Cancer Within a Pandemic: A Telemental Health Intervention

Cancer Clinical Trial

Official title:

Cancer Within a Pandemic: A Telemental Health Intervention Designed to Augment Psychological Resilience Amidst Dual Health Threats

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04659993
• Other study ID #: IRB00070150
• Secondary ID: WFBCCC01520P30CA
• Status: Terminated
• Start date: March 10, 2021
• Est. completion date: June 9, 2021

Study information

• Verified date: November 2023
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: June 9, 2021
• Est. primary completion date: June 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Depression
• Depression, Anxiety
• Survivorship

Intervention

Behavioral:
• Telemental Health Sessions, Support Groups and Questionnaires
Participants will complete initial online questionnaires lasting about 25-30 minutes as well as attend weekly support group meetings online. After 4 weeks, participants will complete seven online follow-up questionnaires that should take no longer than 30 minutes and again at the end of the study.

Locations

Country	Name	City	State
United States	Wake Forest Baptist Health Sciences	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Self-Efficacy in Pandemic Conditions	The improvement of self-efficacy for young adult cancer survivors navigating pandemic conditions will be assessed by comparing the change in the Cancer Behaviour Inventory-Brief (CBI-B) version (a 12-item validated questionnaire used widely as a measure of self-efficacy for coping with cancer) from baseline to Visit 8. To test the change over the 8 weeks, a paired t-test (using the baseline and Visit 8 scores within the same patient) will be used; the expected difference in the CBI-B between the two scores would be no change. Score range is 1 (not at all confident) to 9 (totally confident) (minimum score of 12, maximum score of 108). Sum the scores for the 12 items with higher scores indicating greater coping efficacy.	At baseline up to 8 weeks
Secondary	Changes in Depression and Anxiety Levels	Three instruments will provide information on baseline, Visit 8, and change over time.; 1) The Coronavirus Anxiety Scale (CAS) - 5-item mental health screener of dysfunctional anxiety associated with the coronavirus. Scoring is on a 5-point scale of 0 (not at all) to 4 (nearly every day). Scores greater than or equal to 9 indicates probable dysfunctional coronavirus-related anxiety. 2) Mini-Mental Adjustments to Cancer - 29-items that measures present experiences using a 4-point Likert scale - ''Definitely does not apply to me'' (1) to ''Definitely apply to me'' (4). Five subscales include: Helpless-Hopeless, Anxious Preoccupation, Cognitive Avoidance, Fighting Spirit and Fatalism), AND 3) Purpose in Life Test - 20-items that measures sense of purpose and meaning in life will be utilized to estimate anxiety levels. Score range 20-100. Scores less than 50 may indicate a lack of meaning or purpose in life. A paired t-test will be used to assess the change in the scores.	At baseline up to 10 weeks