Ignite Creation Date:
2024-05-06 @ 10:56 AM
Last Modification Date:
2024-10-26 @ 12:37 PM
Study NCT ID:
NCT03384992
Status:
COMPLETED
Last Update Posted:
2018-04-30
First Post:
2017-12-20
Brief Title:
Targeted eHealth Intervention to Reduce Fear of Recurrence Among Breast Cancer Survivors
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Targeted eHealth Intervention to Reduce Fear of Recurrence Among Breast Cancer Survivors The FoRtitude Trial
Status:
COMPLETED
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FoRtitude
Brief Summary:
The FoRtitude trial aims to evaluate an eHealth intervention designed to teach breast cancer survivors strategies to manage anxiety about cancer recurrence The eHealth intervention includes educational content and interactive tools designed to teach coping strategies andor inert content depending on the study participants randomization assignment The FoRtitude study will examine whether three coping strategies relaxation training cognitive restructuring worry practice are more effective than general health-related content in reducing fear of cancer recurrence
Detailed Description:
The purpose of the FoRtitude trial is to develop and evaluate a targeted eHealth intervention designed to teach breast cancer survivors BCS coping strategies to manage fear about cancer recurrence FoR FoRtitude a web-based program with interactive text messaging capabilities was created to deliver a targeted intervention for BCS with moderate to severe FoR FoRtitude consists of didactic content presented in written and video-based formats and interactive tools designed to teach coping strategies Commonly used cognitive behavior therapy CBT techniques were tailored to the management of FoR and included diaphragmatic breathing and relaxation cognitive restructuring and scheduled worry practice Participants are encouraged to use the FoRtitude site several times per week over a period of 4 weeks The investigators employed principles of user-centered design to create the FoRtitude website and incorporated feedback from 17 BCS to refine site content and improve FoRtitude usability
After refining the FoRtitude site the investigators will conduct a randomized controlled trial using the Multiphase Optimization Strategy MOST to individually evaluate three coping strategies each coping strategy will be compared to health management content Inert content includes general health information and managing comorbid illnesses information on general nutrition and information on nutritional topics of interest to BCS Half of the participants will be randomized to receive telecoaching which included 3-4 telephone-based brief sessions with a motivational interviewer aimed at improving adherence to use of the FoRtitude site Participants will complete questionnaires at baseline 4 weeks immediately after completing the FoRtitude site and at 8 weeks
Study hypotheses
1 BCS randomized to Relaxation training will report a greater reduction in fear of cancer recurrence from pre-post intervention than BCS randomized to inert health management content
2 BCS randomized to Cognitive restructuring will report a greater reduction in fear of cancer recurrence from pre-post intervention than BCS randomized to inert health management content
3 BCS randomized to Scheduled Worry practice will report a greater reduction in fear of cancer recurrence from pre-post intervention than BCS randomized to inert health management content
4 BCS randomized to receive Telecoaching will demonstrate higher adherence to using the FoRtitude site and will report a greater reduction in fear of cancer recurrence from pre-post intervention compared to BCS randomized to no Telecoaching
5 BCS randomized to a higher number of coping strategies will report a greater reduction in fear of cancer recurrence from pre-post intervention than BCS randomized to receive all inert content or fewer coping strategies dose-response effect
After refining the FoRtitude site the investigators will conduct a randomized controlled trial using the Multiphase Optimization Strategy MOST to individually evaluate three coping strategies each coping strategy will be compared to health management content Inert content includes general health information and managing comorbid illnesses information on general nutrition and information on nutritional topics of interest to BCS Half of the participants will be randomized to receive telecoaching which included 3-4 telephone-based brief sessions with a motivational interviewer aimed at improving adherence to use of the FoRtitude site Participants will complete questionnaires at baseline 4 weeks immediately after completing the FoRtitude site and at 8 weeks
Study hypotheses
1 BCS randomized to Relaxation training will report a greater reduction in fear of cancer recurrence from pre-post intervention than BCS randomized to inert health management content
2 BCS randomized to Cognitive restructuring will report a greater reduction in fear of cancer recurrence from pre-post intervention than BCS randomized to inert health management content
3 BCS randomized to Scheduled Worry practice will report a greater reduction in fear of cancer recurrence from pre-post intervention than BCS randomized to inert health management content
4 BCS randomized to receive Telecoaching will demonstrate higher adherence to using the FoRtitude site and will report a greater reduction in fear of cancer recurrence from pre-post intervention compared to BCS randomized to no Telecoaching
5 BCS randomized to a higher number of coping strategies will report a greater reduction in fear of cancer recurrence from pre-post intervention than BCS randomized to receive all inert content or fewer coping strategies dose-response effect
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R21CA173193-01A1 | NIH | None | httpsreporternihgovquickSearch1R21CA173193-01A1 |