonelastic measuring tape at the widest part of hips.

  Baseline, 6 months (mid-treatment), 12 months (post-treatment), 18 months (6-month follow-up), 24 months (12-month follow-up)

Secondary Outcomes (10)

• Change in Quality of Life

  Baseline, 6 months (mid-treatment), 12 months (post-treatment), 18 months (6-month follow-up), 24 months (12-month follow-up)

• Change in Subjective Health

  Baseline, 6 months (mid-treatment), 12 months (post-treatment), 18 months (6-month follow-up), 24 months (12-month follow-up)

• Change in Life Satisfaction

  Baseline, 6 months (mid-treatment), 12 months (post-treatment), 18 months (6-month follow-up), 24 months (12-month follow-up)

• Change in Symptoms of Anxiety and Depression

  Baseline, 6 months (mid-treatment), 12 months (post-treatment), 18 months (6-month follow-up), 24 months (12-month follow-up)

• Change in Body Image

  Baseline, 6 months (mid-treatment), 12 months (post-treatment), 18 months (6-month follow-up), 24 months (12-month follow-up)

Study Arms (1)

Online lifestyle intervention

EXPERIMENTAL

A weekly psychosocial intervention ("Online Lifestyle Intervention") delivered in an online group format, to promote positive changes in physical (eating habits, physical activity) and mental health (body image, self-esteem, self-efficacy).

Behavioral: Online lifestyle intervention

Interventions

Online lifestyle intervention BEHAVIORAL

Online, computer-mediated interactive group-based lifestyle intervention addressing thoughts, feelings, behaviours related to eating, physical activity, and other psychosocial issues related to breast cancer survivorship (e.g., mood, body image, existential issues, social support).

Online lifestyle intervention

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• be 21 years or older
• have been diagnosed with primary BC (stages I-III)
• have completed active treatment within the previous 5 years
• have a BMI above 25 or report a weight increase of 10 pounds or more post-treatment,
• be available to participate in 10 consecutive weeks of the online program
• \) be comfortable using and have access to a computer and secure Internet connection 8) can read and write in English.

You may not qualify if:

• diagnosis of metastatic cancer
• diagnosis of a mental health condition that would interfere with their own, or another group members' ability to benefit from the group (e.g., psychosis)
• diagnosis of an additional medical condition that is not being successfully managed/treated
• plans to undergo a medical procedure within the next year
• plans to participate in another structured weight loss program or take weight loss medication within the next year.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• Canadian Breast Cancer Foundation: collaborator

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Karen Fergus

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2015
• First Posted: August 10, 2016
• Study Start: July 1, 2015
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: December 21, 2018

Record last verified: 2018-12

Locations

CA (1)