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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02861703
Recruitment Status : Completed
First Posted : August 10, 2016
Last Update Posted : December 21, 2018
Sponsor:
Collaborator:
Canadian Breast Cancer Foundation
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre

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.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Online lifestyle intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Feasibility, Acceptability and Preliminary Effectiveness of an Online Lifestyle Intervention for Healthy Weight Management and Improved Quality of Life in Breast Cancer Survivors
Actual Study Start Date : July 2015
Actual Primary Completion Date : July 2018
Actual Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Online lifestyle intervention
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
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).




Primary Outcome Measures :
  1. Change in Body Mass Index [ Time Frame: Baseline, 6 months (mid-treatment), 12 months (post-treatment), 18 months (6-month follow-up), 24 months (12-month follow-up) ]
    Measured as a function of participants' weight (kg), divided by their height (squared metres)

  2. Change in Waist Circumference [ Time Frame: Baseline, 6 months (mid-treatment), 12 months (post-treatment), 18 months (6-month follow-up), 24 months (12-month follow-up) ]
    Measured as the difference across time points on participants' waist circumference in inches, using a nonelastic measuring tape at the widest part of hips.


Secondary Outcome Measures :
  1. Change in Quality of Life [ Time Frame: Baseline, 6 months (mid-treatment), 12 months (post-treatment), 18 months (6-month follow-up), 24 months (12-month follow-up) ]
    Measured as the difference across time points on participants' scores on the Functional Assessment of Cancer Therapy - For Patients with Breast Cancer (FACT-B)

  2. Change in Subjective Health [ Time Frame: Baseline, 6 months (mid-treatment), 12 months (post-treatment), 18 months (6-month follow-up), 24 months (12-month follow-up) ]
    Measured as the difference across time points on participants' scores on the Rand Health Survey--Short Form (SF-36)

  3. Change in Life Satisfaction [ Time Frame: Baseline, 6 months (mid-treatment), 12 months (post-treatment), 18 months (6-month follow-up), 24 months (12-month follow-up) ]
    Measured as the difference across time points on participants' scores on the Satisfaction with Life Scale (SWLS)

  4. Change in Symptoms of Anxiety and Depression [ Time Frame: Baseline, 6 months (mid-treatment), 12 months (post-treatment), 18 months (6-month follow-up), 24 months (12-month follow-up) ]
    Measured as the difference across time points on participants' scores on the Hospital Anxiety and Depression Scale (HADS)

  5. Change in Body Image [ Time Frame: Baseline, 6 months (mid-treatment), 12 months (post-treatment), 18 months (6-month follow-up), 24 months (12-month follow-up) ]
    Measured as the difference across time points on participants' scores on the Body Image Scale (BIS)

  6. Change in Objectified Body Consciousness [ Time Frame: Baseline, 6 months (mid-treatment), 12 months (post-treatment), 18 months (6-month follow-up), 24 months (12-month follow-up) ]
    Measured as the difference across time points on participants' scores on the Objectified Body Consciousness Scale (OBCS)

  7. Change in Dietary Intake [ Time Frame: Baseline, 6 months (mid-treatment), 12 months (post-treatment), 18 months (6-month follow-up), 24 months (12-month follow-up) ]
    Measured as the difference across time points on participants' scores on the Automated Self-administered 24-hour Dietary Recall (ASA24)

  8. Change in 'Intuitive Eating' Habits [ Time Frame: Baseline, 6 months (mid-treatment), 12 months (post-treatment), 18 months (6-month follow-up), 24 months (12-month follow-up) ]
    Measured as the difference across time points on participants' scores on the Intuitive Eating Scale-2 (IES-2)

  9. Change in Exercise Habits [ Time Frame: Baseline, 6 months (mid-treatment), 12 months (post-treatment), 18 months (6-month follow-up), 24 months (12-month follow-up) ]
    Measured as the difference across time points on participants' scores on the Godin Leisure-Time Exercise Questionnaire

  10. Change in Self-Efficacy [ Time Frame: Baseline, 6 months (mid-treatment), 12 months (post-treatment), 18 months (6-month follow-up), 24 months (12-month follow-up) ]
    Measured as the difference across time points on participants' scores on the Nutrition and Physical Exercise Self-Efficacy Scale



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. be 21 years or older
  2. have been diagnosed with primary BC (stages I-III)
  3. have completed active treatment within the previous 5 years
  4. have a BMI above 25 or report a weight increase of 10 pounds or more post-treatment,
  5. be available to participate in 10 consecutive weeks of the online program

7) be comfortable using and have access to a computer and secure Internet connection 8) can read and write in English.

Exclusion Criteria:

  1. diagnosis of metastatic cancer
  2. 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)
  3. diagnosis of an additional medical condition that is not being successfully managed/treated
  4. plans to undergo a medical procedure within the next year
  5. plans to participate in another structured weight loss program or take weight loss medication within the next year.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02861703


Locations
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Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Canadian Breast Cancer Foundation
Investigators
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Principal Investigator: Karen Fergus Sunnybrook Health Sciences Centre
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Responsible Party: Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT02861703    
Other Study ID Numbers: CBCF-092014
First Posted: August 10, 2016    Key Record Dates
Last Update Posted: December 21, 2018
Last Verified: December 2018