Pilot testing a psychological intervention for cancer-related anxiety

Not Applicable

Completed

• Conditions: Mental Health - Anxiety; Cancer; Anxiety; Cancer - Any cancer

• Registration Number: ACTRN12618000406202
• Lead Sponsor: The University of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-03-21
• Study Completion: 2019-11-10
• Last Update Posted: 12 July 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

•Patients with a diagnosis of metastatic cancer or patients who have experienced a recurrence or progression of their cancer or a second cancer diagnosis
•Aged 18 or over
•Fluent in English
•Clinically significant anxiety as measured by a score of 8 or more on the Hospital Anxiety and Depression Scale– Anxiety subscale (HADS-A, Zigmond & Snaith, 1983) OR a score of 19 or more on the Impact of Events Scale - Revised (Weiss & Marmar, 1997) OR a score of 34 or more on the Fear of Progression questionnaire, Short version (Mehnert, Herschbach, Berg, Henrich, & Koch, 2006).
•Willingness to give written informed consent and willingness to participate to and comply with the study.

Exclusion Criteria

•Mental health condition predating cancer diagnosis requiring ongoing treatment, such as major depression, bipolar, psychosis, borderline personality disorder or substance dependence
•Current suicidal risk.
•Receiving concurrent psychological treatment
•Taking psychotropic medication unless
1) the dose has been stable for at least 8 weeks
2) the medication was prescribed as a pre-medication before chemotherapy treatment or a medical procedure or
3) the medication was prescribed specifically to treat nausea.
•Cognitive impairment as measured by a score of <27 on the Telephone Interview for Cognitive Status - modified (Brandt, Spencer, & Folstein, 1988; Welsh, Breitner, & Magruder-Habib, 1993)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Anxiety: Hospital and Anxiety Scales - Anxiety subscale (Zigmond & Snaith, 1983) – 7 items assess symptoms of anxiety.[Baseline (T1), at the completion of each therapy session (T 2-10), and two months post-intervention (T11). ];Cancer-specific distress:Impact of Events Scale - Revised (Weiss & Marmar, 1997) – 22 items assess symptoms of post traumatic stress that characterize cancer-related distress[Baseline (T1), at the completion of the 9 week intervention (T10) and two months post-intervention (T11). ];Cancer-related anxiety: Fear of progression Questionnaire short-form (Mehnert, Herschbach, Berg, Henrich, & Koch, 2006) – 12 items assess fears about cancer recurrence or progression[Baseline (T1), at the completion of the 9 week intervention (T10) and two months post-intervention (T11). ]