Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06554899
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-06-14
Brief Title:
CIFeR - A Clinician-led Intervention to Address Fear of Cancer Recurrence
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Efficacy of a Brief Oncologist-delivered Intervention for Fear of Cancer Recurrence A Cluster-randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The investigators will test a novel Clinician-led Intervention to address Fear of cancer Recurrence in cancer survivors CIFeR by 1 adapting the original Australian intervention manual to the Danish oncology context CIFeR-DK and 2 developing a brief e-learning program to train oncologists The investigators will then 3 compare CIFeR-DK with an active control condition in a cluster-randomized controlled trial with 24 oncologists the cluster unit treating a minimum of 300 patients with breast ovarian lung and prostate cancer at Danish Oncology Departments at four hospitals in Aarhus Vejle Aalborg and Copenhagen and 4 explore fidelity acceptability feasibility and perceived barriers and facilitators to use the intervention in routine follow-up care
Detailed Description:
STUDY DESIGN
The study is designed as a parallel cluster-randomized controlled trial with oncologists cluster unit treating breast ovarian and prostate cancer at the oncology departments at Aarhus University Hospital AUH Vejle Hospital VH Aalborg University Hospital AAUH and Copenhagen University Hospital CUH and randomized 11 to intervention versus active control
Participants
All oncologists treating breast ovarian and prostate cancer at the participating departments are eligible for the study and will be recruited by our collaborators at the participating departments Eligible patients score 13 on the FCRI-SF and have completed their primary treatment ie surgery adjuvant chemotherapy andor radiotherapy for breast ovarian lung and prostate cancer at the participating departments between three weeks and three months previously
Procedure
Patients scheduled for a follow-up visit with the participating oncologists will receive a secure e-mail invitation to participate in the study and a link to a RedCap questionnaire Patients willing to participate will provide their informed consent electronically and complete the 9-item FCRI-SF Patients scoring 13 are provided with additional information about the study and asked for their consent to participate
One week before the planned follow-up consultation they will be asked to complete a RedCap baseline questionnaire T1 One week and three months after the consultation the patients will be asked to complete the RedCap post-intervention T2 and follow-up questionnaires T3
Oncologists will complete a RedCap baseline questionnaire assessing age gender years of experience and self-efficacy in managing patient FCR Oncologists will then be allocated to the intervention or active control arm using a stratified randomization sequence generated by the Aarhus University clinical trial unit ensuring a balanced allocation of oncologists according to the cancer type treated Oncologists will then receive a link to online CIFeR training and report their post-training self-efficacy for managing patient FCR During the consultation the oncologist will deliver the CIFeR intervention and complete a brief 5-item checklist on whether they delivered all five components and if not why After including all patients the oncologist is asked to complete a follow-up RedCap questionnaire on self-efficacy in managing patient FCR
The CIFeR intervention
The intervention includes five components informed by theoretical models and existing interventions for FCR 1 FCR normalization reassurance that FCR is a common and normal phenomenon after treatment for cancer 2 Providing prognostic information asking patients whether they would like information about their risk of recurrence and if yes providing this information 3 Providing education and take-home information on red-flag recurrence symptoms 4 Brief advice on managing worry distraction meditation mindfulness reassurance and links to online resources to manage FCR and 5 referral to a psychologist if FCR is high FCRI-SF 22 or if deemed helpful by the patient or clinician Access will be provided to ConquerFear-Group delivered online by trained psycho-oncologists
Outcome measures
Patients
The primary outcome is the change in FCR assessed with the 9-item Fear of Cancer Recurrence Inventory Short Form FCRI-SF Secondary outcomes include a anxiety and depression assessed with the The Hospital Anxiety and Depression Scale HADS b patient reported intervention usefulness assessed with the Patient Centered Communication Scale PCC c metacognition assessed with the metacognitions questionnaire MCQ-30 d unmet needs assessed with Subscale of the Survivors Unmet Need Survey SUNS-8 e rumination assessed with the Penn State Worry Questionnaire PSWQ and f General Quality of Life QoL assessed with the EQ-5D for later use in cost-effectiveness analysis All measures will be completed at all three time-points T1-T3
At six months the investigators will ask a subset of 15-20 patients to participate in a semi-structured phone interview about their experience with the intervention
Oncologists
Oncologists complete a general item on self-efficacy in managing patient FCR together with the 27-item Self-efficacy in Patient-Centeredness Questionnaire SEPCQ-27 at baseline post-training only oncologists in the intervention group and after completed inclusion Based on a suggested framework for implementation outcomes the investigators will assess with 11-point scales 1 acceptability 2 appropriateness 3 feasibility together with 4 fidelity measured as the average number of components oncologists report having delivered to patients and 5 sustainability measured as the proportion of oncologists in the intervention group who report having used CIFeR at least once within the last three months measured six months after completed inclusion Six months after the inclusion of their last patient all oncologists will be asked to participate in a semi-structured interview and provide feedback on the CIFeR-training and their experiences with the intervention including perceived utility and the perceived barriers and facilitators to implementing CIFeR in routine care The investigators will also examine CIFeR e-training analytics regarding access and time spent on the various parts
The study is designed as a parallel cluster-randomized controlled trial with oncologists cluster unit treating breast ovarian and prostate cancer at the oncology departments at Aarhus University Hospital AUH Vejle Hospital VH Aalborg University Hospital AAUH and Copenhagen University Hospital CUH and randomized 11 to intervention versus active control
Participants
All oncologists treating breast ovarian and prostate cancer at the participating departments are eligible for the study and will be recruited by our collaborators at the participating departments Eligible patients score 13 on the FCRI-SF and have completed their primary treatment ie surgery adjuvant chemotherapy andor radiotherapy for breast ovarian lung and prostate cancer at the participating departments between three weeks and three months previously
Procedure
Patients scheduled for a follow-up visit with the participating oncologists will receive a secure e-mail invitation to participate in the study and a link to a RedCap questionnaire Patients willing to participate will provide their informed consent electronically and complete the 9-item FCRI-SF Patients scoring 13 are provided with additional information about the study and asked for their consent to participate
One week before the planned follow-up consultation they will be asked to complete a RedCap baseline questionnaire T1 One week and three months after the consultation the patients will be asked to complete the RedCap post-intervention T2 and follow-up questionnaires T3
Oncologists will complete a RedCap baseline questionnaire assessing age gender years of experience and self-efficacy in managing patient FCR Oncologists will then be allocated to the intervention or active control arm using a stratified randomization sequence generated by the Aarhus University clinical trial unit ensuring a balanced allocation of oncologists according to the cancer type treated Oncologists will then receive a link to online CIFeR training and report their post-training self-efficacy for managing patient FCR During the consultation the oncologist will deliver the CIFeR intervention and complete a brief 5-item checklist on whether they delivered all five components and if not why After including all patients the oncologist is asked to complete a follow-up RedCap questionnaire on self-efficacy in managing patient FCR
The CIFeR intervention
The intervention includes five components informed by theoretical models and existing interventions for FCR 1 FCR normalization reassurance that FCR is a common and normal phenomenon after treatment for cancer 2 Providing prognostic information asking patients whether they would like information about their risk of recurrence and if yes providing this information 3 Providing education and take-home information on red-flag recurrence symptoms 4 Brief advice on managing worry distraction meditation mindfulness reassurance and links to online resources to manage FCR and 5 referral to a psychologist if FCR is high FCRI-SF 22 or if deemed helpful by the patient or clinician Access will be provided to ConquerFear-Group delivered online by trained psycho-oncologists
Outcome measures
Patients
The primary outcome is the change in FCR assessed with the 9-item Fear of Cancer Recurrence Inventory Short Form FCRI-SF Secondary outcomes include a anxiety and depression assessed with the The Hospital Anxiety and Depression Scale HADS b patient reported intervention usefulness assessed with the Patient Centered Communication Scale PCC c metacognition assessed with the metacognitions questionnaire MCQ-30 d unmet needs assessed with Subscale of the Survivors Unmet Need Survey SUNS-8 e rumination assessed with the Penn State Worry Questionnaire PSWQ and f General Quality of Life QoL assessed with the EQ-5D for later use in cost-effectiveness analysis All measures will be completed at all three time-points T1-T3
At six months the investigators will ask a subset of 15-20 patients to participate in a semi-structured phone interview about their experience with the intervention
Oncologists
Oncologists complete a general item on self-efficacy in managing patient FCR together with the 27-item Self-efficacy in Patient-Centeredness Questionnaire SEPCQ-27 at baseline post-training only oncologists in the intervention group and after completed inclusion Based on a suggested framework for implementation outcomes the investigators will assess with 11-point scales 1 acceptability 2 appropriateness 3 feasibility together with 4 fidelity measured as the average number of components oncologists report having delivered to patients and 5 sustainability measured as the proportion of oncologists in the intervention group who report having used CIFeR at least once within the last three months measured six months after completed inclusion Six months after the inclusion of their last patient all oncologists will be asked to participate in a semi-structured interview and provide feedback on the CIFeR-training and their experiences with the intervention including perceived utility and the perceived barriers and facilitators to implementing CIFeR in routine care The investigators will also examine CIFeR e-training analytics regarding access and time spent on the various parts
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None