Testing the Feasibility of a Virtual Application to Support Breast and Colorectal Cancer Survivors
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNova Scotia Health Authority
About this trial
The goal of this study is to determine the feasibility of implementing a mobile health application for breast and colorectal cancer survivors following primary treatment. Developed in collaboration with Seamless MD, the intervention acts as an information hub, providing users with timely and evidence-based information related to follow-up care as well as health system/community-based resources and programs to meet their needs during this period of care. The goal of the intervention is to encourage open communication regarding survivorship expectations and provide survivors with appropriate information and support to meet their needs.
This study will:
1. Test the feasibility of implementing the virtual intervention at two cancer centres in Atlantic Canada (Nova Scotia and New Brunswick) 2. Gather feedback regarding the intervention from cancer survivors and healthcare providers.
Participants will have access to the intervention for a period of six months. Questionnaires will be distributed to participants through the intervention at baseline, 90 days, and 180 days to assess user experience. Semi-structured interviews will be conducted with select survivor participants and healthcare providers (oncology and primary care) to determine the feasibility and acceptability of this intervention.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults older than 18 years, capable of providing informed consent
Diagnosed with stage I-III breast or colorectal cancer, and have completed primary treatment for their cancer (surgery and/or adjuvant systemic or radiation therapy) 6 months - 5 years ago
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
virtual self-management intervention
BehavioralThe intervention is a supportive information and self-management tool housed on the SeamlessMD mobile app, created in collaboration with the SeamlessMD development program and informed by foundational research. The application will be used as an information hub and self-management/navigation tool alongside usual care, to address the physical, psychosocial, and practical needs of breast and colorectal cancer survivors. Note that the intervention will not seek to change or impact a survivor's follow-up care plan, as decided upon by the participant and their care team.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: virtual self-management interventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Recruitment
Case report forms will be used to track recruitment metrics. The following demographics will be collected to monitor the diversity of those participating: cancer type (breast, colorectal), stage at diagnosis (in situ, stage 1, stage 2, stage 3, do not know), age (in years, prefer not to say), sex assigned at birth (male, female, intersex, prefer not to say), gender (man, woman, non-binary, other, prefer not to say), residence (rural, suburban, urban, prefer not to say), and highest level of education achieved (less than high school, high school, some post-secondary (college or university), diploma or degree, prefer not to say).
Time frame
During enrollment2
Retention
Case report forms will be used to track retention metrics.
Time frame
Enrollment to day 1803
Usage of the Intervention
Usage metrics will be collected using the SeamlessMD software to determine the following: 1) how often the intervention was accessed by participants, 2) what elements of the intervention were accessed most, and 3) what elements of the program were utilized the least.
Time frame
Baseline to day 1804
Survivor and Provider Acceptability and Experience
Assessed via one-on-one semi-structured interviews with a sub-sample of study participants and providers at both study sites. Semi-structured interviews were chosen over focus groups for this component because the research team is seeking individual experiences with the intervention. Interviews will be carried out by a member of the research team on video conferencing software using a predetermined interview guide and will take approximately 45 minutes. The questions will center around the study participant's follow-up care experience while being supported by the intervention. Interviews with providers will focus on the feasibility and acceptability of the supportive self-management tool.
Time frame
Interviews with survivor participants will be conducted after having access to the intervention for 180 days.Secondary outcomes
1
Fear of Recurrence
Will be assessed using the 6-item Cancer Worry Scale, a validated patient-reported instrument. Cancer Worry Scale (CWS) scores range from 6 to 24 points. A score of 6 points indicates low worry, while a score of 24 points indicates very high worry.
Time frame
Outcomes will be captured at baseline (study entry), on days 90 and 180, directly through the Seamless MD app software.2
Patient Activation
Will be assessed with the 13-item Patient Activation Measure (PAM), a validated patient-reported instrument. PAM includes 13 questions that produce a score on a 0-100 scale, which correlates with 1 of 4 activation levels. A level 1 score indicates low activation, while a level 4 score indicates a high activation.
Time frame
Outcomes will be captured at baseline (study entry), on days 90 and 180, directly through the Seamless MD app software.3
Information Provision
There are no validated instruments to assess information provision on its own. Therefore, these will be assessed using modified survey items from the Canadian Transitions Survey, a national survey on survivors' needs and experiences after completing cancer treatment.
Time frame
Outcomes will be captured at baseline (study entry), on days 90 and 180, directly through the Seamless MD app software.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Nova Scotia Health Authority
Lead sponsor
Canadian Cancer Society (CCS)
Collaborator
Source ClinicalTrials.gov