Cancer Within a Pandemic: A Telemental Health Intervention

Wake Forest University (WFU)

Status: Terminated

Conditions: Depression, Anxiety; Survivorship; Cancer

Treatments: Behavioral: Telemental Health Sessions, Support Groups and Questionnaires

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04659993

P30CA012197 (U.S. NIH Grant/Contract)

WFBCCC01520 (Other Identifier)

IRB00070150

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 39 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Telemental Group

Experimental group

Description:

The virtual group will be conducted within a secure platform such as Microsoft WebEx. Assessments (pre-, post-, mid-way) will be distributed through REDCap, a secure virtual platform, as will session handouts and forms.

Treatment:

Behavioral: Telemental Health Sessions, Support Groups and Questionnaires