Cancer Within a Pandemic: A Telemental Health Intervention

September 30, 2025 updated by: Wake Forest University Health Sciences

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 39 years (Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Self-Efficacy in Pandemic Conditions
Time Frame: At baseline up to 8 weeks
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in Depression and Anxiety Levels (CAS)
Time Frame: At baseline up to 8 weeks

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). Minimum score (0): A score of 0 indicates that a person has not experienced any dysfunctional anxiety symptoms related to the coronavirus within the past two weeks. Maximum score (20): A score of 20 indicates the highest level of coronavirus-related anxiety, with the individual experiencing all five symptoms "nearly every day" over the past two weeks.
At baseline up to 8 weeks
Changes in Depression and Anxiety Levels (PIL)
Time Frame: At baseline up to 8 weeks

Three instruments will provide information on baseline, Visit 8, and change over time.

2) The Purpose in Life Test (PIL) - 20-item, 7-point Likert scale designed to measure the extent to which a respondent perceives a general sense of meaning and purpose in life using varying scale labels, scores are aggregated with a minimum score of 20 (lowest purpose) and a maximum score of 140 (highest purpose).
At baseline up to 8 weeks
Changes in Depression and Anxiety Levels (MAC)
Time Frame: At baseline up to 8 weeks

Three instruments will provide information on baseline, Visit 8, and change over time.

3) Mini-Mental Adjustments to Cancer - 29-item, 4-point Likert scale (maximum possible score of 116 and minimum possible score of 29) for rapid assessment of present coping style from 1 (Definitely Does Not Apply to Me) to 4 (Definitely Apply to Me), higher score represents higher endorsement of the adjustment response. (4). Five subscales include: Helpless-Hopeless (score range 8-32), Anxious Preoccupation (score range 8-32), Cognitive Avoidance (score range 4-16), Fighting Spirit (score range 4-16) and Fatalism (score range 5-20).
At baseline up to 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wake Forest University Health Sciences

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Katie Duckworth, Ph.D, Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 10, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 9, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 9, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 2, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 9, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 16, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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