Evaluation of a Web-based Psychological Intervention as add-on to Care as Usual in Breast Cancer Survivors: Effect on Lifestyle and Psychometric Outcome
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Technical University of Dortmund
- Enrollment
- 360
- Locations
- 2
- Primary Endpoint
- Determination of Physical Activity using the International Physical Activity Questionnaire
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
The trial aims to evaluate the effectiveness of a novel web-based intervention (Optimune), which was designed to introduce relevant cognitive-behavioral therapy (CBT) techniques to women with breast cancer who are past the active eradication phase. The present study will test the hypothesis that Optimune has an impact on lifestyle parameters and psychometric outcomes. Therefore, 360 woman with breast cancer will be recruited and randomized to two groups: (1) a control group, in which they may engage with any treatment (Care-as-Usual, CAU) and receive access to Optimune after a delay of 3 months (i.e., CAU/wait list control group), or (2) to a treatment group that immediately receives 12-month access to Optimune and may also use CAU. The primary outcome measure is the effect on quality of life, physical activity and diet three month post-baseline.
Detailed Description
Depression and fatigue is common in breast cancer survivors and its presence is associated with personal suffering, increased inflammatory activity, and worse prognosis. While in the phase of acute treatment many women receive short-term psychological support to better cope with the situation, this is not standard of care in the years following. Web-based psychological interventions are easily accessible and preliminary evidence suggests that such interventions can be effective. However, no trial has yet examined whether a CBT-based internet intervention designed to meet the needs of breast cancer survivors can achieve effects on lifestyle parameters and psychometric outcomes, when offered as adjunct to care as usual. In this study, the investigators will investigate treatment effects of the novel web-based program Optimune when added to treatment as usual. Beyond established CBT techniques targeting depression, anxiety, and fatigue, this intervention specifically includes elements that have shown effects on markers of immune status and inflammation, including sleep and stress management (e.g., mindfulness-based techniques) and lifestyle optimization (dietary and physical activity advice). The delivery and training of content is continuously individualized to match users' preferences and needs, based on responses within the program. The intervention is delivered via the internet and protected by individually assigned passwords. The program can be accessed for 365 days after registration. This randomized controlled trial will include 360 women with breast cancer who are past the active eradication phase. Participants will be recruited from various settings, including web-based advertisement and internet forums/groups. Participants will be randomly assigned to either (1) a control group, in which they receive care as usual (CAU) and are given access to the web-based intervention (Optimune) after a delay of 3 months (i.e., CAU/wait list control group), or (2) a treatment group that may also use CAU and in addition immediately receives 12-month access to the web-based intervention (Optimune). Measurements are collected at pre-treatment (T0) three months (T1) and six months (T2).
Investigators
Carsten Watzl
Scientific Director, IfADo
Technical University of Dortmund
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Determination of Physical Activity using the International Physical Activity Questionnaire
Time Frame: Change from baseline to 3 months (also assessed at 6 months post-baseline)
Physical Activity will be measured using the short version of the International Physical Activity Questionnaire (IPAQ - short). The short version of the IPAQ is a 7-item questionnaire that assesses the types of intensity of physical activity and sitting time that people do as part of their daily lives. Open-ended questions surrounding individuals' last 7-day recall of physical activity are considered to estimate total physical activity min/week and time spent sitting. Interpretation: Three levels (categories) of physical activity are proposed: low, moderate and high.
Determination of Quality of Life using the WHOQOL-BREF
Time Frame: Change from baseline to 3 months (also assessed at 6 months post-baseline)
Quality of Life will be measured using the World Health Organization Quality of Life Questionnaire (WHOQOL-BREF), which is a shorter version of the original instrument. Scale Range: 26 to 130. The WHOQOL-BREF is a 26-item, 5-point rating scale. It measures the following broad domains: physical health, psychological health, social relationships, and environment. Response options range from 1, indicating "very dissatisfied" to 5, indicating "very satisfied" and relate to the last two weeks. Higher scores on the WHOQOL-BREF correspond to higher self-reported levels of quality of life.
Determination of Diet Quality using the Food Quality Questionnaire
Time Frame: Change from baseline to 3 months (also assessed at 6 months post-baseline)
Diet Quality will be measured using the Food Quality Questionnaire (FQQ). Scale Range: 0 to 39. The FQQ is a 10-item, 5-point rating scale. The FQQ is a short food frequency questionnaire, which includes 10 food items on a 5-point rating scale. It focuses on fruit, vegetables, high-sugar foods, processed food, meat and drinks. The aim of the tool is to measure diet quality. Response options range from 0, indicating "daily" to 3" indicating, "once or never". Interpretation: A global diet quality score can be obtained by averaging all the items on the FQQ.
Secondary Outcomes
- Determination of depression(Change from baseline to 3 months (also assessed at 6 months post-baseline))
- Determination of fear of progression(Change from baseline to 3 months (also assessed at 6 months post-baseline))
- Determination of Negative Effects(Assessed at 3 and 6 months)
- Determination of cancer-related emotional stress(Change from baseline to 3 months (also assessed at 6, 9 and 12 months post-baseline))
- Determination of anxiety(Change from baseline to 3 months (also assessed at 6 months post-baseline))
- Determination of cancer-related fatigue using the Brief Fatigue Inventory Questionnaire(Change from baseline to 3 months (also assessed at 6 months post-baseline))
- Determination of insomnia(Change from baseline to 3 months (also assessed at 6 months post-baseline))
- Determination of usefulness of the program(Assessed at 3 and 6 months)