Cancer
Conditions
Keywords
survivorship; navigation
Brief summary
This study seeks to enroll patients receiving a Survivorship Care Plan following curative therapy for cancer. Participants will be randomly assigned to receive usual care or to be followed by a Patient Navigator as part of their Survivorship Care Plan.
Detailed description
This study seeks to enroll patients receiving a Survivorship Care Plan following curative therapy for cancer. Participants will be randomly assigned to receive usual care or to be followed by a Patient Navigator as part of their Survivorship Care Plan. Study participation for all participants will be for up to 9 months, with study visits approximately every 3 months, based on standard clinical follow-up. All participants will be administered quality of life surveys by a Clinical Research Associate at study entry, mid-study (approximately 3-6 months) and at study completion. The following factors will be compared between arms: * Missed/kept appointments * Use of urgent/emergent care * Quality of Life in relation to survivorship care * Participants lost to care
Interventions
OTHERNavigator
Patient Navigation services will be provided to try to eliminate barriers in pursuing survivorship surveillance
Sponsors
Harvard Pilgrim Health Care
Boston Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Stage I, II, III or IVa Cancer diagnosis (may include Solitary plasmacytoma, Diffuse Large B-Cell Lymphoma (DLBCL), ductal carcinoma in situ (DCIS) of the breast) * Completed treatment with curative intent within the past 12 months. (May be on maintenance therapy.)
Exclusion criteria
* Distant Metastatic disease * Non-curable disease * Recurrence of disease prior to enrollment * Require ongoing navigation from the treatment navigator * Enrolled/active in another randomized study (Project SUPPORT)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Missed appointments | 9 months | The research team will document the number of cancer care appointments scheduled and of those, how many appointments were missed (obtained by medical record and by patient report in case a visit was outside of study institution). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Urgent/emergent care | 9 months | The research team will document the number of urgent/emergent care visits attended within the study period of 9 months (obtained by medical record and by patient report in case a visit was outside of study institution). |
| Cancer Needs Distress | 9 months | Participants will rate their feelings about 39 specific cancer needs on a 5 point scale from Not a Problem to Very Severe Problem using the Cancer Needs Distress Inventory (CaNDI) tool. Total scores can range from 39 to 195. Lower scores are associated with less cancer related distress. |
| New Survivor Survey | 9 months | Participants will rate their understanding about 16 specific aspects of survivorship care on a 4 point scale from Strongly Disagree to Strongly Agree using the Preparing for Life as a New Survivor (PLANS) Scale. Total scores can range from 16 to 48. Lower scores are associated with less understanding of the survivorship care process. |
| Lost to Care | 9 months | The research team will document the number of participants lost to care, based on consecutive missed cancer care visits. |
Countries
United States
Outcome results
None listed