Cancer Within a Pandemic: A Telemental Health Intervention

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

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.

Study Overview

• Status: Terminated
• Conditions: Cancer; Depression, Anxiety; Survivorship
• Intervention / Treatment: Behavioral: Telemental Health Sessions, Support Groups and Questionnaires

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.

• Study Type: Observational
• Enrollment (Actual): 9

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Young adult cancer survivors between the ages of 18-39 and have undergone treatment for cancer.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Telemental Group; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Katie Duckworth, Ph.D, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2021
• Primary Completion (Actual): June 9, 2021
• Study Completion (Actual): June 9, 2021

Study Registration Dates

• First Submitted: December 2, 2020
• First Submitted That Met QC Criteria: December 2, 2020
• First Posted (Actual): December 9, 2020

Study Record Updates

• Last Update Posted (Estimated): November 20, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Telemental intervention
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: IRB00070150; P30CA012197 (U.S. NIH Grant/Contract); WFBCCC01520 (Other Identifier: Wake Forest Baptist Comprehensive Cancer Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No