Cancer Within a Pandemic: A Telemental Health Intervention

NCT04659993 | Terminated Results DMC

• 3 other identifiers: IRB00070150WFBCCC01520P30CA012197
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Survivorship; Depression, Anxiety

Keywords

Telemental intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Changes in Depression and Anxiety Levels (CAS)

  At baseline up to 8 weeks

• Changes in Depression and Anxiety Levels (PIL)

  At baseline up to 8 weeks

• Changes in Depression and Anxiety Levels (MAC)

  At baseline up to 8 weeks

Study Arms (1)

Telemental Group

EXPERIMENTAL

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

Interventions

Telemental Health Sessions, Support Groups and Questionnaires BEHAVIORAL

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.

Telemental Group

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Wake Forest Baptist Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Neoplasms; Depression; Anxiety Disorders

Interventions

Self-Help Groups; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: Principal Investigator
• Organization: Wake Forest Baptist Comprehensive Cancer Center

Katie.Duckworth@advocatehealth.org

3367135440

Study Officials

• Katie Duckworth, Ph.D

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2020
• First Posted: December 9, 2020
• Study Start: March 10, 2021
• Primary Completion: June 9, 2021
• Study Completion: June 9, 2021
• Last Updated: October 16, 2025
• Results First Posted: October 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)