The Breast Cancer Online Rehabilitation Program
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      The investigators have developed an online rehabilitation platform to guide women in their
      home-based upper-body exercises after breast cancer surgery. The platform includes
      rehabilitation videos that will guide the women in performing home-based early post-surgery
      upper-body rehabilitation tailored for each individual.

      The primary objective is to assess the feasibility and acceptability of a home-based
      rehabilitation program supported by a supplemental online platform for women after breast
      cancer surgery before conducting a larger pragmatic trial in the future. The feasibility of
      the platform will be tested in 11 municipalities in Denmark.
    

Detailed description: 
      More and more women are being diagnosed with breast cancer worldwide. While a vast majority
      will survive their disease, adverse treatment effects are common, and may persist beyond the
      treatment period and contribute to the burden of cancer. After surviving breast cancer, women
      often struggle with upper-body side effects from the cancer treatment such as tight scar
      tissue, arm swelling, decreased shoulder function. This limits the woman's physical
      well-being, affects her ability to take care of her family, return to work, and ultimately
      impacts her quality of life. Specific upper-body rehabilitation exercises and participation
      in general exercise have been shown to prevent, attenuate or rehabilitate many of the
      physical and psychosocial side effects of breast cancer treatment.

      New ways of delivering rehabilitation are needed to ensure continued capacity to undertake
      the growing demand for cancer rehabilitation. There is currently great diversity in the
      quality and access to cancer rehabilitation. Equal access to evidence-based, homogeneous, and
      high-quality rehabilitation is needed independent of geographical area of residence and
      setting of rehabilitation (municipality or hospital).

      Online rehabilitation integrated in the current survivorship rehabilitation programs offers
      the opportunity to deliver this homogeneous intervention across the country. At this time,
      little effort has been made to develop online rehabilitation platforms for breast cancer
      survivors, thus no evidence to support the expected benefits of online rehabilitation is
      available.

      Study objective:

      The study aims to test if the platform is feasible and acceptable for women who have received
      treatment for breast cancer. The hypothesis is that the support of filmed accessible
      upper-body rehabilitation exercises through a website will promote improved adherence and
      motivation to do the home-based exercises illustrated by ≥75% of participants will perform
      the home-based program 5-7 times weekly and ≥ 75% of participants report to be somewhat or
      very satisfied with the intervention.

      Study design:

      This study will test the feasibility of the intervention among two groups of participants:
      Part 1 will recruit women newly operated for breast cancer; Part 2 will recruit women who
      have completed radiation therapy for breast cancer. Both groups will receive the same
      intervention and the same information will be captured from all enrolled participants on
      retention, adherence, and acceptability of the intervention being tested. Outcomes related to
      the feasibility of the intervention will be collected before and following the 12-week
      intervention.

      Using the PICOT format the trial parameters are:

      Population: Women who underwent surgery for breast cancer within the last 8 weeks (part 1)
      and women who have had surgery and have completed radiation therapy for breast cancer within
      the past 6 weeks (part 2).

      Intervention: Participants will get a leaflet with upper-body rehabilitation exercises and
      have access to an online rehabilitation platform for the 12-week study period. The platform
      is a website with videos of upper body rehabilitation exercises, mindfulness sessions and
      instruction in lymphatic drainage combined with additional information about prevention and
      early detection of late effects after breast cancer treatment. The intervention will be
      tailored to each woman with specific upper body exercises based on the baseline arm
      assessment. The physiotherapist will deliver a leaflet with exercises and educational
      information to support the engagement in home-based exercises. In addition to this
      intervention, all participants will be offered the existing rehabilitation program in the
      trial sites. The programs differ from site to site, but generally include post-surgery
      upper-body rehabilitation group sessions, general whole body aerobic and resistance training
      and individual treatment and instruction by a physiotherapist if issues are noted during the
      group sessions.

      Comparison: For this feasibility study, no control group will be used.

      Outcome: Outcomes are recruitment rate, adherence and retention, participant satisfaction,
      capacity/resources and response-rate to the questionnaires concerning intention, attitude,
      subjective norm, and perceived behavioral control to do home-based exercises, and shoulder
      function.

      Time of intervention: Participants in part 1 will be recruited up to eight weeks after breast
      cancer surgery, when they start the municipal rehabilitation, and after inclusion followed
      for 12 weeks. Participants in part 2 will be recruited when the have completed radiation
      therapy for breast cancer, and after inclusion followed for 12 weeks.

      Study conduct:

      This study has obtained ethical approval from the Danish National Committee on Health
      Research Ethics, the Danish Data Protection Agency and has been submitted for ethical
      approval for the University of British Columbia Clinical Research Ethics Board. The study
      will be conducted in accordance with the protocol and the Helsinki Declaration. All study
      participants will sign an informed consent form prior to beginning the study.

      Participants:

      All patients who have received surgery for breast cancer at the identified clinical sites,
      and meet the eligibility criteria will be approached to participate in the study.
      Specifically, women attending the rehabilitation centers in 11 municipalities in Denmark
      (Copenhagen, Frederiksberg, the 3-municipality collaboration between Gentofte, Rudersdal and
      Lyngby-Taarbæk, and the 6-municipality collaboration between Herlev, Egedal, Ballerup,
      Rødovre, Furesø and Gladsaxe) will be recruited. Patients will be eligible and offered to
      participate if they comply with the inclusion and exclusion criteria.

      Outcomes:

      Outcomes will be assessed at baseline and end of study. The baseline assessment includes
      standardized questionnaires and a clinical upper-body assessment. Similar questionnaires will
      be completed at the 12-week follow up visit.

