Evaluating a Novel Web-based Intervention for Breast Cancer Survivors

NCT03643640 | Completed

• 1 other identifier: Optimune Trial Add-on
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (3)

• Determination of Quality of Life using the WHOQOL-BREF

  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.

  Change from baseline to 3 months (also assessed at 6 months post-baseline)

• Determination of Physical Activity using the International Physical Activity Questionnaire

  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.

  Change from baseline to 3 months (also assessed at 6 months post-baseline)

• Determination of Diet Quality using the Food Quality Questionnaire

  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.

  Change from baseline to 3 months (also assessed at 6 months post-baseline)

Secondary Outcomes (8)

• 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 cancer-related emotional stress

  Change from baseline to 3 months (also assessed at 6, 9 and 12 months post-baseline)

• Determination of depression

  Change from baseline to 3 months (also assessed at 6 months post-baseline)

• Determination of anxiety

  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)

Other Outcomes (5)

• Determination of recurrence of breast cancer (local relapse or remote metastasis)

  Change from baseline to 3 months (also assessed at 6 months post-baseline)

• Frequency of common cold or virus flu

  Change from baseline to 3 months (also assessed at 6 months post-baseline)

• Frequency of unscheduled medical encounters

  Change from baseline to 3 months (also assessed at 6 months post-baseline)

Study Arms (2)

Optimune

EXPERIMENTAL

Optimune is an web-based psychological intervention for women with breast cancer. 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, stress management (e.g., mindfulness-based techniques) and lifestyle optimization (dietary and physical activity advice). Content is continuously adapted to users' concerns and needs. It contains interactive dialogues that can be accessed via computer or smart-phone, illustrations, audio files and motivating text messages. Optional daily text messages with motivational content accompany the program. The program can be accessed for 365 days after registration.

Behavioral: Optimune

Care-as-Usual

ACTIVE COMPARATOR

As in the experimental arm, participants are free to continue to engage with any treatment they require (i.e., CAU). However, they will receive access to Optimune six months post-baseline (i.e., wait list with respect to Optimune access).

Other: Care-As-Usual

Interventions

Optimune BEHAVIORAL

Optimune is a web-based psychological intervention developed for women with breast cancer.

Optimune

Care-As-Usual OTHER

Participants are free to continue to engage with any treatment they require (i.e., CAU).

Care-as-Usual

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Eligible are women who * had breast cancer diagnosed less than 5 years ago * completed acute treatment for breast cancer at least 1 month ago. This applies for surgery, chemotherapy or radiation, whichever occurred last. (Prophylactic treatment with anti-hormones like tamoxifene, aromatase-inhibitors or bisphosphonates is allowed). * are competent in German language * provide written consent to study procedures * are willing to provide the discharge letter from oncology (to verify diagnosis and therapies)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Technical University of Dortmund: lead
• University of Leipzig: collaborator
• Gaia AG: collaborator

Study Sites (2)

Technical University of Dortmund, Leibniz Research Centre for Working Environment and Human Factors

Dortmund, 44139, Germany

Location

University Medical Center Leipzig, Department of Medical Psychology and Medical Sociology, Section Psychosocial Oncology

Leipzig, 04103, Germany

Location

Related Publications (2)

• Holtdirk F, Mehnert A, Weiss M, Mayer J, Meyer B, Brode P, Claus M, Watzl C. Results of the Optimune trial: A randomized controlled trial evaluating a novel Internet intervention for breast cancer survivors. PLoS One. 2021 May 7;16(5):e0251276. doi: 10.1371/journal.pone.0251276. eCollection 2021.

  PMID: 33961667 DERIVED

• Holtdirk F, Mehnert A, Weiss M, Meyer B, Watzl C. Protocol for the Optimune trial: a randomized controlled trial evaluating a novel Internet intervention for breast cancer survivors. Trials. 2020 Jan 29;21(1):117. doi: 10.1186/s13063-019-3987-y.

  PMID: 31996235 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Carsten Watzl, PhD

  Leibniz Research Center (IfADo), TU Dortmund

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientific Director, IfADo

Study Record Dates

• First Submitted: August 21, 2018
• First Posted: August 23, 2018
• Study Start: September 1, 2018
• Primary Completion: June 1, 2020
• Study Completion: September 1, 2020
• Last Updated: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Time Frame: after completion of the study
• Access Criteria: available upon request

Locations

DE (2)