Study Information
PRO-ACTIVE: COMPARING THE EFFECTIVENESS OF PROPHYLACTIC SWALLOW INTERVENTION FOR PATIENTS RECEIVING RADIOTHERAPY FOR HEAD AND NECK CANCER
Dysphagia (difficulty swallowing) is a common and potentially life-threatening toxicity of radiotherapy (RT) for patients with head and neck cancer (HNC), for which patients are commonly referred for swallowing therapy to a Speech-Language Pathologist. Some patients receive early intervention, before a swallowing problem begins – PRO-ACTIVE therapy. Other patients are monitored and prescribed dysphagia interventions only if and when a swallowing problem occurs – RE-ACTIVE therapy. Thus, RE-ACTIVE therapy aims to reverse an already impaired swallowing ability, whereas PRO-ACTIVE therapy aims to prevent or reduce severity of dysphagia.
The primary aim of the PRO-ACTIVE study is to compare the effectiveness of PRO-ACTIVE versus RE-ACTIVE swallowing interventions among patients with head and neck cancer who are scheduled to undergo radiotherapy.
Our study hypothesis is that PRO-ACTIVE therapies are more effective than RE-ACTIVE therapy, and that more intensive PRO-ACTIVE (EAT + EXERCISE) therapy is superior to less intensive PRO-ACTIVE (EAT) therapy. Therapeutic effectiveness will be measured at 12 months following radiotherapy and will be based on reduced feeding tube dependency.
RCT Details
PRO-ACTIVE is a multi-site trial taking place across three hospital sites in Canada and ten in the United States. As of September 2023, we reached 100% of the enrolment target (n=952)
PRO-ACTIVE is a pragmatic clinical trial, meaning that it explores a “real world” approach in the design and implementation of this randomized clinical trial. The primary outcome of feeding tube dependency was chosen, as it is equally valued by all stakeholders, including patients, caregivers and therapy providers.
For more information,
please visit the Patient-Centered Outcomes Research Institute.
For detailed study information on ClinicalTrials.gov
please click here.
Engagement Details
The stakeholder engagement process has been integral across all stages of this trial, from fine-tuning its design, to planning implementation, and eventually advising on knowledge dissemination of study findings. The study PIs have carefully chosen a qualitative approach with four stakeholder groups (patients and caregivers, allied health (AH) clinicians, MD clinicians, and payer and policy makers) in Canada and the US. AH clinicians include a variety of professionals (i.e Speech Language Pathologists, Nurses, Dietitians, etc). Likewise, MDs include Surgeons, Radiation Oncologists, etc. Policy makers include experts who make decisions regarding high level healthcare resource allocation. Finally, patients and caregivers include those who have had the lived experience of head and neck cancer but have now completed treatment.
The Stakeholder Advisory Board (SAB) consists of two to three representatives from each group who meet to reach a combined opinion across all stakeholders. There is a SAB in Canada and the US. This combined perspective from the SABs is formally presented to the trial Executive Committee for consideration to implement in the study. Finally, in an effort to ensure accountability, study investigators report back to all stakeholders, detailing how their recommendations will be adopted.
PRO-ACTIVE ENGAGEMENT ACTIVITIES (TO-DATE)
- Operationalized the ‘trigger’ criteria for arm one patients, ensuring an accurate, reproducible and feasible initiation of swallowing intervention for patients at all sites not receiving prophylactic swallowing therapy.
- Refined the list of secondary outcome measures used to assess benefits of swallowing therapy across study treatment arms.
- Standardized the consenting process, enabling recruiters and clinicians to provide relevant information during informed consent discussion, yet not contaminate the treatment arms.
- Informed the study team with innovative strategies to mitigate barriers in patient recruitment, retention and overall data collection.
- Advised on how to incorporate public health restrictions due to COVID-19 without compromising study integrity, yet optimize overall study outcomes.
Members of the Stakeholder Advisory Board (SAB) in Canada engaging in focus group session in Toronto, ON
Study Team Events
STUDY LAUNCH (VIRTUAL CALL), JANUARY 2018
Prior to study launch, the study teams across Canada and US met over a virtual toast to celebrate this milestone. At this call, the PIs of each site had the opportunity to virtually introduce their study teams to each other and get to know their counterparts across the border.
ENGAGEMENT TEAM MEETING, HOUSTON, FEBRUARY 2019
The Engagement Research Team held their first in-person meeting in Houston, TX on Feb 20-21, 2019. The team met to discuss the status of the trial, as well as plans for future stakeholder engagement activities. In addition, our Engagement leads, Dr. Fitch and Dr. Macdonald, led discussions on the review of the engagement process to-date, as well as plans for data analysis and knowledge dissemination.
INVESTIGATORS MEETING, TORONTO, OCTOBER 2019
The first annual PRO-ACTIVE Investigators’ Meeting was hosted in Toronto in October 2019. This was the first opportunity of its kind for site leadership and their teams to all come together and meet with the Co-PIs and the engagement leads, to share lessons learned and current challenges across all sites. As part of this meeting, each site also engaged in discussions brainstorming how best to address their site’s unique challenges in areas of recruitment, retention and data fidelity, and had the opportunity to review engagement stakeholder recommendations as a guide to address their challenges.
PRO-ACTIVE END OF ENROLLMENT CELEBRATION, SEPTEMBER 2023
On September 27, 2023, an all-sites celebration marked the enrollment of the 952nd and final patient into the PRO-ACTIVE trial. Study team members in Toronto joined the celebration in-person. a simultaneous Zoom call connected the other 12 participating sites and team members who could not attend live.
