Clinical trial · Interventional
Self-Management and Activation to Reduce Treatment-Related Toxicities (SMARTCare)
A Multi-Centre, Randomized Controlled Trial of Self-Management and Activation to Reduce Treatment-Related Toxicities in Patients Receiving Adjuvant or First-Line Metastatic Oral or Systematic Therapy for Colorectal, Lymphoma or Lung Cancer (SMARTCare)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Recruitment was halted prematurely due to the COVID-19 pandemic.
Summary
Brief summary (as posted)
The investigators will undertake a multi-centre, randomized controlled trial to implement and evaluate a proactive model of care (SMARTCare) during active cancer treatment that incorporates self-management support (SMS). Patients allocated to the control arm will receive care from ambulatory clinic nurses trained in SMS. Patients allocated to the intervention arm will will receive care from ambulatory clinic nurses trained in SMS, in addition to being given access to a web-based, self-management education program and nurse-led health coaching during the first four months following the first systemic therapy administration.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colo-rectal Cancer | — | UNRESOLVED | — |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control | Other | — | UNRESOLVED |
| SMARTCare | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SMARTCare
- description
- 1. Training in self-management support (SMS) strategies for ambulatory nursing staff 2. A web-based self-management education (I-Can-Manage Cancer) for patients 3. Telephone-based, nurse-led health coaching 4. Optional end of study patient interview (sub-study)
- interventionNames
- Other: SMARTCare
- type
- ACTIVE_COMPARATOR
- label
- Control
- description
- 1\. Training in self-management support (SMS) strategies for ambulatory nursing staff
- interventionNames
- Other: Control
Primary outcomes (6)
- measure
- Reasons for non-participation
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of lymphoma (Hodgkin's or non-Hodgkin's), colorectal, or lung cancer. * Initiating adjuvant or first-line metastatic treatment with oral or systemic therapy within the accrual period at a participating centre. Patients receiving treatment with immunotherapy are eligible to participate. * Eastern Cooperative Oncology Group (ECOG) \</=2. * Ability to understand and provide written informed consent. * Access to an electronic device and internet connection to allow the participant to access the web-based I-Can-Manage Cancer education modules. * Language and literacy skills consistent with completing validated questionnaires, and willingness to complete questionnaires as required. Exclusion Criteria: * Currently participating in a clinical trial involving receipt of an investigational agent.
References
Publications (1)
- DERIVEDHowell D, Pond GR, Bryant-Lukosius D, Powis M, McGowan PT, Makuwaza T, Kukreti V, Rask S, Hack S, Krzyzanowska MK. Feasibility and Effectiveness of Self-Management Education and Coaching on Patient Activation for Managing Cancer Treatment Toxicities. J Natl Compr Canc Netw. 2023 Mar;21(3):247-256.e8. doi: 10.6004/jnccn.2022.7095. PMID 36898363