      Primary outcomes: The primary objective of this study is to determine the feasibility and
      acceptability of this type of online rehabilitation to breast cancer survivors prior to
      progression to a full RCT. Feasibility will be measured using the four indicators listed
      below.

      Recruitment rate: All reasons for ineligibility or participant refusal to participate will be
      recorded to explain if any changes should be made to eligibility criteria in future studies.

      Retention and Adherence and safety to the intervention: Participants will be asked to record
      their adherence to their home-based rehabilitation program (i.e. sessions per week) in a
      logbook on a weekly basis and return the logbook at the end of the study. Program-specific
      outcomes such as the time spent doing rehabilitation exercises, pain/discomfort during or
      following the home-based rehabilitation exercises and reasons for discontinuing the
      rehabilitation program are included in this logbook, as well as participation in other
      rehabilitation exercise activities, breast cancer-specific group-based rehabilitation
      sessions or treatment by a physiotherapist. Participant adherence to the home-based exercise
      prescription will be calculated by the proportion of weeks where the home-based program was
      performed 5 to 7 times. In addition, the participants' use of the website will be tracked,
      specifically the website will track the number of times and the duration a participant has
      been logged onto the website across the 12 weeks. Participants who are enrolled in the study
      but fail to complete the end of study assessment will be recorded as dropouts. All dropouts
      will be contacted to determine reasons for non-participation and to collect suggestions for
      changes. If willing, they will be asked to complete the participant satisfaction
      questionnaire (see below for details). Feasibility will be defined as a drop out of <10% and
      adherence of > 75% to the prescribed home-based exercise sessions as determined by reports of
      performing the home-based program 5 to 7 times weekly in the weekly logbooks.

      Participant Satisfaction: At the end of the study data describing participant satisfaction
      will be collected to answers questions on acceptability. All participants will be given a
      questionnaire, delivered by Easy Research, and will be asked to rank various aspects of the
      intervention such as the home-based exercises supported by videos, mode of delivery,
      software, etc. "as not at all satisfied", "not very satisfied", "somewhat satisfied" or "very
      satisfied". Feasibility will be defined as >75% of participants reporting they are "very" or
      "somewhat satisfied" with the intervention.

      Capacity/ Resources: The amount of time spent with each participant during the standard
      upper-body assessments, instruction of the home-based intervention and assistance needed with
      using the website during the study period will be tracked. We will also record any additional
      appointments required to teach the home-based rehabilitation program or to assist in using
      the website.

      Secondary outcomes: In addition to the feasibility outcomes, the aim is to examine changes in
      outcomes of interest that may occur as a result of participation in this 12-week
      intervention.

      Intention, Attitude, Subjective norm, and Perceived behavior control for rehabilitation
      exercises: To further answers questions on motivation, the participants' reaction to the
      intervention, intend to use, and perceived appropriateness of the rehabilitation exercises
      will be answered. Behavioral changes in motivation to do home-based rehabilitation exercises
      will be measured as this is fundamental to adherence. The study method is theoretically based
      in the framework of Theory of Planned Behavior and has been validated in measuring motivation
      for exercise among cancer survivors including breast cancer patients. The Intention, Attitude
      and Subjective Norm Questionnaire is a 13-item Theory of Planned Behavior questionnaire
      modified for use with online home-based rehabilitation.

      Clinical outcomes in upper-body function: At baseline and after the 12-week intervention,
      physiotherapists blinded to prior baseline measurements will perform a standard upper-body
      assessment in all participants. Following measures will be assessed: 1) active shoulder
      mobility for flexion and external rotation 2) upper body muscle strength using Manual Muscle
      Testing 3) arm circumference will be measured at five points along the arm using a
      standardized protocol and measurement tape 4) patient-reported pain and tightness will be
      measured using a 0-10 VAS scale.

      Ability to perform activities of daily living: The self-reported QuickDASH (Disabilities of
      the Arm, Shoulder, and Hand) is an 11-item questionnaire assessing arm disability affecting
      multiple arm joints. The QuickDASH will be administered at baseline and at the 12-week follow
      up visit, and will be used to assess changes in arm function during the study period.

      Timeline and proposed sample size:

      This study is the first to assess the feasibility of a new online rehabilitation platform.
      The aim is to start recruitment for the feasibility study from all 11 sites as soon as
      ethical approval has been obtained. For this feasibility study, the goal is to recruit as
      many women as possible during an eight-week recruitment period. Following the 12-week
      intervention, the study is expected to be completed in June 2016.
    

Intervention name(s): Home-based upper-body rehabilitation with online support
Intervention type(s): Other
Intervention description(s): Participants will be given written educational material, in which the physiotherapist marks the exercises specifically recommended for the individual patient. In addition, participants will get a personal password giving access to the BRECOR website for 12 weeks. The website contains professionally filmed videos of upper-body rehabilitation exercises (joint mobility and muscle strength) and instructions in scar tissue massage and manual lymph drainage. Furthermore, mindfulness sessions and additional information about prevention and early detection of late effects after breast cancer treatment are available on the website.
On average, participants will complete three rehabilitation exercises 5-7 times weekly with an anticipated duration of approximately 20 minutes.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: This study was conducted in two parts and thereby had two groups of participants. Part 1 participants were newly operated for breast cancer. Part 2 participants had completed surgery and radiation therapy for breast cancer. Both groups received the same intervention, namely a home-based rehabilitation program.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rehabilitation; Home-Based Intervention