Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06459271
Status:
RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-06-05
Brief Title:
Feasibility of CALM in Patients With Ovarian Cancer
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
A Feasibility Trial of Managing Cancer and Living Meaningfully CALM in Patients With Newly Diagnosed and Recurrent Advanced Ovarian Cancer
Status:
RECRUITING
Status Verified Date:
2024-07
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:
None
Brief Summary:
The goal of this feasibility trial is to determine the feasibility and acceptability of implementing a brief evidence-based psychotherapeutic intervention Managing Cancer And Living Meaningfully CALM at the time of a new diagnosis and recurrence of ovarian cancer OC
The main questions are
1 Is it feasible and acceptable to implement CALM for patients with newly diagnosed or recently recurred advanced OC
2 What are the prevalence and correlates of traumatic stress symptoms at baseline in patients with newly diagnosed or recently recurred advanced OC
Participants will be asked to complete questionnaires at baseline and at 3 and 6 months following a diagnosis or recurrence of stage III or IV OC Participants will also be invited to participate in 3-6 sessions of CALM therapy
The main questions are
1 Is it feasible and acceptable to implement CALM for patients with newly diagnosed or recently recurred advanced OC
2 What are the prevalence and correlates of traumatic stress symptoms at baseline in patients with newly diagnosed or recently recurred advanced OC
Participants will be asked to complete questionnaires at baseline and at 3 and 6 months following a diagnosis or recurrence of stage III or IV OC Participants will also be invited to participate in 3-6 sessions of CALM therapy
Detailed Description:
While CALM has demonstrated effectiveness in reducing depression death anxiety and increasing preparation for end of life among patients with advanced cancer later in the illness trajectory its feasibility and effectiveness in addressing traumatic stress symptoms TSS soon after a diagnosis of advanced cancer has not previously been established Findings of this study could inform the potential development of a larger randomized effectiveness trial This study will involve a multi-method single-arm feasibility trial approaching a total of 100 OC patients 50 newly diagnosed and 50 recently recurred at Princess Margaret Cancer Centre PM Measurements will be administered at baseline 3 months and 6 months Participants who declined to participate in the intervention will be invited to share their reasons for opting out contributing valuable insights to our records A subset of purposefully sampled participants will also complete qualitative interviews following the completion of outcome measures at 6 months
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