Clinical trial NCT04659993: Cancer Within a Pandemic: A Telemental Health Intervention
Official title: Cancer Within a Pandemic: A Telemental Health Intervention Designed to Augment Psychological Resilience Amidst Dual Health Threats
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cancer
Survivorship
Depression, Anxiety
Keywords: Telemental intervention
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-12-09
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this research study is to test an online support group designed to help young adults who have had cancer treatment to manage their mood during a pandemic. Investigators hope to learn more about what effects a support group may have upon the health and well-being of young adults who have undergone cancer treatment by offering an online support group that teaches healthy coping skills in a practical and acceptable way. Investigators would also like to know if certain parts of the online material is more effective in helping subjects manage their mood.

Detailed description: Primary Objective: To improve self-efficacy for young adult cancer survivors navigating pandemic conditions.

Secondary Objective: To reduce depression and anxiety levels through meaning-making.

Eligibility criteria: Inclusion Criteria:

* Documented cancer diagnosis within the Wake Forest Baptist Medical Center medical record;
* Outpatient Cancer Survivor (diagnosis, treatment, or post-treatment);
* Aged 18-39
* Must speak English
* Must have computer with audio and visual capabilities.
* Must live within North Carolina
* Must have experienced health-related anxiety and/or distress in last 3 months.

Exclusion Criteria:

* Exclusion criteria will be determined by pre-screening data and medical chart reviews
* Active inpatient hospitalization
* Major cognitive impairment, marked concerns with working memory, concentration, or word finding difficulties that significantly impairs daily functioning documented in most recent clinic note or self-reported
* Recent suicide attempt(s), psychiatric hospitalization, or psychotic processing (last 3 years)
* Bipolar disorder (I or II) diagnosis, as evidenced by an ICD-10 code within the past year or revealed during subject interview
* Moderate to severe alcohol or drug abuse; as evidenced by an ICD-10 codes related to alcohol or illicit substance abuse in the medical record within the past year or revealed during subject interview.
* Severe eating disorders; as evidenced by an ICD-10 code in the medical record such as anorexia nervosa or bulimia within the past year or revealed during patient interview
* Repeated "acute" crises for example: repeated acute crises consisting of marked psychological distress that impairs function and warrants clinician intervention (e.g., occurring once a month or more frequently); this we be evaluated by the clinician screener.

Primary outcomes:
measure: Change in Self-Efficacy in Pandemic Conditions
timeFrame: At baseline up to 8 weeks
Secondary outcomes:
measure: Changes in Depression and Anxiety Levels
timeFrame: At baseline up to 10 weeks
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Katie Duckworth, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: